ArticlePDF AvailableLiterature Review

Abstract

Quality of health care is a hot topic, especially with regard to cancer. Although rectal cancer is, in many aspects, a model oncologic entity, there seem to be substantial differences in quality of care between countries, hospitals and physicians. PROCARE, a Belgian multidisciplinary national project to improve outcome in all patients with rectum cancer, identified a set of quality of care indicators covering all aspects of the management of rectal cancer. This set should permit national and international benchmarking, i.e. comparing results from individual hospitals or teams with national and international performances with feedback to participating teams. Such comparison could indicate whether further improvement is possible and/or warranted.
DEMETTER P.
1
Quality of care indicators in rectal cancer
P. Demetter1, W. Ceelen2, E. Danse3, K. Haustermans4, A. Jouret-Mourin5, A. Kartheuser6, S.
Laurent7, G. Molle8, N. Nagy9, P. Scalliet10, E. Van Cutsem11, M. Van Den Eynde12, J. Van de
Stadt13, E. Van Eycken14, J.-L. Van Laethem15, K. Vindevoghel16, F. Penninckx17
1Pathology, Erasme University Hospital (ULB); 2Surgery, Ghent University Hospital (UG) ;
3Radiology, Cliniques Universitaires St.-Luc (UCL) ; 4Radiotherapy, Universitair Ziekenhuis
Gasthuisberg (KUL) ; 5Pathology, Cliniques Universitaires St.-Luc (UCL) ; 6Surgery, Cliniques
Universitaires St.-Luc (UCL); 7Gastroenterology, Ghent University Hospital (UG); 8Surgery,
Hôpital de Jolimont; 9Pathology, CHU Charleroi; 10Radiotherapy, Cliniques Universitaires St.-
Luc (UCL); 11Gastroenterology, Universitair Ziekenhuis Gasthuisberg (KUL);
12Gastroenterology, Cliniques Universitaires St.-Luc (UCL); 13Surgery, Erasme University
Hospital (ULB); 14Stichting Kankerregister, Brussels; 15Gastroenterology, Erasme University
Hospital (ULB); 16Surgery, O.L.V. van Lourdes Ziekenhuis Waregem; 17Surgery, Universitair
Ziekenhuis Gasthuisberg (KUL)
Corresponce: Pieter Demetter
Department of Pathology
Erasme University Hospital
Route de Lennik 808
B-1070 Bruxelles
Fax +32 (0)2 555 47 90
E-mail pieter.demetter@erasme.ulb.ac.be
DEMETTER P.
2
ABSTRACT
Quality of health care is a hot topic, especially with regard to cancer. Although rectal cancer
is, in many aspects, a model oncologic entity, there seem to be substantial differences in
quality of care between countries, hospitals and physicians. PROCARE, a Belgian
multidisciplinary national project to improve outcome in all patients with rectum cancer,
identified a set of quality of care indicators covering all aspects of the management of rectal
cancer. This set should permit national and international benchmarking, i.e. comparing
results from individual hospitals or teams with national and international performances with
feedback to participating teams. Such comparison could indicate whether further
improvement is possible and/or warranted.
DEMETTER P.
3
Quality of healthcare can be defined as “the degree to which health services for individuals
and populations increase the likelihood of desired health outcomes and are consistent with
current professional knowledge”(1). This is a hot topic, especially for cancer care.
Rectal carcinoma is, in many aspects, a model oncologic entity. Major milestones in rectal
cancer treatment during the past 25 years were the introduction of total mesorectal excision
(TME) (2) and the development of a multimodal neo-adjuvant therapy concept (3).
Nevertheless, there seem to be substantial differences in quality of care between countries,
hospitals and physicians (4-6). To reduce hospital variation, most initiatives aim on selective
referral, encouraging patients to seek care in high-volume hospitals, where cancer care is
concentrated to site-specialist multidisciplinary teams (7). There is, however, a growing
awareness that population-based audit of cancer services is essential to ensure high quality
cancer care: as an alternative to volume-based referral, hospitals and surgeons can also
improve their results by learning from their own outcome statistics and those from
colleagues treating a similar patient group.
Although this is widely recognised, the vast majority of reports on the relation between
quality and outcome of rectal cancer focuses on surgical outcomes mainly related to surgeon
or hospital volume (8-10), level of surgical training (11), ethnicity or socio-economic status
(12,13) of the patients. Those are in fact basically structural factors. The number of initiatives
developing indicators to measure the quality of rectal cancer care taking into account the
whole process from patient presentation to postoperative follow-up are scarce (14,15).
PROCARE (PROject on CAncer of the REctum), a Belgian multidisciplinary national project to
improve outcome in all patients with rectum cancer (4,16,17), has been launched in 2006.
Guidelines were made by a multidisciplinary group (18) and are also available on the web
(19). Decentralised implementation of guidelines was organised by the scientific and
professional organisations. Overall quality of care is assured by registration in a specific
national database starting in 2006. Through feedback all centres are able to position
themselves in comparison to national indicators. The quality of care indicators cover the
following domains: diagnosis and staging, neoadjuvant treatment, surgery, adjuvant
treatment, palliative treatment, follow-up and histopathologic examination. Some indicators
cover most if not all of these items, and can be considered general quality indicators.
General quality indicators
In this group five indicators are considered: overall survival by stage, disease-specific survival
by stage, disease-free survival, relative survival and proportion of patients with local
recurrence.
DEMETTER P.
4
Both survival and local recurrence rate are affected by most processes of rectal cancer care
(18). Therefore, survival, disease-free survival and local recurrence are frequently used in
clinical studies on rectal cancer (18,20-23).
Diagnosis and staging
With regard to these indicators, PROCARE considers proportion of patients (a) with a
documented distance from the anal verge, (b) in whom a CT of the abdomen and X-ray or CT
thorax was performed before any treatment, (c) in whom a CEA was performed before any
treatment, (d) in whom complete large bowel-imaging was performed before undergoing
elective surgery, (e) in whom a transrectal ultrasonograpgy (TRUS) and pelvic CT and/or
pelvic MRI were performed before any treatment and (f) with cStage II-III rectal cancer that
have a reported cCRM (clinical circumferential resection margin). Other indicators taken into
account are time between first histopathologic diagnosis and first treatment, accuracy of
cM0 staging, accuracy of cT/cN staging in case of no or short radiotherapy, use of TRUS in
cT1/cT2 stages, and use of MRI in cStage II or III.
