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Docetaxel Plus Gemcitabine or Docetaxel Plus Cisplatin in Advanced Pancreatic Carcinoma: Randomized Phase II Study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group

From the University of Ulm, Ulm; Westdeutsches Tumorzentrum, Essen; University of Dresden, Dresden; University Hospital Charite, Berlin; Horst-Schmidt-Kliniken, Wiesbaden, Germany; University Hospital Gasthuisberg, Leuven; Hôpital Universitaire Erasme, Brussels; European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium; University Medical Center, Nijmegen; Laurentius Ziekenhuis, Roermond, the Netherlands; Centre Hospitalier Universitaire Angers; Centre P. Papin, Angers; Centre Hospitalier Universitaire Ambroise Pare, Boulogne; Hôpital Pasteur, Colmar; Clinique Armoricaine de Radiotherapie, Saint Brieuc; Institut Gustave Roussy, Villejuif, France; and National Cancer Institute, Cairo, Egypt.

Address reprint requests to Manfred P. Lutz, MD, Caritasklinik St Theresia, Rheinstr 2, 66113 Saarbruecken, Germany; e-mail: m.lutz{at}caritasklinik.de

PURPOSE: To define the efficacy and toxicity of docetaxel plus gemcitabine or docetaxel plus cisplatin for advanced pancreatic carcinoma.

PATIENTS AND METHODS: Chemotherapy-naive patients with measurable disease and WHO performance status less than 2 were randomly assigned to receive 21-day cycles of gemcitabine 800 mg/m² on days 1 and 8 plus docetaxel 85 mg/m² on day 8 (arm A) or docetaxel 75 mg/m² on day 1 plus cisplatin 75 mg/m² on day 1 (arm B). Primary end points were tumor response and rate of febrile neutropenia grade.

RESULTS: Of 96 randomly assigned patients (49 patients in arm A and 47 patients in arm B), 70 patients were analyzed for response (36 in arm A and 34 in arm B) and 89 patients were analyzed for safety (45 in arm A and 44 in arm B). Confirmed responses were observed in 19.4% (95% CI, 8.2% to 36.0%) of patients in arm A and 23.5% (95% CI, 10.7% to 41.2%) in arm B. In arm A, the median progression-free survival (PFS) was 3.9 months (95% CI, 3.0 to 4.7 months), median survival was 7.4 months (95% CI, 5.6 to 11.0 months), and 1-year survival was 30%. In arm B, the median PFS was 2.8 months (95% CI, 2.6 to 4.6 months), median survival was 7.1 months (95% CI, 4.8 to 8.7 months), and 1-year survival was 16%. Febrile neutropenia occurred in 9% and 16% of patients in arms A and B, respectively.

CONCLUSION: Both regimens are well tolerated and show activity in advanced pancreatic carcinoma. The safety profile and survival analyses favor docetaxel plus gemcitabine for further evaluation.

Supported by an unrestricted educational grant to the European Organisation for Research and Treatment of Cancer Gastrointestinal Group by Aventis and by Grants No. 5U10 CA11488-29 through 5U10 CA11488-34 from the National Cancer Institute, Bethesda, MD.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, 2002, Orlando, FL.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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