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Quality of life after radical treatment for invasive bladder cancer
Abstract
Considerable effort has been put into improving the quality of life after radical therapy for bladder cancer, though it has proved difficult to demonstrate conclusively that these aims have been achieved. There can be little doubt that the impact of a cystectomy is substantial but that it can be lessened by the use of continent and orthotopic diversion. Quality-of-life studies have, however, shown the remarkable ability of patients to adapt well to the more commonly used incontinent ileal conduit. Chemoradiation appears to have little impact on bladder function for about three-quarters of all patients and this effect will likely be lessened in the future by the use of partial bladder irradiation or better targeting using fiducial markers. Both radical surgery and chemoradiation can perturb bowel function but this may be reduced by choosing less functionally critical portions of bowel for diversion or by better targeted pelvic nodal radiation. Male sexual function is profoundly affected by both treatment approaches although conformal radiation or nerve-sparing cystectomy may help in the future. Female sexual function has never been fully examined but the impact of both approaches is likely very high.
... Hasta mesanenin korunması amacı ile radikal sistektomiye alternatif olarak konservatif yaklaşılan hastaların yaşam kalitesinin daha iyi olduğu iddiasına rağmen bu konuda az sayıda çalışma mevcuttur ve retrospektiflerdir. Kemoterapi ve radyoterapi ile tedavi edilen hasta çalışmalarını yorumlamada bazı problemler vardır (32). Yayınlanmış çoğu çalışmada hastalar değişik takip sürelerine sahiptir. ...
... Yaşam kalitesinin fiziksel, sosyal, ailesel, emosyonel ve fonksiyonel alanları içermesi gerektiği hakkında fikir birliği mevcuttur. Yaşam kalitesini tespit etmekte kullanılan ölçekler güvenilir ve hasta popülasyonlarında kullanılmak için uygun olmalıdır (32). Geçmişte çoğu araştırmacının kullandığı ölçekler artık kullanılmamalı, yalnızca metodolojik çerçevede kullanılan ve bilinen psikometrik özellikleri olan sağlam ölçekler kullanılmalıdır. ...
31 DERLEME M esane kanserlerinde uygulanan tedavi seçenekleri has-taların sağlığını olumlu ya da olumsuz etkilediği kadar, hastanın yaşamının diğer alanlarında, örneğin fiziksel, işlevsel, sosyal alanlarda da değişikliğe neden olmak-tadır. Bu etkilerle ilgili olarak, son yıllarda giderek artan sayıda ça-lışmalar yapılmaktadır. Mesane kanseri gibi çok uzun süreli takip ve tedaviler zincirine gereksinim duyulan bir hastalığın yaşam kalitesini olumsuz etkilememesi mümkün değildir. Gerek mesane kanserin-deki olası girişimler, sistoskopiler, transüretral rezeksiyonlar, mesane içi ilaç uygulamaları, gerekse invaziv mesane kanserinde uygulanan radikal girişimler yaşam kalitesinde büyük bir bozulmaya yol açmak-tadır. Bu bozulmanın ölçülmesinde ilgi alanı daha çok invazif mesane kanserinin radikal tedavisi sonrası uygulanan üriner diversiyonların yaşam kalitesine olan etkilerinin değerlendirilmesi üzerine yoğun-laşmıştır. Mesanenin çıkarılması sonrası, aktif fonksiyonu nedeni ile mutlaka yerine yeni bir oluşum gerektirmektedir ki, bu da hastanın günlük aktivitesini, emosyonel durumunu ve cinsel fonksiyonları gibi yaşamının pek çok alanını doğrudan etkilemektedir (1). Bazı araştır-macılar yaşam kalitesi değerlendirmelerinin kontinan üriner rekons-trüksiyonların geliştirilmesinde ana itici güç olduğunu savunmakta-dırlar. Bu iddia, neden yaşam kalitesi çalışmalarının radikal sistektomi geçiren mesane kanseri hastaları üzerinde odaklandığını açıklaya-bilir. İlginç olan, diğer tedavi modellerine gelince literatürde yaşam kalitesi ile ilgili pek bilgi olmamasıdır. Bu alanda çalışan araştırmacılar için, yüzeyel mesane kanserinin yineleme tehlikesi, çok sayıda sistos- ÖZET Mesane kanserli hastalarda uygulanan tedavi seçenekleri has-taların sağlığını olumlu ya da bazen olumsuz etkilediği kadar, has-tanın yaşamının birçok alanında da değişikliğe sebep olmaktadır. Gerek mesane kanserindeki tanı ve tedavi girişimleri, gerekse invaziv mesane kanserinde uygulanan radikal girişimler yaşam kalitesinde büyük bir bozulmaya yol açmaktadır. Bu etkilerle ilgili olarak, son yıllarda giderek artan sayıda çalışmalar yapılmaktadır. Mesane kanseri ile ilgili literatür incelendiğinde, evrelere göre uy-gulanan tedavilerin sonucunda ortaya çıkan yaşam kalitesi hak-kında yeterli ve uygun çalışma olmadığı görülmektedir. Yaşam kalitesini tespit etmekte kullanılan ölçekler güvenilir ve hasta popülasyonları için uygun, bilinen psikometrik özellikleri olan sağlam ölçekler olmalıdır. Konuyla ilgili olarak, iyi tasarlanmış, di-siplinler arası çalışmaların ön planda olduğu, metodolojik olarak uygun ve herkesin üzerinde hemfikir olduğu yaşam kalitesi ölçek-lerinin kullanıldığı, prospektif, uygun eşleştirilmiş kontrol grupları olan çalışmalara ihtiyaç bulunmaktadır. ABSTRACT The choices of treatment alternatives in patients with bladder cancer effects the health positively or sometimes negatively but can cause changes in many areas of their life. Either attempts di-agnostic and treatment and radical surgeries in invasive bladder cancer have a major impact on quality of life. Recently, there is a major effort on studies about these effects. On review of litera-ture, it can be seen that lack of adequate studies about quality of life after treatment according to stage. The instruments used on determining quality of life, must be established, reliable and con-venient for patient populations and have known psychometric properties. There is need studies about subject that well designed, interdisciplinary forcefulled, methodologically appropriate, used universally agreed QoL instruments, prospective longitudinal and have properly matched controls.
... 43,46,48,58 Of the studies examining radiotherapy, there are a limited number of studies looking at long-term quality of life following this treatment strategy. 49,51,66,67 These studies have produced a limited amount of data relating to the impact on female sexual function. 68 These data suggest some impact on sexual function, more so in females with less sexual satisfaction but less associated distress. ...
Background:
Bladder cancer (BC) treatments are known to be invasive; nevertheless, research into the long-term effects is limited and in the context of sexual function often male focussed. Female sexual dysfunction (FSD) has been reported in up to 75% of female patients. This systematic scoping review examines the literature on sexual consequences of BC in female patients.
Objective:
This study aimed to systematically evaluate the evidence on female sexual function in BC to identify areas of unmet need and research priorities.
