TY - JOUR
T1 - Prospective observational comparison of clinical outcomes between African-American and caucasian patients receiving second-line treatment with pemetrexed for advanced non-small-cell lung cancer
AU - Pennella, Eduardo
AU - Obasaju, Coleman K.
AU - Pohl, Gerhardt
AU - Peltz, Gerson
AU - Girvan, Allicia C.
AU - Winfree, Katherine B.
AU - Martinez, Betzaida
AU - Marciniak, Martin
AU - Walker, Mark S.
AU - Stepanski, Edward
AU - Schwartzberg, Lee S.
AU - Adjei, Alex
N1 - Funding Information:
This study (H3E-US-B001) was sponsored by Eli Lilly and Company, Indianapolis, IN . The authors acknowledge the medical writing assistance of Dr Durisala Desaiah, from Eli Lilly and Company, with the revisions and drafting the manuscript and Dr Li Li, from Eli Lilly and Company, for assistance in statistical analyses of the OARS-IADL and MDASI-LC.
PY - 2013/11
Y1 - 2013/11
N2 - Introduction This prospective observational study evaluated the effect of race on disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in patients with NSCLC treated with second-line pemetrexed. Patients and Methods Eligibility criteria included stage IIIB or IV NSCLC patients receiving single-agent pemetrexed for second-line therapy in routine clinical practice. Noninferiority was evaluated using logistic regression analysis of DCR, controlling for predefined covariates. Noninferiority was considered if the upper 95% confidence bound on the adjusted odds ratio (OR) for Caucasian vs. African-American individuals was less than 1.78, corresponding to a difference in proportion of 14% assuming Caucasian individuals to have a DCR of approximately 50%. The bound was chosen to be half of the anticipated difference between treatment and no second-line treatment. PFS and OS were estimated using the Kaplan-Meier method. Tools were used to measure functional status and symptom burden. Results The unadjusted DCR was 43.7% (117/268) for Caucasian and 45.0% (27/60) for African-American individuals (unadjusted OR, 0.95; 95% confidence interval [CI], 0.54-1.66). The adjusted OR in the final logistic regression model was 0.82 (95% CI, 0.43-1.58). This upper 95% confidence bound was within the prespecified acceptable bound of 1.78. Median PFS times (months) were 2.7 (95% CI, 2.4-3.4) for Caucasian and 3.0 (95% CI, 2.3-4.7) for African-American individuals (P =.91). Median OS times (months) were 6.7 (95% CI, 5.7-7.9) for Caucasian and 6.9 (95% CI, 4.5-8.9) for African-American individuals (P =.92). Baseline and functional status after baseline assessment and mean symptom burden did not differ substantially among races. Conclusion African-American race was not considered to be a significant predictor of disease control after second-line treatment with pemetrexed.
AB - Introduction This prospective observational study evaluated the effect of race on disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in patients with NSCLC treated with second-line pemetrexed. Patients and Methods Eligibility criteria included stage IIIB or IV NSCLC patients receiving single-agent pemetrexed for second-line therapy in routine clinical practice. Noninferiority was evaluated using logistic regression analysis of DCR, controlling for predefined covariates. Noninferiority was considered if the upper 95% confidence bound on the adjusted odds ratio (OR) for Caucasian vs. African-American individuals was less than 1.78, corresponding to a difference in proportion of 14% assuming Caucasian individuals to have a DCR of approximately 50%. The bound was chosen to be half of the anticipated difference between treatment and no second-line treatment. PFS and OS were estimated using the Kaplan-Meier method. Tools were used to measure functional status and symptom burden. Results The unadjusted DCR was 43.7% (117/268) for Caucasian and 45.0% (27/60) for African-American individuals (unadjusted OR, 0.95; 95% confidence interval [CI], 0.54-1.66). The adjusted OR in the final logistic regression model was 0.82 (95% CI, 0.43-1.58). This upper 95% confidence bound was within the prespecified acceptable bound of 1.78. Median PFS times (months) were 2.7 (95% CI, 2.4-3.4) for Caucasian and 3.0 (95% CI, 2.3-4.7) for African-American individuals (P =.91). Median OS times (months) were 6.7 (95% CI, 5.7-7.9) for Caucasian and 6.9 (95% CI, 4.5-8.9) for African-American individuals (P =.92). Baseline and functional status after baseline assessment and mean symptom burden did not differ substantially among races. Conclusion African-American race was not considered to be a significant predictor of disease control after second-line treatment with pemetrexed.
KW - Ethnicity
KW - Nonsquamous NSCLC
KW - Observational study
KW - Pemetrexed
KW - Symptoms
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U2 - 10.1016/j.cllc.2013.06.011
DO - 10.1016/j.cllc.2013.06.011
M3 - Article
C2 - 23910068
AN - SCOPUS:84887229364
SN - 1525-7304
VL - 14
SP - 726
EP - 735
JO - Clinical lung cancer
JF - Clinical lung cancer
IS - 6
ER -