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

Eduardo Pennella, Coleman K. Obasaju, Gerhardt Pohl, Gerson Peltz, Allicia C. Girvan, Katherine B. Winfree, Betzaida Martinez, Martin Marciniak, Mark S. Walker, Edward Stepanski, Lee Schwartzberg, Alex Adjei

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)726-735
Number of pages10
JournalClinical Lung Cancer
Volume14
Issue number6
DOIs
StatePublished - Nov 1 2013

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Pemetrexed
Non-Small Cell Lung Carcinoma
African Americans
Confidence Intervals
Disease-Free Survival
Logistic Models
Odds Ratio
Survival
Therapeutics
Symptom Assessment
Observational Studies
Regression Analysis
Prospective Studies

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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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. / Pennella, Eduardo; Obasaju, Coleman K.; Pohl, Gerhardt; Peltz, Gerson; Girvan, Allicia C.; Winfree, Katherine B.; Martinez, Betzaida; Marciniak, Martin; Walker, Mark S.; Stepanski, Edward; Schwartzberg, Lee; Adjei, Alex.

In: Clinical Lung Cancer, Vol. 14, No. 6, 01.11.2013, p. 726-735.

Research output: Contribution to journalArticle

Pennella, Eduardo ; Obasaju, Coleman K. ; Pohl, Gerhardt ; Peltz, Gerson ; Girvan, Allicia C. ; Winfree, Katherine B. ; Martinez, Betzaida ; Marciniak, Martin ; Walker, Mark S. ; Stepanski, Edward ; Schwartzberg, Lee ; Adjei, Alex. / 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. In: Clinical Lung Cancer. 2013 ; Vol. 14, No. 6. pp. 726-735.
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abstract = "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.",
author = "Eduardo Pennella and Obasaju, {Coleman K.} and Gerhardt Pohl and Gerson Peltz and Girvan, {Allicia C.} and Winfree, {Katherine B.} and Betzaida Martinez and Martin Marciniak and Walker, {Mark S.} and Edward Stepanski and Lee Schwartzberg and Alex Adjei",
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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

AU - Adjei, Alex

PY - 2013/11/1

Y1 - 2013/11/1

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.

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