Phase I/II Study of S-1 Plus Cisplatin Alternating With S-1 Plus Docetaxel in Patients With Advanced Gastric Cancer. (October 2018)

• Record Type: Journal Article
• Authors: Hosokawa, Ayumu; Ando, Takayuki; Ogawa, Kohei; Ueda, Akira; Yoshita, Hiroki; Mihara, Hiroshi; Fujinami, Haruka; Kajiura, Shinya; Yabushita, Kazuhisa; Horikawa, Naoki; Kobayashi, Yuka; Yoshioka, Akira; Origasa, Hideki; Sugiyama, Toshiro
• Is Part Of: American journal of clinical oncology. Volume 41:Number 10(2018)
• Publication Date: 2018-10
• Subjects: gastric cancer -- S-1 -- cisplatin -- docetaxel -- alternating chemotherapy; Cancer -- Treatment -- Periodicals; Oncology -- Periodicals; Tumors -- Periodicals; 616.994005
• DOI: 10.1097/COC.0000000000000405
• Languages: English
• ISSNs: 0277-3732

Abstract

Abstract : Objectives: To investigate the usefulness of S-1 plus cisplatin alternating with S-1 plus docetaxel as first-line treatment in patients with advanced gastric cancer, we conducted a phase I/II study to determine the maximum tolerated dose and recommended dose, and evaluate efficacy and toxicity. Materials and Methods: Patients with histologically confirmed unresectable and recurrent gastric cancer were enrolled in this study. Cisplatin was administered on day 1 and the dose escalated by 10 mg/m 2 from a starting dose of 40 mg/m 2 in the phase I part. S-1 was given orally at 80 mg/m 2 on days 1 to 14 and docetaxel at 40 mg/m 2 on day 22 in combination with S-1 80 mg/m 2 on days 22 to 35. The treatment was repeated every 6 weeks. The primary endpoint of the phase II analysis was the response rate. Results: Nine patients entered the phase I and 24 the phase II part. Because 50% of patients (3/6) developed dose-limiting toxicities in the phase I part, the maximum tolerated dose of cisplatin was presumed to be 50 mg/m 2 . Therefore, the estimated recommended dose of cisplatin was 40 mg/m 2 ; 27 patients received that dose. The response rate was 59.3% (95% confidence interval, 40.8-77.8) and the median follow-up 26.2 months. The median progression-free survival was 7.9 months and the median overall survival 18.6 months. The most common grade 3/4 toxicities were neutropenia (59.3%), leucopenia (37.0%), and anemia (29.6%). These toxicities were tolerable and manageable. Conclusion: This alternating treatment seems to have promising activity with tolerable toxicities in the first-line treatment of patients with advanced gastric cancer.