National Institute of Sensory Organs, National Tokyo Medical Center, 2-5-1, Higashigaoka, Meguro-ku, Tokyo 152-8902, Japan.
Jpn J Clin Oncol. 2010 Mar;40(3):214-21. doi: 10.1093/jjco/hyp153. Epub 2009 Nov 23.
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 anorexia (26.5%), nausea (14.7%), neutropenia/thrombocytopenia (11.8%) and anemia/fatigue (8.8%).
This is considered to be an effective regimen with acceptable toxicities for HNC.
本研究旨在确定 S-1 联合顺铂（CDDP）治疗晚期/复发性头颈部癌（HNC）的最大耐受剂量（MTD）和推荐剂量（RD），并评估使用该 RD 的安全性和疗效。
S-1 口服，剂量为 40 mg/m²，每日 2 次，连用 14 天；CDDP 于第 8 天输注，剂量为 60 和 70 mg/m²。每 4 周重复一个疗程。
共登记了 38 例患者，10 例患者进行了 I 期研究，另外 28 例患者进行了 II 期研究。虽然在 CDDP 60 mg/m²（Level 1）组中未观察到剂量限制毒性（DLT），但在 CDDP 70 mg/m²（Level 2）组的 6 例患者中有 2 例出现 DLT（乏力/腹泻）。I 期研究未达到 MTD。因此，Level 2 被确定为 RD。在 II 期研究中，包括 I 期研究中的 6 例患者在内，共评估了 34 例患者。治疗结束时，确认的缓解率为 44.1%（15/34，95%CI：27.4-60.8）。无充分持续时间的最佳缓解率为 67.6%（95%CI：51.9-83.4）。中位生存时间为 16.7 个月，1 年生存率为 60.1%。3 级或以上主要毒性为厌食（26.5%）、恶心（14.7%）、中性粒细胞减少/血小板减少（11.8%）和贫血/乏力（8.8%）。
对于 HNC，这被认为是一种有效且毒性可接受的方案。
