Subgroup analysis of African American patients from a randomized phase 3 trial of gemcitabine (G) in combination with carboplatin (Cb) or paclitaxel (P) compared to P plus Cb in advanced (stage IIIB, IV) non-small cell lung cancer (NSCLC)

Abstract

18066 Background: A relationship between race and prognosis in patients with NSCLC has been suggested with African Americans (AA) having higher incidence and lower survival rates compared to whites (W) with a similar stage of disease. However, due to under representation of AA in clinical trials there is little data to substantiate this hypothesis. To investigate the possibility of a race effect on the efficacy and safety of standard chemotherapy doublet regimens in AA pts, we conducted a retrospective subgroup analysis of our Phase 3 randomized trial comparing 3 regimens for advanced NSCLC (Treat, et al: Abst#7025, Proc ASCO 2005). Methods: A Phase 3 study in advanced (stage IIIB/IV) NSCLC chemonaive patients with ECOG PS <2 was designed to compare the efficacy of a G-containing platinum regimen GCb (G 1000 mg/m2 IV D 1, 8 plus Cb AUC 5.5, D 1) to a nonplatinum G doublet GP (G 1000 mg/m2 IV D 1,8 plus P 200 mg/m2, D 1) and a reference regimen of PCb (P 225 mg/m2 plus Cb AUC 6.0, D 1). Outcome and toxicity data of AA pts vs. W pts were compared. Survival (OS) was the primary endpoint with secondary endpoints being response rate (RR), time to progression (TTP) and toxicity. Data from all 3 arms were pooled for this analysis. Results: A total of 128 AA and 906 W pts were analyzed. There were no significant differences in the OS or TTP distributions in AA compared to W pts ( Table 1 ). The incidence and grade of hematologic toxicity in AA vs. W pts were comparable. AA demonstrated slightly lower incidences of Grade 3–4 constitutional (5.1% vs. 9.0%), hemorrhage (1.4 % vs. 2.5 %), and metabolic (4.4% vs. 7.0%) toxicities compared with W pts. Conclusions: Use of standard chemotherapy doublets as first-line chemotherapy in AA pts with advanced NSCLC demonstrated similar efficacy and safety compared to W pts treated under similar conditions. [Table: see text] No significant financial relationships to disclose.