| Autor: |
Ozaka, Masato, Matsumura, Yuji, Ishii, Hiroshi, Omuro, Yasushi, Itoi, Takao, Mouri, Hisatsugu, Hanada, Keiji, Kimura, Yasutoshi, Maetani, Iruru, Okabe, Yoshinobu, Tani, Masaji, Ikeda, Takaaki, Hijioka, Susumu, Watanabe, Ryouhei, Ohoka, Shinya, Hirose, Yuki, Suyama, Masafumi, Egawa, Naoto, Sofuni, Atsushi, Ikari, Takaaki |
| Předmět: |
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| Zdroj: |
Cancer Chemotherapy & Pharmacology; May2012, Vol. 69 Issue 5, p1197-1204, 8p |
| Abstrakt: |
Purpose: To evaluate the efficacy and safety of the combination of gemcitabine (GEM) and S-1 (GS) in comparison to GEM alone (G) for unresectable pancreatic cancer. Methods: In this multicenter randomized phase II study, we randomly assigned unresectable pancreatic cancer patients to either the GS group or the G group. The GS group regimen consists of intravenous 1,000 mg/m GEM during 30 min on days 1 and 8, combined with 80 mg/m oral S-1 twice daily on days 1-14, repeated every 3 weeks. On the other hand, the G group regimen consists of intravenous 1,000 mg/m GEM on days 1, 8, and 15, repeated every 4 weeks. The primary endpoint was objective response rate (ORR). Secondary end points included treatment toxicity, clinical response benefit, progression-free survival (PFS), and overall survival. Results: We registered 117 patients from 16 institutions between June 2007 and August, 2010. The ORR of the GS group was 28.3%, whereas that of the G group was 6.8%. This difference was statistically significant ( P = 0.005). The disease control rate was 64.2% in the GS group and 44.1% in the G group. Median PFS was 6.15 months in the GS group and 3.78 month in the G group. This was also statistically significant ( P = 0.0007). Moreover, the median overall survival (OS) of the GS group was significantly longer than that of the G group (13.7 months vs. 8.0 months; P = 0.035). The major grade 3-4 adverse events were neutropenia (54.7% in the GS group and 22.0% in the G group), thrombocytopenia (15.1% in the GS group and 5.1% in the G group), and skin rash (9.4% in the GS group). Conclusions: The GS group showed stronger anticancer activity than the G group, suggesting the need for a large randomized phase III study to confirm GS advantages in a specific subset. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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