A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002)

• Published in: European journal of cancer (1990) Vol. 109; pp. 183 - 191
• Main Authors: Wang, Zhen, Huang, Cheng, Yang, Jin-Ji, Song, Yong, Cheng, Ying, Chen, Gong-Yan, Yan, Hong-Hong, Ben, Xiao-Song, Wang, Bin-Chao, Xu, Chong-Rui, Jiang, Ben-Yuan, Zhou, Qing, Chen, Hua-Jun, Wu, Yi-Long
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.03.2019; Elsevier Science Ltd
• Subjects: 130-Nm albumin-bound paclitaxel; Adult; Aged; Albumins - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carboplatin; Carboplatin - administration & dosage; Carcinoma; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Chemotherapy; Clinical trials; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Female; Follow-Up Studies; Gemcitabine; Humans; Lung cancer; Lung carcinoma; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Middle Aged; Non-small cell lung carcinoma; Paclitaxel; Paclitaxel - administration & dosage; Patients; Prognosis; Quality of Life; Randomization; Squamous cell; Survival; Survival Rate; Carcinoma; Gemcitabine; Squamous cell; 130-Nm albumin-bound paclitaxel
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2019.01.007

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. •Nab-paclitaxel/carboplatin and gemcitabine/carboplatin had the same efficacy in advanced squamous cell lung carcinoma.•Both progression-free survival and overall survival had no difference between the two arms.•Both nab-PC and GC are well tolerated.•Nab-PC had advantage of improving quality of life.