The distance from the lower edge of the tumour to the anal verge is an important clinical
parameter, since it co-determines the indication for neoadjuvant treatment, the type of
surgery and the outcome (18,24,25). The aim of imaging techniques such as CT, MRI and PET
is to detect hepatic and extrahepatic metastatic disease (18). A combined thorax and
abdomen/pelvis spiral contrast-enhanced CT is recommended for routine use (14). Pre-
treatment CEA levels have been related to cancer stage and survival independent of pTN
stage in nonmetastatic colorectal cancer (18). Therefore, the serum CEA level should be
determined in all patients before the start of any treatment (25). It is recommended that
patients with rectal cancer undergo a total colonoscopy with resection of concomitant
polyps if possible (18). However, if colonoscopy is judged to be too risky or if colonoscopy is
refused, a high-quality double contrast barium enema or virtual colonoscopy should be
performed (14,24-26). Patients with rectal cancer should have locoregional cTN staging.
TRUS and high-resolution MRI (or CT) play an important role in the staging of rectal cancer
(18). An important outcome of the preoperative staging is the CRM, which is a predictor of
local and distant recurrence as well as survival (27-32). The CRM can be reliably predicted by
preoperative high-resolution MRI (18). According to the guidelines of the Association of
Coloproctology of Great Britain and Ireland (ACPGBI), the interval between making a
diagnosis of cancer and the start of treatment should be less than 4 weeks (18,33).
Neoadjuvant treatment
In this category seven indicators are considered: proportion of cStage I patients that
received neoadjuvant radio(chemo)therapy, proportion of cStage II-III patients (a) that
received a neoadjuvant pelvic radiotherapy (RT), (b) treated with neoadjuvant 5-FU based
chemoradiation that received a continuous infusion of 5-FU, (c) treated with a long course of
DEMETTER P.
5
preoperative pelvic RT or chemoradiation that completed this neoadjuvant treatment within
the planned timing and (d) treated with a long course of preoperative pelvic RT or
chemoradiation that was operated 4 to 12 weeks after completion of the (chemo)radiation,
the proportion of patients with cCRM < or = 2mm on MRI/CT that received long course
neoadjuvant radio(chemo)therapy, and the rate of acute grade 4 radio(chemo)therapy-
related complications.
Preoperative (chemo)radiation therapy has become a common practice for stage II and III
rectal cancers (34). It has been well documented that neoadjuvant chemoradiation induces
tumour regression and downstaging, and therefore increases tumour resectability and the
rate of sphincter preservation (35-37). Furthermore, as shown by a large, prospective,
randomised trial conducted by the German Rectal Cancer Study Group (3), this treatment
modality results in a significantly reduced rate of local recurrence and treatment toxicity
when compared with postoperative chemoradiation, while preoperative chemoradiation
does not seem to offer survival advantage. Although many quality indicators on
chemotherapy and radiotherapy are identified in the literature (24-26), none of these
specifically address neoadjuvant treatment. Therefore, the PROCARE recommendations on
neoadjuvant treatment were used as a basis to formulate additional indicators (18).
Surgery
The list of surgery-related quality of care indicators includes 10 items: (a) proportion of R0
resections, (b) (y)p distal margin involved (positive) after SSO or Hartmann’s procedure for
low rectal cancer (< or = 5cm), (c) mesorectal (y)pCRM positivity after radical surgical
resection, (d) proportion of abdominoperineal anorectal excision (APR), Hartmann’s
procedure or proctocolectomy with definitive ileostomy, (e) proportion of patients with
stoma 1 year after sphincter-sparing surgery, (f) major leakage after partial mesorectal
excision (PME) + SSO + reconstruction, (g) major leakage after TME + SSO + reconstruction
(global, i.e. with or without primary derivative stoma), (h) inpatient or 30-day mortality, (i)
rate of intra-operative rectal perforation and (j) postoperative major surgical morbidity
requiring reintervention under narcosis after radical surgical resection.
Curative resection rate is used very often as a quality indicator (14,25,26). Indeed, the main
emphasis of surgery is to obtain clear surgical margins yielding a curative R0 resection (no
residual tumour) (15). TME has been considered the optimal surgical modality for the
treatment of rectal cancer since Heald et al. reported TME in 1982 (2); therefore, the
proportion of APR and Hartmann’s procedure is considered a very important quality
indicator (being an outcome of importance to patients) (26). Surgeons should aim, wherever
possible and desirable, to preserve the anal sphincter (18). A temporary defunctioning stoma
should be considered each time the anastomosis is at risk for leakage after sphincter-sparing
surgery (18). In general, a temporary stoma is closed within 1 year after surgery, i.e. after the
end of adjuvant chemotherapy. Inpatient or 30-day mortality is an outcome that is affected
DEMETTER P.
6
by many factors (14,18,26), such as stage, age, comorbidity, mode of surgery i.e.
elective/scheduled vs. urgent/emergency. These factors need to be taken into account at
risk-adjustment for appropriate interpretation of this indicator (26). Intra-operative
perforation increases local recurrence and decreases survival; it occurs more frequently
during APR as compared with anterior resection (18).
Adjuvant treatment
F or this item the PROCARE Workgroup selected five quality indicators: (a) proportion of
(y)pStage III patients with R0 resection that received adjuvant chemotherapy within 3
months after surgery, (b) proportion of pStage II-III patients with R0 resection that received
adjuvant radiotherapy or chemoradiotherapy within 3 months after surgery, (c) proportion
of (y)pStage II-III patients with R0 resection that started adjuvant chemotherapy within 12
weeks after surgical resection, (d) proportion of (y)pStage II-III patients with R0 resection
treated with adjuvant chemo(radio)therapy, that received 5-FU based chemotherapy and (e)
rate of acute grade 4 chemotherapy-related complications.
The rationale for early adjuvant therapy is that it is able to treat micrometastatic disease at a
time when tumour burden is at a minimum. 5-FU given by intravenous injection for 5 days
every 4 weeks for 6 cycles is the regimen for which the most evidence is available and that is
clearly effective in prolonging survival in patients with stage III (18). Treatment with
chemotherapy is associated with an acceptable complication rate. However, the occurrence
of complication is dose-dependent and can be kept low artificially by lowering the dose.
Palliative treatment
The proportion of cStage IV patients receiving chemotherapy is the only quality indicator
that was retained in this setting. The aim of palliative systemic therapy is to improve survival
and quality of live in patients with metastatic disease (18).
Follow-up
In this domain, the rate of curatively treated patients that received a colonoscopy within 1
year after resection, and late grade 4 complications of radiotherapy or chemoradiation were
selected.
For curatively treated patients it is recommended to perform a colonoscopy within 1 year
after resection; the aim is to detect local recurrence at an early potentially (surgically)
curable stage, and to detect new primary tumours (18,26).
Histopathologic examination
The list of quality indicators in the domain of histopathologic examination includes (a) the
use of a specific pathology report sheet, (b) the quality of TME according to Quirke (38,39)
DEMETTER P.
