【分享】小细胞肺癌的免疫治疗

来源：中华医学会胸心分会

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复发或转移性SCLC患者接受两种或两种以上治疗后的使用派姆单抗：来自KEYNOTE-028和KEYNOTE-158研究的结果 

— 结论 —

无论PD-L1的表达如何，派姆单抗单抗在接受过两种或两种以上治疗的复发或转移性SCLC患者中表现出持久的抗肿瘤活性。

派姆单抗耐受性良好。 

TPembrolizumab exhibited durable antitumor activity in a subset of patients with recurrent or metastatic SCLC who had undergone two or more previous lines of therapy, regardless of PD-L1 expression. Pembrolizumab was well tolerated.

—背景—

派姆单抗在1b期多中心研究KEYNOTE-028（NCT 02054806）和2期多中心研究KEYNOTE-158（NCT 02628067）中对先前治疗的复发或转移性SCLC患者显示了临床益处。

我们对KEYNOTE-028和KEYNOTE-158中接受过两种或两种以上SCLC治疗的患者进行了汇总分析。 

Pembrolizumab has shown clinical benefit in patients with previously treated recurrent or metastatic SCLC in the phase 1b multicohort study KEYNOTE-028 (NCT02054806) and the phase 2 multicohort study KEYNOTE-158 (NCT02628067). We present a pooled analysis of patients from KEYNOTE-028 and KEYNOTE-158 who had received two or more lines of previous therapy for SCLC.

—方法 —

符合条件的患者年龄在18岁及以上，经组织学或细胞学证实为无法治愈的复发或转移性SCLC，体力状态为1及以下，并且接受过两种或两种以上的既往治疗。

KEYNOTE-028中的患者需要有一个程序性死亡配体1（PD-L1）阳性肿瘤。患者接受派姆单抗（KEYNOTE-028中每2周10 mg/kg或KEYNOTE-158中每3周200 mg）长达2年。

主要终点是实体瘤1.1版中每个反应评价标准的客观反应率。

Eligible patients were aged 18 years and above, had histologically or cytologically confirmed incurable recurrent or metastatic SCLC, had an Eastern Cooperative Oncology Group performance status of 1 and below, and had received two or more lines of previous therapy. Patients in KEYNOTE-028 were required to have a programmed death ligand 1 (PD-L1)–positive tumor. Patients received pembrolizumab (10 mg/kg every 2 weeks in KEYNOTE-028 or 200 mg every 3 weeks in KEYNOTE-158) for up to 2 years. The primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1, which is presented here per independent review.

—结果—

研究纳入83名接受过两种或两种以上治疗的患者（KEYNOTE-028，n=19；KEYNOTE-158，n=64）。

中位随访时间为7.7（0.5-48.7）个月。客观有效率为19.3%（95%可信区间：11.4-29.4），完全缓解2例（1例PD-L1阳性），部分缓解14例（13例PD-L1阳性）。

中位反应持续时间未达到（范围4.1‒35.8+mo；加号表示持续反应）；61%的反应持续18个月或更长。

51例（61.4%）出现任何级别的治疗相关不良事件；8例（9.6%）出现3级或更高级别的事件。 

Eighty-three patients who had received two or more lines of previous therapy (KEYNOTE-028, n = 19; KEYNOTE-158, n = 64) were included. Median follow-up duration was 7.7 (range, 0.5–48.7) months. Objective response rate was 19.3% (95% confidence interval: 11.4–29.4); two patients had complete response (one with a PD-L1–positive tumor), and 14 patients had partial response (13 with PD-L1–positive tumors). The median duration of response was not reached (range, 4.1‒35.8+ mo; plus sign indicates ongoing response); 61% of responders had responses lasting 18 months or longer. Fifty-one patients (61.4%) experienced any-grade treatment-related adverse events; eight patients (9.6%) had grade 3 or higher events.

来源：知识城邦

作者：多喝热水