Evidence acquisition:
We performed a critical review of PubMed, PsychMed, CINAHL, MEDLINE and the Cochrane Library in March 2020 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) extension for Scoping Reviews statement following Levac et al. methodology. Identified reports were reviewed according to the Critical Appraisal Skills Programme (CASP) criteria. 45 publications were included.
Evidence synthesis:
There was an inconsistent use of patient-reported outcome measures (PROMs), with commonly used PROMs having a narrow symptom focus. However, common symptoms emerged: loss of desire, orgasmic disorders, vaginal dryness, dyspareunia, difficult intromission, reduced clitoral sensation, psychological concerns related to diagnosis, fear of contamination and body image. Sexual activity was reduced in most groups, despite women expressing a motivation to retain sexual function. The degree of symptom distress associated with FSD is underreported. Evidence emerged regarding a gap for women in clinician counselling and follow-up.
Conclusions:
The patient's perspective of FSD in BC patients is poorly understood and under-addressed in clinical practice. There have been very few qualitative studies of FSD in BC. Any intervention designed to address the problem must start with greater understanding of both the patients' and clinicians' perspective.
Lay summary:
We examined the evidence on sexual consequences of BC in women. It is apparent that despite common themes of sexual dysfunction emerging, the problem is poorly understood and addressed in clinical practice.
... La entrega del diagnóstico implica, ya por sí misma numerosas reacciones emocionales, tales como, ansiedad, depresión, ira, culpabilidad, soledad e incomprensión que, en combinación con las preocupaciones por el futuro que genera, pueden dar lugar a la aparición de un cuestionamiento sobre la continuidad del proyecto vital del paciente (Cimprich, 1999;Fallowfield, 2008;Fawcy, 1999;Shepherd & Fisher, 2004;Stark et al., 2002). Con el inicio de este proceso, se suman los tratamientos oncológicos, como son la cirugía, la quimioterapia y/o la radioterapia, entre otros, los cuales pueden contribuir a distintas limitaciones en la vida diaria, problemas económicos y diversas pérdidas físicas, funcionales, personales y sociales (Schultz, Klein, Beck, Stava, & Sellin, 2005;Zietman & Skinner, 2005). Todo ello se ha relacionado con un impacto negativo en el estado emocional y físico, peores resultados clínicos y un peor afrontamiento y adaptación a la enfermedad que, en definitiva, se traducen en una peor calidad de vida para el paciente con una importante repercusión en su entorno (Fallowfield, 2008;Montarezi, 2008;Stark et al., 2002;Yokoyama et al., 2012). ...
... Furthermore, radical cystectomy with ileal conduit has a major impact on healthrelated quality of life, especially in the early stages. [30][31][32] Voiding dysfunction can occur after simple suture owing to impaired bladder volume, although this is not frequent. 28 We, however, did not evaluate long-term functional results in this study. ...
Background
Bladder invasion by colon cancer is rare; however, its management is still controversial. Our objective was to report outcomes and identify risk factors for local recurrence in colon cancer with clinically suspected bladder invasion.
Methods
We conducted a retrospective study in 23 centers in France. All patients who underwent colon surgery with bladder resection (2010–2017) were included. Metastatic and recurrent colon cancers were excluded.
Results
One hundred and seventeen patients (men = 73) were included. Partial cystectomy occurred in 108 patients (92.3%), with a total cystectomy occurring in 9 patients (7.7%). Neoadjuvant treatment was given to 31 patients (26.5%). Major morbidity was 20.5%. R0 resection rates were 87.2%. Histologically confirmed bladder invasion was present in 47%. Thirty-four patients were pN+, while 60 patients (51.3%) received adjuvant chemotherapy. Mean follow-up was 33.8 months. Three-year overall survival and disease-free survival were 82.9% and 59.5%. Rates of local recurrence and distant recurrence were 14.5% and 18.8%, respectively; the local recurrences (11/17; 65%) were in the bladder, while 4 of these patients had a bladder recurrence despite not having histologically confirmed bladder invasion at the index surgery. The rate of bladder recurrence after histologic bladder invasion was 13% (7/55), while the rate of bladder recurrence without primary bladder invasion was 7% (4/62) (P = .343). Neoadjuvant therapy, type of cystectomy, and adjuvant therapy did not influence local recurrence (P > .445 each). R1 bladder resections, when compared with a R0 bladder resections, were associated with an increased rate of local recurrence (63% vs 10%; P < .0001).
Conclusion
Clinically suspected bladder invasion increases local recurrence even in the absence of histologically confirmed bladder invasion. Only complete resections with R0 margins decrease local recurrence. Careful, detailed postoperative surveillance is required, even without pathologic bladder invasion.
... The navel is the only physiological scar present on the human body, and its loss secondary to surgery may alter the patient's self-image with severe psychological implications. 12 Data in the literature reports a tendency for local recurrence in the pelvic area and progression to metastatic disease in the first 2 years. 13 There were no umbilicus recurrences during the entire follow-up period. ...
Urachal adenocarcinoma represents the third most common histological type of non-urotelial bladder cancer. A very low incidence of this disease and the lack of prospective studies have led to a rich and heterogeneous treatment history. Currently, the standard of care for these patients is represented by partial cystectomy en bloc with resection of the urachal ligament and total omphalectomy. The aim of this article is to present our experience and results in the management of patients with urachal adenocarcinoma. Between 2005 and 2015, 16 patients have undergone surgical treatment for urachal adenocarcinoma in “Fundeni” Clinical Institute and Madrid University Hospital “Infanta Sofia.” Partial cystectomy was performed in 11 (68.76%) patients, while radical cystectomy en bloc with omphalectomy was performed in 5 (31.25%) patients, which were not amendable to a limited resection. The Sheldon classification was used, as it provides appropriate disease staging and is the most commonly utilized. Postoperative pathological results showed that 7 (43.75%) patients had localized tumors, and more than one-third (37.5%) of the patients had locally advanced Sheldon III disease, while 3 patients had distant metastasis at the time of surgery. Lymph node involvement was present in 3 patients (18.75%). Mean follow-up time was 2.5 years, ranging from 4 months to 7.6 years. Three patients (18.75%) were lost to follow-up, without any documented signs of local or systemic recurrence and were cancer free at the time of the last evaluation. In cases with lymph node involvement, local recurrence or distant metastasis, patients underwent cisplatin- or 5-fluorouracil-based salvage chemotherapy. Surgical treatment represents the gold standard, while adjuvant chemotherapy has a limited impact on overall survival. The utility of navel resection is questionable due to the rarity of direct invasion or local recurrence.
... Second, high rates of occult metastases require that efforts to eradicate occult metastases that have already developed in as many as 50% of muscle-invasive cancer(Joung et al., 2008). All have the potential to improve the quality of life and cure the disease as reported by several institutions and cooperative groups over the last 15 years(Zietman and Skinner, 2005). ...