7
mentioned in the pathology report, (c) the distal tumour-free margin mentioned in the
pathology report, (d) the number of lymph nodes examined, (e) the (y)pCRM mentioned in
mm in the pathology report, and (f) the tumour regression grade (40) mentioned in the
pathology report (after neoadjuvant treatment).
The quality of TME according to Quirke, the harvested lymph nodes and the status of the
circumferential resection margin illustrate the quality of TME and affect the patient’s
oncological outcome (38,41-44). The pathologist should find as many lymph nodes as
possible. The median number found is an indication of the quality of the pathological
examination. According to the current TNM guidelines at least 12 lymph nodes need to be
examined in rectal cancer specimens (45), but higher numbers are desirable and achievable
in most cases, even after preoperative radiotherapy (46). Examining greater number of
nodes increases the likelihood of proper staging (47). Yields will vary in relation to many
factors; they can, however, be maximised through high-quality surgery and diligent
pathological examination (48). Examination of 6 or fewer lymph nodes is related to poor
prognosis (49). Best practice demands the reporting of CRM by radiologists and pathologists
alike (28,29,38). Grading of tumour regression is important since outcome is better in case of
complete regression than in case of residual microscopic disease which, in turn, is associated
with better prognosis than cases without or with only minor regression (40,50-52).
CONCLUSIONS AND PROSPECTS
Patients deserve consistent standards regardless of where they live or are treated. The
pursuit of excellence requires the definition of standards and the search is on to find what
parameters best guarantee equal patient outcome and care.
Based on literature search and expert opinions, the PROCARE Workgroup has identified a set
of quality of care indicators (summarised in the table) covering all aspects of the
management of rectal cancer. Ideally population-based audit should be risk-adjusted; such
approach requires intensive collaboration between clinicians and statisticians. In order to
provide teams with simple, userfriendly but relevant feedback information, it might be
useful to construct one quality index for the outcome (aggregating e.g. overall survival,
proportion of R0 resections and postoperative major surgical morbidity with reintervention
under narcosis after radical surgical resection) and one quality index for the process of
treating rectal cancer (with e.g. time between first histopathological diagnosis and first
treatment, proportion of APR and Hartmann’s procedure or total excision of colon and
rectum with definitive ileostomy, and number of lymph nodes examined).
In addition to national benchmarking, i.e. comparing results from individual hospitals or
teams with national performances with feedback to participating teams, we should also aim
for international benchmarking. This comparison could indicate whether further
improvement is possible and/or warranted.
DEMETTER P.
8
GENERAL QUALITY INDICATORS
Overall survival by stage
Disease-specific survival by stage
Disease-free survival
Relative survival
Proportion of patients with local recurrence
DIAGNOSIS AND STAGING
Proportion of patients with a documented distance from the anal verge
Proportion of patients with abdominal CT and thoracal X-ray or CT before any treatment
Proportion of patients in whom a CEA was performed before any treatment
Proportion of patients with complete large bowel-imaging before elective surgery
Proportion of patients with TRUS and pelvic CT and/or pelvic MRI before any treatment
Proportion of patients with cStage II-III rectal cancer that have a reported cCRM
Time between first histopathologic diagnosis and first treatment
Accuracy of cM0 staging
Accuracy of cT/cN staging in case of no or short radiotherapy
Use of TRUS in cT1/cT2 stages
Use of MRI in cStage II or III
NEOADJUVANT TREATMENT
Proportion of cStage I patients that received neoadjuvant radio(chemo)therapy
Proportion of cStage II-III patients that received a neoadjuvant pelvic radiotherapy
Proportion of cStage II-III patients with neoadjuvant chemoradiation that received a continuous 5-FU infusion
Proportion of patients completing long course neoadjuvant pelvic RT or chemoradiation within planned timing
Proportion of patients operated 4 to 12 weeks after completion of long course pelvic RT or chemoradiation
Proportion of patients with cCRM < or = 2mm that received long course neoadjuvant radio(chemo)therapy
Rate of acute grade 4 radio(chemo)therapy-related complications
SURGERY
Proportion of R0 resections
(y)p distal margin involved (positive) after SSO or Hartmann’s procedure for low rectal cancer (< or = 5cm)
Mesorectal (y)pCRM positivity after radical surgical resection
Poportion of APR, Hartmann’s procedure or proctocolectomy with definitive ileostomy
Proportion of patients with stoma 1 year after sphincter-sparing surgery
Major leakage after partial mesorectal excision + SSO + reconstruction
Major leakage after TME + SSO + reconstruction (global, i.e. with our without primary derivative stoma)
Inpatient or 30-day mortality
Rate of intra-operative rectal perforation
Postoperative major surgical morbidity requiring reintervention under narcosis after radical surgical resection
ADJUVANT TREATMENT
Proportion of (y)pStage III patients with R0 resection receiving adjuvant chemotherapy within 3 months
Proportion of pStage II-III patients with R0 resection receiving adjuvant (chemo)radiotherapy within 3 months
Proportion of (y)pStage II-III patients with R0 resection that started adjuvant chemotherapy within 12 weeks
Proportion of (y)pStage II-III patients with R0 resection treated with adjuvant chemotherapy receiving 5-FU
Rate of acute grade 4 chemotherapy-related complications
PALLIATIVE TREATMENT
Proportion of cStage IV patients receiving chemotherapy
FOLLOW-UP
Rate of curatively treated patients that received a colonoscopy within 1 year after resection
Late grade 4 complications of radiotherapy or chemoradiation
HISTOPATHOLOGIC EXAMINATION
Use of a specific pathology report sheet
Quality of TME according to Quirke mentioned in the pathology report
Distal tumour-free margin mentioned in the pathology report
Number of lymph nodes examined
(y)pCRM mentioned in mm in the pathology report
Tumour regression grade mentioned in the pathology report
DEMETTER P.
9
REFERENCES
1. Lohr KN, editor. Medicare: a strategy for quality assurance. Washington (DC):
National Academy Press; 1990.
2. Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery clue to
pelvic recurrence? Br J Surg 1982; 69: 613-616.
3. Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, et al.
Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J
Med 2004; 351: 1731-1740.
4. Penninckx F, Van Eycken L, Michiels G, Mertens R, Bertrand C, De Coninck D, et al.
Survival of rectal cancer patients in Belgium 1997-98 and the potential benefit of a
national project. Acta Chir Belg 2006; 106: 149-157.
5. van Gijn W, van de Velde CJ. Quality assurance through outcome registration in
colorectal cancer: an ECCO initiative for Europe. Acta Chir Iugosl 2010; 57: 17-21.
6. Morris EJ, Sandin F, Lambert PC, Bray F, Klint A, Linklater K, et al. A population-based
comparison of the survival of patients with colorectal cancer in England, Norway and
Sweden between 1996 and 2004. Gut 2011 Feb 8 [Epub ahead of print].
