TY - JOUR
TI - Carboplatin plus gemcitabine in patients with inoperable or metastatic
pancreatic cancer: a phase II multicenter study by the Hellenic
Cooperative Oncology Group
AU - Xiros, N
AU - Papacostas, P
AU - Economopoulos, T
AU - Samelis, G and
AU - Efstathiou, E
AU - Kastritis, E
AU - Kalofonos, H
AU - Onyenatum, A and
AU - Skarlos, D
AU - Bamias, A
AU - Gogas, H
AU - Bafaloukos, D
AU - Samantas, E
AU - and Kosmidis, P
JO - Annals of Oncology
PY - 2005
VL - 16
TODO - 5
SP - 773-779
PB - Oxford University Press
SN - 0923-7534, 1569-8041
TODO - 10.1093/annonc/mdi160
TODO - carboplatin; gemcitabine; pancreatic cancer
TODO - 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.
ER -