Page 122 - 《中国药房》2022年8期
P. 122
milars/general/Biosimilars-of-bevacizumab. patients with stage Ⅳ nsNSCLC[EB/OL]. [2021-07-13].
[ 5 ] 国家食品药品监督管理总局.生物类似药研发与评价技 https://clinicaltrials.gov/ct2/show/results/NCT04633564?
术指导原则:试行[EB/OL].[2021-07-13]. https://www. id=NCT02754882+OR+NCT04633564&draw=2&rank=
dcpc.com/xwzx/zcfg/gjsyjzj/201503/P0201503045414475- 1&load=cart.
70315.pdf. [17] Boehringer Ingelheim. Phase Ⅲ trial BI 695502 plus che-
[ 6 ] 中国药品综合评价指南项目组.中国药品综合评价指南 motherapy vs. Avastin ® plus chemotherapy in patients
参考大纲:第二版[J].药品评价,2015,12(8):6. with lung cancer[EB/OL].[2021-07-13]. https://clinical-
[ 7 ] 郭瑞臣.抗肿瘤生物类似药的发展与临床应用[J].实用肿 trials.gov/ct2/show/NCT02272413?term=NCT02272413&
瘤杂志,2020,35(4):310-313. draw=2&rank=1.
[ 8 ] HODA S A. AJCC cancer staging manua,8th edition[J]. [18] THATCHER N,GOLDSCHMIDT J H,THOMAS M,et al.
Adv Anat Pathol,2017,24(2):112. Efficacy and safety of the biosimilar ABP 215 compared
[ 9 ] EISENHAUER E A,THERASSE P,BOGAERTS J,et al. with bevacizumab in patients with advanced nonsqua-
New response evaluation criteria in solid tumours:revised mous non-small cell lung cancer(MAPLE):a rando-
RECIST guideline:version 1.1[J]. Eur J Cancer,2009,45 mized,double-blind,phase Ⅲ study[J]. Clin Cancer Res,
(2):228-247. 2019,25(7):2088-2095.
[10] HIGGINS J P T,THOMAS J,CHANDLER J,et al. [19] YANG Y P,WU B,HUANG L N,et al. Biosimilar can-
Cochrane handbook for systematic reviews of inter- didate IBI305 plus paclitaxel/carboplatin for the treatment
ventions[EB/OL].[2021-07-13]. https://training.cochrane. of non-squamous non-small cell lung cancer[J]. Transl
org/handbook. Lung Cancer Res,2019,8(6):989-999.
[11] TRUKHIN D,PODDUBSKAYA E,ANDRIC Z,et al. [20] REINMUTH N,BRYL M,BONDARENKO I,et al.
Efficacy,safety and immunogenicity of MB02(bevacizu- PF-06439535(a bevacizumab biosimilar)compared with
mab biosimilar)versus reference bevacizumab in advanced reference bevacizumab(Avastin ),both plus paclitaxel
®
non-small cell lung cancer:a randomized,double-blind, and carboplatin,as first-line treatment for advanced
phase Ⅲ study(STELLA)[J]. BioDrugs,2021,35(4): non-squamous non-small-cell lung cancer:a randomized,
429-444. double-blind study[J]. Bio Drugs,2019,33(5):555-570.
[12] CHU T Q,LU J,BI M H,et al. Equivalent efficacy study [21] Biocad. A safety and efficacy study of BCD-021 with
of QL1101 and bevacizumab on untreated advanced non- paclitaxel and carboplatin compared to avastin with paclitaxel
squamous non-small cell lung cancer patients:a phase 3 and carboplatin in non-small cell lung cancer[EB/OL].[2021-
randomized,double-blind clinical trial[J]. Cancer Biol 07-13]. https://clinicaltrials.gov/ct2/show/NCT01763645?
Med,2021,18(3):816-824. term=NCT01763645&draw=2&rank=1.
[13] Centus Biotherapeutics Limited. Evaluation of FKB238 [22] 毕明宏.贝伐珠单抗治疗非小细胞肺癌进展[J].临床肺科
and avastin in patients with advanced/recurrent non-squa- 杂志,2018,23(10):1909-1914.
mous non-small cell lung cancer(AVANA)[EB/OL]. [2021- [23] SANDLER A,GRAY R,PERRY M C,et al. Paclitaxel-
07-13]. https://clinicaltrials.gov/ct2/show/NCT02810457? carboplatin alone or with bevacizumab for non-small-cell
term=NCT02810457&draw=2&rank=1. lung cancer[J]. N Engl J Med,2006,355(24):2542-2550.
[14] SHI Y K,LEI K J,JIA Y M,et al. Bevacizumab biosimilar [24] PLANCHARD D,POPAT S,KERR K,et al. Correction
LY01008 compared with bevacizumab(Avastin)as first- to:“metastatic non-small cell lung cancer:ESMO clinical
line treatment for Chinese patients with unresectable,me- practice guidelines for diagnosis,treatment and follow-up”
tastatic,or recurrent non-squamous non-small-cell lung [J]. Ann Oncol,2019,30(5):863-870.
cancer:a multicenter,randomized,double-blinded,phase [25] ETTINGER D S,AISNER D L,WOOD D E,et al. NCCN
Ⅲ trial[J]. Cancer Commun(Lond),2021,41(9):889-903. guidelines insights:non-small cell lung cancer,version
[15] RECK M,LUFT A,BONDARENKO I,et al. A phase Ⅲ, 5.2018[J]. J Natl Compr Canc Netw,2018,16(7):807-821.
randomized,double-blind,multicenter study to compare [26] CARGNIN S,SHIN J I,GENAZZANI A A,et al. Compa-
the efficacy,safety,pharmacokinetics,and immunogenicity rative efficacy and safety of trastuzumab biosimilars to the
between SB8 (proposed bevacizumab biosimilar) and reference drug:a systematic review and meta-analysis of
reference bevacizumab in patients with metastatic or recur- randomized clinical trials[J]. Cancer Chemother Pharmacol,
rent nonsquamous non-small cell lung cancer[J]. Lung 2020,86(5):577-588.
Cancer,2020,146:12-18. (收稿日期:2021-09-17 修回日期:2022-02-23)
[16] Mylan Inc.. MYL-1402O compared with Avastin ,in (编辑:陈 宏)
®
·1008 · China Pharmacy 2022 Vol. 33 No. 8 中国药房 2022年第33卷第8期