Background: Bladder cancer is the 4th most common malignancy among men in the Western world and accounts for approximately 5–10% of all cancers in Europe and United States (U.S). Egypt could be included as one of the countries with the highest bladder cancer incidence (26.9/100000 males and 5.5/100000 females).Over the past decades, many phase II bladder-sparing programmes using TURB plus Cth or CRT have been undertaken. As the use of combined modality treatment for muscle invasive bladder cancer has matured, the opportunity for bladder preservation has developed.
Purpose: This study will evaluate the outcomes of patients with muscle-invasive stage T2-4a bladder carcinoma managed by tri-modality therapy aiming for preservation of functioning bladder for better quality of life, DFS and OS.
Patients and Methods: This study is a prospective randomized clinical trial which included 43 patients with muscle invasive bladder cancer; T2-T4a N0 who presented to Clinical Oncology & Nuclear Medicine Department, Mansoura University Hospital during the period from May 2008 to September 2010. Patients were randomized to two arms: Arm I: included 24 patients, who underwent TURB then treated with concomitant CRT in two phases, induction and consolidation. Arm II: included 19 patients, who received same protocol but with different chemotherapeutic agents. The chemotherapy used was cisplatin plus paclitaxel in arm I & cisplatin and 5.Flurouracil in arm II. Accelerated hyperfractionated radiotherapy schedule was given. One patient was excluded because he died before continuation of the induction phase. All patients who showed CR after induction and consolidation phases were given adjuvant chemotherapy (gemcitabine, paclitaxel& cisplatin) for 4 cycles every 3 weeks.
Results: In arm I: 15 patients (65.2%) completed the treatment protocol. In arm II: 12 patients (63.2%) completed the treatment protocol. In arm I: 1 patient (4.3%) showed disease progression (DP), 3 patients (13%) had only partial response (PR) and 19 patients (82.6%) showed complete response (CR). Patients who achieved CR entered the consolidation phase of treatment protocol. In arm II, 4 patients (21.1%) showed partial response & 15 patients (78.9%) showed complete response. Arm I demonstrated a superior DFS at 3-years compared with arm II. The DFS was 78.26% & 68.42% for both arms respectively. The 3-year OS was slightly better for arm II. The 3-year OS was 60.87% & 68.42% for both arms respectively.
Conclusions: Bladder preservation protocol is a good choice for treatment of bladder cancer but with good selection of the cases and careful follow up of them to avoid major toxicities that may lead to interruption or even stoppage of the preservation protocol.
... The bladder continually changes volume and position on a daily basis, and as a result, treating a bladder typically requires at least a 1.5-to 2-cm isotropic setup margin in radiotherapy [1,2]. Such a large margin and treatment field may result in late bladder and bowel toxicity [3,4]. Conformal irradiation of the bladder may reduce these complication risks. ...
In-room cone-beam computerized tomography (CBCT) imaging is a promising method to reduce setup errors, especially in organs such as the bladder that often have large intrafractional variations due to organ movement. CBCT image quality is limited by low contrast and imaging artifacts, but few data have been reported about inter-observer variability of bladder boundary delineation on CBCT. The aim of this work was to analyze and evaluate the inter-observer contouring uncertainties of bladder boundary delineation on CBCT images in a prospective fashion.
Five radiation oncologists contoured 10 bladders using the CBCT datasets of consecutive 10 patients (including 4 females) who were irradiated to the pelvic region. Prostates were also contoured in male patients. Patients who had had prostatectomy were excluded. The coefficient of variation (COV), conformity index (CIgen), and coordinates of center-of-mass (COM) of the bladder and prostate were calculated for each patient.
The mean COV for the bladder and prostate was 0.08 and 0.20, respectively. The mean CIgen of the bladder and prostate was 0.81 and 0.66, respectively. The root mean square (RMS) of the inter-observer standard deviation (sigma) of the COM displacement in the left-right (LR) and anterior-posterior (AP) direction was 0.79, 0.87 and 0.54 for the bladder and 0.63, 0.99 and 1.72 for the prostate. Regarding the mean COV and CIgen for the bladder, the differences between males and females were not significant.
Inter-observer variability for bladder delineation on CBCT images was substantially small regardless of gender. We believe that our results support the applicability of CBCT in adaptive radiotherapy for bladder cancer.
... Only one of the studies included a pre-operative baseline eva- luation.[2] Based on findings from general QOL instruments, most of these studies concluded that patients who have recovered from a radical cystectomy generally report a high HRQOL, not significantly different than people of similar age in the general population. Thus, despite the magnitude of the surgery and the degree of change in a major organ function, patients who recover from surgery and are cured appear to maintain or regain their HRQOL [18]. However, it is possible that these general measures are not sensitive to issues of unique importance to bladder cancer patients. ...
Over the past two decades, there has been an increasing focus on quality of life outcomes in urological diseases. Patient-reported outcomes research has relied on structured assessments that constrain interpretation of the impact of disease and treatments. In this study, we present content analysis and psychometric evaluation of the Quality of Life Appraisal Profile. Our evaluation of this measure is a prelude to a prospective comparison of quality of life outcomes of reconstructive procedures after cystectomy.
Fifty patients with bladder cancer were interviewed prior to surgery using the Quality of Life Appraisal Profile. Patients also completed the EORTC QLQ-C30 and demographics. Analysis included content coding of personal goal statements generated by the Appraisal Profile, examination of the relationship of goal attainment to content, and association of goal-based measures with QLQ-C30 scales.
Patients reported an average of 10 personal goals, reflecting motivational themes of achievement, problem solving, avoidance of problems, maintaining desired circumstances, letting go of roles and responsibilities, acceptance of undesirable situations, and attaining milestones. 503 goal statements were coded using 40 different content categories. Progress toward goal attainment was positively correlated with relationships and activities goals, but negatively correlated with health concerns. Associations among goal measures provided evidence for construct validity. Goal content also differed according to age, gender, employment, and marital status, lending further support for construct validity. QLQ-C30 functioning and symptom scales were correlated with goal content, but not with progress toward goal attainment, suggesting that patients may calibrate progress ratings relative to their specific goals. Alternately, progress may reflect a unique aspect of quality of life untapped by more standard scales.
The Brief Quality of Life Appraisal Profile was associated with measures of motivation, goal content and progress, as well as relationships with demographic and standard quality of life measures. This measure identifies novel concerns and issues in treating patients with bladder cancer, necessary for a more comprehensive evaluations of their health-related quality of life.
Radical cystectomy (RC) for bladder cancer can be associated with significant morbidity and alterations in health-related quality of life (HRQOL). The Functional Assessment of Cancer Therapy--Vanderbilt Cystectomy Index (FACT-VCI) is a condition-specific HRQOL survey for patients undergoing RC and urinary diversion (UD) for bladder cancer. This study evaluates the reliability, validity, and responsiveness of the Vanderbilt cystectomy index (VCI).
The FACT-VCI was administered to patients with bladder cancer undergoing RC and UD (n = 190) at 2 major cancer centers. Statistical methods included principal components analysis, Cronbach's coefficient alpha, and nonparametric correlation coefficients. The Functional Assessment of Cancer Therapy--General (FACT-G) was used to test criterion-related validity and a linear mixed model tested the effects of time and diversion type on longitudinal VCI scores.
