PURPOSE Gemcitabine and albumin-bound paclitaxel (ABP) exhibit synergistic antitumor efficacy, with ABP serving to increase the intratumoral gemcitabine concentration. Both drugs are active in squamous cell lung cancers (SQCLC) and are conventional partners for carboplatin. We hypothesized that combining gemcitabine and ABP would enhance the antitumor activity in patients with advanced SQCLCs. PATIENTS AND METHODS This was a Simon two-stage, open-label, single-arm, multicenter phase II study that enrolled patients between August 1, 2015 and June 1, 2018. We enrolled 37 patients with chemotherapy-naïve, PD-L1 low/unknown advanced stage IV SQCLC. Patients were administered weekly intravenous gemcitabine (1,000 mg/m2) plus ABP (100 mg/m2) in a 3-week on, 1-week off schedule during stage I and a 2-week on, 1-week off schedule in stage II. The primary endpoint was best objective response rate (ORR). Next-generation sequencing by MSK-IMPACT was used to calculate tumor mutation burden and genome doubling and assess somatic variants for correlations with efficacy. RESULTS Thirty-two patients were evaluable for response assessment. The study satisfied its primary endpoint, with confirmed partial responses in 18 of 32 patients and a complete response in 1 patient [ORR 59%; 95% confidence interval (CI), 42%-74%]. Median progression-free survival (PFS), a secondary endpoint, was 7.5 (95% CI, 6.7-10.5) months. There were no unexpected toxicities. CONCLUSIONS Gemcitabine plus ABP was a safe, tolerable, and effective first-line therapy for patients with chemotherapy-naïve SQCLCs, with an ORR and median PFS substantially higher than carboplatin doublet regimens and efficacy comparable with carboplatin plus taxane plus pembrolizumab.

中文翻译：

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白蛋白结合型紫杉醇和吉西他滨在新诊断的IV期鳞状细胞肺癌患者中的II期试验。

目的吉西他滨和白蛋白结合的紫杉醇（ABP）表现出协同的抗肿瘤功效，其中ABP可以增加肿瘤内吉西他滨的浓度。两种药物均对鳞状细胞肺癌（SQCLC）有活性，并且是卡铂的常规伴侣。我们假设吉西他滨和ABP联合使用可增强晚期SQCLC患者的抗肿瘤活性。患者与方法这是一项Simon于2015年8月1日至2018年6月1日之间进行的两阶段，开放标签，单臂，多中心II期临床研究，纳入患者。我们纳入了37例未接受过化疗，PD-L1低/未知的IV级SQCLC。在第一阶段，患者每周接受3周，每周1周的静脉注射吉西他滨（1,000 mg / m2）和ABP（100 mg / m2）静脉注射，而在第二阶段，对患者进行2周，每周1周的静脉注射吉西他滨。主要终点是最佳客观反应率（ORR）。通过MSK-IMPACT进行的下一代测序可用于计算肿瘤突变负担和基因组倍增，并评估体细胞变异体与疗效的相关性。结果32例患者可进行反应评估。该研究达到了其主要终点，在32名患者中有18名确认了部分缓解，在1名患者中确认了完全缓解[ORR 59％；95％置信区间（CI），42％-74％]。中位无进展生存期（PFS）为次要终点，为7.5（95％CI，6.7-10.5）个月。没有意外的毒性。结论吉西他滨联合ABP对未接受过化疗的SQCLC患者是一种安全，可耐受且有效的一线治疗，