Timing of adjuvant chemotherapy in stage III colon cancer as a measure of quality: Reasons for noncompliance.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 640-640
Author(s):  
Omar M. Rashid ◽  
Karen A. Coyne ◽  
Thomas W. Ross ◽  
David Shibata
Keyword(s):  
Colon Cancer ◽  
Cancer Care ◽  
Tertiary Care ◽  
Stage Iii ◽  
Cancer Center ◽  
Patient Centered ◽  
Stage Iii Colon Cancer ◽  
Lost To Follow Up

640 Background: The Institute of Medicine's report on improving cancer care, along with the evolution of ASCO's Quality Oncology Practice Initiative, has helped to develop process measures into critical quality of cancer care indicators. One such measure relates to "receipt of chemotherapy for stage III colon cancer (CC) within 120 days of diagnosis" and is now being incorporated into processes including hospital accreditation (American College of Surgeons; ACS), managed care contracts and Center for Medicare and Medicaid Services (CMS) quality monitoring. To better understand potential pitfalls related to the strict guidelines of this measure, we sought to evaluate institutional adherence at a tertiary care cancer center and to examine the reasons for non-compliance. Methods: A retrospective review was performed of all cases of stage III colon cancer reported at a single institution from 2008 – 2012. Coding for compliance was performed using standard ACS guidelines. Results: A total of 122 eligible cases were identified and consisted of 49 (40.2%) women and 73 (59.8%) men with a median age of 58 (range 32 - 77). Overall, 15 (12.3%) cases were non-compliant with 2 (1.6%) lost to follow up. Of the non-compliant cases, 14 (93.3%) cases did go on to receive chemotherapy while 1 (6.7%) never received adjuvant treatment. Of those receiving delayed treatment, 7 were due to patient-centered factors [e.g. patient timing preference (n=4), request for chemotherapy closer to home (n=2) and lost to follow up (n=1)]. Other reasons included delays at outside facilities (n=4), postoperative complications (n=1) and insurance approval (n=1). In 2 cases, designation of date of diagnosis based on suspicion rather than definitive biopsy contributed to non-compliant status. Conclusions: Our center averaged an annual compliance with the CC adjuvant therapy measure of approximately 90%. Larger scale studies are indicated to determine whether refinements in coding guides that account for patient preferences, clear diagnosis dates and cross-facility care could better reflect quality of care, and also promote improved patient-centered multidisciplinary management.

Should Total Number of Lymph Nodes be Used as a Quality of Care Measure for Stage III Colon Cancer?

2010 ◽  
Vol 251 (1) ◽  
pp. 184-185
Author(s):  
Jiping Wang ◽  
Mahmoud Kulaylat ◽  
James Hassett ◽  
Kelli Bullard Dunn ◽  
Merril Dayton ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Quality Of Care ◽  
Lymph Nodes ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
Care Measure

Clinical efficacy and safety of early adjuvant chemotherapy for stage III colon cancer: Short-term outcomes of a multicenter, randomized, open-label, phase 3 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3598-3598
Author(s):  
Jun Seok Park ◽  
Soo Yeun Park ◽  
Gyu-Seog Choi ◽  
Hye Jin Kim ◽  
Jong Gwang Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adverse Events ◽  
Surgical Complication ◽  
Phase Iii ◽  
Stage Iii ◽  
Survival Outcomes ◽  
Stage Iii Colon Cancer

3598 Background: Adjuvant chemotherapy (AC) is recommended to commence within 8 weeks since after surgical resection of stage II or III colon cancer. Results of many retrospective studies showed inferior survival outcomes following delay of AC delay. Moreover, preclinical studies showed that the progression of disseminated cancer cells is profound during the postoperative period. This study is the first prospective trial to evaluate early (≤ 14 days postoperative) AC for patients (pts) with stage III colon cancer. Methods: This study is a prospective, multicenter, randomized phase III trial. Pts with pathological stage III colon cancer were enrolled and randomized 1:1 to early AC (starting AC ≤ 14 days after surgery) or conventional AC (starting AC > 14 days after surgery). Pts were recommended to receive 12 cycles of FOLFOX-6 for AC. The primary endpoint was disease-free survival. The secondary endpoints were overall survival, adverse events, surgical complication during AC, and patient-reported outcomes (quality of life) during 1 year after surgery. Herein, safety data, chemotherapy delivery, and quality of life are presented. Results: This study randomized 443 pts either early AC arm (221pts) or early AC arm (222 pts) to the during September 2011 to March 2020. 380 pts who received at least one cycle of FOLFOX-6 were included in the safety analysis (192 and 188 in the early and conventional AC arms, respectively). The baseline characteristics of the two groups were well-balanced except for the interval from the surgery to the initial AC. The early and conventional AC arms started their first chemotherapy at median of 13 (4-43 days) and 29 (17-53 days) after surgery (p < 0.001), respectively. No significant differences were seen in the median chemotherapy cycles, AC completion, and relative oxaliplatin dose intensity between groups. AC Completion without any change of dose or schedule delay was seen in 18% and 20% in early and conventional AC arms respectively, while dose reduction or delay was 65% and 61%, respectively. Toxicities of grade 3 or more were seen in 28% in both groups. One patient in the early AC arm underwent an emergent operation for anastomotic leakage on the second day of 5-fluorouracil infusion (postoperative day 14). However, the surgical complication was not seen in any other patient. The scores of the European Organization for Research and Treatment of Cancer Quality of Life core 30 questionnaire were similar in both arms at baseline (before starting AC), and 1 month, 3 months, 6 months, and 12 months after surgery. Conclusions: Early AC was safe and did not increase either chemotherapy-related adverse events or surgery-related complications during treatment. Moreover early AC did not reduce the quality of life of the pts during 1 year after surgery. This study continues to follow-up the patients for survival outcomes. Clinical trial information: NCT01460589.

Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer

2017 ◽  
Author(s):  
Kelly McLeon
Keyword(s):  
Colon Cancer ◽  
Adjuvant Treatment ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Reference Standard ◽  
Free Survival ◽  
Stage Iii Colon Cancer ◽  
Study Intervention ◽  
Disease Free

The landmark MOSAIC trial examined whether the addition of oxaliplatin to a postoperative adjuvant treatment regimen of fluorouracil and leucovorin affected disease-free survival from colon cancer. The MOSAIC trial established the efficacy of FOLFOX over 5-FU/LV as adjuvant treatment for stage III colon cancer and established FOLFOX4 as the reference standard for adjuvant treatment for stage III disease. This chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case.

VEGF and VEGF receptor-2 (VEGFR2) gene polymorphisms predict tumor recurrence in stage II and III colon cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4004-4004 ◽  
Author(s):  
G. Lurje ◽  
A. M. Schultheis ◽  
A. E. Hendifar ◽  
S. Ashouri ◽  
W. Zhang ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Tumor Recurrence ◽  
Stage Ii ◽  
Stage Iii ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Vegf Receptor ◽  
Stage Iii Colon Cancer ◽  
Increased Risk

4004 Background: Despite recent advances in the treatment of metastatic colorectal cancer, tailoring adjuvant treatment of stage II and III colon cancer patients remains controversial. Identifying a reliable panel of prognostic and predictive markers for tumor recurrence is critical in selecting an individualized and tailored chemotherapy. Tumor angiogenesis plays an important role in tumor development, progression and metastasis. In this retrospective study, we tested whether a specific pattern of 40 functionally significant polymorphisms in 37 genes involved in angiogenesis and tumor microenvironment will predict the risk of tumor recurrence in stage II and III colon cancer patients treated with adjuvant chemotherapy. Methods: Between 1999 and 2006 blood specimens from 140 patients (69 females and 71 males with a median age of 59 years; range=28–86) were obtained at the University of Southern California/Norris Comprehensive Cancer Center (USC/NCCC). Sixty-three patients had stage II and 77 had stage III colon cancer. The median follow-up was 5.4 years (range=2.0–16.8). 51 of 140 patients (36.4%) developed tumor recurrence with a 5-year probability of 0.28 ± 0.06 for stage II and 0.40 ± 0.06 for stage III colon cancer patients. Genomic DNA was extracted from peripheral blood and genotypes were determined using PCR based RFLP. Results: Polymorphisms in VEGF (C936T; p=0.009, log-rank) and VEGFR2 (+4422 AC- repeat; p=0.04, log-rank and +1416 T/A; p=0.0009, log-rank) were associated with risk of tumor recurrence in stage III colon cancer patients (n=77). VEGFR2 AC-repeat polymorphisms were additionally associated with risk of recurrence in Stage II colon cancer patients (n=63, p=0.02, log-rank). Conclusion: VEGF C936T and VEGFR2 (+4422 AC-repeat and +1416 T/A) polymorphisms may help to identify Stage II and III colon cancer patients who are at increased risk for developing tumor recurrence. Angiogenesis seems to play a crucial role in tumor recurrence, thus targeting VEGF and VEGFR2 may be of clinical benefit for stage II and stage III colon cancer patients. Large prospective trials are needed to validate these preliminary data. No significant financial relationships to disclose.

Early postoperative PET-CT in patients with pathological stage III colon cancer may change their outcome: Results from a large single-institution study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15163-e15163
Author(s):  
Assaf Moore ◽  
Irit Ben-Aharon ◽  
Ofer Purim ◽  
Gali Perl ◽  
Olga Ulitsky ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Preoperative Staging ◽  
Prospective Trial ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Pathological Stage ◽  
Stage Iii Colon Cancer ◽  
Postoperative Changes ◽  
Pet Ct

e15163 Background: Staging of patients (pts) with pathological stage III colon cancer (CC) is currently suboptimal; many pts still recur despite an unremarkable preoperative staging. We previously reported that early postoperative PET-CT can alter the stage and management of up to 15% of pts with high risk stage III CC and later reported also encouraging preliminary results in a larger cohort of consecutive pts with stage III CC, in which staging and management were altered in 14.5%. The aim of the current study was to expand the previous one to a larger cohort and to evaluate the actual impact of early postoperative PET-CT on pts outcome. Methods: A Retrospective study of all consecutive pts with stage III CC who were treated at our institution and underwent early postoperative PET-CT between 2007-2016. Demographic and clinicopathological data were retrieved. Statistical analyses were done using standard methods. Results: 348 pts, 166 (47.7%) males, with a median age of 66 years (range, 29-92), were included. Pathological stage was IIIA, IIIB and IIIC in 21(6%), 254 (73%) and 73 (21%) pts, respectively. The median number of lymph nodes examined and of positive ones were 14 (range, 3-54) and 2 (range, 0-32), respectively. High FDG-uptake was noted in 95 (27.3%) pts, including 23 (6.6%) with clear postoperative changes and 18 (5.2%) with a false positive uptake, of whom 6 underwent invasive diagnostic procedures. PET-CT results modified the management of 52 pts (14.9%) who were found to have true positive findings: 44 (12.6%) with overt metastatic disease and 8 (2.3%) with a second primary tumor. At a median follow-up of 45.6 months, the estimated 5y disease-free survival for true stage III pts was 81.9% and the 6y overall survival of the entire cohort was 76.4%. Interestingly, of the 44 pts found to be metastatic, 12 (27.3%) underwent curative treatments and 8 (66.7%) of those remain free of disease, with a median follow-up of 64.7 months. Conclusions: In this large cohort, early postoperative PET-CT changed the staging and management of 14.9% of pts with resected stage III CC, with encouraging outcome results. We are conducting a prospective trial to further evaluate this strategy.

The role of early postoperative PET-CT in patients with pathological stage III colon cancer: Results from a large single institution study.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 562-562
Author(s):  
Assaf Moore ◽  
Irit Ben-Aharon ◽  
Ofer Purim ◽  
Gali Perl ◽  
Olga Ulitsky ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Lymph Nodes ◽  
Metastatic Disease ◽  
Stage Iii ◽  
Individual Risk ◽  
Pathological Stage ◽  
Stage Iii Colon Cancer ◽  
Pet Ct

562 Background: Current staging of patients (pts) with pathological stage III colon cancer is suboptimal; many pts still recur despite unremarkable preoperative staging work-up. We previously reported that early postoperative PET-CT can alter the stage and management of pts with high risk stage III colon cancer in up to 19% of patients. The aim of the current study was to expand the previous one to a larger cohort and to determine the role of early postoperative PET-CT in the general population of stage III colon cancer pts, regardless of their individual risk. Methods: A retrospective chart review of all consecutive pts with stage III colon cancer who underwent early postoperative PET-CT between 2007 and 2016. Demographic and clinicopathological data were collected. Results: 247 pts, 124 (50%) males, with a median age of 66 years (range, 30-92), were included. Pathological stage was IIIA, IIIB and IIIC in 18 (7.3%), 161 (65.1%) and 72 (29.1%) pts, respectively. The median number of lymph nodes retrieved was 15 (range, 6-64) and that of positive lymph nodes was 2 (range, 0-21). High FDG-uptake was observed in 52 (21.0%) pts, including 6 (2.4%) who had clear postoperative changes, 10 (4.0%) who had a false positive abnormal uptake of whom 6 underwent invasive diagnostic procedures. The PET-CT results modified the management of 36 pts (14.5%) who were found to have true positive findings: 30 (12.1%) were proven to have overt metastatic disease and in 6 (2.4%) a second primary was discovered. With the median follow-up of 39.0 months (range 7.2-98.4 months), of the 30 pts found to be metastatic, 10 (33.3%) underwent curative treatments and are currently with no evidence of disease (NED). Updated data, on more patients and a longer follow-up, will be presented at the meeting. Conclusions: Early postoperative PET-CT changed the staging and treatment of 14.5% of resected stage III pts, and has the potential for early detection of curable metastatic disease. We currently evaluate this strategy and its actual impact in a prospective trial.

Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer

2011 ◽  
Vol 29 (11) ◽  
pp. 1465-1471 ◽  
Author(s):  
Daniel G. Haller ◽  
Josep Tabernero ◽  
Jean Maroun ◽  
Filippo de Braud ◽  
Timothy Price ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Therapy ◽  
Folinic Acid ◽  
Mayo Clinic ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Primary Study ◽  
Primary Analysis ◽  
Stage Iii Colon Cancer

PurposeThis multicenter, randomized trial compared capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil (FU) and folinic acid (FA) as adjuvant therapy for patients with stage III colon cancer.Patients and MethodsPatients who had undergone curative resection were randomly assigned to XELOX (oxaliplatin 130 mg/m2on day 1 plus capecitabine 1,000 mg/m2twice daily on days 1 to 14 every 3 weeks for 24 weeks) or a standard bolus FU/FA adjuvant regimen (Mayo Clinic for 24 weeks or Roswell Park for 32 weeks). The primary study end point was disease-free survival (DFS).ResultsThe intention-to-treat population comprised 1,886 patients; 944 patients were randomly assigned to XELOX and 942 to FU/FA (Mayo Clinic, n = 664; Roswell Park, n = 278). After 57 months of follow-up for the primary analysis, 295 patients (31.3%) in the XELOX group had relapsed, developed a new primary colon cancer, or died compared with 353 patients (37.5%) in the FU/FA group (hazard ratio [HR] for DFS, 0.80; 95% CI, 0.69 to 0.93; P = .0045). The 3-year DFS rate was 70.9% with XELOX and 66.5% with FU/FA. The HR for overall survival (OS) for XELOX compared to FU/FA was 0.87 (95% CI, 0.72 to 1.05; P = .1486). The 5-year OS for XELOX and FU/FA were 77.6% and 74.2%, respectively. Follow-up is ongoing. Preplanned multivariate and subgroup analyses supported the robustness of these findings.ConclusionThe addition of oxaliplatin to capecitabine improves DFS in patients with stage III colon cancer. XELOX is an additional adjuvant treatment option for these patients.

Capecitabine plus oxaliplatin (XELOX) versus bolus 5-fluorouracil/leucovorin (5-FU/LV) as adjuvant therapy for stage III colon cancer: Survival follow-up of study NO16968 (XELOXA).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 388-388 ◽  
Author(s):  
Hans-Joachim Schmoll ◽  
Josep Tabernero ◽  
Jean Alfred Maroun ◽  
Filippo G. De Braud ◽  
Timothy Jay Price ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Therapy ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Study Endpoint ◽  
Primary Study ◽  
Stage Iii Colon Cancer ◽  
Systemic Treatments ◽  
Resected Stage

388 Background: The MOSAIC trial demonstrated that adding oxaliplatin to 5-FU/LV (FOLFOX4) improved 3-year disease-free survival (DFS) compared to infusional and bolus 5-FU/LV as adjuvant therapy in patients (pts) with stage II/III colon cancer [André et al. NEJM 2004]. A significant survival advantage for FOLFOX4 versus 5-FU/LV was not evident until after median duration of follow-up had exceeded 6 years [André et al. JCO 2009]. Study NO16968 demonstrated that XELOX was superior to bolus 5-FU/LV as adjuvant therapy in pts with stage III colon cancer in terms of DFS at 57 months median follow-up (HR 0.80; 95% CI 0.69–0.93; p=0.0045) [Haller et al. JCO 2011]. The difference between treatment groups in overall survival (OS) was not significant at 59 months median follow-up (HR=0.87; p=0.1486). Data from the planned final analysis of NO16968 are presented. Methods: Pts with resected stage III colon cancer were randomized to receive XELOX (8 cycles, 24w) or bolus 5-FU/LV (Mayo Clinic, 6 cycles; 24w or Roswell Park, 4 cycles; 32w). The primary study endpoint was DFS. Secondary endpoints included OS. Results: The ITT population included 1886 pts (XELOX, n=944; 5-FU/LV, n=942). After a median follow-up of 74 months, the HR (XELOX vs 5-FU/LV) for DFS was 0.80 (95% CI 0.69–0.93; p=0.0038). Seven-year DFS rates were 63% for XELOX and 56% for 5-FU/LV. After a median follow-up of 83 months, the HR for OS was 0.83 (95% CI 0.70–0.99; p=0.0367). Absolute 7-year OS rates were 73% with XELOX and 67% with 5-FU/LV. After adjusting for stratification and prognostic variables, HRs remained essentially unchanged for both DFS (0.79; 95% CI 0.68–0.91; p=0.0016) and OS (0.84; 95% CI 0.71–1.00; p=0.0477). Locoregional / systemic treatments after recurrence were given in 230 (24%) XELOX pts and 308 (33%) 5-FU/LV pts. Conclusions: The combination of oxaliplatin and capecitabine improves OS significantly compared with 5-FU/LV in the adjuvant treatment of stage III colon cancer after a median follow-up of 83 months; these data are comparable to those achieved with FOLFOX4 in the MOSAIC trial. XELOX is an effective adjuvant therapy option for pts with resected stage III colon cancer.

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