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Multicenter Phase II Trial of S-1 Plus Cisplatin in Patients With Untreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

From the Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX; University of New Mexico, Albuquerque, NM; University of Chicago; Northwestern University, Chicago, IL; University of Pennsylvania, Philadelphia, PA; University of Southern California, Los Angeles; Hazel Hawkins Hospital, Hollister, CA; and University of Bochum, Herne, Germany

Address reprint requests to Jaffer A. Ajani, MD, The University of Texas M.D. Anderson Cancer Center, Mail Stop 426, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: jajani{at}mdanderson.org

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 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.

Supported by a grant from Taiho Pharma USA Inc, Princeton, NJ.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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