Efficacy of Second-Line Oxaliplatin, Leucovorin, and Fluorouracil in Gemcitabine-Refractory Pancreatic Cancer

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Second-line oxaliplatin, leucovorin, and fluorouracil significantly increased overall survival.
Second-line oxaliplatin, leucovorin, and fluorouracil significantly increased overall survival.

According to a new study published in the Journal of Clinical Oncology, second-line oxaliplatin, leucovorin (folinic acid), and fluorouracil (5-FU) (OFF) significantly increased overall survival compared with leucovorin and 5-FU (FF) for the treatment of patients with advanced gemcitabine-refractory pancreatic cancer.

Researchers found that OFF extended duration of overall survival by 2.6 months over treatment with FF (P=0.010).

Furthermore, researchers found that treatment with OFF significantly increased median time to disease progression by 0.9 months when compared with FF (P=0.019). Both groups experienced anemia, diarrhea, leukopenia, nausea and vomiting, pain, and thrombocytopenia; however, patients treated with OFF had a significantly increased incidence of neuropathy (P<0.001).1

In the randomized, open-label, phase 3 study, researchers enrolled 77 patients to receive OFF and 91 patients to the FF intervention from 2004 to 2007. Patients with advanced pancreatic cancer were eligible if they experienced disease progression while being treated with first-line gemcitabine.

RELATED: GSTM1-Null Genotype Predicts Oxaliplatin-Associated Sinusoidal Obstruction Syndrome in Metastatic Colorectal Cancer

Patients assigned to FF received leucovorin 200 mg/m2 followed by a continuous intravenous infusion of 5-FU 2,000 mg/m2 over 24 hours on days 1, 8, 15, and 22. Patients assigned to OFF receive the same regimen as those in the FF group plus oxaliplatin 85 mg/m2 intravenously administered prior to FF on days 8 and 22 only. After a 3-week rest period, patients initiated day 1 of cycle 2 on day 43.1

After disease progression while on gemcitabine, there is no consensus among clinicians surrounding second-line therapy for patients with advanced pancreatic cancer. The authors acknowledge that this study was initiated prior to FOLFIRINOX and nab-paclitaxel with gemcitabine becoming first-line treatment for those with advanced pancreatic cancer. Because that regimen contains OFF, overlapping neurotoxicities were not anticipated in this study.

The researchers suggest that OFF therapy may be beneficial in patients who have been treated gemcitabine plus the tyrosine-kinase inhibitor erlotinib or in patients who have undergone therapy with nab-paclitaxel plus gemcitabine.1


  1. Oettle H, Riess H, Stieler JM, et al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014;32(23):2423-2429.

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