Annals of Oncology 11:1399-1403, 2000
© 2000 European Society for Medical Oncology
research-article |
Gemcitabine and cisplatin in the treatment of advanced or metastatic pancreatic cancer
1Klinikum Grosshadern München, Germany
2Westdeutsches Tumorzentrum Essen, Germany
3Medizinische Klinik II der Charité Berlin, Germany
4Medizinische Klinik der Universität Tübingen Tübingen, Germany
5Medizinische Universitätsklinik Erlangen Erlangen, Germany
6Städt Klinik, Abteilung Hämatologie Onkologie Oldenburg, Germany
7Lilly Deutschland GmbH Bad Homburg, Germany
8Klinikum Rechts der Isar München, Germany
Correspondence to: V. Heinemann, MD Klinikum Grosshadern Medizinisches Klinik III Marchioninistrasse 15 81377 München Germany E-mail: Volker.Heinemann{at}med3.med.uni-muenchen.de
BACKGROUND: This phase II study was initiated to determine the efficacy and safety of gemcitabine plus cisplatin in patients with pancreatic cancer.
PATIENTS AND METHODS: Gemcitabine 1000 mg/m2 was given on days 1, 8, and 15 of a 28-day schedule, and cisplatin 50 mg/m2 on days 1 and 15 to chemonaive patients with locally advanced or metastatic pancreatic cancer.
RESULTS: Of the 41 patients enrolled (median age 57, and 61% male), median Karnofsky performance status was 80%. Patients received a median of 4.2 cycles (range 1–11). In 35 evaluable patients, one complete response (CR) and three partial responses (PR) were observed, for an overall response rate of 11% (95% confidence interval (95% CI): 3.2%–26.7%). Stable disease (SD) >3 months occurred in 20 (57%) patients; 6 survived 
1 year. Median time to progressive disease was 4.3 months (95% CI: 3.0–5.7 months). For all patients, median survival was 8.2 months (95% CI: 6.1–10.6 months) with a one-year survival rate of 27%. Therapy was well tolerated. Grade 3–4 neutropenia (no grade 3–4 infection), thrombocytopenia (no bleeding), nausea/vomiting, and alopecia were reported in 29%, 13%, and 2.6% of patients, respectively.
CONCLUSIONS: The combination of gemcitabine and cisplatin is a moderately active treatment for patients with locally advanced and metastatic pancreatic cancer without compromising tolerability.
cisplatin, combination chemotherapy, gemcitabine, pancreatic cancer, prolonged survival
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