TY - JOUR
T1 - Exploratory subset analysis of African Americans from the PointBreak study
T2 - 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
AU - Reynolds, Craig H.
AU - Patel, Jyoti D.
AU - Garon, Edward B.
AU - Olsen, Mark R.
AU - Bonomi, Philip
AU - Govindan, Ramaswamy
AU - Pennella, Eduardo J.
AU - Liu, Jingyi
AU - Guba, Susan C.
AU - Li, Shi
AU - Spigel, David R.
AU - Hermann, Robert C.
AU - Socinski, Mark A.
AU - Obasaju, Coleman K.
N1 - Funding Information:
C.H.R. has received support for travel, consultancy, and payment for lectures, including services on speaker's bureaus, payment for the development of education presentations; his institution has received grants from Eli Lilly and Company. E.B.G.'s institution has received funding from Eli Lilly and Company. P.B.'s institution has received funding from Eli Lilly and Company and Genentech. R.G. has received consultancies from Boehringer Ingleheim, Pfizer, Merck, Bayer, Covidien, Bristol-Myers Squibb, Roche-Genentech, GlaxoSmithKline, and Mallinckrodt. C.K.O., E.J.P., J.L., and S.C.G. are employed by Eli Lilly and Company and own stock. S.L. is employed by Eli Lilly and Company. D.R.S. has received a consulting fee and honorarium from Eli Lilly and Company. R.C.H. has received payment for lectures, including services on speaker's bureaus, from Roche-Genentech. The remaining authors have stated that they have no competing interests.
Publisher Copyright:
© 2015 Elsevier Inc.
PY - 2015/5/1
Y1 - 2015/5/1
N2 - 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.
AB - 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.
KW - Alimta
KW - Avastin
KW - Minority groups
UR - http://www.scopus.com/inward/record.url?scp=84928706378&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2014.11.004
DO - 10.1016/j.cllc.2014.11.004
M3 - Article
C2 - 25516338
AN - SCOPUS:84928706378
SN - 1525-7304
VL - 16
SP - 200
EP - 208
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 3
ER -