比较拟用生物类似药LA-EP2006与参比制剂培非格司亭治疗乳腺癌的随机双盲研究。
Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
作者信息
Harbeck Nadia, Lipatov Oleg, Frolova Mona, Udovitsa Dmitry, Topuzov Eldar, Ganea-Motan Doina Elena, Nakov Roumen, Singh Pritibha, Rudy Anita, Blackwell Kimberly
机构信息
Breast Center & CCCLMU, University of Munich, Munich, Germany.
Republican Clinical Oncology Dispensary of the Ministry of Public Health of Bashkortostan Republic, Ufa, Russia.
出版信息
Future Oncol. 2016 Jun;12(11):1359-67. doi: 10.2217/fon-2016-0016. Epub 2016 Mar 29.
AIM
This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1).
PATIENTS & METHODS: Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 10(9)/l) with equivalence confirmed if 90% and 95% CIs were within a ±1 day margin.
RESULTS
For DSN, LA-EP2006 was equivalent to reference (difference: 0.07 days; 90% CI: -0.09-0.23; 95% CI: -0.12-0.26).
CONCLUSION
LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.
目的
本随机双盲试验比较了拟用的生物类似药LA-EP2006与参比培非格司亭在接受乳腺癌化疗的女性中的疗效（PROTECT-1）。
患者与方法
年龄≥18岁的女性被随机分配接受LA-EP2006（n = 159）或参比培非格司亭（n = 157）（Neulasta(®)，安进公司），用于≤6周期的（新）辅助TAC化疗。主要终点为第1周期严重中性粒细胞减少症的持续时间（DSN）（绝对中性粒细胞计数<0.5×10⁹/L的连续天数），如果90%和95%置信区间在±1天范围内，则确认具有等效性。
结果
对于DSN，LA-EP2006与参比药物等效（差异：0.07天；90%置信区间：-0.09 - 0.23；95%置信区间：-0.12 - 0.26）。
结论
在接受化疗的乳腺癌患者中，LA-EP2006和参比培非格司亭在疗效和安全性方面无临床意义上的差异。
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