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Annals of Oncology Advance Access published online on March 31, 2005
Annals of Oncology, doi:10.1093/annonc/mdi160
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© 2005 European Society for Medical Oncology
Received June 25, 2004
Revised December 24, 2004
Accepted December 27, 2004

Original article

Carboplatin plus gemcitabine in patients with inoperable or metastatic pancreatic cancer: a phase II multicenter study by the Hellenic Cooperative Oncology Group

N. Xiros 1*, P. Papacostas 2, T. Economopoulos 1, G. Samelis 2, E. Efstathiou 3, E. Kastritis 2, H. Kalofonos 4, A. Onyenadum 4, D. Skarlos 5, A. Bamias 6, H. Gogas 7, D. Bafaloukos 8, E. Samantas 9, and P. Kosmidis 10

1 Second Department of Internal Medicine, Propaedeutic & Research Institute, University General Hospital ‘Attikon’, University of Athens, Athens, Greece
2 Oncology Unit, Ippokration Hospital, Athens, Greece
3 Department of Clinical Therapeutics, University of Athens, Athens, Greece
4 Division of Oncology, University of Patras, Patras, Greece
5 Second Department of Medical Oncology, ‘Henry Dynan’ Hospital, Athens, Greece
6 Department of Oncology, University of Ioannina, Ioannina, Greece
7 First Department of Medicine, Laiko Hospital, University of Athens, Athens, Greece
8 Oncology Department, Metropolitan Hospital, Athens, Greece
9 Third Department of Medical Oncology, ‘Agii Anargiri’ Hospital, Athens, Greece
10 Department of Oncology, ‘Hygeia’ Hospital Athens, Greece

* To whom correspondence should be addressed.
N. Xiros, E-mail: nxiros{at}otenet.gr


  Abstract

Background: In the present phase II multicenter study, we assessed the efficacy and tolerability of the combination of gemcitabine and carboplatin in patients with advanced pancreatic cancer.

Patients and methods: Patients with previously untreated, locally advanced or metastatic pancreatic cancer were treated with gemcitabine 800 mg/m2 on days 1 and 8 and carboplatin at an AUC of 4 on day 8 of a 3-week cycle, for a total of six cycles. Primary end points were response rate and clinical benefit; secondary end points were, survival, time to progression (TTP) and toxicity.

Results: A total of 50 patients were enrolled in the study, 47 of whom were eligible for treatment. The median age was 63 years (range 34-76) and the median Karnofsky performance status (PS) was 80%. Patients received a median of six cycles (range 1-11). Among 35 patients evaluable for response, eight (17%) achieved partial response; 15 (32%) and 12 (25%) patients had stable and progressive disease, respectively. The median overall survival was 7.4 months; the median TTP was 4.4 months and the 1-year survival was 28%. The observed clinical benefit response was remarkable. After the second cycle of chemotherapy, 21 of 31 (68%) patients experienced pain improvement and reduced analgesic consumption. At the same time, 35% and 56% of our patients significantly improved their Karnofsky PS and weight, respectively. Overall, the treatment was well tolerated. The most common grade 3-4 toxicities were hematological, including 8% anemia, 6% neutropenia and 13% thrombocytopenia.

Conclusions: The combination of gemcitabine plus carboplatin is a moderately active treatment for patients with locally advanced and metastatic pancreatic cancer. This regimen has an acceptable toxicity profile and provides a significant clinical benefit, and hence warrants further investigation.

Keywords: carboplatin; gemcitabine; pancreatic cancer.
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