A randomized, controlled, multicenter phase Ⅲ study to compare efficacy and safety of lobaplatin plus paclitaxel versus carboplatin plus paclitaxel as the first-line therapy in Chinese patients with advanced non-small cell lung cancer
QIN Shukui
CHENG Ying
LI Jin
SHI Jianhua
CHEN Zhendong
LIU Wei
HUANG Cheng
ZHANG Helong
OUYANG Xuenong
WU Gang
LIU Wenchao
GUO Qisen
LIANG Jun
YU Hao
Abstract：Objective To compare the efficacy and safety of lobaplatin (LBP) plus paclitaxel (TL regimen) versus carboplatin (CBP) plus paclitaxel (TC regimen) as the first-line therapy in Chinese advanced non-small cell lung cancer (NSCLC). Methods A prospective, randoimzed, controlled national multicenter phase Ⅲ clinical study was designed. NSCLC treatment-naive patients with stage ⅢB/Ⅳ were included in this study, randomly divided into TL group and TC group. TL group: paclitaxel (175 mg/m2 by intravenous infusion on day 1) and LBP (30 mg/m2 by intravenous infusion on day 2), 21 days as a cycle for 6 cycles. TC group: paclitaxel (175 mg/m2 by intravenous infusion on day 1) and CBP(AUC = 5 on day 2), 21 days as a cycle for 6 cycles. The primary endpoint was progression free survival (PFS). The secondary endpoints included overall survival(OS), obje ctive response rate (ORR), disease control rate (DCR) and quality of life (QoL). Resu lts A total of three hundred and fifty-nine patients were enrolled from 13 centers in China, including 181 patients in TL group and 178 patients in TC group. The median PFS in TL and TC group was 5.37 vs.5.17 months (HR = 0.874, 95％ CI: 0.678-1.126;P = 0.2962) respectively, the median OS was 12.90 vs.12.17 months(HR = 0.967, 95％ CI: 0.774-1.208; P=0.7666). ORR and DCR in TL and TC group were 35.47％ vs.38.64％(P = 0.5795) and 80.23％ vs.80.11 ％ (P = 1.0000), respectively. In terms of safety, the overall incidence of AE and grade 3/4 AEs in TL and TC group were 95.51％ vs.99.44％ (P = 0.0463) and 66.29％ vs.80.90％ (P = 0.0018), respectively. Some indicators of TL group were better than those of TC group in quality of life. Conclusion The efficacy of TL regimen was almost same with TC regimen, but safety and quality of life of TL regimen were better than those of TC regimen. Thus TL regimen containing LBP may offer an alternative first-line therapy regimen for Chinese advanced NSCLC patients, and it is worth to be widely applied in clinical practice further.
Keywords：Non-small cell lung cancer(NSCLC)Combined chemotherapyLobaplatinCarboplatinPaclitaxel
Publication Date：2018-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 193-199 )