Faculty Collaboration Database

Multicenter phase II trial of S-1 plus cisplatin in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol 2006 Feb 01;24(4):663-7

Date

02/01/2006

Pubmed ID

16446338

DOI

10.1200/JCO.2005.04.2994

Scopus ID

2-s2.0-33644833992 (requires institutional sign-in at Scopus site)   93 Citations

Abstract

PURPOSE: S-1 plus cisplatin is considered highly active in Japanese gastric cancer patients. We conducted a phase II multi-institutional trial, in the West, in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma to evaluate activity and safety of this combination.

METHODS: Patients received cisplatin intravenously at 75 mg/m2 on day 1 and S-1 orally at 25 mg/m2/dose bid (50 mg/m2/d) on days 1 to 21, repeated every 28 days. Patients with histologic proof of gastric or gastroesophageal junction adenocarcinoma with a Karnofsky performance status (KPS) of > or = 70% and near-normal organ function were eligible. All patients provided a written informed consent. To observe a 45% confirmed overall response rate (ORR), 41 assessable patients were needed.

RESULTS: All 47 patients were assessed for safety and survival, and 41 patients were assessed for ORR. The median age was 56 years and median KPS was 80%. The median number of chemotherapy cycles was four. The confirmed ORR was 51% (95% CI, 35% to 67%) and it was 49% by an independent review. At the 6-month interval, 71% of patients were alive, with a median survival time of 10.9 months. Frequent grade 3 or 4 toxicities included fatigue (26%), neutropenia (26%), vomiting (17%), diarrhea (15%), and nausea (15%); however, stomatitis (2%) and febrile neutropenia (2%) were uncommon. There was one (2%) treatment-related death.

CONCLUSION: S-1 plus cisplatin is active against gastric cancer and has a favorable toxicity profile. A global phase III study of S-1 plus cisplatin versus fluorouracil plus cisplatin currently is accruing patients.

Author List

Ajani JA, Lee FC, Singh DA, Haller DG, Lenz HJ, Benson AB 3rd, Yanagihara R, Phan AT, Yao JC, Strumberg D

Author

Alexandria T. Phan MD Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adenocarcinoma
Adult
Aged
Antimetabolites, Antineoplastic
Antineoplastic Combined Chemotherapy Protocols
Cisplatin
Drug Administration Schedule
Drug Combinations
Esophagogastric Junction
Female
Humans
Male
Middle Aged
Oxonic Acid
Pyridines
Stomach Neoplasms
Survival Analysis
Tegafur
Treatment Outcome