Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012

Herbert H. Pang, Xiaofei Wang, Thomas E. Stinchcombe, Melisa L. Wong, Perry Cheng, Apar Kishor P Ganti, Daniel J. Sargent, Ying Zhang, Chen Hu, Sumithra J. Mandrekar, Mary W. Redman, Judith B. Manola, Richard L. Schilsky, Harvey J. Cohen, Jeffrey D. Bradley, Alex A. Adjei, David Gandara, Suresh S. Ramalingam, Everett E. Vokes

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Abstract

Purpose: Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung cancer trials. Methods: We analyzed data for 23,006 National Cancer Institute cooperative group lung cancer trial participants and 578,476 patients with lung cancer from the SEER registry from 1990 to 2012. The enrollment disparity difference (EDD) and enrollment disparity ratio (EDR) were calculated on the basis of the proportion of each subgroup in the trial population and the US lung cancer population. Annual percentage changes (APCs) in the subgroup proportions in each population were compared over time. Results: Enrollment disparity for patients ≥ 70 years of age with non-small-cell lung cancer improved from 1990 to 2012 (test of parallelism, P = .020), with a remaining EDD of 0.22 (95% CI, 0.19 to 0.25) and EDR of 1.65 (95% CI, 1.51 to 1.82) in 2010 to 2012. No improvement was seen for elderly patients with small-cell lung cancer (SCLC), with an APC of 0.20 (P = .714) among trial participants, despite a rising proportion of elderly patients with SCLC in the US population (APC, 0.32; P = .020). Enrollment disparity for women with lung cancer improved overall, with the gap closing by 2012 (EDD, 0.03 [95% CI, 0.00 to 0.06]; EDR, 1.07 [95% CI, 1.00 to 1.16]). Enrollment disparities persisted without significant improvement for elderly women, blacks, Asians/Pacific Islanders, and Hispanics. Conclusion: Under-representation in lung cancer trials improved significantly from 1990 to 2012 for elderly patients with non-small-cell lung cancer and for women, but ongoing efforts to improve the enrollment of elderly patients with SCLC and minorities are needed. Our study highlights the importance of addressing enrollment disparities by demographic and disease subgroups to better target under-represented groups of patients with lung cancer.

Original languageEnglish (US)
Pages (from-to)3992-3999
Number of pages8
JournalJournal of Clinical Oncology
Volume34
Issue number33
DOIs
StatePublished - Nov 20 2016

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Lung Neoplasms
Clinical Trials
Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
Population
National Cancer Institute (U.S.)
Hispanic Americans
Registries
Demography
Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012. / Pang, Herbert H.; Wang, Xiaofei; Stinchcombe, Thomas E.; Wong, Melisa L.; Cheng, Perry; Ganti, Apar Kishor P; Sargent, Daniel J.; Zhang, Ying; Hu, Chen; Mandrekar, Sumithra J.; Redman, Mary W.; Manola, Judith B.; Schilsky, Richard L.; Cohen, Harvey J.; Bradley, Jeffrey D.; Adjei, Alex A.; Gandara, David; Ramalingam, Suresh S.; Vokes, Everett E.

In: Journal of Clinical Oncology, Vol. 34, No. 33, 20.11.2016, p. 3992-3999.

Research output: Contribution to journalArticle

Pang, HH, Wang, X, Stinchcombe, TE, Wong, ML, Cheng, P, Ganti, AKP, Sargent, DJ, Zhang, Y, Hu, C, Mandrekar, SJ, Redman, MW, Manola, JB, Schilsky, RL, Cohen, HJ, Bradley, JD, Adjei, AA, Gandara, D, Ramalingam, SS & Vokes, EE 2016, 'Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012', Journal of Clinical Oncology, vol. 34, no. 33, pp. 3992-3999. https://doi.org/10.1200/JCO.2016.67.7088
Pang, Herbert H. ; Wang, Xiaofei ; Stinchcombe, Thomas E. ; Wong, Melisa L. ; Cheng, Perry ; Ganti, Apar Kishor P ; Sargent, Daniel J. ; Zhang, Ying ; Hu, Chen ; Mandrekar, Sumithra J. ; Redman, Mary W. ; Manola, Judith B. ; Schilsky, Richard L. ; Cohen, Harvey J. ; Bradley, Jeffrey D. ; Adjei, Alex A. ; Gandara, David ; Ramalingam, Suresh S. ; Vokes, Everett E. / Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 33. pp. 3992-3999.
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abstract = "Purpose: Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung cancer trials. Methods: We analyzed data for 23,006 National Cancer Institute cooperative group lung cancer trial participants and 578,476 patients with lung cancer from the SEER registry from 1990 to 2012. The enrollment disparity difference (EDD) and enrollment disparity ratio (EDR) were calculated on the basis of the proportion of each subgroup in the trial population and the US lung cancer population. Annual percentage changes (APCs) in the subgroup proportions in each population were compared over time. Results: Enrollment disparity for patients ≥ 70 years of age with non-small-cell lung cancer improved from 1990 to 2012 (test of parallelism, P = .020), with a remaining EDD of 0.22 (95{\%} CI, 0.19 to 0.25) and EDR of 1.65 (95{\%} CI, 1.51 to 1.82) in 2010 to 2012. No improvement was seen for elderly patients with small-cell lung cancer (SCLC), with an APC of 0.20 (P = .714) among trial participants, despite a rising proportion of elderly patients with SCLC in the US population (APC, 0.32; P = .020). Enrollment disparity for women with lung cancer improved overall, with the gap closing by 2012 (EDD, 0.03 [95{\%} CI, 0.00 to 0.06]; EDR, 1.07 [95{\%} CI, 1.00 to 1.16]). Enrollment disparities persisted without significant improvement for elderly women, blacks, Asians/Pacific Islanders, and Hispanics. Conclusion: Under-representation in lung cancer trials improved significantly from 1990 to 2012 for elderly patients with non-small-cell lung cancer and for women, but ongoing efforts to improve the enrollment of elderly patients with SCLC and minorities are needed. Our study highlights the importance of addressing enrollment disparities by demographic and disease subgroups to better target under-represented groups of patients with lung cancer.",
author = "Pang, {Herbert H.} and Xiaofei Wang and Stinchcombe, {Thomas E.} and Wong, {Melisa L.} and Perry Cheng and Ganti, {Apar Kishor P} and Sargent, {Daniel J.} and Ying Zhang and Chen Hu and Mandrekar, {Sumithra J.} and Redman, {Mary W.} and Manola, {Judith B.} and Schilsky, {Richard L.} and Cohen, {Harvey J.} and Bradley, {Jeffrey D.} and Adjei, {Alex A.} and David Gandara and Ramalingam, {Suresh S.} and Vokes, {Everett E.}",
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T1 - Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012

