Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China.
Fujian Province Cancer Hospital, 91 Fu Ma Road, Fuzhou, China.
Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7.
Nab-paclitaxel/carboplatin (nab-PC) and gemcitabine/carboplatin (GC) are the standard first-line chemotherapy in non-small cell lung carcinoma. Up to now, there is no head to head trial to compare nab-PC with GC in advanced squamous cell lung carcinoma.
A multicentre randomised phase II trial was performed to compare the efficacy and safety for nab-PC with GC in previously untreated patients with advanced squamous cell lung carcinoma. The primary end-point was objective response rate (ORR). Progression-free survival (PFS), overall survival (OS), treatment-related adverse events and quality of life (QoL) were also analysed.
Totally 127 participants were eligible for this study (62/65 nab-PC/GC). Nab-PC has higher ORR than GC without statistical significance (42% versus 27%, P > 0.05). After a median follow-up of 14.5 months, both PFS and OS had no difference between the two arms (6.7 versus 5.8 months, hazard ratio [HR] 0.75, P = 0.143; 11.6 versus 14.4 months, HR 0.92, P = 0.846). Both regimens were well tolerated; however, more dose reduction occurred after cycle 2 in GC (27%) than in nab-PC (12%) (P < 0.05). Significant QoL improvement measured by trial outcome index was seen in nab-PC than in GC (P < 0.05).
The first-line nab-PC and GC had the same response, PFS, and OS in patients with advanced squamous cell lung carcinoma. Nab-PCM has advantage over GC in QoL improvement.
NCT01236716.
纳布紫杉醇/卡铂（nab-PC）和吉西他滨/卡铂（GC）是治疗非小细胞肺癌的标准一线化疗药物。到目前为止，尚无头对头试验比较nab-PC 与 GC 在晚期鳞状细胞肺癌中的疗效。
进行了一项多中心随机 II 期试验，比较了nab-PC 与 GC 在未经治疗的晚期鳞状细胞肺癌患者中的疗效和安全性。主要终点是客观缓解率（ORR）。无进展生存期（PFS）、总生存期（OS）、治疗相关不良反应和生活质量（QoL）也进行了分析。
共有 127 名患者符合本研究条件（62/65 名nab-PC/GC）。nab-PC 的 ORR 高于 GC，但无统计学意义（42% vs 27%，P>0.05）。中位随访 14.5 个月后，两组 PFS 和 OS 无差异（6.7 个月 vs 5.8 个月，HR 0.75，P=0.143；11.6 个月 vs 14.4 个月，HR 0.92，P=0.846）。两种方案均耐受良好；然而，GC 组在第 2 周期后剂量减少的发生率（27%）高于 nab-PC 组（12%）（P<0.05）。nab-PC 组的试验结局指数测量的 QoL 改善明显优于 GC 组（P<0.05）。
在晚期鳞状细胞肺癌患者中，一线 nab-PC 和 GC 的反应、PFS 和 OS 相同。nab-PC 在 QoL 改善方面优于 GC。
NCT01236716。
