Chinese multicenter randomized trial of customized chemotherapy based on BRCA1 (breast cancer susceptibility gene 1)-RAP80 (receptora-ssociaet d protein 80) mRNA expr ession ina dvanced non-small cell lu ng cancer (NSCLC) pa tients
10.3760/cma.j.issn.0253-3766.2016.11.013
- VernacularTitle:乳腺癌易感基因1和受体相关蛋白80 mRNA表达水平指导肺癌患者个体化治疗的多中心随机对照临床研究
- Author:
Jia WEI
1
;
Xiaoping QIAN
;
Zhengyun ZUO
;
Lifeng WANG
;
Lixia YU
;
Chuanwen YOU
;
Yong SONG
;
Huiyu LU
;
Wenjing HU
;
Jing YAN
;
Xingxiang XU
;
Xiaofei CHEN
;
Ya Xign LI
;
Qinfnag WU
;
Yan ZHOU
;
Feiling ZHNAG
;
Rui Bao LIU
Author Information
1. 210008,南京大学医学院附属鼓楼医院肿瘤科
- Keywords:
Carcinoma,non-small-cell lung;
Drug therapy;
Breast cancer susceptibility gene 1;
Receptor-associated protein 80;
Treatment outcome
- From:
Chinese Journal of Oncology
2016;38(11):868-873
- CountryChina
- Language:Chinese
-
Abstract:
[Abstrca t] Objective BRCA 1 ( breast cancer susceptibility gene 1) and RAP80 ( receptor-associated protein 80) play key roles in predicting chemosensitivity of platinum and taxanes .A randomized trial was carried out to compare non-selected cisplatin-based chemotherapy with therapy customized according to BRCA1 and RAP80 expression.Methods Advanced stage NSCLC patients whose tumor specimen was sufficient for molecular analysis were randomized (1∶3) to the control or experimental arm.Patients in the control arm received docetaxel/cisplatin; in the experimental arm , patients with low RAP 80 expression received gemcitabine/cisplatin ( Arm 1 ) , those with intermediate/high RAP 80 expression and low/intermediate BRCA 1expression received docetaxel/cisplatin ( Arm 2 ) , and those with intermediate/high RAP80 expression and high BRCA1 expression received docetaxel alone (Arm 3).The primary end point was progression-free survival (PFS).Results 226 patients were screened and 124 were randomized in this trial.ORR in the four subgroups was 22.6%, 48.4%, 30.3%and 19.2%, respectively (P=0.08);PFS was 4.74, 5.59, 3.78 and 2.73 months, respectively (P=0.55); and OS was 10.82, 14.44, 10.86 and 10.86 months, respectively (P=0.84).The common adverse effects included neutropenia , nausea, anemia and fatigue.Conclusions No statistically significant difference of ORR , PFS or OS is observed in the experimental arms compared with the control arm .Patients with low RAP 80 mRNA levels have a trend of better survival and higher response rate to gemcitabine /cisplatin chemotherapy .
