Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: Preliminary analysis of the PETACC-2-study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3563-3563 ◽  
Author(s):  
A. Carrato ◽  
C. Köhne ◽  
L. Bedenne ◽  
I. Popov ◽  
O. Bouche ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Lymphatic Invasion ◽  
Hazard Ratio ◽  
Stage Iii ◽  
High Dose ◽  
Uicc Stage ◽  
Stage Iii Colon Cancer ◽  
Hand Foot Syndrome ◽  
Grade 3

3563 Background: Patients with stage III colon cancer have a high risk for recurrence. Infusional 5-FU may be more active than bolus application. Methods: From 01/1997 to 03/2004 a total of 1601 patients with UICC stage III colon cancer were randomized to receive the Mayo-Clinic regimen or infusional 5-FU either the weekly high dose AIO regimen, the bi-weekly LV5FU2 regimen or the Spanish weekly high dose TTD-regime. The major aim of this study was to demonstrate a difference of 7 % in the 5 year survival rate in favour of the infusional arm for which a total of 424 events were required. Results: After a median follow-up of 31 months 478 events have occurred. 804 patients received the standard arm and 797 the experimental arm (AIO N=331, EORTC N=92, FFCD N=211, TTD N=163). The median age was 64 years; patients were well distributed according to TNM-category (T3 73 vs. 75%, T4 17 vs. 16%, N2 31 vs. 34%), vascular and lymphatic invasion and grading. The bolus regimen induced a higher rate of grade 3 or 4 leukopenia (7.1% versus 2.0%), stomatitis grade 3 or 4 (9.8% versus 3.3%) or diarrhea grade 3 or 4 (16% vs. 15%). Hand-Foot-Syndrome was more frequent in the experimental arm (4.4% versus 0.4%). There was no difference in the recurrence free survival at 5 years (57% versus 56%; hazard ratio 1.00, 95% CI, 0.84 to 1.21; P=0.9) or overall survival at 5 years 71% versus 72%; hazard ratio 0.91, 95% CI, 0.71 to 1.16; P=0.44). Conclusions: Infusional 5-FU does not improve RFS or overall survival of stage III colon cancer compared to the Mayo regimen but is less toxic. Supported by Deutsche Krebshilfe No significant financial relationships to disclose.

Randomized Phase III Trial Comparing Biweekly Infusional Fluorouracil/Leucovorin Alone or With Irinotecan in the Adjuvant Treatment of Stage III Colon Cancer: PETACC-3

2009 ◽  
Vol 27 (19) ◽  
pp. 3117-3125 ◽  
Author(s):  
Eric Van Cutsem ◽  
Roberto Labianca ◽  
György Bodoky ◽  
Carlo Barone ◽  
Enrique Aranda ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Primary Objective ◽  
Phase Iii ◽  
Stage Iii ◽  
High Dose ◽  
Phase Iii Trial ◽  
Efficacy Analysis ◽  
Stage Iii Colon Cancer

PurposeThe primary objective of this randomized, multicenter, phase III trial was to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in patients with stage III colon cancer.Patients and MethodsAfter curatively intentioned surgery, patients with stage II and III colon cancer were randomly allocated surgery to receive LV5FU2 (LV 200 mg/m2as a 2-hour infusion, followed by FU; as a 400 mg/m2bolus and then a 600 mg/m2continuous infusion over 22 hours, days 1 and 2, every 2 weeks for 12 cycles: de Gramont regimen) with or without irinotecan (180 mg/m2as a 30- to 90-minute infusion, day 1, every 2 weeks). In total, 260 (7.9%) of 3,278 patients received an alternative high-dose infusional FU/LV regimen (Arbeitsgemeinschaft Internische Onkologie regimen) with or without irinotecan.ResultsThe principal efficacy analysis was based on 2,094 treated patients with stage III disease, randomly allocated in the LV5FU2 strata. After a median follow-up of 66.3 months, the 5-year DFS rate was 56.7% with irinotecan/LV5FU2 and 54.3% with LV5FU2 alone (primary end point: log-rank P = .106). Combining irinotecan with LV5FU2 did not significantly improve overall survival in this patient group compared with LV5FU2 alone (5-year rate 73.6% v 71.3%, respectively; log-rank P = .094). The addition of irinotecan to LV5FU2 was associated with an increased incidence of grade 3 to 4 GI events and neutropenia.ConclusionIrinotecan added to LV5FU2 as adjuvant therapy did not confer a statistically significant improvement in DFS or overall survival in patients with stage III colon cancer compared with LV5FU2 alone.

Phase III Trial of Capecitabine Plus Oxaliplatin As Adjuvant Therapy for Stage III Colon Cancer: A Planned Safety Analysis in 1,864 Patients

2007 ◽  
Vol 26 (1) ◽  
pp. 102-109 ◽  
Author(s):  
Hans-Joachim Schmoll ◽  
Thomas Cartwright ◽  
Josep Tabernero ◽  
Marek P. Nowacki ◽  
Arie Figer ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Therapy ◽  
Safety Analysis ◽  
Phase Iii ◽  
Stage Iii ◽  
Tolerability Profile ◽  
Phase Iii Trial ◽  
Stage Iii Colon Cancer ◽  
Hand Foot Syndrome ◽  
Grade 3

PurposeTo report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer.Patients and MethodsPatients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned.ResultsThe safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6% in the XELOX group and 0.6% in the FU/LV group.ConclusionXELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months.

