scholarly journals Incomplete 5-FU based adjuvant chemotherapy in patients with stage III colon cancer significantly prolongs overall survival

2018 ◽  
Vol 14 ◽  
pp. 19-26
Author(s):  
Martin Hoffmann ◽  
Lucky Ogbonnaya ◽  
Claudia Benecke ◽  
Ruediger Braun ◽  
Markus Zimmermann ◽  
...  
2021 ◽  
Vol 4 (3) ◽  
pp. e213587
Author(s):  
Devon J. Boyne ◽  
Winson Y. Cheung ◽  
Robert J. Hilsden ◽  
Tolulope T. Sajobi ◽  
Atul Batra ◽  
...  

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4037-4037
Author(s):  
C. Fuchs ◽  
S. Ogino ◽  
J. A. Meyerhardt ◽  
N. Irahara ◽  
D. Niedzwiecki ◽  
...  

4037 Purpose: KRAS mutation in stage IV colorectal cancer predicts resistance to anti-EGFR targeted treatment (cetuximab or panitumumab). However, whether the presence of KRAS mutation independently predicts the survival of colon cancer patients remains uncertain. Methods: We conducted a prospective observational study of 508 cases identified among 1264 patients with stage III colon cancer who enrolled in a randomized adjuvant chemotherapy trial (5-fluorouracil, leucovorin with or without irinotecan) between April 1999 and May 2001 (CALGB 89803; Saltz et al. J Clin Oncol 2007). KRAS mutations were detected in 178 tumors (35%) by Pyrosequencing. Kaplan-Meier and Cox proportional hazard models were used to assess the significance of KRAS mutational status and adjusted for potential confounders including age, sex, tumor location, T stage, N stage, performance status, adjuvant chemotherapy arm and microsatellite instability (MSI) status. Results: When compared to patients with wild-type KRAS, those with a mutation in KRAS did not experience any difference in disease-free (DFS), recurrence-free (RFS), or overall survival (OS) (log-rank P>0.56 for DFS, RFS, and OS). Five-year DFS was 62% for KRAS-mutated and 63% for KRAS-wild-type patients. Five-year RFS was 64% for KRAS-mutated and 66% for KRAS- wild-type patients. Five-year OS was 74% for KRAS-mutated and 73% for KRAS-wild-type patients. The effect of KRAS mutation on patient survival did not differ according to clinical features, chemotherapy arm or MSI status, and the effect of adjuvant chemotherapy assignment on outcome did not differ according to KRAS status. Conclusions: In this large clinical trial of chemotherapy in patients with stage III colon cancer, KRAS mutational status was not associated with any significant influence on disease-free or overall survival. No significant financial relationships to disclose.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 863-863
Author(s):  
Samip R. Master ◽  
Lawrence Shi ◽  
Chintan Shah ◽  
Runhua Shi

863 Background: Data on safety and efficacy of adjuvant chemotherapy for stage II and III colon cancer in elderly patients is area of controversy as these patients are underrepresented in clinical trials. We did a retrospective analysis of Medicare patients aged 70 or older with stage II and stage III colon cancer to investigate the adjuvant chemotherapy effect on colon cancer patients’ survival. Methods: Data was analyzed from 110, 993 men and women (≥ 70 years of age) registered in the National Cancer Database (NCDB) who were diagnosed with AJCC Stage II and Stage III colon cancer between 2004 and 2012 and had follow-ups to end of 2013. The primary predictor variable was adjuvant chemotherapy received, and overall survival was the outcome variable. Only patients with Medicare insurance were investigate for ease of analysis. Additional variables addressed and adjusted included gender, age, race, Charlson Comorbidity Index, the level of education, income, grade of tumor, distance traveled, facility type and diagnosing/treating facility. Results: The mean age was 79.5 years and SD was 5.9 years. In multivariate analysis, after adjusting for secondary predictor variables, receipt of adjuvant chemotherapy was a statistically significant predictor of overall survival of the stage II and stage III colon cancer. Relative to patients who did not receive adjuvant chemotherapy, the patients who got single agent adjuvant chemotherapy had 47.7% and those who were treated with multi agent chemotherapy had 49.8% decreased risk of mortality. There was no significant survival difference between single agent and multi agent adjuvant chemotherapy. Among the factors analyzed, age, gender, race, comorbidity index, diagnosing /treating facility and grade of tumor were found to be significant predictors of survival. Conclusions: Among the patients aged 70 years or older with stage II and stage III colon cancer, adjuvant chemotherapy lead to improved survival outcomes. However, survival difference between single agent vs multi agent adjuvant chemotherapy was not statistically significant.


