Gridelli Cesare, Chen Tianlei, Ko Amy, O'Brien Mary E, Ong Teng Jin, Socinski Mark A, Postmus Pieter E
Division of Medical Oncology, S. G. Moscati Hospital, Avellino, Italy.
Biostatistics, Celgene Corporation, Summit, NJ, USA.
Drug Des Devel Ther. 2018 May 24;12:1445-1451. doi: 10.2147/DDDT.S155750. eCollection 2018.
Limited data on elderly patients with squamous advanced non-small cell lung cancer (NSCLC) preclude optimal treatment. Here, we report the outcomes of a retrospective analysis of a subset of patients ≥70 years with squamous histology from the Phase III trial that evaluated nab-paclitaxel/carboplatin vs paclitaxel/carboplatin.
Patients with stage IIIB/IV NSCLC received (1:1) nab-paclitaxel 100 mg/m on days 1, 8, and 15 or paclitaxel 200 mg/m on day 1, both with carboplatin area under the curve 6 mg×min/mL on day 1 every 3 weeks. The primary endpoint was independently assessed overall response rate as per the Response Evaluation Criteria in Solid Tumors v1.0. Secondary endpoints included progression-free survival, overall survival, and safety.
Sixty-five patients ≥70 years with squamous histology were included (nab-paclitaxel/carboplatin, n=35; paclitaxel/carboplatin, n=30). nab-Paclitaxel/carboplatin vs paclitaxel/carboplatin, respectively, resulted in an overall response rate of 46% vs 20% (response rate ratio, 2.29, =0.029) and a median overall survival of 16.9 vs 8.6 months (hazard ratio, 0.50, =0.018). No difference was observed in median progression-free survival (5.7 months for both). Incidences of grade 3/4 neutropenia (50% vs 63%), leukopenia (29% vs 37%), fatigue (3% vs 13%), and peripheral neuropathy (3% vs 13%) were lower, but those of thrombocytopenia (21% vs 10%) and anemia (21% vs 7%) were higher with nab-paclitaxel/carboplatin vs paclitaxel/carboplatin.
nab-Paclitaxel/carboplatin was efficacious and tolerable in patients ≥70 years with squamous NSCLC. These results build upon prior analyses, indicating that nab-paclitaxel/carboplatin is effective for this difficult-to-treat patient subgroup.
关于老年鳞状细胞晚期非小细胞肺癌(NSCLC)患者的数据有限,这使得无法进行最佳治疗。在此,我们报告了一项回顾性分析的结果,该分析针对一项III期试验中年龄≥70岁的鳞状组织学患者亚组,该试验评估了白蛋白结合型紫杉醇/卡铂与紫杉醇/卡铂的疗效。
IIIB/IV期NSCLC患者按1:1比例随机分组,一组在第1、8和15天接受白蛋白结合型紫杉醇100mg/m²,另一组在第1天接受紫杉醇200mg/m²,两组均在第1天联合卡铂,曲线下面积为6mg×min/mL,每3周重复一次。主要终点是根据实体瘤疗效评价标准v1.0独立评估的总缓解率。次要终点包括无进展生存期、总生存期和安全性。
纳入65例年龄≥70岁的鳞状组织学患者(白蛋白结合型紫杉醇/卡铂组,n = 35;紫杉醇/卡铂组,n = 30)。白蛋白结合型紫杉醇/卡铂组与紫杉醇/卡铂组相比,总缓解率分别为46%和20%(缓解率比值为2.29,P = 0.029),中位总生存期分别为16.9个月和8.6个月(风险比为0.50,P = 0.018)。中位无进展生存期无差异(两组均为5.7个月)。白蛋白结合型紫杉醇/卡铂组与紫杉醇/卡铂组相比,3/4级中性粒细胞减少(50%对63%)、白细胞减少(29%对37%)、疲劳(3%对13%)和周围神经病变(3%对13%)的发生率较低,但血小板减少(21%对10%)和贫血(21%对7%)的发生率较高。
白蛋白结合型紫杉醇/卡铂在年龄≥70岁的鳞状NSCLC患者中有效且耐受性良好。这些结果基于先前的分析,表明白蛋白结合型紫杉醇/卡铂对这个难以治疗的患者亚组有效。