| 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). | |
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MedLine Citation:
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PMID: 22249272 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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(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. 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. |
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Authors:
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Masato Ozaka; Yuji Matsumura; Hiroshi Ishii; Yasushi Omuro; Takao Itoi; Hisatsugu Mouri; Keiji Hanada; Yasutoshi Kimura; Iruru Maetani; Yoshinobu Okabe; Masaji Tani; Takaaki Ikeda; Susumu Hijioka; Ryouhei Watanabe; Shinya Ohoka; Yuki Hirose; Masafumi Suyama; Naoto Egawa; Atsushi Sofuni; Takaaki Ikari; Toshifusa Nakajima |
Publication Detail:
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Type: Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2012-01-17 |
Journal Detail:
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Title: Cancer chemotherapy and pharmacology Volume: 69 ISSN: 1432-0843 ISO Abbreviation: Cancer Chemother. Pharmacol. Publication Date: 2012 May |
Date Detail:
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Created Date: 2012-04-26 Completed Date: 2012-06-18 Revised Date: 2013-06-03 |
Medline Journal Info:
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Nlm Unique ID: 7806519 Medline TA: Cancer Chemother Pharmacol Country: Germany |
Other Details:
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Languages: eng Pagination: 1197-204 Citation Subset: IM |
Affiliation:
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Department of Gastroenterology, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan. masato.ozaka@jfcr.or.jp |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adenocarcinoma
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drug therapy*,
pathology Adult Aged Antineoplastic Combined Chemotherapy Protocols / adverse effects, therapeutic use* Deoxycytidine / administration & dosage, analogs & derivatives Disease-Free Survival Drug Combinations Female Humans Male Middle Aged Oxonic Acid / administration & dosage Pancreatic Neoplasms / drug therapy*, pathology Survival Rate Tegafur / administration & dosage Time Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Drug Combinations; 150863-82-4/S 1 (combination); 17902-23-7/Tegafur; 937-13-3/Oxonic Acid; 951-77-9/Deoxycytidine; B76N6SBZ8R/gemcitabine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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