2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 119-119
Author(s):  
Aaron Gehr ◽  
Yan Lu ◽  
Bassam Ghabach ◽  
Kalyani Narra ◽  
Latha Sri Neerukonda ◽  
...  

119 Background: The National Quality Forum endorsed initiation of adjuvant chemotherapy within 120 days of diagnosis for stage III colon cancer patients aged < 80 years. Nevertheless, no trials were conducted to establish this 120-day threshold and observational studies used to justify this threshold may be sensitive to recently identified sources of bias. Therefore, we aimed to assess the effect of initiating adjuvant chemotherapy within 120 days on survival among patients with stage III colon cancer. Methods: We used institutional registry data from the JPS Center for Cancer Care (JPS), an accredited Comprehensive Community Cancer Program. Eligible patients were adults aged < 80 years, diagnosed with first primary stage III colon cancer between 2011 and 2015, and received at least part of their first course treatment at JPS. Overall survival was defined as time from cancer diagnosis to death, loss to follow-up, or end of study. We emulated a pragmatic trial and estimated the intention to treat 36-month restricted mean survival difference and 95% confidence limits (CL) for initiating adjuvant chemotherapy within 120 days using a marginal structural model with stabilized inverse probability of treatment weights to reduce confounding bias. Results: Our study population comprised 62 patients, of whom 61% were aged 55 – 64 years, 58% were females, 61% were racial/ethnic minorities, 69% were uninsured, and 61% initiated adjuvant chemotherapy within 120 days after cancer diagnosis. The mean survival after 36 months of follow-up was 31 months (95% CL: 27, 34) for patients who initiated and 31 months (95% CL: 28, 34) for patients who did not initiate adjuvant chemotherapy within 120 days (mean survival difference = -0.10 months, 95% CL: -3.6, 3.4). Conclusions: Our results suggest no meaningful difference in overall survival between initiating or not initiating adjuvant treatment within 120 days of diagnosis for patients with stage III colon cancer, but our estimates are compatible with either a 3-month survival benefit or harm. A larger sample size may provide greater certainty whether the 120-day threshold is a questionable quality measure, as observed in our study.


Author(s):  
Yasir G. Malik ◽  
Lars Gustav Lyckander ◽  
Jonas C. Lindstrøm ◽  
Olof Vinge-Holmquist ◽  
Ariba E. Sheikh ◽  
...  

Abstract Purpose Adjuvant chemotherapy for colon cancer with lymph node involvement (Stage III) has been the standard of care since the 1990s. Meanwhile, considerable evolvement of surgery combined with dedicated histopathological examinations may have led to stage migration. Furthermore, prognostic factors other than lymph node involvement have proven to affect overall survival. Thus, adjuvant chemotherapy in Stage III colon cancer should be reconsidered. The objective was to compare recurrence rates and survival in stage III colon cancer patients treated with or without adjuvant chemotherapy. Further, to assess the impact of extensive mesenterectomy, lymph node stage and vascular invasion on outcome. Methods Consecutive patients operated for Stage III colon carcinoma between 31 December 2005 and 31 December 2015 were identified in the pathological code register by matching colon (T67) and either adenocarcinoma (M81403) or mucinous adenocarcinoma (M84803), with lymph node (T08) and metastasis of adenocarcinoma (M81406 or M84806). Medical records of all identified patients were reviewed. Results Of 216 identified patients, 69 received no postoperative adjuvant chemotherapy (group NC), 69 insufficient adjuvant chemotherapy (FLV or < minimum recommended 6 cycles FLOX, group IC), and 78 sufficient adjuvant chemotherapy (≥ 6 cycles FLOX, group SC). When adjusted for age and comorbidity, 5-year overall survival did not differ statistically significant between groups (76% vs. 83% vs. 85%, respectively). Vascular invasion and a high lymph node ratio significantly reduced overall survival. Conclusion The findings imply that subgroups of Stage III colon cancer patients have good prognosis also without adjuvant chemotherapy. For definite conclusions about necessity of adjuvant chemotherapy, prospective trials are needed.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4046-4046 ◽  
Author(s):  
G. J. Chang ◽  
K. Y. Lee ◽  
C. Eng ◽  
K. M. Kattepogu ◽  
S. Richey ◽  
...  

