Comparing nanoparticle polymeric micellar paclitaxel and solvent-based paclitaxel as first-line treatment of advanced non-small-cell lung cancer: an open-label, randomized, multicenter, phase III trial

作者：Shi, M.; Gu, A.; Tu, H.; Huang, C.; Wang, H.; Yu, Z.; Wang, X.; Cao, L.; Shu, Y.; Yang, R.; Li, X.; Chang, J.; Hu, Y.; Shen, P.; Guo, Z.; Tao, M.; Zhang, Y.; Liu, X.; Sun, Q.; Zhang, X.; Jiang, Z.; Zhao, J.; Chen, F.; Yu, H.; Zhang, W.; Sun, J.; Li, D.; Zhou, J.; Han, B.^*; Wu, Y. L.^*

来源：Annals of Oncology, 2021, 32(1): 85-96.

DOI：10.1016/j.annonc.2020.10.479

• non-small-cell lung cancer
• chemotherapy
• pm-paclitaxel

Background: Polymeric micellar paclitaxel (pm-Pac) is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel. We aimed to compare the efficacy and safety between pm-Pac plus cisplatin and solvent-based paclitaxel (sbPac) plus cisplatin in advanced non-small-cell lung cancer (NSCLC). @@@ Patients and methods: A total of 448 stage IIIB to IV NSCLC patients were randomly assigned (2:1) to receive six 3-week cycles of either pm-Pac (230 mg/m(2) =) plus cisplatin (70 mg/m(2); n= 300), followed by dose escalation of pm-Pac to 300 mg/m(2) from the second 3-week cycle if prespecified toxic effects were not observed after the first cycle, or sb-Pac (175 mg/m(2)) plus cisplatin (70 mg/m(2); n= 148). The primary end point was objective response rate (ORR) assessed by independent review committees (IRCs). The secondary end points included IRC-assessed progression-free survival (PFS), overall survival (OS), and safety. @@@ Results: Patients in the pm-Pac-plus-cisplatin group showed significant improvements in IRC-assessed ORR compared with those in the sb-Pac-plus-cisplatin group (SO% versus 26%; rate ratio 1.91; P < 0.0001). Additionally, subgroup analysis showed that a higher ORR was consistently observed in both squamous and nonsquamous histological types. IRC-assessed median PFS was significantly higher in the pm-Pac-plus-cisplatin group than in the sb-Pac-pluscisplatin group (6.4-month versus 5.3-month; hazard ratio 0.63; P = 0.0001). Median OS was not significantly different between the two groups. The incidence of treatment-related serious adverse events (9% versus 18%; P 0.0090) was significantly lower in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group. @@@ Conclusion: Pm-Pac plus cisplatin yielded superior ORR and PFS along with a favorable safety profile and should become an option for patients with advanced NSCLC.

• 单位
  1; 复旦大学; 上海交通大学; 青岛大学; 苏州大学; 郑州大学; 山东大学; 广东省人民医院; 中山大学; 同济大学; 浙江大学