多西他赛与S-1用于既往治疗过的晚期非小细胞肺癌患者的I/II期研究：LOGIK0408

Phase I/II Study of Docetaxel and S-1 in Previously-Treated Patients with Advanced Non-Small Cell Lung Cancer: LOGIK0408.

作者信息

Takayama Koichi, Uchino Junji, Fujita Masaki, Tokunaga Shoji, Imanaga Tomotoshi, Morinaga Ryotaro, Ebi Noriyuki, Saeki Sho, Matsukizono Kazuya, Wataya Hiroshi, Yamada Tadaaki, Nakanishi Yoichi

机构信息

Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka 8190395, Japan.

Department of Respiratory Medicine, Kyoto Prefectural University of Medicine, Kyoto 6020841, Japan.

出版信息

J Clin Med. 2019 Dec 12;8(12):2196. doi: 10.3390/jcm8122196.

DOI:10.3390/jcm8122196

PMID:31842381

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6947543/

Abstract

BACKGROUND

As docetaxel plus S-1 may be feasible for cancer treatment, we conducted a phase I/II trial to determine the recommended docetaxel dose and the fixed S-1 dose (phase I), as well as confirm the regimen's efficacy and safety (phase II) for previously-treated patients with advanced non-small cell lung cancer.

METHODS

Patients ≤75 years with performance status ≤1 and adequate organ function were treated at three-week intervals with docetaxel on day 1 and 80 mg/m oral S-1 from days 1-14. The starting docetaxel dose was 45 mg/m and this was escalated to a maximum of 70 mg/m. In phase II, response rate, progression-free survival (PFS), overall survival (OS), and safety were assessed.

RESULTS

The recommended doses were 50 mg/m docetaxel (day 1) and 80 mg/m S-1 (days 1-14). Grades 3 and 4 leukocytopenia and neutropenia occurred in 44% and 67% of patients, respectively. Nonhematologic toxicities were generally mild. Overall response to chemotherapy was 7.7% (95% confidence interval (CI), 1.6-20.9%), and median PFS and OS were 18.0 weeks (95% CI; 11.3-22.9 weeks) and 53.0 weeks, respectively.

CONCLUSION

Fifty mg/m docetaxel plus 80 mg/m oral S-1 had a lower response rate than anticipated; however, the survival data were encouraging. A further investigation is warranted to select the optimal patient population.

摘要

背景

鉴于多西他赛联合S-1可能对癌症治疗有效，我们开展了一项I/II期试验，以确定多西他赛的推荐剂量和固定的S-1剂量（I期），并确认该方案对既往接受过治疗的晚期非小细胞肺癌患者的疗效和安全性（II期）。

方法

年龄≤75岁、体能状态≤1且器官功能良好的患者，每三周接受一次治疗，第1天给予多西他赛，第1 - 14天给予80mg/m²口服S-1。多西他赛起始剂量为45mg/m²，逐步递增至最大70mg/m²。在II期，评估缓解率（RR）、无进展生存期（PFS）、总生存期（OS）和安全性。

结果

推荐剂量为多西他赛50mg/m²（第1天）和S-1 80mg/m²（第1 - 14天）。44%和67%的患者分别出现3级和4级白细胞减少和中性粒细胞减少。非血液学毒性一般较轻。化疗的总体缓解率为7.7%（95%置信区间（CI），1.6 - 20.9%），PFS和OS的中位数分别为18.0周（95%CI；11.3 - 22.9周）和53.0周。