Treatment of pancreatic cancer with docetaxel and granulocyte colony-stimulating factor: A multicenter phase II study

Purpose: To determine the efficacy and tolerance of single-agent docetaxel and granulocyte colony-stimulating factor in patients with advanced pancrea tic cancer. Patients and Methods: Thirty-three chemotherapy-naive patients (median age, 65 years) with histologically confirmed pancreatic cancer were treated, af ter appropriate premedication, with docetaxel (100 mg/m(2)) and granulocyte colony-stimulating factor(150 mu g/m(2)/d subcutaneously days 2 through 10 ) every 3 weeks. World Health Organization performance status was 0 to 1 in 28 patients (85%) and 2 in 5 patients (15%), Twenty-nine patients had stag e III and IV disease. Results: One complete response (3%) and one partial response (3%) were obse rved far an overall response rate of 6% (95% confidence interval, 2.1% to 1 4.2%), Nineteen patients (58%) had stable disease and 12(36%) had progressi ve disease. The duration of the two objective responses was 10 and 28 weeks , and the median time to tumor progression was 20 weeks. The median overall survival was 36 weeks. The actuarial I-year survival was 36.4%, The perfor mance status improved in seven of 21 assessable patients (24%) and pain imp roved in 14 of 21 (67%) assessable patients; five patients (29%) experience d weight gain during treatment. Disease-related asthenia, anorexia, vomitin g, and diarrhea improved in 29%, 15%, 67%, and 47% of the assessable patien ts, respectively. Serum concentrations of CA 19-9 were decreased by more th an 50% in seven patients (35%). Grade 3 and 4 neutropenia occurred in four patients (12%) and eight patients (24%), respectively, with two episodes of febrile neutropenia. There were no treatment-related deaths. Grade 3/4 ast henia occurred in three patients. Conclusion: Although docetaxel teas a marginal objective activity in pancre atic cancer, it seems to have an important effect on tumor growth control, conferring a clinical benefit, (C) 1999 by American Society of Clinical Onc ology.