A single summary score of 15 gender-neutral items (VCI-15) represented the optimum solution for postoperative data, which was internally consistent (α = 0.85), had strong retest reliability (ρ = 0.891), and was associated with all FACT-G scales and total score (ρ ≥ 0.38, P <.001). Preoperatively, the VCI-15 was internally consistent (α = 0.77) and was associated with the FACT-G physical and functional scales and total score (ρ ≥ 0.41, P <.001). Although VCI-15 scores at postoperative year 1 did not differ from preoperative values overall (P = .145), they did differ by diversion type (P = .027), with no substantive change after orthotopic neobladder (40 ± 9 vs 39 ± 10) but with a clinically significant improvement after an ileal conduit (39 ± 11 vs 44 ± 11).
The VCI-15 is a reliable and valid condition-specific HRQOL survey for patients with bladder cancer undergoing RC and UD. Future studies of RC patients should measure HRQOL using validated, condition-specific forms, such as the FACT-VCI.
Ileal orthotopic neobladder (ONB) has not proved to provide better health-related quality of life (HRQoL) than other urinary diversion techniques after radical cystectomy. The aim of the study is to compare HRQoL assessed by four questionnaires between ONB and uretero-ureterocutaneostomy (UUC).
Thirty-nine patients (35 men and 4 women) aged 66.95 ± 8.18 years old underwent radical cystectomy due to invasive bladder cancer and urinary diversion. Patients randomized to ileal ONB and UUC groups, except if certain limitations did not allow performing an ONB. Patients were interviewed face-to-face 7-84 months (median 17) after the operation and completed the Functional Assessment of Cancer Therapy Scale-General (FACT-G), the FACT Vanderbilt Cancer Index (FACT-VCI), the Beck Depression Index (BDI), and the generic RAND 36-item Health Survey Short Form (SF)-36 questionnaire, to asses HRQoL.
Comparing the two groups there were no statistically significant differences for the scores of FACT-G, FACT-VCI, and BDI. For VCI score there was a borderline nonsignificant difference (P = 0.051). No statistically significant differences were noticed also from the comparison of SF-36 subgroups for the two groups except SF. Role emotional subgroup on behalf of UUC (P = 0.022).
Patients with UUC surprisingly presented at least equal quality of life than the presumably less debilitating and more recent ONB. This could be explained due to lower complication rate and to lower expectations of the UUC group. UUC is a considerable option for urinary diversion after radical cystectomy in the era of HRQoL for selected patients.
With the advancement in endoscopic surgery, radiation treatment planning and execution, as well as the use of new chemotherapeutic regimens, bladder conservation has evolved into a competing alternative to radical cystectomy. Trimodality treatment has the great advantage of preserving a normally functioning urinary bladder. Despite the absence of direct randomized trials comparing both modalities, trimodality treatment comprising maximal transuretheral resection of bladder tumors followed by different regimens of combined radiochemotherapy achieved comparable results to radical cystectomy in many trials. Those who did not achieve complete remission after induction radiochemotherapy were salvaged by radical cystectomy. Improving the radiotherapeutic window is a challenging issue. In radiotherapy for bladder cancer, uncertainties include set-up errors, patient movement, internal organ movement and volume changes due to bladder filling (both inter- and intrafraction). The advancement in treatment verification procedures in modern radiotherapy and the use of fiducial markers reduces set-up errors, while adaptive radiotherapy could decrease the unnecessary irradiation of normal tissues by tracking bladder volume changes. In addition, new radiotherapeutic techniques, such as intensity-modulated radiotherapy and volume-modulated radiotherapy, permit dose escalation to the target without increasing the dose to the surrounding normal tissues.
To evaluate bladder preservation and functional quality after concurrent chemoradiotherapy for muscle-invasive cancer in 53 patients included in a Phase II trial.
Pelvic irradiation delivered 45 Gy, followed by an 18-Gy boost. Concurrent chemotherapy with cisplatin and 5-fluorouracil by continuous infusion was performed at Weeks 1, 4, and 7 during radiotherapy. Patients initially suitable for surgery were evaluated with macroscopically complete transurethral resection after 45 Gy, followed by radical cystectomy in case of incomplete response. The European Organization for Research and Treatment of Cancer quality of life questionnaire QLQ-C30, specific items on bladder function, and the Late Effects in Normal Tissues-Subjective, Objective, Management, and Analytic (LENT-SOMA) symptoms scale were used to evaluate quality of life before treatment and 6, 12, 24, and 36 months after treatment.
Median age was 68 years for 51 evaluable patients. Thirty-two percent of patients had T2a tumors, 46% T2b, 16% T3, and 6% T4. A visibly complete transurethral resection was possible in 66%. Median follow-up was 8 years. Bladder was preserved in 67% (95% confidence interval, 52-79%) of patients. Overall survival was 36% (95% confidence interval, 23-49%) at 8 years for all patients, and 45% (28-61%) for the 36 patients suitable for surgery. Satisfactory bladder function, according to LENT-SOMA, was reported for 100% of patients with preserved bladder and locally controlled disease 6-36 months after the beginning of treatment. Satisfactory bladder function was reported for 35% of patients before treatment and for 43%, 57%, and 29%, respectively, at 6, 18, and 36 months.
Concurrent chemoradiation therapy allowed bladder preservation with tumor control for 67% patients at 8 years. Quality of life and quality of bladder function were satisfactory for 67% of patients.
For patients with invasive bladder cancer the usual recommended treatment is radical cystectomy, although transurethral resection of the tumor, systemic chemotherapy, and radiotherapy are each effective in some patients. This retrospective study evaluated the experience of the Clinical Oncology Department, Tanta University Hospital with combined modality treatment and selective bladder preservation in patients with muscle-invading bladder cancer with assessment of its safety, tolerance, and efficacy to determine whether these treatments in combination might be as effective as radical cystectomy and thus might allow the bladder to be preserved and the cancer cured and to identify factors that may predict treatment response, risk of relapse and survival.
Between January 2000 and January 2006, 55 consecutive patients with muscleinvading bladder cancer (stages T2 through T4, NX M0) were treated with as complete transurethral surgery as possible, followed by induction combination chemotherapy, and irradiation with 4500 cGy with concurrent cisplatin administration. Urologic evaluation by cystoscopy, cytology, and rebiopsy 2-3 weeks later of the tumor response directed further therapy: either radical cystectomy in the patients who had incomplete responses, or additional chemotherapy with the same drugs and doses and radiotherapy up to 6480 cGy in the patients who had complete responses. The median follow-up was 48 months.
