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No added benefit with fixed-dose gemcitabine or gemcitabine plus oxaliplatin in pancreatic cancer
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Patients with advanced pancreatic cancer may not experience added benefit from either fixed-dose gemcitabine or gemcitabine plus oxaliplatin compared to single-agent gemcitabine, according to data from a phase-3, randomized trial from the Eastern Cooperative Oncology Group. Neither the fixed-dose nor the combination significantly increased survival or symptom benefit.
The study included 832 patients with metastatic or locally advanced pancreatic cancer, normal organ function and performance status of 0 to 2, according to the researchers. Patients were randomly assigned to gemcitabine 1,000 mg/m2/30 minutes, fixed-dose gemcitabine 1,500 mg/m2/150 minutes or gemcitabine 1,000 mg/m2/100 minutes/day plus oxaliplatin 100 mg/m2 on day two every 14-day cycle. The researchers compared OS among the groups.
Median survival and one-year survival varied among the treatment arms. Median survival was 4.9 months for gemcitabine (95% CI, 4.5-5.6), 6.2 months for fixed-dose gemcitabine (95% CI, 5.4-6.9) and 5.7 months for gemcitabine plus oxaliplatin (95% CI, 4.9-6.5). One-year survival was 16% for gemcitabine and 21% for both fixed-dose gemcitabine (HR=0.83; P=.04) and gemcitabine plus oxaliplatin (HR=0.88; P=.22). Differences among the groups did not meet statistical significance. Survival for patients with locally advanced disease was 9.2 months vs. 5.4 months for those with metastatic disease.
Fixed-dose gemcitabine was associated with grade-3/4 neutropenia and thrombocytopenia. Gemcitabine plus oxaliplatin was associated with higher rates of nausea, vomiting and neuropathy.
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