Oncology Medical News about Gemcitabine, Oxaliplatin, Pancreatic carcinoma

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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
Journal of Clinical Oncology, 08/10/09

Poplin E et al. - Neither fixed-dose rate gemcitabine (GEM FDR) nor GEM plus oxaliplatin (GEMOX) resulted in substantially improved survival or symptom benefit over standard GEM in patients with advanced pancreatic cancer.

Methods

Study was designed to compare overall survival (OS) of:
- Standard weekly GEM 1,000 mg/m2/30 minutes vs GEM FDR 1,500 mg/m2/150 min or
- GEM 1,000 mg/m2/100 min/d 1 plus oxaliplatin 100 mg/m2/day 2 every 14 days (GEMOX)
in pts 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 with 81% power, and
- Also maintaining a significance level of 2.5% in a 2-sided test for each of the 2 primary comparisons

Results

832 pts were enrolled; median survival and 1-yr survival were:
- 4.9 mo and 16% for GEM
- 6.2 mo and 21% for GEM FDR, and
- 5.7 mo and 21% for GEMOX
Neither of these differences met the prespecified criteria for significance
Survival was 9.2 mo for pts with locally advanced disease; 5.4 mo 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

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