In 37 patients (67.3%) the bladder was free of invasive tumor and functioning well, even though in 13(23.6%) a superficial tumor recurred and required further transurethral surgery and intravesical drug therapy. Of the 18 (32.7%) patients who still had detectable tumor after initial treatment, all of them underwent radical cystectomy. None of the patients had required a cystectomy for radiation toxicity. Of the 37 (67.3%) patients who had complete responses with no tumor detectable on urine cytology or rebiopsy after initial treatment, 89.2% had functioning tumor-free bladders. The overall survival (OAS) at 5 years is 43.12%. The three year bladder intact survival rate is 60%. A total of 10 patients (18.2%) developed grade 3 hematologic toxicity in conjunction with this treatment. Complete response (CR) was achieved in 67.3% of patients. Local control after CR without muscle-invasive relapse was maintained in 60% of patients at 3 years. Distant metastases were diagnosed in 24 patients (43.6%) with an actuarial rate of distant metastasis-free survival of 43.68% at 5 years. Early tumor stage, absence of hydronephrosis and a complete response were the most important factors predicting bladder preservation rate and survival (all p=< or 01).
Conservative combination treatment may be an acceptable alternative to immediate cystectomy in selected patients with bladder cancer. Both the 67.3% complete response rate to induction therapy and the 60% three-year survival with an intact bladder are encouraging, although a randomized clinical trial that included a group for simultaneous comparison would be required to produce definitive results. Longer follow-up will be necessary to assess efficacy.
To evaluate the risk factors for invasive bladder cancer and to develop a predictive model for the improvement of individual comprehensive therapy for invasive bladder cancers.
The records of 356 patients with invasive bladder cancer, operated on at three Chinese medical institutes, were reviewed. The Cox proportional hazards regression model was used to assess the clinical and pathological variables affecting disease-free survival (DFS). The regression coefficients determined by Cox regression analysis were used to construct a predictive index (PI). PI was used to categorize the patients into different risk groups. Kaplan-Meier survival curves followed with log-rank test were plotted to compare the difference.
Tumor configuration (RR = 1.60, P = 0.01), multiplicity (RR = 1.41, P = 0.04), histological subtype (RR = 2.13, P < 0.01), tumor stage (RR = 2.50, P < 0.01), tumor grade (RR = 2.35, P < 0.01), node status (RR = 2.48, P < 0.01), and neoadjuvant chemotherapy (RR = 0.46, P = 0.02), had independent prognostic significance for DFS. PI = 0.47 x (configuration) + 0.34 x (multiplicity) + 0.76 x (tumor histological subtype) + 0.92 x (stage) + 0.86 x (grade) + 0.91 x (node status) - 0.79 x (neoadjuvant chemotherapy). The range of PI was -0.32 to 6.52, which was equally divided into three risk groups with significant differences on Kaplan-Meier curves and a log-rank test (P < 0.01). Meanwhile, the patient's probability of survival could be calculated by PI.
Seven factors (tumor configuration, multiplicity, histological subtype, tumor stage, tumor grade, node status, neoadjuvant chemotherapy) affect the prognosis after radical cystectomy (RC) for invasive bladder cancer. PI can be used to optimize the individual comprehensive therapy. Given fewer perioperative complications, fast recovery from surgery and relatively satisfactory quality of life, ureterocutaneostomy, and ileal conduit are suitable for the patients with short expected life spans.
Therapy for invasive bladder cancer should aim at cure, and besides radical organ-removing surgery, bladder-sparing alternatives are available. Here I report the current status on quality-of-life issues after therapy for invasive bladder cancer.
Consensus has not been reached on the definition of the concept 'quality of life', resulting in numerous ways of measuring it. It is reasonable to believe that the individually self-assessed level of quality of life is affected by the total post-therapeutic symptom burden, that is, the long-term side effects of a therapy are predictors for quality of life. The affection on quality of life by a symptom on an individual can never be predicted because of differences in symptom tolerance. On the group level, however, some symptoms are generally highly distressful, whereas others are generally low distressors. A new area of quality-of-life research is evolving, measuring symptoms, symptom distress and effects on quality of life.
Cystectomy followed by orthotopic bladder replacement seems to keep a high level of quality of life in select cases; however, ileal conduit is still an excellent option in other patients. Bladder-sparing alternatives are available. An individual pre-therapeutic consultation will aid in determining the radical therapeutic method in each individual patient.
Urinary diversion is a common final outcome in patients with refractory long-term incontinence. It is even more common in young patients with neurogenic bladders and in such cases the bladder is disconnected and left in situ. We present a unique case of adenocarcinoma of the bladder which occurred 31 years following such a diversion procedure. We ask whether, despite the comorbidity associated with cystectomy, the patient is in danger of developing effectively silent tumours within these non-functioning bladders.
This study reports the changes in the quality of life (QoL) of 44 patients observed prospectively from pre-surgery to one year post-surgery. Two kinds of surgeries were compared: continent and incontinent urinary diversion. In most areas the QoL returned to the prior level within one year after surgery. However, patients were restricted in their physical activity, sexual activity, and emotional well-being. Using individual weights for different aspects of life (Fragen zur Lebenszufriedenheit – Module FLZM), QoL was higher than when using an unweighted measurement (Short Form 36, MOS). Two trends for the different developments in the QoL were established: general life satisfaction and social functioning tended to improve after a continent diversion but decreased after an incontinent diversion. The perceived global satisfaction with both kinds of diversion was high – 75% of the patients would choose the same kind of diversion again.
There has been a recent marked increase in interest in continent urinary diversions. While considerable time has been spent on the technical aspects of these diversions the psychological impact has not yet been fully explored. We describe an extensive survey that was conducted among 100 consecutive adults (87 respondents) who had undergone urinary diversion via an ileal conduit and 100 consecutive adults (85 respondents) in whom a continent Kock ileal reservoir was created during the last 3 to 5 years at our university by the same surgeons. The Kock pouch patients were stratified further into 63 with primary diversion and 22 who underwent conversion from previous conduit diversions. The survey consisted of a questionnaire that included a social and sexual survey, the Beck Depressive Inventory, the Profile of Mood States and a physical impact study. The results revealed that all patients surveyed generally were satisfied with the diversions and they had adapted reasonably socially, physically and psychologically. The key to adaptation seemed to be a detailed, realistic preoperative education about the type of diversion used. Patients with ileal conduit diversions had the lowest expectations of the form of diversion as defined by the preoperative awareness of the need to wear an external ostomy appliance with its associated inconveniences and change in the external body image. Postoperatively, ileal conduit patients also had the poorest self images as defined by a decrease in sexual desire and in all forms of physical contact (sexual and nonsexual). The subset of patients who underwent conversion from conduit diversions to Kock pouches, however, were statistically the most satisfied, and they were the most physically and sexually active. We conclude that the Kock continent urostomy offers an important alternative to noncontinent forms of diversion.
Quality of life (QOL) has rarely been assessed in nonmetastatic bladder cancer patients (NMBC). Therefore, very little information is available for comparing the impact of different treatments on QOL for patients affected by NMBC.
We developed an "ad hoc" self-administered questionnaire and evaluated its psychometric properties. We then carried out a retrospective study by mailing the questionnaire to a consecutive series of 93 patients treated for NMBC between 1981 and 1994. The patients were treated either with a conservative approach (CT), based on radiotherapy with or without chemotherapy, or with cystectomy followed by urostomy (US).