7. van Gijn W, van de Velde CJ; members of the EURECCA consortium. Improving quality
of cancer care through surgical audit. Eur J Surg Oncol 2010; 36 Suppl 1: S23-S26.
8. Kressner M, Bohe M, Cedermark B, Dahlberg M, Damber L, Lindmark G, et al. The
impact of hospital volume on surgical outcome in patients with rectal cancer. Dis
Colon Rectum 2009; 52: 1542-1549.
9. Elferink MA, Krijnen P, Wouters MW, Lemmens VE, Jansen-Landheer ML, van de
Velde CJ, et al. Variation in treatment and outcome of patients with rectal cancer by
region, hospital type and volume in the Netherlands. Eur J Surg Oncol 2010; 36 Suppl
1: S74-S82.
10. Nugent E, Neary P. Rectal cancer surgery: volume-outcome analysis. Int J Colorectal
Dis 2010; 25: 1389-1396.
11. Martling A, Holm T, Rutqvist LE, Johansson H, Moran BJ, Heald RJ, et al. Impact of a
surgical training programme on rectal cancer outcomes in Stockholm. Br J Surg 2005;
92: 225-229.
DEMETTER P.
10
12. Shaw C, Blakely T, Sarfati D, Fawcett J, Peace J. Trends in colorectal cancer mortality
by ethnicity and socio-economic position in New Zealand, 1981-99: one country,
many stories. Aust N Z J Public Health 2006; 30: 64-70.
13. Cavalli-Björkman N, Lambe M, Eaker S, Sandin F, Glimelius B. Differences according to
educational level in the management and survival of colorectal cancer in Sweden. Eur
J Cancer 2011 Jan 13 [Epub ahead of print].
14. Gagliardi AR, Simunovic M, Langer B, Stern H, Brown AD. Development of quality
indicators for colorectal cancer surgery, using a 3-step modified Delphi approach. Can
J Surg 2005; 48: 441-452.
15. Vergara-Fernandez O, Swallow CJ, Victor JC, O’Connor BI, Gryphe R, MacRae HM, et
al. Assessing outcomes following surgery for colorectal cancer using quality of care
indicators. J Can Chir 2010, 53: 232-240.
16. Penninckx F, Danse E; PROCARE Workgroup. On the role of radiologists in the Belgian
PROject on CAncer of the REctum, PROCARE. JBR-BTR 2006; 89: 19-22.
17. Leonard D, Penninckx F, Fieuws S, Jouret-Mourin A, Sempoux C, Jehaes E, et al.
Factors predicting the quality of total mesorectal excision for rectal cancer. Ann Surg
2010; 252: 982-988.
18. Penninckx F, Roels S, Leonard D, Laurent S, Decaestecker J, De Vleeschouwer C, et al.
Kwaliteit van rectale kankerzorg, fase 1: Een praktijkrichtlijn voor rectale kanker.
Good Clinical Practice (GCP). Brussel: Federaal Keniscentrum voor de
Gezondheidszorg (KCE); KCE reports 69A, 2007.
19. Belgian Cancer Registry. Multidisciplinary Belgian Project on Cancer of the Rectum
(PROCARE). Multidisciplinary guidelines for the treatment of rectal cancer, available
at: www.kankerregister.be.
20. den Dulk M, van de Velde CJ. Quality assurance in surgical oncology: the tale of the
Dutch rectal cancer TME trial. J Surg Oncol 2008; 97: 5-7.
21. Katoh H, Yamashita K, Wang G, Sato T, Nakamura T, Watanabe M. Prognostic
significance of preoperative bowel obstruction in stage III colorectal cancer. Ann Surg
Oncol 2011 Mar 3 [Epub ahead of print].
22. Yasuda K, Sunami E, Kawai K, Nagawa H, Kitayama J. Laboratory blood data have a
significant impact on tumor response and outcome in preoperative
chemoradiotherapy for advanced rectal cancer. J Gastrointest Cancer 2011 Mar 3
[Epub ahead of print].
DEMETTER P.
11
23. Yoon WS, Park W, Choi DH, Ahn YC, Chun HK, Lee WY, et al. Which patients benefit
from preoperative chemoradiotherapy for intermediate staged rectal cancer?
Onkologie 2011; 34: 36-41.
24. Malin JL, Schneider EC, Epstein AM, Adams J, Emanuel EJ, Kahn KL. Results of the
National Initiative for Cancer Care Quality: how can we improve the quality of cancer
care in the United States? J Clin Oncol 2006; 24: 626-634.
25. McGory ML, Shekelle PG, Ko CY. Development of quality indicators for patients
undergoing colorectal cancer surgery. J Natl Cancer Inst 2006; 98: 1623-1633.
26. Patwardhan MB, Samsa GP, McCrory DC, Fisher DA, Mantyh CR, Morse MA, et al.
Cancer care quality measures: diagnosis and treatment of colorectal cancer. Evid Rep
Technol Assess (Full Rep) 2006; 138: 1-116.
27. Bernstein TE, Endreseth BH, Romundstad P, Wibe A; Norwegian Colorectal Cancer
Group. Circumferential resection margin as a prognostic factor in rectal cancer. Br J
Surg 2009; 96: 1348-1357.
28. Nagtegaal ID, Quirke P. What is the role for the circumferential margin in the modern
treatment of rectal cancer? J Clin Oncol 2008; 26: 303-312.
29. Maugham NJ, Quirke P. Modern management of colorectal cancer a pathologists’s
view. Scand J Surg 2003; 92: 11-19.
30. Quirke P, Durdey P, Dixon MF, Williams NS. Local recurrence of rectal
adenocarcinoma due to inadequate surgical resection. Histopathological study of
lateral tumor spread and surgical excision. Lancet 1986; 2: 996-999.
31. Adam IJ, Mohamdee MO, Martin IG, Scott N, Finan PJ, Johnston D, et al. Role of
circumferential margin involvement in the local recurrence of rectal cancer. Lancet
1994: 344:707-11.
32. Wibe A, Rendedal PR, Svensson E, Norstein J, Eide TJ, Myrvold HE, et al. Prognostic
significance of the circumferential resection margin following total mesorectal
excision for rectal cancer. Br J Surg 2002; 89: 327-334.
33. ACPGI. Guidelines for the management of colorectal cancer. The Association of
Coloproctology of Great Britain and Ireland, 2007.
34. Balch GC, De Meo A, Guillem JG. Modern management of rectal cancer : a 2006
update. World J Gastroenterol 2006; 12: 3186-3195.
DEMETTER P.
