Phase I/II study of s-1 plus cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer

Japanese Journal of Clinical Oncology
Masato FujiiToshiki Tomita

Abstract

The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC). S-1 was administered orally at 40 mg/m(2) twice daily for 14 consecutive days, and CDDP was infused on day 8 at a dose of 60 and 70 mg/m(2). Each course was repeated every 4 weeks. A total of 38 patients were registered, 10 patients for the Phase I study and an additional 28 patients for the Phase II study. Although no dose-limiting toxicity (DLT) was observed in the CDDP 60 mg/m(2) (Level 1) group, two of six patients in the CDDP 70 mg/m(2) (Level 2) group exhibited DLT (fatigue/diarrhea). The MTD was not achieved in the Phase I study. Level 2 was therefore determined as the RD. In the Phase II study, 34 patients, including 6 patients from the Phase I study, were evaluated. At the termination of treatment, the confirmed response rate was 44.1% (15/34, 95% CI: 27.4-60.8). The best response rate without an adequate duration time was 67.6% (95% CI: 51.9-83.4). The median survival period was 16.7 months, and the 1-year survival rate was 60.1%. The main toxicities of Grade 3 or above were anore...Continue Reading

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Citations

Feb 12, 2013·Acta Pharmacologica Sinica·Zhi-xiang ZhuangHong Zhang
May 5, 2009·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Tokujiro YanoUNKNOWN Lung Oncology Group in Kyushu (LOGIK)
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Jan 13, 2011·The Tohoku Journal of Experimental Medicine·Yukako IchimiyaHiromasa Horiguchi
Sep 25, 2021·Updates in Surgery·Takamasa TakahashiKazuaki Seita
Apr 15, 2011·Current Opinion in Oncology

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