Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial
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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 : outcomes from the CONKO-003 trial. / Oettle, Helmut; Riess, Hanno; Stieler, Jens M; Heil, Gerhard; Schwaner, Ingo; Seraphin, Jörg; Görner, Martin; Mölle, Matthias; Greten, Tim F; Lakner, Volker; Bischoff, Sven; Sinn, Marianne; Dörken, Bernd; Pelzer, Uwe.
In: J CLIN ONCOL, Vol. 32, No. 23, 10.08.2014, p. 2423-9.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial
T2 - outcomes from the CONKO-003 trial
AU - Oettle, Helmut
AU - Riess, Hanno
AU - Stieler, Jens M
AU - Heil, Gerhard
AU - Schwaner, Ingo
AU - Seraphin, Jörg
AU - Görner, Martin
AU - Mölle, Matthias
AU - Greten, Tim F
AU - Lakner, Volker
AU - Bischoff, Sven
AU - Sinn, Marianne
AU - Dörken, Bernd
AU - Pelzer, Uwe
N1 - © 2014 by American Society of Clinical Oncology.
PY - 2014/8/10
Y1 - 2014/8/10
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Deoxycytidine/analogs & derivatives
KW - Disease Progression
KW - Drug Resistance, Neoplasm
KW - Female
KW - Fluorouracil/administration & dosage
KW - Humans
KW - Leucovorin/administration & dosage
KW - Male
KW - Middle Aged
KW - Organoplatinum Compounds/administration & dosage
KW - Oxaliplatin
KW - Pancreatic Neoplasms/drug therapy
KW - Survival Analysis
KW - Treatment Outcome
U2 - 10.1200/JCO.2013.53.6995
DO - 10.1200/JCO.2013.53.6995
M3 - SCORING: Journal article
C2 - 24982456
VL - 32
SP - 2423
EP - 2429
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 23
ER -
