Zhen Wang1, Cheng Huang2, Jin-Ji Yang3, Yong Song4, Ying Cheng5, Gong-Yan Chen6, Hong-Hong Yan7, Xiao-Song Ben8, Bin-Chao Wang9, Chong-Rui Xu10, Ben-Yuan Jiang11, Qing Zhou12, Hua-Jun Chen13, Yi-Long Wu14. 1. 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. Electronic address: hunterol@hotmail.com. 2. Fujian Province Cancer Hospital, 91 Fu Ma Road, Fuzhou, China. Electronic address: cheng671@sina.com. 3. 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. Electronic address: yangjinji2003@163.com. 4. Nanjing General Hospital, 305 Zhong Shan Dong Road, Nanjing, China. Electronic address: yong_song6310@yahoo.com. 5. Jilin Province Cancer Hospital, 1018 Hu Guang Road, Changchun, China. Electronic address: jl.cheng@163.com. 6. Heilongjiang Province Cancer Hospital, 150 Ha Ping Road, Harbin, China. Electronic address: chengongyan@163.com. 7. 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. Electronic address: yanhonghong385@126.com. 8. 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. Electronic address: benxs@163.com. 9. 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. Electronic address: wbc_gz@hotmail.com. 10. 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. Electronic address: xucr@hotmail.com. 11. 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. Electronic address: jiangben1000@126.com. 12. 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. Electronic address: gzzhouqing@126.com. 13. 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. Electronic address: chjdoctor@163.com. 14. 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. Electronic address: syylwu@live.cn.
Abstract
BACKGROUND: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. PATIENTS AND METHODS: 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. RESULTS: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). CONCLUSIONS: 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. TRIAL REGISTRATION NUMBER: NCT01236716.
RCT Entities:
BACKGROUND: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. PATIENTS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION NUMBER: NCT01236716.