12
35. Chen ET, Mohiuddin M, Brodovsky H, Fishbein G, Marks G. Downstaging of advanced
rectal cancer following combined preoperative chemotherapy and high dose
radiation. Int J Radiat Oncol Biol Phys 1994; 30: 169-175.
36. Janjan NA, Khoo VS, Abbruzzese J, Pazdur R, Dubrow R, Cleary KR, et al. Tumor
downstaging and sphincter preservation with preoperative chemoradiation in locally
advanced rectal cancer: the M.D. Anderson Cancer Center experience. Int J Radiat
Oncol Biol Phys 1999; 44: 1027-1038.
37. Minsky BD, Cohen AM, Enker WE, Paty P. Sphincter preservation with preoperative
radiation therapy and coloanal anastomosis. Int J Radiat Oncol Biol Phys 1995; 31:
553-559.
38. Nagtegaal ID, van de Velde CJ, van der Worp E, Kapitein E, Quirke P, van Krieken
JHJM, et al. Macroscopic evaluation of rectal cancer resection specimen: clinical
significance of the pathologist in quality control. J Clin Oncol 2002; 20: 1729-1734.
39. Sebag-Montefiore D, Quirke P, Steele RJ. CR07: Pre-operative radiotherapy and
selective post-operative chemotherapy in rectal cancer. Available at:
www.ctu.mrc.ac.uk/studies/cr07.asp.
40. Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after
preoperative radiochemotherapy. Int J Colorect Dis 1997; 12: 19-23.
41. Maslekar S, Sharma A, MacDonald A, Gunn J, Monson JRT, Hartley JE. Mesorectal
grades predicts recurrences after curative resection for rectal cancer.
42. Lee HY, Choi HJ, Park KJ, Shin JS, Kwon HC, Roh MS, et al. Prognostic significance of
metastatic lymph node ratio in node-positive colon carcinoma. Ann Surg Oncol 2007;
14: 1712-1717.
43. Le Voyer TE, Sigurdson ER, Hanlon AL, Mayer RJ, Macdonald JS, Catalano PJ, et al.
Colon cancer survival is associated with increasing number of lymph nodes analyzed:
a secondary survey of intergroup trial INT-0089. J Clin Oncol 2003; 21: 2912-2919.
44. Swanson RS, Compton CC, Stewart AK, Bland KI. The prognosis of T3N0 colon cancer
is dependent on the number of lymph nodes examined. Ann Surg Oncol 2003; 10: 65-
71.
45. TNM classification of malignant tumours. 7th edn. New York: Wiley; 2010.
46. Mekenkamp LJM, van Krieken JHJM, Marijnen CAM, van de Velde CJH, Nagtegaal ID,
for the Pathology Review Committee and the Co-operative Clinical Investigators.
Lymph node retrieval in rectal cancer is dependent on many factors the role of the
DEMETTER P.
13
tumor, the patient, the surgeon, the radiotherapist, and the pathologist. Am J Surg
Pathol 2009; 33: 1547-1553.
47. Tepper JE, O’Connell MJ, Niedzwiecki D, Hollis D, Compton C, Benson AB 3rd, et al.
Impact of number of nodes retrieved on outcome in patients with rectal cancer. J Clin
Oncol 2001; 19: 157-163.
48. Morris EJA, Maughan NJ, Forman D, Quirke P. Identifying stage III colorectal cancer
patients: the influence of the patient, surgeon, and pathologist. J Clin Oncol 2007; 25:
2573-2579.
49. Caplin S, Cerottini J-P, Bosman FT, Constanda MT, Givel J-C. For patients with Dukes’
B (TNM stage II) colorectal carcinoma, examination of six or fewer lymph nodes is
related to poor prognosis. Cancer 1998; 83: 666-672.
50. Bouzourene H, Bosman FT, Seelentag W, Matter M, Coucke P. Importance of tumor
regression assessment in predicting the outcome in patients with locally advanced
rectal carcinoma who are treated with preoperative radiotherapy. Cancer 2002; 94:
1121-1130.
51. Rödel C, Martus P, Papadoupolos T, Füzesi L, Klimpfinger M, Fietkau R, et al.
Prognostic significance of tumor regression after preoperative chemoradiotherapy
for rectal cancer. J Clin Oncol 2005; 23: 8688-8696.
52. Quirke P. Pathology for the radiologist. Pathological insights into colorectal cancer.
In: Brown G, editor. Contemporary issues in cancer imaging. Colorectal cancer.
Cambridge: University Press; 2007.
... PROCARE (PROject on CAncer of the REctum), a Belgian multidisciplinary national project to improve outcome in patients with rectal cancer, was launched in 2006. Guidelines were produced by a multidisciplinary group [6] and quality-of-care indicators were determined [7]. Decentralized implementation of guidelines was organized by the national scientific and professional organizations. ...
... Over the past 10 years, standards for lymph node harvests in colorectal cancer have been proposed. Several studies have recommended examination of at least 12 lymph nodes in the specimen and this number is now used as a reflection of surgical and pathological quality [7,25,26]. Higher numbers are, however, desirable and achievable in most cases, even after short-course neoadjuvant radiotherapy with a short interval to surgery [27]. Examining a higher number of nodes increases the likelihood of proper staging [28]. ...
Article
Data on quality control of the pathologic evaluation of total mesorectal excision specimens are scarce. We aimed to assess differences between evaluation by local pathologists participating in PROCARE, a Belgian improvement project on rectal cancer, and by a review panel of experts. Based on photographic material and histopathology slides, a review committee of gastrointestinal expert pathologists re-evaluated the mesorectal plane, the tumour differentiation grade, the (y)pT stage and the tumour regression grade in 444 cases previously routinely assessed by local pathologists. The surgical plane was reported in 89% and the circumferential resection margin in 88% of cases by the local pathologist. The median number of lymph nodes harvested in patients undergoing neoadjuvant radiochemotherapy was 11, and 14 in the other patients. The review committee downgraded the surgical plane in 17% from (intra)mesorectal to intramuscular, and upgraded it in 27% from intramuscular to (intra)mesorectal. Tumour differentiation grade, T stage and tumour regression grade differed between local pathologists and review committee in 15%, 10% and 38%, respectively. T stage was upgraded in 8% of cases, mainly from T2 to T3. Tumour regression was judged by the review panel to be less advanced in 15% of cases. Acknowledging some shortcomings, this study gives a realistic view of clinical practice. There are differences in interpretation with regard to both macroscopic and microscopic analysis of TME specimens. These findings indicate a need for more objective and reproducible criteria in histopathology. Being aware of this is a first step for improvement. This article is protected by copyright. All rights reserved.
