@article{3093943, title = "Carboplatin plus gemcitabine in patients with inoperable or metastatic pancreatic cancer: a phase II multicenter study by the Hellenic Cooperative Oncology Group", author = "Xiros, N and Papacostas, P and Economopoulos, T and Samelis, G and and Efstathiou, E and Kastritis, E and Kalofonos, H and Onyenatum, A and and Skarlos, D and Bamias, A and Gogas, H and Bafaloukos, D and Samantas, E and and Kosmidis, P", journal = "Annals of Oncology", year = "2005", volume = "16", number = "5", pages = "773-779", publisher = "Oxford University Press", issn = "0923-7534, 1569-8041", doi = "10.1093/annonc/mdi160", keywords = "carboplatin; gemcitabine; pancreatic cancer", 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 800mg/m(2) on days I 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 I-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." }