Phase II study of gemcitabine and cisplatin in the treatment of patients with advanced pancreatic carcinoma.

摘要: BACKGROUND Pancreatic carcinoma is considered among the most chemoresistant of human malignancies. The commonly used cytotoxic single agents, 5-fluorouracil and 2′-deoxy-2′,2′-difluorocytidine (gemcitabine), have objective response rates less than 10% in large studies. Hypothesizing noncross resistance a synergistic interaction between gemcitabine cisplatin, early clinical studies demonstrated significant activity with this combination patients several types malignant disease. A Phase II study was undertaken to determine efficacy cisplatin locally advanced metastatic pancreatic based on these considerations. METHODS The eligibility criteria included histologically confirmed, advanced, unresectable or exocrine pancreas no prior therapy; adjuvant therapy allowed provided last day at least 6 months starting treatment; clinically measurable evaluable disease; Southwest Oncology Group scale performance status 0–2; life expectancy > 12 weeks; adequate bone marrow, hepatic, renal function. total 42 patients, 4 disease 38 disease, were treated received 211 cycles May 1997 March 1999. median age 61.5 years. outpatient setting 1,000 mg/M2 intravenously over 30 minutes administered Days 1, 8, 15 each cycle 50 after infusion 1 prehydration accompanied by urinary output. Cycles repeated every 28 days. Response toxicity assessed according World Health Organization standard criteria. RESULTS The complete partial rate all registered 11 (26%; 95% confidence interval, 0.14–0.42). Stabilization seen (38%). Two additional who achieved major responses chemotherapy rendered free surgically, achieving status. overall survival 7.1 (95% interval [CI], 6.3–9.1 months), 64% alive 19% months. time progression 5.4 (range, 0.9–20.8 months). Major toxicities neutropenia thrombocytopenia, one episode neutropenic fever. CONCLUSIONS The appeared significantly greater single-agent study, tolerable toxicity. antitumor needs be confirmed multi-institutional comparative trials. Cancer 2001;92:569–77. © 2001 American Society.