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A phase I and extension study of S-1 and carboplatin for previously untreated patients aged 75 years or more with advanced non-small cell lung cancer -TCOG 1101.
International Journal of Clinical Oncology ( IF 3.3 ) Pub Date : 2020-02-14 , DOI: 10.1007/s10147-020-01629-6
Takashi Kasai 1 , Kiyoshi Mori 2 , Kazuma Kishi 3 , Takayuki Kaburagi 4 , Yukio Hosomi 5 , Hisao Imai 6 , Yutaka Yamada 4 , Makiko Yomota 5 , Syuhei Moriguchi 7 , Masahiro Seike 8 , Koichi Minato 6 , Akihiko Gemma 8 ,
Affiliation  

PURPOSE Combination carboplatin and S-1 is active in the treatment of non-small cell lung cancer (NSCLC). However, data on this combination for elderly patients with NSCLC are insufficient. METHODS Eligibility criteria were no prior chemotherapy, Stage IIIB or IV NSCLC, performance status 0-1, age ≥ 75 years, and adequate hematological, hepatic, and renal functions. Carboplatin was administered on day 1 and S-1 was administered orally, twice a day, between days 1 and 14, repeated every 3 weeks. In phase I, the primary purpose was determination of the recommended dose. Starting doses of carboplatin and S-1 were area under the curve (AUC) of 4 and 80 mg/m2/day, respectively. In the extension study, the effects and tolerability of this combination therapy of recommended dose were confirmed. RESULTS A total of 10 patients were entered into phase I and 14 patients were entered into the extension study. The recommended doses for this drug combination are AUC 5 for carboplatin and 80 mg/m2/day every 3 weeks for S-1. With carboplatin and S-1 combination therapy at the recommended dose, the response rate was 30.0% [95% confidence interval (CI) 12-54%] and the disease control rate was 90.0% (95% CI 68-99%). Thrombocytopenia and neutropenia were major adverse events. CONCLUSIONS The recommended doses for this combination therapy are carboplatin AUC 5 and S-1 80 mg/m2/day every 3 weeks, and this combination is effective with tolerable toxicities for advanced NSCLC patients ≥ 75 years old.

中文翻译:

S-1和卡铂的I期和扩展研究用于先前未接受治疗的75岁或以上的晚期非小细胞肺癌-TCOG 1101患者。

目的卡铂和S-1组合在非小细胞肺癌(NSCLC)的治疗中具有活性。然而,对于老年NSCLC患者,这种组合的数据不足。方法入选标准为既往未接受过化学疗法,IIIB或IV期NSCLC,工作状态为0-1,年龄≥75岁以及血液,肝和肾功能良好。卡铂在第1天给药,S-1在第1天至第14天之间每天两次口服给药,每3周重复一次。在第一阶段,主要目的是确定推荐剂量。卡铂和S-1的起始剂量分别为曲线下面积(AUC)4和80 mg / m2 / day。在扩展研究中,证实了推荐剂量的这种联合疗法的效果和耐受性。结果共有10例患者进入了I期研究,其中14例患者进入了扩展研究。对于卡铂,此药物组合的推荐剂量为AUC 5,对于S-1,每3周为80 mg / m2 /天。推荐剂量的卡铂和S-1联合治疗时,缓解率为30.0%[95%置信区间(CI)为12-54%],疾病控制率为90.0%(95%CI为68-99%)。血小板减少和中性粒细胞减少是主要的不良事件。结论该联合疗法的推荐剂量为每3周卡铂AUC 5和S-1 80 mg / m2 /天,这种联合疗法对≥75岁的晚期NSCLC患者有效,且具有可耐受的毒性。对于卡铂,此药物组合的推荐剂量为AUC 5,对于S-1,每3周为80 mg / m2 /天。推荐剂量的卡铂和S-1联合治疗时,缓解率为30.0%[95%置信区间(CI)为12-54%],疾病控制率为90.0%(95%CI为68-99%)。血小板减少和中性粒细胞减少是主要的不良事件。结论该联合疗法的推荐剂量为每3周卡铂AUC 5和S-1 80 mg / m2 /天,这种联合疗法对≥75岁的晚期NSCLC患者有效,且具有可耐受的毒性。对于卡铂,此药物组合的推荐剂量为AUC 5,对于S-1,每3周为80 mg / m2 /天。推荐剂量的卡铂和S-1联合治疗时,缓解率为30.0%[95%置信区间(CI)为12-54%],疾病控制率为90.0%(95%CI为68-99%)。血小板减少和中性粒细胞减少是主要的不良事件。结论该联合疗法的推荐剂量为每3周卡铂AUC 5和S-1 80 mg / m2 /天,这种联合疗法对≥75岁的晚期NSCLC患者有效,且具有可耐受的毒性。
更新日期:2020-02-14
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