Twenty-nine questionnaires (66%) mailed to conservatively treated patients and 30 (61%) mailed to cystectomized patients were returned. The questionnaire used in the study showed sufficient psychometric properties: an alpha-Cronbach coefficient > 0.8 was reached and validity was established in all of its aspects. The items were grouped into seven subscales reflecting different QOL domains. The two treatment groups reported differences in QOL adjustment. QOL after cystectomy, marked by stoma presence, was reduced by a lack of sexual activity and a worsened physical condition, but social and recreational life were little affected. Conversely, a low incidence of urinary symptoms and an acceptable sexual adjustment were found in the CT sample; the physical, psychologic, and sociorelational adjustments were also good. QOL in the CT group was consistently better than in the US group. All subscale scores were higher in the CT group than in the US group, with a statistically significant difference in four of six subscales.
QOL is better after conservative therapy than after cystectomy, as expected. Prospective studies with repeated measurements covering all fields of interest in QOL would offer an accurate assessment of QOL in NMBC patients.
Now that creation of continent urinary reservoirs has become a standardized and clinically well established surgical technique with known morbidity and mortality rates, we reassessed the psychological and social aspects of this treatment compared with wet urostomy.
We developed a questionnaire (102 items) addressing general aspects of quality of life, disease related social support, coping strategies and stoma related issues. It was mailed to 600 patients with ileal conduits and 130 with continent reservoirs. Final analysis was restricted to 192 patients operated upon within the last 5 years (mean followup 2.7 years).
The resulting groups were matched and paralleled regarding most treatment related and sociodemographic data. Final analysis did not reveal differences between the groups in disease related social support, coping strategies or quality of life when expressed as a total score. We found statistically significant superiority of continent reservoirs regarding all stoma related items, patient global self-assessment of their quality of life (single item, p < 0.005), physical strength, mental capacity, leisure time activities and social competence (p < 0.05).
Continent diversion is clearly advantageous with respect to all items directly related to the stoma. The significant superiority of continent diversion in patient global self-assessment of their quality of life reflects the highly subjective dimension of the concept. Superiority in self-ratings of physical strength, mental capacity, leisure time activities and social competence could be interpreted as indicators of enhanced vitality in those patients, thus, supporting our understanding that women and men who actively participate in life have a special benefit from continent reservoirs.
PurposeRadical cystectomy for bladder cancer is associated with many changes in bodily function with sexual and urinary dysfunction most prevalent. However, little research has been done on how efforts to improve erectile function relate to quality of life. Also, the psychological benefits associated with continent urinary diversion have not been fully explored. We compared long-term quality of life outcomes among 3 urinary diversion groups, and between patients who had and had not received an inflatable penile prosthesis.Materials and Methods
The 224 participating patients completed 4 self-reporting questionnaires, including the profile of mood states, and adapted versions of the sexual history form, body image dissatisfaction scale and quality of life questionnaire. We compared self-reports of emotional distress, global quality of life, sexuality, body image dissatisfaction, urinary diversion problems, and problems with social, physical and functional activities in patients with advanced bladder cancer who underwent urinary diversion, including an ileal conduit in 25, cutaneous Kock pouch in 93 and urethral Kock pouch in 103. Patients who had or had not received an inflatable penile prosthesis after cystectomy were also compared in regard to quality of life variables.ResultsRegardless of type of urinary diversion the majority of patients reported good overall quality of life, little emotional distress and few problems with social, physical or functional activities. Problems with urinary diversion and sexual functioning were identified as most common. After controlling for age analysis of variance showed no significant differences among urinary diversion subgroups in any quality of life area. However, t tests controlling for age indicated that penile prosthesis placement was significantly associated with better sexual function and satisfaction.Conclusions
Quality of life appears good in these long-term survivors of advanced bladder cancer. The type of urinary diversion does not appear to be associated with differential quality of life. Findings suggest that physicians may wish to discuss urinary diversion problems and sexual dysfunction as long-term correlates of radical cystectomy for bladder cancer. Furthermore, they may also wish to discuss the option of erectile aids in men with erectile dysfunction after cystectomy.
To compare two quality-of-life (QOL) questionnaires for cancer patients, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (Fact-G), on the basis of empirical data.
Two hundred forty-four patients with a diagnosis of breast cancer or Hodgkin's disease completed both the EORTC QLQ-C30 and the FACT-G (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis, canonical correlation, and multiple linear regression.
Correlations between corresponding subscales of the FACT-G and the EORTC QLQ-C30 ranged from r =.14 for the social domain (very poor agreement) to r =.66 for the physical domain (good agreement), with r values for the other domains lying between these extremes. Canonical correlation analysis for the two sets of subscales revealed that overall agreement between the two instruments was only moderate (first canonical correlation coefficient r =.85, but overall redundancy less than 40%). Of the five FACT-G subscales, only one, physical well-being, was well represented by the EORTC QLQ-C30 subscales (multiple linear regression, R(2) =.67). Only three of eight EORTC QLQ-C30 subscales (physical functioning, global QOL, general symptoms) were represented fairly well by FACT-G subscales (R(2) =.43 to.60). The lowest R(2) values (<.15; ie, virtually no representation by the other instrument) were found for the FACT-G social well-being and relation with doctors and EORTC QLQ-C30 cognitive functioning subscales.
For the sample investigated, the EORTC QLQ-C30 and the FACT-G were found to measure markedly different aspects of QOL, despite considerable overlap. Replicability provided, this implies that neither of the two QOL instruments can be replaced by the other and that a direct comparison of results obtained with the two instruments is not possible.
Patients frequently complain about changes in their everyday life after radical cystectomy and urinary diversion. The aim of this study was to compare subjective morbidity of ileal neobladder to the urethra versus ileal conduit urinary diversion and to elucidate its influence on quality of life. A total of 102 patients who underwent radical cystectomy due to a bladder malignancy were included in the study: 69 patients (67.6%) with an orthotopic neobladder and 33 patients (32.4%) with an ileal conduit. The compliance was 99% and mean follow-up was 37 months. All patients completed two retrospective quality-of-life questionnaires, namely the QLQ-C30 and a questionnaire developed at our institution to elucidate specific items regarding urinary diversion. The questioning was performed by a nonurologist. The results obtained from the validated (QLQ-C30) and our self-designed questionnaire clearly demonstrate that patients with an orthotopic neobladder better adapt to the new situation than patients with an ileal conduit. In addition, neobladder to the urethra improves quality of life due to a better self-confidence, better rehabilitation as well as restoration of leisure, professional, traveling, and social activities, and reduced risk of inadvertent loss of urine. For example, 74.6% of neobladder patients felt absolutely safe with the urinary diversion in contrast to 33.3% in the ileal conduit group. Only 1.5% of neobladder patients had wet clothes caused by urine leakage during day versus 48.5% of ileal conduit patients; 92.8% of neobladder patients felt not handicapped at all; and 87% felt not sickly or ill in contrast to 51.5% and 66.7% of ileal conduit patients, respectively. Moreover, 97% of our neobladder patients would recommend the same urinary diversion to a friend suffering from the same disease in contrast to only 36% of ileal conduit patients. The results obtained by this study demonstrate that quality of life is preserved in a higher degree after orthotopic neobladder than after ileal conduit urinary diversion.
