S-1与奈达铂用于头颈部癌复发患者的I期研究。
Phase I study of S-1 and nedaplatin for patients with recurrence of head and neck cancer.
作者信息
Kodaira Takeshi, Fuwa Nobukazu, Tachibana Hiroyuki, Hidano Satoshi
机构信息
Department of Therapeutic Radiation Oncology, Aichi Cancer Center Hospital, 464-8681 Nagoya, Aichi, Japan.
出版信息
Anticancer Res. 2006 May-Jun;26(3B):2265-8.
UNLABELLED
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.
MATERIALS AND METHODS
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.
RESULTS
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.
CONCLUSION
The recommended phase II dose of nedaplatin combined with oral S-1 was identified as 80 mg/m2.
未标注
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。
材料与方法
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。
结果
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。
结论
奈达铂联合口服S-1的推荐II期剂量确定为80mg/m²。
Zotero 插件