Kodaira Takeshi, Fuwa Nobukazu, Tachibana Hiroyuki, Hidano Satoshi
Department of Therapeutic Radiation Oncology, Aichi Cancer Center Hospital, 464-8681 Nagoya, Aichi, Japan.
Anticancer Res. 2006 May-Jun;26(3B):2265-8.
A phase I study of chemotherapy was planned with S-1 and nedaplatin to find the optimal dose for patients with recurrent head and neck cancer.
Oral administration of S-1 (days 1-14) and intravenous nedaplatin (day 8) were tested for patients with recurrent head and neck cancer in a phase-I setting. The dose of S-1 was fixed and the dose of nedaplatin was escalated from 80 mg/m2, with an increase of 10 mg/m2 per step, to find the maximum tolerated dose.
Nine patients were recruited in this trial. The maximum tolerated dose (MTD) of nedaplatin was 90 mg/m2. At this dose level, dose-limiting toxicity (DLT) was observed in two out of three patients. One experienced grade 4 thrombocytopenia and febrile grade 3 neutropenia, while the other suffered myelosuppression causing more than a two-week delay of the second chemotherapy cycle. Myelosuppression was the DLT of this regimen.
The recommended phase II dose of nedaplatin combined with oral S-1 was identified as 80 mg/m2.
计划开展一项关于S-1和奈达铂的化疗I期研究，以确定复发性头颈癌患者的最佳剂量。
在I期研究中，对复发性头颈癌患者进行了口服S-1（第1 - 14天）和静脉注射奈达铂（第8天）的测试。S-1剂量固定，奈达铂剂量从80mg/m²开始逐步递增，每次增加10mg/m²，以确定最大耐受剂量。
本试验招募了9名患者。奈达铂的最大耐受剂量（MTD）为90mg/m²。在此剂量水平下，三名患者中有两名出现剂量限制性毒性（DLT）。一名患者出现4级血小板减少症和3级发热性中性粒细胞减少症，另一名患者出现骨髓抑制，导致第二个化疗周期延迟超过两周。骨髓抑制是该方案的剂量限制性毒性。
奈达铂联合口服S-1的推荐II期剂量确定为80mg/m²。
