IMPROVEMENTS IN SURVIVAL AND CLINICAL BENEFIT WITH GEMCITABINE AS FIRST-LINE THERAPY FOR PATIENTS WITH ADVANCED PANCREAS CANCER - A RANDOMIZED TRIAL

Purpose: Most patients with advanced pancreas cancer experience pain a nd must limit their daily activities because of tumor-related symptoms , To date, no treatment has had a significant impact on the disease. I n early studies with gemcitabine, patients with pancreas cancer experi enced an improvement in disease-related symptoms. Based on those findi ngs, a definitive trial was performed to assess the effectiveness of g emcitabine in patients with newly diagnosed advanced pancreas cancer. Patients and Methods: One hundred twenty-six patients with advanced sy mptomatic pancreas cancer completed a lead-in period to characterize a nd stabilize pain and were randomized to receive either gemcitabine 1, 000 mg/m(2) weekly x 7 followed by 1 week of rest, then weekly x 3 eve ry 4 weeks thereafter (63 patients), or to fluorouracil (5-FU) 600 mg/ m(2) once weekly (63 patients). The primary efficacy measure was clini cal benefit response, which was a composite of measurements of pain (a nalgesic consumption and pain intensity), Karnofsky performance status , and weight, Clinical benefit required a sustained (greater than or e qual to 4 weeks) improvement in at least one parameter without worseni ng in any others. Other measures of efficacy included response rate, t ime to progressive disease, and survival, Results: Clinical benefit re sponse was experienced by 23.8% of gemcitabine-treated patients compar ed with 4.8% of 5-FU-treated patients (P = .0022), The median survival durations were 5.65 and 4,41 months for gemcitabine-treated and 5-FU- treated patients, respectively (P = .0025), The survival rate at 12 mo nths was 18% for gemcitabine patients and 2% for 5-FU patients, Treatm ent wets well tolerated. Conclusion: This study demonstrates that gemc itabine is more effective than 5-FU in alleviation of some disease-rel ated symptoms in patients with advanced, symptomatic pancreas cancer. Gemcitabine also confers a modest survival advantage over treatment wi th 5-FU, (C) 1997 by American Society of Clinical Oncology.