[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 .

[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 .