4046 Background: Microsatellite instability (MSI) is an alternative pathway to colon cancer pathogenesis and may be categorized by the degree of MSI exhibited as MSI-high (MSI-H), MSI-low (MSI-L) or microsatellite stable (MSS). The aim of this study was to determine the prognostic impact MSI status on survival in stage III colon cancer. Methods: A total of 197 patients who received curative resection of stage III colon cancer from 1991 through 2002 were identified. Records of these patients were retrospectively evaluated to determine chemotherapy (CTx) use and vital status. DNA extracted from paraffin embedded tumor specimens was amplified by polymerase chain reaction using a panel of 7 markers. MSI-H was defined as instability in >40% of markers and low as instability in >0% but <40% of markers. Overall survival based on MSI and CTx status was compared using Kaplan-Meier analysis and the log-rank test and Cox multiple regression to adjust for covariates. Results: Median follow-up was 5.4 years. There were 25 (13%) MSI-H, 38 (19%) MSI-L and 134 (68%) MSS patients. Median age was 56 years (MSI-H), 65 years (MSI-L) and 62 years (MSS). 5-fluorouracil adjuvant CTx was completed in 135 (69%), not completed in 36 (18%) and unknown in 26 (13%) patients. Tumors were left sided in 56% of the cohort, 72% among MSI-H, 60% among MSI-L, 51% among MSS. 5-year overall survival after adjuvant CTx ranged 71–82% and was not significantly different among the groups. Completion of CTx improved survival among MSS, HR 0.18 (95% confidence [CI] 0.07–0.42, p<0.0001), but not among MSI- H, HR 0.83 (95% CI 0.19–3.60, p=0.79), with an intermediate effect among MSI-L, HR 0.36 (95% CI 0.09–1.47, p=0.0562). The effect of completing adjuvant CTx persisted after adjustment for age, sex, stage (IIIA, B, C), and histology, RR 0.19 (95% CI 0.089–0.41, p<0.0001), RR 0.059 (95% CI 0.009–0.39, p=0.003), RR 0.26 (95% CI 0.01–13.3, p=0.31) for MSS, MSI-L, and MSI-H, respectively. Conclusions: 5-fluorouracil based adjuvant chemotherapy did not affect overall survival in patients with stage III colon cancer who are MSI-H due to a high baseline survival rate without adjuvant therapy. Adjuvant chemotherapy did improve survival in patients who are MSS and an intermediate effect was seen in paitents who are MSI-L. No significant financial relationships to disclose.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 648-648
Author(s):  
Praveen Ramakrishnan Geethakumari ◽  
Sherry Pomerantz ◽  
John Charles Leighton

648 Background: It is standard to use results of randomized controlled trials (RCT’s) for therapeutic decisions in community oncology. However participant selection in trial environments may not reflect real-world scenario. We aim to perform a retrospective analysis of patient profile and treatment outcomes in a community cancer center. Methods: Patients with stage III colon cancer offered adjuvant chemotherapy after curative resection from 2003-2010 (N=177) were reviewed. Eighty-seven patients with complete medical records were analyzed. Patient eligibility was assessed on criteria from the MOSAIC and NSABP C-07 trials. Eligible and ineligible patients were compared using Fisher’s exact test, Student’s t-test and Kaplan-Meier survival analysis. Results: The study group (females: 53%) with mean age of 65 years, was predominantly African American (60%). ECOG performance status was ≥ 2 in 13% patients. Only 29% satisfied all standard eligibility criteria. Ineligibility characteristics included age > 75 years (21%), non-malignant severe systemic disease (10%) and > 42 days from surgery to chemotherapy (39%). Seventy-five patients (86%) received chemotherapy. Chemotherapy regimens included FOLFOX (51%), FLOX (10%), FL (29%) and Capecitabine (8%). Total planned dose had to be modified in 64% patients with mean doses of 89% 5-fluorouracil and 79% oxaliplatin employed. The 3-year disease free survival (DFS) was 53% and 5-year overall survival (OS) was 56%. Age ≥ 69 years was significantly associated with poor 3-year DFS (P=0.013). On Kaplan-Meier survival analysis, the ineligible patient group had significantly reduced overall survival (hazard ratio, 2.88; 95% CI, 1.05-4.82; P= 0.037). Conclusions: This pilot venture studied adjuvant management of Stage III colon cancer in a real-world setting. Our results reveal that over 70% patients did not meet standard eligibility criteria and show decreased 5-year OS among these patients that needs to be addressed in future prospective RCT’s.


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