A randomized, controlled, multicenter phase III study to compare lobaplatin／paclitaxel versus carboplatin／paclitaxel as the first?line therapy in Chinese patients with advanced non?small cell lung cancer: Subgroup analysis of the patients over 60 years old
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 further compare the efficacy and safety of lobaplatin plus paclitaxel (TL) regimen with carboplatin plus paclitaxel (TC) regimen in the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in elder-ly patients over 60 years of age in a multicenter phase III clinical study (HNCA001).Methods In the HNCA001 trial, advanced eld- erly NSCLC patients over 60 years old were analyzed, including TL group (paclitaxel 175 mg／m2 iv d1and lobaplatin 30 mg／m2 iv d2) and TC Group (paclitaxel 175 mg／m2 d1and carboplatin AUC＝5 iv d2), and 21 days was a cycle for at most 6 cycles. The objective efficacy and adverse event (AE) were assessed according to RECIST 1. 1 and NCI CTC 3. 0 criteria, respectively. The primary end-point 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 123 patients over 60 years old were randomly enrolled from 13 centers in China, including 59 patients in TL group and 64 patients in TC group. In terms of efficacy, the median PFS in TL group and TC group were both 5. 50 months. However, the PFS (P75) of both groups were 11. 93 months and 7. 60 months, respectively. A-bout 7 months later, the two PFS curves of TL and TC group began to diverge significantly. HR of PFS for both groups was 0. 604 (95% CI: 0. 380-0. 958, P＝0. 0304).The ORR, DCR and median OS were 32. 73% vs.43. 75%(P＝0. 2593),85. 45% vs.81. 25%(P＝0. 6270) and 14. 43 months vs.13. 87 months (P＝0. 7770). In terms of safety, the overall incidence of AE and grade 3／4 AE in TL and TC groups were 91. 38% vs. 100%(P＝0. 0221) and 63. 79% vs. 84. 38%(P＝0. 0122). The overall incidence of grade 3／4 adverse drug reactions in TL and TC groups were 56. 90% vs.82. 81%(P＝0. 0026).The indicators EQ-VAS at cycle 2, 3, 4 and 6 in TL group were better than those in TC group in quality of life. Conclusion The efficacy, safety and quality of life of TL regimen are better than those of TC regimen. TL regimen may offer an alternative first-line therapy choice for elderly patients with advanced NSCLC.
Keywords：Non-small cell lung cancer(NSCLC)Elderly patientsChemotherapyLobaplatinCarboplatinPa-clitaxel
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( 732-737 )