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 ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Stage Iii ◽  
Stage Iii Colon Cancer

scholarly journals Association of a Shortened Duration of Adjuvant Chemotherapy With Overall Survival Among Individuals With Stage III Colon Cancer

2021 ◽  
Vol 4 (3) ◽  
pp. e213587
Author(s):  
Devon J. Boyne ◽  
Winson Y. Cheung ◽  
Robert J. Hilsden ◽  
Tolulope T. Sajobi ◽  
Atul Batra ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Stage Iii ◽  
Stage Iii Colon Cancer

Prognostic Significance of Tumor Deposits in Combination with Lymph Node Metastasis in Stage III Colon Cancer: A Propensity Score Matching Study

2020 ◽  
Vol 86 (2) ◽  
pp. 164-170
Author(s):  
Peilin Zheng ◽  
Chen Lai ◽  
Weimin Yang ◽  
Zhikang Chen
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Lymph Node Metastasis ◽  
Propensity Score ◽  
Confidence Interval ◽  
Propensity Score Matching ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
Node Metastasis

Tumor deposits in colon cancer are related to poor prognosis, whereas the prognostic power of tumor deposits in combination with lymph node metastasis (LNM) is controversial. This study aimed to compare the overall survival between LNM alone and LNM in combination with tumor deposits, and to verify whether the number of tumor deposits can be considered LNM in patients with both LNM and tumor deposits in stage III colon cancer by propensity score matching (PSM). Patients carrying resected stage III adenocarcinoma of colon cancer were identified from the Surveillance, Epidemiology, and End Results database (2010–2015). The Kaplan-Meier method, Cox proportional hazard models and PSM were used. On the whole, 23,168 patients (20,451 (88.3%) with only LNM and 2,717 (11.7%) with both LNM and tumor deposits) were selected. After undergoing PSM, patients with both LNM and tumor deposits showed worse overall survival (hazard ratio = 1.33, 95% confidence interval: 1.20–1.47, P < 0.001). After the number of tumor deposits was added with that of positive regional lymph nodes, patients with both LNM and tumor deposits seemed to have prognostic implications similar to those with LNM alone (hazard ratio = 1.02, 95% confidence interval: 0.93–1.12, P = 0.66). The simultaneous presence of LNM and tumor deposits, as compared with the presence of only LNM, had an association with a worse outcome. Tumor deposits should be considered as LNM in patients with both tumor deposits and LNM in stage III colon cancer.

scholarly journals Retrospective comparison of efficacy and safety of CAPOX and FOLFOX regimens as adjuvant treatment in patients with stage III colon cancer

2019 ◽  
Vol 47 (6) ◽  
pp. 2507-2515 ◽  
Author(s):  
Serkan Degirmencioglu ◽  
Ozgur Tanrıverdi ◽  
Atike Gokcen Demiray ◽  
Hande Senol ◽  
Gamze Gokoz Dogu ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Adjuvant Treatment ◽  
Survival Rates ◽  
Mortality Rates ◽  
Stage Iii ◽  
Efficacy And Safety ◽  
Stage Iii Colon Cancer ◽  
Significant Difference

Objective This study aimed to evaluate the efficacy and safety profile of capecitabine and oxaliplatin (CAPOX) and 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) regimens as adjuvant treatment in patients with stage III colon cancer. Methods A total of 243 patients who received CAPOX and FOLFOX chemotherapy between 2014 and 2018 for stage III colon cancer in two centers were retrospectively studied. Among the patients, 106 (43.6%) and 137 (56.4%) were treated using CAPOX and FOLFOX regimens, respectively. Efficacy, treatment-related side effects, and overall survival rates with these two regimens were compared. Results The rate of disease progression was significantly higher in the presence of moderately/poorly differentiated histology, and KRAS and NRAS mutations. An increased number of metastatic lymph nodes and prolonged time from surgery to chemotherapy significantly increased disease progression. Patients who received CAPOX were significantly older than those who received FOLFOX. Disease progression, metastasis, and mortality rates were significantly higher in the FOLFOX arm than in the CAPOX arm. There was no significant difference in the overall survival rate between the two regimens. Conclusion The CAPOX regimen is preferred in older patients. Disease progression, metastasis, and mortality rates are higher with FOLFOX than with CAPOX.

KRAS mutation, cancer recurrence, and patient survival in stage III colon cancer: Findings from CALGB 89803

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4037-4037
Author(s):  
C. Fuchs ◽  
S. Ogino ◽  
J. A. Meyerhardt ◽  
N. Irahara ◽  
D. Niedzwiecki ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Kras Mutation ◽  
Patient Survival ◽  
Stage Iii ◽  
Wild Type ◽  
Stage Iii Colon Cancer ◽  
Mutational Status ◽  
Disease Free

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.

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