A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)
A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)
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DOI：
10.1007/s00280-017-3432-4
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发表时间：
2017-11-01
影响因子：
3
通讯作者：
Nishimura, Masaharu
中科院分区：
文献类型：
--
作者：
Ikezawa, Yasuyuki;Asahina, Hajime;Nishimura, Masaharu
很大一部分野生型 EGFR 非小细胞肺癌 (NSCLC) 患者接受三线及以上治疗，但没有前瞻性随机试验解决该问题。本研究旨在选择最合适的方案作为野生型 EGFR NSCLC 的三线或四线治疗。 这项在日本进行的多中心、随机 II 期研究纳入了患有野生型或未知 EGFR 的复发或晚期 NSCLC 患者，这些患者在之前的两到三次化疗后病情进展。患者每 3 周被随机分配至厄洛替尼（150 毫克/天，第 1-21 天）或 S-1（80-120 毫克/天，第 1-14 天），直至疾病进展或出现不可接受的毒性。主要终点是疾病控制率（DCR）。次要终点包括总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、毒性和生活质量（QOL）。2011年至2016年，37名患者被随机分配接受厄洛替尼（E组，n = 19）和S-1（S组，n = 18）治疗。由于患者应计情况不佳，该研究提前终止。 E 组的 DCR/ORR 为 42.1%/15.8%，S 组的 DCR/ORR 为 66.7%/16.7%。 E 组的中位 PFS/OS 为 1.6 个月/8.0 个月，S 组为 3.3 个月/12.2 个月。在两组中，最常见的 3-4 级毒性是疲劳、厌食和恶心。 S臂发生1例5级肺炎。 QOL 没有显着差异。S-1 作为野生型 EGFR NSCLC 的三线或四线治疗显示出比厄洛替尼更好的临床结果。UMIN000005308。
A high proportion of patients with wild-type EGFR non-small cell lung cancer (NSCLC) receive third-line therapy and beyond, with no prospective randomized trials addressing the issue. This study aimed to select the most suitable regimen as a third- or fourth-line therapy for wild-type EGFR NSCLC.This multicenter, randomized phase II study in Japan included patients with recurrent or advanced NSCLC with wild-type or unknown EGFR, who progressed after two or three previous chemotherapies. The patients were randomly assigned to erlotinib (150 mg/day, days 1-21) or S-1 (80-120 mg/day, days 1-14) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR). The secondary endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), toxicity, and quality of life (QOL).From 2011 to 2016, 37 patients were randomly assigned to receive erlotinib (E arm, n = 19) and S-1 (S arm, n = 18). This study was terminated prematurely because of poor patient accrual. DCR/ORR were 42.1%/15.8% in the E arm and 66.7%/16.7% in the S arm. Median PFS/OS were 1.6 months/8.0 months in the E arm and 3.3 months/12.2 months in the S arm. In both groups, the most commonly reported grade 3-4 toxicities were fatigue, anorexia, and nausea. One grade 5 pneumonitis occurred in the S arm. No significant difference was seen in QOL.S-1 as a third- or fourth-line therapy for wild-type EGFR NSCLC showed numerically better clinical outcomes than erlotinib.UMIN000005308.