A randomized, controlled, multicenter phase III study to compare lobaplatin／paclitaxel vs.carboplatin／pa?clitaxel as the first?line therapy in Chinese patients with advanced non?small cell lung cancer:Subgroup a?nalysis of lung squamous carcinoma
QIN Shukui
CHENG Ying
LUO Linhua
LI Jin
SHI Jianhua
CHEN Zhendong
LIU Wei
HUANG Cheng
ZHANG Helong
OUYANG Xuenong
WU Gang
LIU Wenchao
GUO Qisen
LIANG Jun
YU Hao
SUN Xu
ZHOU Wei.
Abstract：Objective To observe the subgroups data of advanced lung squamous carcinoma in the HNCA001 phaseⅢtrial, and further compare the efficacy and safety of lobaplatin plus paclitaxel (TL) regimen vs. carboplatin plus paclitaxel (TC) regimen as the first?line therapy in Chinese population of advanced NSCLC. Methods In the HNCA001 trial, advanced lung squamous carcinoma patients with stage IIIB／IV were analyzed, including TL group ( paclitaxel 175 mg／m2 iv d1and lobaplatin 30 mg／m2 iv d2 ) and TC group (paclitaxel 175 mg／m2 d1 and carboplatin AUC＝5 iv d2), and 21 days was a cycle for at most 6 cycles. The objective efficacy and adverse events (AE) were assessed according to RECIST 1. 1 and NCI CTC 3. 0 criteria, respectively. The primary endpoint was progression?free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate ( ORR), disease control rate (DCR), safety and quality of life.Results A total of 122 patients with advanced lung squamous carcinoma were randomly enrolled from 13 centers in China, including 58 patients in TL group and 64 patients in TC group. In terms of efficacy, the median PFS of TL group and TC group was 5. 13 months vs. 4. 73 months (P＝0. 0669),the median OS was 14. 53 months vs.12. 17 months( P＝0. 6735). ORR was 37. 04% vs. 34. 92%(P＝0. 8484) and DCR was 81. 48% vs. 76. 19%( P＝0. 5079), respectively. In terms of safety, the overall incidence of AEs and grade 3／4 AEs in TL and TC groups were 92. 86% vs.100. 00%(P＝0. 0447)and 60. 71% vs. 78. 13%(P＝0. 0467), respectively. Some indicators of TL group were better that those of TC group in quality of life. Conclusion The efficacy of TL regimen was almost the same with that of TC regimen for patients with advanced lung squamous carcinoma, but safety and quality of life of TL regimen may be a little bit better. Thus, TL regimen may offer an alternative first?line therapy choice for Chi?nese patients with advanced lung squamous carcinoma.
Keywords：Lung squamous carcinomaChemotherapyLobaplatinCarboplatinPaclitaxel
Publication Date：2019-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 621-626 )