The Association of Preoperative Radiotherapy and Pathologic Downstaging with Sphincter Preservation in Clinical Stage II and III Rectal Cancer

2014 ◽  
Vol 186 (2) ◽  
pp. 504
Author(s):  
S. Mohammed ◽  
G. Chen ◽  
D. Anaya ◽  
S.S. Awad ◽  
D.H. Berger ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Preoperative Radiotherapy ◽  
Clinical Stage ◽  
Sphincter Preservation ◽  
Stage Ii

Implementation of a statewide quality assessment program for rectal cancer.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 4-4
Author(s):  
Samantha K. Hendren ◽  
Ellen McKeown ◽  
Sandra L. Wong ◽  
Mary Oerline ◽  
Darrell A. Campbell ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Quality Assessment ◽  
Neoadjuvant Therapy ◽  
Clinical Stage ◽  
Surgical Care ◽  
Quality Measures ◽  
Sphincter Preservation ◽  
Stage Ii ◽  
Mesorectal Excision ◽  
Assessment Program

4 Background: The quality of surgical care for rectal cancer (RC) has been extensively studied in Europe; however, efforts in the United States are limited by the lack of detail about surgical care in available registries. We describe a unique quality assessment program for RC designed within the Michigan Surgical Quality Collaborative (MSQC), a collaborative quality improvement organization that includes community and academic medical centers. Methods: 10 MSQC hospitals contributed to this retrospective cohort study (2007-2012). Experienced nurse reviewers were trained to abstract cancer surgery-specific data from hospital medical records and local tumor registries. Five RC surgery-specific quality measures were designed based on literature review and current guidelines: adequate lymph node (LN) procurement (>=12); use of mesorectal excision; rate of margin positivity; use of neoadjuvant therapy for clinical stage II/III; and sphincter preservation rate for mid/upper RC. Results: 353 RC cases were studied (333 radical surgery, 20 local surgery). Participating hospitals varied in size (5 <400 beds), teaching status (6 major teaching, 2 minor teaching, 2 non-teaching), and urban/rural location (9 urban). Challenges encountered in the data abstraction training process included overcoming technical jargon in pathology and operative reports. Regular conference calls, access to a specialist for questions, and modifications to definitions helped overcome difficulties; 9 of 10 abstractors scored >90% correct on test cases. Analysis reveals wide variation between hospitals on quality measures. 75% of cases had adequate LN procurement (range by hospital 64-100%); mesorectal excision was performed in 76% of cases (38-97%); 9% had positive margins (0-17%); 94% of clinical stage II/III cases had neoadjuvant therapy (67-100%); and 86% of eligible cases had sphincter preservation (62-100%). Conclusions: A program designed to provide salient feedback to surgeons regarding RC treatment is feasible, and reveals that high-quality processes of care are not consistently used. These data suggest opportunities for process improvement. The program will be disseminated statewide for prospective data feedback and quality assessment.

Outcome of patients with clinical stage II or III rectal cancer treated without adjuvant radiotherapy

2008 ◽  
Vol 23 (11) ◽  
pp. 1073-1079 ◽  
Author(s):  
Shin Fujita ◽  
Seiichiro Yamamoto ◽  
Takayuki Akasu ◽  
Yoshihiro Moriya
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Radiotherapy ◽  
Clinical Stage ◽  
Stage Ii

NSABP FR-2: Phase II study of durvalumab following neoadjuvant chemoRT in stage II-IV rectal cancer.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. TPS727-TPS727
Author(s):  
Thomas J. George ◽  
Greg Yothers ◽  
James J. Lee ◽  
Samuel A. Jacobs ◽  
Melvin Deutsch ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Stage Iv ◽  
Sphincter Preservation ◽  
Stage Ii ◽  
Systemic Steroid ◽  
Clinical Role

TPS727 Background: Locally advanced rectal cancer remains a clinical challenge with few improvements noted over the past few decades. Although immunotherapy has no current clinical role in microsatellite stable (MSS) colorectal cancer, preclinical models suggest that radiotherapy (RT) can enhance neoantigen presentation, modulate the microenvironment, and improve the likelihood of anti-tumor activity with checkpoint inhibitor use. This prospective phase II trial will test that hypothesis in addition to confirming safety of this approach using a “window-of-opportunity” study design with the anti-PD-L1 agent durvalumab (MEDI4736). Methods: This multi-center phase II trial is currently enrolling patients (pts) with rectal cancer who are undergoing standard NCCN guideline-compliant neoadjuvant chemoradiotherapy (CRT). Eligibility includes pts with MSS stage II-IV rectal cancer with adequate organ function and pre-treatment diagnostic tumor available for profiling who are undergoing CRT with intentions to proceed to surgical resection. Stage IV disease must be limited such that the primary pelvic tumor requires definitive management. Standard ineligibility criteria include active infections, systemic steroid use, or other conditions making immunotherapy use unsafe. Treatment includes durvalumab (750mg IV infusion once every 2 wks) for 4 total doses beginning within 3-7 days after CRT completion. Surgery must be within 8-12 wks of the final CRT dose. Primary endpoint is a demonstrated improvement in Neoadjuvant Rectal Cancer (NAR) score compared to historical controls targeting a 20% relative risk reduction in DFS and 3-4% absolute OS improvement. Secondary endpoints include OS, DFS, toxicity, pCR, cCR, therapy completion, negative surgical margins, sphincter preservation, off-target “abscopal” effects for the subset of stage IV pts, and exploratory assessments of tumor infiltrating lymphocytes, circulating immunologic profiles, and molecular predictors of response. A safety run-in phase has completed as a precedent to full enrollment. Enrollment now continues to 47 total pts to achieve 41 surgically evaluable pts. NCT03102047. Support: AstraZeneca-Medimmune, NSABP Foundation Clinical trial information: NCT03102047.