To compare the health-related quality of life (HRQoL) after radical cystectomy in patients with an ileal conduit or an orthotopic neobladder.
The study included 85 men who underwent radical cystectomy for bladder cancer, comprising 48 with an orthotopic neobladder (26 with an ileal and 22 with a colon neobladder) and 37 with an ileal conduit. HRQoL was evaluated using the Short Form-36 survey containing 36 questions assessing eight aspects, including physical functioning, role-physical functioning, bodily pain, general health, vitality, social functioning, role-emotional functioning and mental health.
The mean follow-up periods for patients with a neobladder (ileal and sigmoid) and with an ileal conduit was 45.9 (38.2 and 53.1, respectively) and 130.9 months, respectively. Scale scores were not affected by the duration of follow-up in either group. There was no significant difference in any scale scores between the neobladder and ileal conduit groups. However, general health and social functioning in both the neobladder and ileal conduit groups appeared to be significantly lower than those in the general population in the USA. Furthermore, patients with a colon neobladder had a significantly higher score for role-emotional functioning than those with an ileal neobladder, while there was no significant difference in the remaining seven scores between patients with ileal and colon neobladders.
Six of the eight scales of HRQoL were favourable in both patients with a neobladder or an ileal conduit, and there was no significant difference between these groups. In addition, the HRQoL of patients with an orthotopic neobladder (except for role-emotional functioning) was unaffected by the segment of the intestine used for neobladder construction. Therefore, patients with both types of urinary diversion were generally satisfied with their overall health and quality of life.
Radical radiotherapy for muscle-invasive urinary bladder cancer can sterilize the tumour with preserved organ function. Here we studied symptoms, symptom distress and trade-off among long-term survivors and compared figures to those of population controls and patients who had undergone cystectomy.
We identified 71 patients who had had urinary bladder cancer treated with radical radiotherapy before 1995. For comparison, 325 patients treated with radical cystectomy and urostomy, continent or non-continent, during the same period and 460 individuals randomly selected from the general population were included. Information was collected by means of an anonymously answered postal questionnaire to avoid investigator-related bias.
Answers were obtained from 58 (82%) radiated patients, 251 (85%) cystectomized patients and 310 (71%) population controls. Of the radiated patients, 74% reported little or no distress from symptoms from the urinary tract, 38% had had intercourse the previous month and 57% (men) reported they had ejaculated. Among the cystectomized patients, 13% had had intercourse and 0% (men) had ejaculated. Moderate or much distress from symptoms from the gastrointestinal tract was reported by 32% of the radiated patients, 24% of the cystectomized patients and 9% of the population controls. After radical radiotherapy, 46% of the patients were willing to accept some risk of decreased survival to become symptom-free.
About 3/4 of these long-term survivors after radical radiotherapy for bladder cancer had a functioning urinary bladder with little or no distress from the urinary tract. The prevalence of sexual dysfunction was lower than after cystectomy and the prevalence of distress from the gastrointestinal tract was comparable.
We compared subjective quality of life, well-being, urinary tract symptoms and distress in patients after radical cystectomy and orthotopic urinary reconstruction with those in a matched control population.
Included in this study were 101 consecutive recurrence-free patients who underwent radical cystectomy and orthotopic bladder substitution with an ileal urethral Kock neobladder at Herlev Hospital with a minimum followup of 1 year. A frequency matched control group comprising 147 individuals was selected from the same geographical region. Information was collected by an anonymous postal questionnaire and analyzed externally in Sweden.
The prevalence of low or moderate psychological well-being (32% versus 36%) and subjective quality of life (30% versus 38%), and high or moderate anxiety (23% versus 18%) and depression (26% versus 37%) was similar in patients with an orthotopic neobladder and population controls. Patients with a neobladder felt as attractive as the control population. Of the operated men 94% had erectile dysfunction compared with 48% of controls. Daytime and nighttime urinary frequency was similar in patients and controls (3% and 3%, and 15% and 13%, respectively), while the prevalence of urinary leakage at least once monthly was higher in patients (18% versus 5%). Intermittent self-catheterization was performed by 26% of patients with a neobladder. Urinary tract infection (14% versus 6%) was more common and the prevalence of distressful bowel symptoms (14% versus 9%) was slightly more common in patients than in controls.
Well-being and subjective quality of life in patients after radical cystectomy and orthotopic bladder substitution were similar to those in a matched control population.
Health related quality of life after urinary diversion has been increasingly recognized as an important outcome measure. However, few studies have directly compared patients with an ileal conduit with those with a continent orthotopic neobladder and even fewer have used validated quality of life instruments. Therefore, we compared health related quality of life in patients who underwent neobladder versus ileal conduit creation using validated questionnaires.
We mailed 2 validated questionnaires that are measures of health related quality of life, namely the RAND 36-Item Health Survey (SF-36) and Functional Assessment of Cancer Therapy-General (FACT-G), to patients who underwent radical cystectomy for urothelial carcinoma between January 1995 and December 1999. Statistical analysis was performed, including univariate and multivariate analysis.
A total of 112 patients were available for assessment. A total of 72 (64%) questionnaires were returned, including 23 (32%) and 49 (68%) from patients with an ileal conduit and neobladder, respectively. On the SF-36 questionnaire there were significant univariable relationships between treatment and age (p <0.001 and 0.01, respectively). Younger patients and those with a neobladder had higher health related quality of life scores, including significant differences in 5 of the 9 SF-36 domains (general health, physical functioning, physical health, social functioning and energy/fatigue). There was no relationship between health related quality of life and the final pathological stage (p = 0.25). On multivariate analysis adjusting for age led to a suggestive but nonsignificant difference in health related quality of life scores favoring neobladders (p = 0.09). On the FACT-G there were no significant differences in health related quality of life due to treatment (p = 0.28), pathological stage (p = 0.5), age (p = 0.72) or current disease status (p = 0.27). On the FACT-G 2 of the 4 domains (emotional and functional well-being) were significantly in favor of neobladders. Overall satisfaction was high in the 2 groups with 96% and 85% of patients with a neobladder and ileal conduit, respectively, reporting that they would make the same choice of diversion.
Based on validated health related quality of life instruments these findings suggest that patients with an orthotopic neobladder have marginal quality of life advantages over those with an ileal conduit. However, differences in health related quality of life in the 2 types of urinary diversion are confounded by age since patients who underwent orthotopic diversion were younger and as a result of age would be expected to have a higher health related quality of life score. A prospective longitudinal study of health related quality of life after adjusting for differences in age among patients undergoing urinary diversion is currently underway to extend further these observations.
