Gemcitabine in advanced pancreatic cancer - A phase II trial

The 5-year survival for pancreatic cancer is usually less than 5%, and no t reatment has demonstrated consistent effect on patient survival and disease -related symptoms. Early studies with gemcitabine suggested a modest antitu mor activity with significant improvement in disease-related symptoms. This phase II study reports the activity of gemcitabine on 33 consecutive patie nts with unresectable pancreatic carcinoma. Twenty-three patients had metas tatic and 10 locally advanced unresectable disease. Twenty-six patients had not received any previous treatment and seven had received first-line chem otherapy with 5-fluorouracil. Gemcitabine 1,000 mg/m(2) was administered in travenously in 30 minutes in the first cycle once weekly for up to 7 weeks followed by 1 week rest; then in subsequent cycles, once weekly for 3 of ev ery 4-week cycle. Four patients obtained partial response (12%). Fifteen pa tients (45%) had stable disease with a median duration of 32 weeks (range: 16-75 weeks), and 14 patients experienced progressive disease. Median durat ion of response was 34.5 weeks (range: 19-50 weeks). Median survival was 33 weeks (range: 2-91 weeks). All 4 responding patients and 14 of 15 (93%) pa tients with stable disease had improvement in performance status and decrea se in daily analgesic requirement. Toxicity was mild and mainly consisted o f moderate and rapidly reversible myelosuppression. We conclude that gemcit abine chemotherapy was very well tolerated and determined a significant cli nical improvement with modest antitumoral activity in patients with advance d pancreatic cancer.