... [13][14][15][16] There has been increased interest in use of hospital quality indicators to improve treatment and outcomes of individuals with cancer. [17][18][19] We hypothesized that the use of multimodal therapy in rectal cancer has increased over time, and community and academic hospitals have similar management patterns and adherence to treatment guidelines. The objective of the study was to compare the use of multimodal treatment in Stage II and III rectal cancer between community and academic hospitals. ...
... Other groups have used national quality indicators, performance feedback, and changes in organizational structure to improve colorectal cancer care. 17,19 The current study provides a national perspective on the use of multimodal treatment for Stage II and III P Value rectal cancer. Small but important differences were identified in adherence to evidence-based guidelines in community hospitals compared with academic research hospitals. ...
Article
Although multimodal treatment (surgery, chemotherapy±radiation) has improved survival in patients with rectal cancer, there are inconsistent treatment patterns in hospitals in the United States. The objective of the study was to evaluate whether treatment paradigms have changed for patients with Stage II and III rectal cancer in community hospitals compared with academic research hospitals, i.e., teaching or comprehensive hospitals engaged in research. The National Cancer Database was queried to identify all patients diagnosed with Stage II or III rectal adenocarcinoma between 2000 and 2008. The first course of treatment and patient clinicodemographic factors were evaluated. Of 70,409 patients in the study cohort, 7,235 (62.9%) at community hospitals, 24,465 (66.9%) at comprehensive hospitals, and 14,868 (66.6%) at teaching hospitals received multimodal therapy. Community hospitals were more likely to treat individuals who were older, white, and with lower income compared with the other facility types. Teaching hospitals treated a higher proportion of uninsured patients. Despite differences in patient demographics, community hospitals have increased the use of multimodal treatment for rectal cancer but continue to remain below academic research hospital standards.
Article
Aim: To develop a priority set of quality indicators (QIs) for use by colorectal cancer (CRC) multidisciplinary teams (MDTs). Methods: The review search strategy was executed in four databases from 2009-August 2019. Two reviewers screened abstracts/manuscripts. Candidate QIs and characteristics were extracted using a tailored abstraction tool and assessed for scientific soundness. To prioritize candidate indicators, a modified Delphi consensus process was conducted. Consensus was sought over two rounds; (1) multidisciplinary expert workshops to identify relevance to Australian CRC MDTs, and (2) an online survey to prioritize QIs by clinical importance. Results: A total of 93 unique QIs were extracted from 118 studies and categorized into domains of care within the CRC patient pathway. Approximately half the QIs involved more than one discipline (52.7%). One-third of QIs related to surgery of primary CRC (31.2%). QIs on supportive care (6%) and neoadjuvant therapy (6%) were limited. In the Delphi Round 1, workshop participants (n = 12) assessed 93 QIs and produced consensus on retaining 49 QIs including six new QIs. In Round 2, survey participants (n = 44) rated QIs and prioritized a final 26 QIs across all domains of care and disciplines with a concordance level > 80%. Participants represented all MDT disciplines, predominantly surgical (32%), radiation (23%) and medical (20%) oncology, and nursing (18%), across six Australian states, with an even spread of experience level. Conclusion: This study identified a large number of existing CRC QIs and prioritized the most clinically relevant QIs for use by Australian MDTs to measure and monitor their performance.
Article
Aim: In colorectal cancer care, many indicators for assessment and improvement of quality of care are being used. These quality indicators serve as national and international benchmarks to compare health care on hospital and patient level. However, the scientific basis of these indicators is often unclear. Therefore, the aim of this systematic review is to examine reported quality indicators used in multidisciplinary colorectal cancer care and categorise these indicators based on scientific evidence. Methods: We searched PubMed from 2005 to 2015 for original articles reporting on development, evaluation or validation of quality indicators in colorectal cancer care. Included articles were categorised in consensus-based, evidence-based and validation cohort studies. Extracted quality indicators were divided into structure, process and outcome indicators and grouped per discipline(s) involved. Results: From 1163 studies, 41 articles were included: 12 (29%) consensus-based, 7 (17%) evidence-based and 22 (54%) validation cohort studies. In total, we identified 389 reported quality indicators: consensus-based (n = 349), evidence-based (n = 7) and validation (n = 33), respectively. Of all reported indicators, 45% (n = 186) concerned surgical items. The vast majority were process indicators (n = 315; 81%) and the remaining outcome (n = 57; 15%) or structure measurements (n = 17; 4%). Only 5 indicators were reported in the majority (≥7/12 articles) of consensus-based papers and 7 indicators were successfully validated. Conclusions: There is an abundance of reported colorectal cancer quality indicators, of which the majority are surgical, consensus-based process measures, which have not been validated in cohort studies. There is a need for international consensus on a limited evidence-based data set of validated quality indicators, with a focus on outcome indicators.
Article
Describe the methodology and selection of quality indicators (QI) to be implemented in the EFFECT (EFFectiveness of Endometrial Cancer Treatment) project. EFFECT aims to monitor the variability in Quality of Care (QoC) of uterine cancer in Belgium, to compare the effectiveness of different treatment strategies to improve the QoC and to check the internal validity of the QI to validate the impact of process indicators on outcome. A QI list was retrieved from literature, recent guidelines and QI databases. The Belgian Healthcare Knowledge Center methodology was used for the selection process and involved an expert's panel rating the QI on 4 criteria. The resulting scores and further discussion resulted in a final QI list. An online EFFECT module was developed by the Belgian Cancer Registry including the list of variables required for measuring the QI. Three tests phases were performed to evaluate the relevance, feasibility and understanding of the variables and to test the compatibility of the dataset. 138 QI were considered for further discussion and 82 QI were eligible for rating. Based on the rating scores and consensus among the expert's panel, 41 QI were considered measurable and relevant. Testing of the data collection enabled optimization of the content and the user-friendliness of the dataset and online module. This first Belgian initiative for monitoring the QoC of uterine cancer indicates that the previously used QI selection methodology is reproducible for uterine cancer. The QI list could be applied by other research groups for comparison.
Article
Full-text available
Colorectal cancer (CRC) has a high prevalence in western countries. Diagnosis and treatment of CRC is complex and requires multidisciplinary collaboration across the interface of health care sectors. In Germany, a new nationwide established program aims to provide quality information of healthcare delivery across different sectors. Within this context, this study describes the development of a set of quality indicators charting the whole pathway of CRC-care including data specifications that are necessary to operationalize these indicators before practice testing. Indicators were developed following a systematic 10 step modified 'RAND/UCLA Appropriateness Method' which involved a multidisciplinary panel of thirteen participants. For each indicator in the final set, data specifications relating to sources of quality information, data collection procedures, analysis and feedback were described. The final indicator set included 52 indicators covering diagnostic procedures (11 indicators), therapeutic management (28 indicators) and follow-up (6 indicators). In addition, 7 indicators represented patient perspectives. Primary surgical tumor resection and pre-operative radiation (rectum carcinoma only) were perceived as most useful tracer procedures initiating quality data collection. To assess the quality of CRC care across sectors, various data sources were identified: medical records, administrative inpatient and outpatient data, sickness-funds billing code systems and patient survey. In Germany, a set of 52 quality indicators, covering necessary aspects across the interfaces and pathways relevant to CRC-care has been developed. Combining different sectors and sources of health care in quality assessment is an innovative and challenging approach but reflects better the reality of the patient pathway and experience of CRC-care.
