Randomized phase II study of gemcitabine and S-1 combination versus gemcitabine alone in the treatment of unresectable advanced pancreatic cancer (Japan Clinical Cancer Research Organization PC-01 study)
| Autor: | Takao Itoi, Masato Ozaka, Yuki Hirose, Atsushi Sofuni, Masafumi Suyama, Naoto Egawa, Yoshinobu Okabe, Masaji Tani, Yasushi Omuro, Takaaki Ikeda, Yuji Matsumura, Yasutoshi Kimura, Toshifusa Nakajima, Iruru Maetani, Hiroshi Ishii, Takaaki Ikari, Susumu Hijioka, Ryouhei Watanabe, Shinya Ohoka, Hisatsugu Mouri, Keiji Hanada |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Time Factors medicine.medical_treatment Phases of clinical research Neutropenia Adenocarcinoma Toxicology Gastroenterology Deoxycytidine Disease-Free Survival Pancreatic cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Medicine Humans Pharmacology (medical) Adverse effect Aged Tegafur Pharmacology Chemotherapy business.industry Middle Aged medicine.disease Gemcitabine Pancreatic Neoplasms Survival Rate Regimen Drug Combinations Oxonic Acid Treatment Outcome Female business medicine.drug |
| Zdroj: | Cancer chemotherapy and pharmacology. 69(5) |
| ISSN: | 1432-0843 |
| Popis: | 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.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(2) GEM during 30 min on days 1 and 8, combined with 80 mg/m(2) 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(2) 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.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).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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink