Pancreatic Cancer - Gemcitabine Therapy

3/29/00 (Del Rio)

Group: Wednesday Residents

RE: A 55 year old male presenting with history of weight loss and nausea/vomiting for 3 weeks.

Question: Is gemcitabine an effective therapy for advanced pancreatic cancer?

Link Directly to Fulltext Article at Publisher

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Unique Identifier: 99203013

Authors: Storniolo AM. Enas NH. Brown CA. Voi M. Rothenberg ML. Schilsky R.

Institution: Lilly Research Laboratories, Indianapolis, Indiana 46285-2225, USA.

Abstract: BACKGROUND: An Investigational New Drug (IND) treatment program allows patients access to a drug that has: shown activity against a serious or life-threatening disease prior to full Food and Drug Administration (FDA) review and: approval. This treatment IND program, in which patients with locally advanced or metastatic pancreatic carcinoma: were treated with gemcitabine, began in 1995. METHODS: Eligibility criteria were < or =1 prior chemotherapy: regimen; a Karnofsky performance status (KPS) of > or =50; and adequate bone marrow, liver, and renal function.: Gemcitabine was given at a dose of 1000 mg/m2 weekly x 7 followed by a week of rest, then weekly x 3 every 4: weeks thereafter. In this program, disease-related symptom improvement (DRSI) was defined retrospectively as 1): improvement in pain (on a 7-point scale) and/or analgesic class (e.g., morphine improving to codeine) and/or KPS (> or: =20 points), or 2) stability of these three parameters with a 7% increase in weight from baseline. RESULTS: A total of: 3023 patients enrolled. At baseline, 80% of them had Stage IV disease, and 84% had a baseline KPS > or = 70. The: median age was 65 years, and 56% of the patients were male. The cumulative DRSI response rate after the fourth cycle: was 18.4%. Of 982 patients with tumor response data, there were 14 with complete response and 104 with partial: response, for an overall response rate of 12.0% (95% confidence interval [CI], 10.0-14.0%). For 2380 patients with: survival data, the median survival was 4.8 months (95% CI, 4.5-5.1 months) and the 12-month survival was 15%.: Gemcitabine was well tolerated; only 4.6% of discontinuations were due to adverse events. CONCLUSIONS:: Notable disease-related symptom improvement and survival were seen with gemcitabine in this large,: compassionate-use setting, and these findings were in agreement with those of earlier registration trials.