To compare the quality of life (QoL) in men after radical cystectomy who had either a continent cutaneous diversion or orthotopic bladder substitution.
Eighty men with at least 6 months of follow-up and with no signs of recurrent disease after radical cystectomy for bladder carcinoma, and who had either a continent cutaneous diversion or orthotopic bladder substitution, were sent two types of questionnaire, the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl) and the Hospital Anxiety and Depression Scale (HADS), to determine their QoL.
The FACT-Bl and HADS questionnaires were returned by 90% and 71% of the patients, respectively (P < 0.05). In the replies to the generic version of FACT-Bl there were no differences between the groups in any domain, the scores being high in all. In questions covering intestinal, urinary and sexual items, patients with continent diversion had less trouble controlling urine (P < 0.0001), had to empty less often (P < 0.001), and had fewer symptoms when emptying (P < 0.05). Patients with neobladders had a better appreciation of appearance and better preserved erectile function (both P < 0.05). In the answers to the HADS, the mean scores were low (within the normal ranges) and did not differ between the groups.
Using two instruments tested for validity and reliability, there were no differences between patients with continent diversion and those with orthotopic substitution.
In this prospective study our aim was to establish the time it takes cystectomized patients' to adapt to their new health status.
A total of 68 patients, having radical cystectomy for bladder cancer (64 males and 4 females) were enrolled in the study. The mean age of the group was 55.4 +/- 8.0 years (range 38-70 years). Continent urinary diversion was applied to 17 while the rest had incontinent urinary diversions. There was no statistical difference between those who had continent and incontinent diversions in regard to pre-operative stage. All patients were given a Beck's Depression Inventory (BDI), an EORTC-QLQ C-30 Version 2 (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire C-30 Version 2) quality of life measurement scale pre-operatively, and post-operatively 3, 6, 12 and >12 months (every 6 months). Log-rank and Student's t-test was used for statistical analysis of the results.
The mean follow-up of the study group was 27.7 +/- 7.3 months (range 12-46 months). Five patients at the first 3rd-month control, seven at the 6th-month control and eight at the 12th-month control did not appear for interview, but their available results were also included in the overall assessment. The mean functional score of the study group, evaluated by QLQ C-30, was 80 +/- 25.4 pre-operatively. There is dramatic decrease at the 3rd-month control (56.9 +/- 25.1; p < 0.01). The overall functional score after 12 months (80 +/- 20) is back to the pre-operative value. The mean symptom score of the group pre-operatively was 29.5 +/- 16.7, which showed similar results at 3 and 6 months post-operatively of 29.8 +/- 16.7 and 30.6 +/- 19.4, respectively (p > 0.05). At the 12th-month and thereafter the symptom scores of the patients decreased significantly in comparison to both the pre-operative and the post-operative 3-6 months (23.4 +/- 13.7 and 21.8 +/- 18.5, respectively; p < 0.01 for all). The self-rating general health status of this group was lowest pre-operatively with a mean of 49.8 +/- 26.5. Interestingly, there was a statistically significant increase in the general health status assessment of the patients even at the early post-operative period of 3 months (61.4 +/- 17.2; p < 0.01). The increase in the well-being of the patients increased linearly until the 12th-month control and stabilized thereafter. There was a 23% pre-operative depression rate, which comes down to 16% at the 12th-month control. The peak depression scores suggesting depression are observed at the 3rd-month controls. There is a gradual decrease in depression score starting from the 6th-month controls and all reach minimum scores after 12 months. Ninety-six percent of the study group showed scores even lower than the pre-operative ones. The mean pre-operative and post-operative 12th-month control scores were 11.5 +/- 7.7, and 8.1 +/- 6.8, respectively (p < 0.01).
Both psychological and health-related quality of life measures come to baseline values and stabilize after the 12th-month period, suggesting that the time frame for the adaptation of patients is 12 months in patients undergoing radical cystectomy surgery. Therefore, we believe it is better to perform any quality of life assessment as an end-point criterion for comparison of treatment modalities in radical cystectomy patients after 12 months.
The impact of treatment on the health related quality of life (HRQOL) of patients is being recognized with increasing importance, particularly in those with urological malignancies. However, a validated disease and treatment specific instrument to assess HRQOL following radical cystectomy (RC) and urinary diversion (UD) is currently lacking. We report the results of a new questionnaire designed specifically to measure HRQOL in these patients.
A 45-item questionnaire consisting of the Functional Assessment of Cancer Therapy (FACT)-General and 17 additional items designed to measure disease and treatment specific health outcomes were combined to form the Vanderbilt Cystectomy Index (FACT-VCI). FACT-VCI and the generic RAND 36-Item Health Survey (SF-36) were administered to 50 patients from our institution RC data base who were more than 1 year from the time of surgery. Each patient was asked to complete the survey at 1 and 4 weeks. The results of the SF-36 and FACT-VCI were correlated along with the first and second administration of the FACT-VCI.
Overall FACT-VCI was found to have adequate internal consistency (Cronbach's alpha >0.70). Furthermore, intraclass correlation for the first and second administration of the VCI was 0.79. In addition, there was good correlation between the validated SF-36 and FACT-VCI (r = 0.81). The result was initial validation of a questionnaire for the assessment of HRQOL in patients following RC and UD.
Instruments designed to measure accurately HRQOL following RC and UD are in early development. We have now constructed and validated a disease and treatment specific questionnaire that can objectively assess HRQOL following RC and UD. A prospective longitudinal study of FACT-VCI is currently ongoing.
Transurethral resection, chemotherapy and radiation with salvage cystectomy may be used as alternatives to immediate radical cystectomy in the management of invasive bladder cancer. Concern exists about the function of the retained bladder after such therapy.
Of 221 patients with clinical T2-4a bladder cancer treated at Massachusetts General Hospital from 1986 to 2000 with trimodality therapy, 71 were alive with native bladders and disease-free in 2001. These patients were asked to undergo a urodynamic study and to complete a quality of life questionnaire. A total of 69% participated in some component of this study with a median time from trimodality therapy of 6.3 years (range 1.6 to 14.9).
Of 32 patients 24 had normally functioning bladders by urodynamic study. Decreased bladder compliance was seen in 7. Bladder hypersensitivity, involuntary detrusor contractions and incontinence were present in 2 women. The questionnaire showed that flow symptoms occurred in 6%, urgency in 15% and control problems in 19%. Of all women 11% wore pads. Distress from urinary symptoms was half as common as prevalence. Bowel symptoms occurred in 22% with 14% recording any level of distress. The majority of men retained sexual function. Global health related quality of life was high.
The majority of patients treated with trimodality therapy retain good bladder function. A fifth have evidence of bowel dysfunction.
Wellbeing after cystectomy with a bladder substitute
- L Henningsohn
- K Steven
- E-B Kallestrup
- Steineck
Henningsohn L, Steven K, Kallestrup E-B, Steineck G: Wellbeing after cystectomy with a bladder substitute. Eur Urol 146, 2001 (suppl 5)