Originally published as JCO Early Release 10.1200/JCO.2008.20.9007 on July 6 2009

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Phase III, Randomized Study of Gemcitabine and Oxaliplatin Versus Gemcitabine (fixed-dose rate infusion) Compared With Gemcitabine (30-minute infusion) in Patients With Pancreatic Carcinoma E6201: A Trial of the Eastern Cooperative Oncology Group

From the Cancer Institute of New Jersey, Brunswick, NJ; Dana-Farber Cancer Institute, Boston, MA; Vanderbilt University Medical Center, Nashville, TN; Pfizer; New York University Cancer Institute, New York, NY; Thomas Jefferson University; University of Pennsylvania, Philadelphia, PA; Mayo Clinic, Rochester, MN; and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.

Corresponding author: Elizabeth Poplin, MD, Cancer Institute of New Jersey,195 Little Albany St, New Brunswick, NJ 08903; e-mail: poplinea{at}umdnj.edu.

Purpose Single-agent gemcitabine (GEM) is standard treatment of metastatic pancreatic cancer. Fixed-dose rate (FDR) GEM and GEM plus oxaliplatin have shown promise in early clinical trials. E6201 was designed to compare overall survival (OS) of standard weekly GEM 1,000 mg/m²/30 minutes versus GEM FDR 1,500 mg/m²/150 minutes or GEM 1,000 mg/m²/100 minutes/day 1 plus oxaliplatin 100 mg/m²/day 2 every 14 days (GEMOX).

Methods This trial included patients with metastatic or locally advanced pancreatic cancer, normal organ function, and performance status of 0 to 2. The study was designed to detect a 33% difference in median survival (hazard ratio [HR] 0.75 for either of the experimental arms) with 81% power while maintaining a significance level of 2.5% in a two-sided test for each of the two primary comparisons.

Results Eight hundred thirty-two patients were enrolled. The median survival and 1-year survival were 4.9 months (95% CI, 4.5 to 5.6) and 16% for GEM, 6.2 months (95% CI, 5.4 to 6.9), and 21% for GEM FDR (HR, 0.83; stratified log-rank P = .04), and 5.7 months (95% CI, 4.9 to 6.5) and 21% for GEMOX (HR, 0.88; stratified log-rank P = .22). Neither of these differences met the prespecified criteria for significance. Survival was 9.2 months for patients with locally advanced disease, and 5.4 months for those with metastatic disease. Grade 3/4 neutropenia and thrombocytopenia were greatest with GEM FDR. GEMOX caused higher rates of nausea, vomiting, and neuropathy.

Conclusion Neither GEM FDR nor GEMOX resulted in substantially improved survival or symptom benefit over standard GEM in patients with advanced pancreatic cancer.

This study was coordinated by the Eastern Cooperative Oncology Group (Robert L. Comis), and supported in part by Public Health Service Grants No. CA23318, CA66636, CA21115, CA25224 and CA17145 from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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