Article
Purpose: To assess the potential downstaging of advanced rectal cancer with combined preoperative chemoradiation. Methods and materials: Thirty-one patients with fixed rectal cancers (stage > or = cT3) were treated with concomitant preoperative chemotherapy and high-dose radiation in an effort to improve resectability. Three (10%) patients had partially fixed low rectal cancers, 24 (77%) patients had fixed tumors, and 4 (13%) had advanced fixation with pelvic sidewall invasion. Radiation was delivered to the whole pelvis using shaped anterior and posterior and lateral fields to 45 Gy followed by a boost to the tumor. Median total radiation dose was 55.8 Gy. Chemotherapy consisted of low dose continuous infusion of 5-FU (200-300 mg/m2/day) for the duration of radiation treatment. All 31 patients underwent surgical resection of tumor 6-8 weeks following treatment. Median follow up is 24 months (range 9-60). Results: Twenty-three (74%) of the tumors were clinically downstaged following preoperative treatment. Of 24 fixed cancers, 11 (46%) became mobile, 6 (25%) became partially fixed, and 7 remained fixed. Of the four tumors with advanced fixation, two (50%) became mobile and two (50%) no longer had tumor extension to the pelvic sidewall. Two of the three initially partially fixed cancers became mobile and one remained partially fixed. Following surgery, the pathologic postradiation T-stages were as follows: T0: 10%, T1: 0%, T2: 32%, T3: 42%, and T4:16%. Seven patients (23%) were also node-positive (T0-2: 2, T3: 4, T4: 1), and two patients (6%) had liver metastases at surgery. Preoperative chemoradiation was well tolerated. There was no significant hematological toxicity. Acute grade 3 gastrointestinal toxicity was seen in six patients requiring a short hospitalization for dehydration and/or abdominal discomfort. No patient developed grade 4 toxicity. Five patients (16%) developed local recurrence of disease (T0-2: 0/13, T3: 1/13, and T4: 4/5). The actuarial 3-year survival is 68%. Conclusions: Concomitant preoperative chemoradiation using low dose continuous infusional 5-FU for advanced rectal cancer is relatively safe with acceptable morbidity. This approach is associated with considerable clinical and pathologic downstaging of cancer. Tumor resectability is improved with potential for improved local control of disease and survival.
Article
Introduction, For many decades, the management of colorectal cancer was looked upon as the domain of the surgeon. In the last 10 years, this opinion has changed and with the change to multidisciplinary management significant improvements in the management and outcomes of patients have occurred. Initially this has been seen in rectal cancer, but colonic cancer will also benefit by improved radiological and pathological staging. The radiologist and pathologist are central to this process and can learn from each other to gain new insights into their respective fields. First, I will address the rectum and secondly, more briefly, the colon. The rectum, The success of magnetic resonance imaging in the rectum and its increasing resolution has led to an important need for the radiologist to understand the anatomy and gross pathology of rectal cancer. This is best learnt prospectively prior to starting reporting high-resolution MRIs by visiting the pathologist in the cut-up room and then seeing the pathological cross-sectional images at the multidisciplinary team meetings. The radiologist, like the pathologist, will continue to learn and improve with increasing experience of the images. For example, the accuracy of prediction of the circumferential margin is 92% in the hands of an experienced radiologist but only 82% in the large multicentre Mercury study. The accuracy of diagnosis is not reported post chemoradiotherapy but it is likely to be lower.
Article
Lymph node status is the strongest prognostic factor for survival in colorectal cancer. There are several guidelines concerning the minimum numbers of lymph nodes that need to be examined to make reliable staging possible, but there is no consensus in the available literature. In this study, we determine in patients with rectal cancer factors that relate to the number of lymph nodes found and the presence of lymph node metastasis. In addition, the number of examined lymph nodes was correlated with prognosis. A total of 1227 patients were selected from a multicenter prospective randomized trial investigating the value of neoadjuvant radiotherapy. The median number of examined lymph nodes in all patients was 7.0. The number of retrieved lymph nodes in patients with node metastasis was significantly higher than in node negative patients. After neoadjuvant radiotherapy fewer lymph nodes were retrieved (6.9 vs. 8.5; P<0.0001). Variations in lymph node yield between pathology laboratories and individual pathologists were striking. The following patient and tumor characteristics are associated with a significant lower lymph node retrieval: age over 60 years, overweight, small size, and low invasion depth of the tumor, poor differentiation grade, and absence of a lymphoid reaction. Node negative patients in whom seven or less lymph nodes were examined had a lower recurrence free interval than patients in whom at least 8 lymph nodes were examined (17.0% vs. 10.7%, P=0.016). We conclude that in pathology laboratories a median of at least 8 lymph nodes need to be examined in rectal cancer specimens, but that higher numbers are desirable and achievable in most cases, even after preoperative radiotherapy.
Article
BACKGROUND Lymph node status is pivotal to the staging of colorectal carcinoma. The diagnosis of a lymph node negative tumor should imply a good prognosis; however, the outcomes for Dukes' B (TNM Stage II) patients remain variable, possibly in part due to understaging. The aim of this study was to determine whether examining a specified minimum number of lymph nodes using conventional techniques would eliminate the risk of understaging and thus have an effect on prognosis.METHODS Data on patients who underwent surgery for colorectal carcinoma at a single institution between 1985 and 1990 were reviewed. Patients with Dukes' B (TNM Stage II) or C (TNM Stage III) tumors and histologically confirmed disease-free resection margins who were treated with curative intent were included. Correlations among variables were assessed using the chi-square test, and survival comparisons were made using Kaplan-Meier curves and the log rank test. Multivariate analysis was performed using a Cox regression model.RESULTSDukes' B (TNM Stage II) patients with ≤6 lymph nodes examined had significantly poorer overall survival than those with ≥7 lymph nodes examined (P = 0.0014). Such a significant difference was not observed among Dukes' C (TNM Stage III) patients (P = 0.7). Survival of Dukes' C patients was significantly worse compared with that of Dukes' B patients overall and Dukes' B patients with ≥7 lymph nodes examined (P < 0.0001). There was no significant difference in survival between Dukes' C and Dukes' B patients with ≤6 lymph nodes examined (P = 0.02). The number of examined lymph nodes was the only significant parameter correlated with survival in the multivariate analysis (P = 0.002).CONCLUSIONS Because Dukes' B patients with ≤6 examined lymph nodes have poorer outcomes than those with a higher number examined (probably due to understaging), the total number of examined lymph nodes should always be reported. Cancer 1998;83:666-672. © 1998 American Cancer Society.
