69156
document
Exploratory Subset Analysis of African Americans From the PointBreak Study : Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer . INTRODUCTION African Americans have a greater incidence of lung cancer than whites and have been underrepresented in clinical trials . In the PointBreak trial ( pemetrexed-carboplatin-bevacizumab and maintenance pemetrexed-bevacizumab [ PemCBev ] vs. paclitaxel-carboplatin-bevacizumab and maintenance bevacizumab [ PacCBev ] ) , 10 % of the patients were African American . PointBreak had negative findings ; PemCBev did not demonstrate superior overall survival ( OS ) . MATERIALS AND METHODS PointBreak subgroup efficacy and safety data were retrospectively analyzed : African Americans versus whites for PemCBev ; PemCBev versus PacCBev in African Americans ; and academic versus community settings for African Americans . Hazard ratios ( HRs ) and P values were derived from a multivariate Cox proportional hazards model after adjusting for covariates . RESULTS Of 939 intent-to-treat ( ITT ) patients , 94 were African American and 805 were white . African-American enrollment was uniform across the study sites ( median , 1 African American per site ) . In the PemCBev arm , OS ( HR , 1.125 ; P = .525 ) , progression-free survival ( PFS ) ( HR , 1.229 ; P = .251 ) , response ( P = .607 ) , and toxicity profiles were similar in African Americans versus whites . For African Americans , OS ( HR , 1.375 ; P = .209 ) , PFS ( HR , 0.902 ; P = .670 ) , response ( P = 1.000 ) , and toxicity profiles were similar in the PemCBev versus PacCBev arm . For African Americans , no significant differences were seen in OS ( HR , 0.661 ; P = .191 ) or PFS ( HR , 0.969 ; P = .915 ) in academic versus community practice settings . CONCLUSION In the PemCBev arm , this exploratory analysis showed no significant differences between African Americans and whites for the efficacy outcomes or toxicity profiles . Consistent with the ITT population negative trial result , for African Americans , the median OS was not superior for either arm . For African Americans , PFS and OS were similar in the academic and community settings . Additional outcomes data for African Americans should be collected in lung cancer studies .
69157
Intervention_Pharmacological
Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab
69158
Outcome_Mortality
demonstrate superior overall survival ( OS )
69159
Outcome_Other
efficacy
69160
Outcome_Other
safety
69161
Outcome_Physical
Hazard ratios ( HRs ) and P values
69162
Outcome_Physical
a multivariate Cox
69163
Outcome_Mortality
progression-free survival ( PFS )
69164
Outcome_Other
response
69165
Outcome_Physical
toxicity profiles
69166
Outcome_Physical
toxicity profiles
69167
Outcome_Physical
efficacy
69168
Outcome_Physical
toxicity
69169
Participant_Condition
Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer
69170
Participant_Condition
lung cancer
69171
Participant_Condition
PemCBev
69172
Participant_Condition
PemCBev
69173
Participant_Condition
PacCBev