Long-term quality of life (QoL) for stage II/III rectal cancer survivors in the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 584-584
Author(s):  
Mary E. Charlton ◽  
Karyn Beth Stitzenberg ◽  
Chi Lin ◽  
Grelda Yazmin Juarez ◽  
Thorvardur Ragnar Halfdanarson ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Health Status ◽  
Neoadjuvant Chemoradiation ◽  
Sphincter Preservation ◽  
Stage Ii ◽  
Multiple Trials ◽  
Care Outcomes ◽  
Self Reported Health Status

584 Background: Standard therapy for stage II/III rectal cancer includes surgery, radiation, and chemotherapy. Multiple trials demonstrated neoadjuvant chemoradiation (CRT) provides better local control and decreased morbidity compared to adjuvant CRT, though differences in overall survival and long-term QoL have not been demonstrated. We examined impact of treatment (pre-op CRT/post-op CRT/no CRT) on long-term QoL. Methods: CanCORS patients with survey/medical record data diagnosed in 2003-2005 with stage II/III rectal (non-rectosigmoid) cancer had resection and survived > 7 years were included. QoL (SF-36, EQ-5D) measures and defecation problems were derived from surveys at 14 months and 7 years post-diagnosis. Mean scores were adjusted for the following when significant: age, gender, stage, sphincter preservation, comorbidities, and baseline self-reported health status and QoL scores. Results: Of 119 patients, 53% received pre-op CRT, 23% post-op CRT, and 24% no CRT. Of 114 patients with 14-month follow-up, Pre-op CRT and No CRT groups had better EQ-5D adjusted mean scores but worse defecation scale (DS) scores compared to the Post-op CRT group. Of 49 disease-free survivors with 7 years follow-up, there were no differences among groups in QoL scores, but the No CRT group had better DS scores than other groups. Conclusions: No major differences were detected in long-term QoL based on treatment aside from the DS, though sample sizes became small. Regardless of treatment, long term (7y) mental health and vitality were generally comparable to U.S. norms, while physical health and overall health status (EQ-5D) were somewhat lower. [Table: see text]

A phase II clinical trial of preoperative chemoradiotherapy (CRT) with oral S-1 plus bevacizumab in patients with middle or lower rectal adenocarcinoma.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 575-575 ◽  
Author(s):  
Sotaro Sadahiro ◽  
Toshiyuki Suzuki ◽  
Akira Tanaka ◽  
Kazutake Okada ◽  
Gota Saito ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Perioperative Complications ◽  
Clinical Stage ◽  
Rectal Adenocarcinoma ◽  
Sphincter Preservation ◽  
Stage Ii ◽  
Oncologic Outcomes ◽  
Tumor Shrinkage ◽  
Preservation Rate

575 Background: Preoperative CRT decreases local failure and increases sphincter preservation in patients with clinical stage II or III rectal cancer. Patients with ypCR after CRT reveal better oncologic outcomes. S-1 is an oral fluoropyrimidine with radiosensitizing activity. We previously reported preoperative CRT with S-1 was effective (ypCR 22.2%) and safe (Oncology 2011). Combining bevacizumab with 5-FU- or capecitabine-based CRT had been reported to provide promising results. We evaluated the effectiveness and safety of bevacizumab plus S-1-based CRT. Methods: The subjects were 46 patients with clinical stage II or III adenocarcinoma of the mid or low rectum enrolled from Feb. 2011 through May 2013. Pelvic radiotherapy was given in a total dose of 45 Gy, delivered in 25 factions. S-1 (80 mg/m2/day) was given orally twice daily for a total of 28 days during weeks 1, 2, 4, and 5. Bevacizumab (5 mg/kg) was administered a total of 3 times at day 1, 15, and 29. Mesorectal excision was performed 6 to 8 weeks after the completion of CRT. The primary endpoint was the ypCR rate. Secondary endpoints were the degree of tumor shrinkage, sphincter-preservation rate, and safety. Results: Clinical stage was II in 13 patients and III in 33. The median interval from the completion of CRT to surgery was 8 weeks (range, 4 to 9). The ypCR rate was 21.7% (10/46), with a T downstaging rate of 54.3% and an N downstaging rate of 50.0%. The degree of tumor shrinkage was 51.8 ± 16.6% (mean ± SD) on barium enema and 77.7 ± 11.1% on a volumetric analysis based on MRI. The sphincter-preservation rate was 76.1% (35/46). Grade 3 or higher adverse event occurring during CRT was leukopenia in 1 patient (2.2%). Surgery was not postponed because of adverse events in any patient. However, 63.0% of the patients had anal pain (grade 1, 6 patients; grade 2, 23). Postoperative complications occurred in 32.6%: anastomotic leakage in 25.7% (9/35) in LAR and perineal wound dehiscence in 18.2% (2/11) in APR. Conclusions: CRT with S-1 plus bevacizumab had similar antitumor effectiveness and adverse events as CRT only with S-1, but was associated with higher incidences of perioperative complications related to wound healing. Clinical trial information: 10R-113.

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