Article
BACKGROUND Locally advanced rectal carcinoma has a poor prognosis. However, since the introduction of preoperative radiotherapy, the outcome of patients with rectal carcinoma has been reported to have improved. Nevertheless, to the authors' knowledge few data are available regarding the histopathologic response to radiotherapy as assessed on surgical specimens as a potential predictive factor for outcome.METHODS To estimate the effect of radiotherapy on rectal carcinoma, the authors retrospectively reviewed the surgical specimens of 102 patients with T3-4, N0 or ≥ N1 rectal carcinoma and 1 patient with T2 but N1 rectal carcinoma. All patients were treated preoperatively with a hyperfractionated accelerated radiotherapy schedule in a prospective protocol (Trial 93-01). Using a standardized approach, tumor regression was graded using a system that varies from Grade 1 (tumor regression Grade [TRG] 1) when complete tumor regression is observed to Grade 5 (TRG5) when no tumor regression is observed.RESULTSRadiotherapy resulted in tumor downstaging in 43% of the patients. There were 2 pT1 tumors (2%), 21 pT2 tumors (20%), 66 pT3 tumors (64%), and 14 pT4 tumors (14%) after treatment. Regional lymph nodes were involved in 55 patients (53%). None of the patients demonstrated a complete tumor regression after radiotherapy, but in 79% of the specimens a partial tumor regression was observed (TRG1: 0%; TRG2: 20%; TRG3: 39%; TRG4: 20%; and TRG5: 21%). The median actuarial overall survival (OS) and disease-free survival (DFS) were 52 months. Actuarial local recurrence rates at 2 years and 5 years were 6.4% and 7.6%, respectively. Univariate analysis showed the actuarial DFS to be significantly lower in patients with lymph node metastases (P = 0.0004) and advanced pT stages (pT3-4) (P = 0.03). A favorable outcome for OS, DFS, and local control was observed in patients with TRG2-4 (i.e., responders) compared with patients with TRG5 (i.e., nonresponders), but also in patients with low residual tumor cell density (TRG2, 3, and 4). On multivariate analysis, TRG remained an independent prognostic indicator for local tumor control.CONCLUSIONS Tumor regression as well as residual tumor cell density were found to be predictive factors of survival in rectal carcinoma patients after preoperative radiotherapy. Even after preoperative radiotherapy, the pathologic stage of the surgical specimen remained a prognostic factor. The use of a standardized approach for pathologic evaluation must be implemented to allow comparison between the results of various treatment approaches.
Article
Purpose: To evaluate the rates of tumor downstaging after preoperative chemoradiation for locally advanced rectal cancer.Materials and Methods: Preoperative chemoradiotherapy (CTX/XRT) that delivered 45 Gy in 25 fractions over 5 weeks with continuous infusion 5-fluorouracil (300 mg/m2/day) was given to 117 patients. The pretreatment stage distribution, as determined by endorectal ultrasound (u), included uT2N0 in 2%, uT3N0 in 47%, uT3N1 in 49%, and uT4N0 in 2% of cases; endorectal ultrasound was not performed in 13% of cases (15 patients). Approximately 6 weeks after completion of CTX/XRT, surgery was performed.Results: The pathological tumor stages were Tis-2N0 in 26%, T2N1 in 5%, T3N0 in 21%, T3N1 in 15%, T4N0 in 5%, and T4N1 in 1%; a complete response (CR) to preoperative CTX/XRT was pathologically confirmed in 32 (27%) of patients. Tumor downstaging occurred in 72 (62%) cases. Only 3% of cases had pathologic evidence of progressive disease. Pretreatment tumor size (< 5 cm vs. ≥ 5 cm) was the only factor predictive of tumor downstaging (p < 0.04). A decrease of >1 T-stage level was accomplished in 45% of those downstaged. Overall, a sphincter-saving (SP) procedure was possible in 59% of patients and an abdominoperineal resection (APR) was required in 41% of cases. Factors predictive of SP included downstaging (p < 0.03), age > 40 years (p < 0.007), pretreatment tumor distance, 3 to 6 cm from the anal verge (p < 0.00001), tumor size <6 cm (p < 0.02), mobility (p < 0.004), tumor stage <T4 (p < 0.01), and uN negative (p < 0.008). SP was performed in 23 patients (72%) with a CR and in 48 (67%) of downstaged cases. Among the 69 tumors located < 6 cm from the anal verge, 29 (42%) were resected with a SP. The level of response was important for tumors located < 6 cm from the anal verge because a SP was performed in 9 of the 17 (53%) CRs in this group while only 20 of 52 patients (38%) had a SP when residual disease was present after CTX/XRT. For tumors located > 6 cm from the anal verge, SP was performed in 14 of the 15 (93%) patients with a CR and 32 of 33 (97%) of patients with residual disease (p < 0.00004).Conclusions: Significant tumor downstaging results from preoperative chemoradiation allowing sphincter sparing surgery in over 40% of patients whose tumors were located < 6 cm from the anal verge and who otherwise would have required colostomy.
Article
This paper has outlined a strategy proposed by an IOM study committee for a quality review and assurance program for Medicare. The committee intended that such a program respond to several major issues, including: the burdens of harm of poor quality of care (poor performance of clinicians in both technical and interpersonal ways, unnecessary and inappropriate services, and lack of needed and appropriate services); difficulties and incentives presented by the organization and financing of healthcare; the state of scientific knowledge; the problems of adversarial, punitive, and burdensome external QA activities and the need to foster successful internal, organization-based QA programs; the adequacy of quality review and assurance methods and tools; and the human and financial resources for quality assurance. In comparison with the existing federal peer review organization program, the IOM's proposed program is intended to focus far more directly on quality assurance, cover all major settings of care, emphasize both a wide range of patient outcomes and the process of care, and have a greatly expanded program evaluation component and greater public oversight and accountability. In laying out the details of such a program, the IOM committee advanced 10 recommendations to support its proposed program. Two of these call for the Secretary of DHHS to support and expand research and educational activities designed to improve the nation's knowledge base and capacity for quality assurance. Finally, the committee emphasized both the extraordinary challenges of quality assurance and the diversity of support for addressing those challenges, noting that patients, providers, and societal agents all have a responsibility in this regard. Building the nation's capacity through additional research and expanded educational efforts is a major cornerstone of the entire enterprise.