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Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer : outcomes from the CONKO-003 trial

Item Type:Article
Title:Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer : outcomes from the CONKO-003 trial
Creators Name:Oettle, H. and Riess, H. and Stieler, J.M. and Heil, G. and Schwaner, I. and Seraphin, J. and Goerner, M. and Moelle, M. and Greten, T.F. and Lakner, V. and Bischoff, S. and Sinn, M. and Doerken, B. and Pelzer, U.
Abstract:PURPOSE: To assess the efficacy of a second-line regimen of oxaliplatin and folinic acid-modulated fluorouracil in patients with advanced pancreatic cancer who have experienced progression while receiving gemcitabine monotherapy. PATIENTS AND METHODS: A randomized, open-label, phase III study was conducted in 16 institutions throughout Germany. Recruitment ran from January 2004 until May 2007, and the last follow-up concluded in December 2012. Overall, 168 patients age 18 years or older who experienced disease progression during first-line gemcitabine therapy were randomly assigned to folinic acid and fluorouracil (FF) or oxaliplatin and FF (OFF). Patients were stratified according to the presence of metastases, duration of first-line therapy, and Karnofsky performance status. RESULTS: Median follow-up was 54.1 months, and 160 patients were eligible for the primary analysis. The median overall survival in the OFF group (5.9 months; 95% CI, 4.1 to 7.4) versus the FF group (3.3 months; 95% CI, 2.7 to 4.0) was significantly improved (hazard ratio [HR], 0.66; 95% CI, 0.48 to 0.91; log-rank P = .010). Time to progression with OFF (2.9 months; 95% CI, 2.4 to 3.2) versus FF (2.0 months; 95% CI, 1.6 to 2.3) was significantly extended also (HR, 0.68; 95% CI, 0.50 to 0.94; log-rank P = .019). Rates of adverse events were similar between treatment arms, with the exception of grades 1 to 2 neurotoxicity, which were reported in 29 patients (38.2%) and six patients (7.1%) in the OFF and FF groups, respectively (P < .001). CONCLUSION: Second-line OFF significantly extended the duration of overall survival when compared with FF alone in patients with advanced gemcitabine-refractory pancreatic cancer.
Keywords:Antineoplastic Combined Chemotherapy Protocols, Deoxycytidine, Disease Progression, Fluorouracil, Leucovorin, Neoplasm Drug Resistance, Organoplatinum Compounds, Pancreatic Neoplasms, Survival Analysis, Treatment Outcome
Source:Journal of Clinical Oncology
ISSN:0732-183X
Publisher:American Society of Clinical Oncology (U.S.A.)
Volume:32
Number:23
Page Range:2423-2429
Date:10 August 2014
Official Publication:https://doi.org/10.1200/JCO.2013.53.6995
PubMed:View item in PubMed

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