AU - Pang, Herbert H.

AU - Wang, Xiaofei

AU - Stinchcombe, Thomas E.

AU - Wong, Melisa L.

AU - Cheng, Perry

AU - Ganti, Apar Kishor P

AU - Sargent, Daniel J.

AU - Zhang, Ying

AU - Hu, Chen

AU - Mandrekar, Sumithra J.

AU - Redman, Mary W.

AU - Manola, Judith B.

AU - Schilsky, Richard L.

AU - Cohen, Harvey J.

AU - Bradley, Jeffrey D.

AU - Adjei, Alex A.

AU - Gandara, David

AU - Ramalingam, Suresh S.

AU - Vokes, Everett E.

PY - 2016/11/20

Y1 - 2016/11/20

N2 - Purpose: Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung cancer trials. Methods: We analyzed data for 23,006 National Cancer Institute cooperative group lung cancer trial participants and 578,476 patients with lung cancer from the SEER registry from 1990 to 2012. The enrollment disparity difference (EDD) and enrollment disparity ratio (EDR) were calculated on the basis of the proportion of each subgroup in the trial population and the US lung cancer population. Annual percentage changes (APCs) in the subgroup proportions in each population were compared over time. Results: Enrollment disparity for patients ≥ 70 years of age with non-small-cell lung cancer improved from 1990 to 2012 (test of parallelism, P = .020), with a remaining EDD of 0.22 (95% CI, 0.19 to 0.25) and EDR of 1.65 (95% CI, 1.51 to 1.82) in 2010 to 2012. No improvement was seen for elderly patients with small-cell lung cancer (SCLC), with an APC of 0.20 (P = .714) among trial participants, despite a rising proportion of elderly patients with SCLC in the US population (APC, 0.32; P = .020). Enrollment disparity for women with lung cancer improved overall, with the gap closing by 2012 (EDD, 0.03 [95% CI, 0.00 to 0.06]; EDR, 1.07 [95% CI, 1.00 to 1.16]). Enrollment disparities persisted without significant improvement for elderly women, blacks, Asians/Pacific Islanders, and Hispanics. Conclusion: Under-representation in lung cancer trials improved significantly from 1990 to 2012 for elderly patients with non-small-cell lung cancer and for women, but ongoing efforts to improve the enrollment of elderly patients with SCLC and minorities are needed. Our study highlights the importance of addressing enrollment disparities by demographic and disease subgroups to better target under-represented groups of patients with lung cancer.

AB - Purpose: Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung cancer trials. Methods: We analyzed data for 23,006 National Cancer Institute cooperative group lung cancer trial participants and 578,476 patients with lung cancer from the SEER registry from 1990 to 2012. The enrollment disparity difference (EDD) and enrollment disparity ratio (EDR) were calculated on the basis of the proportion of each subgroup in the trial population and the US lung cancer population. Annual percentage changes (APCs) in the subgroup proportions in each population were compared over time. Results: Enrollment disparity for patients ≥ 70 years of age with non-small-cell lung cancer improved from 1990 to 2012 (test of parallelism, P = .020), with a remaining EDD of 0.22 (95% CI, 0.19 to 0.25) and EDR of 1.65 (95% CI, 1.51 to 1.82) in 2010 to 2012. No improvement was seen for elderly patients with small-cell lung cancer (SCLC), with an APC of 0.20 (P = .714) among trial participants, despite a rising proportion of elderly patients with SCLC in the US population (APC, 0.32; P = .020). Enrollment disparity for women with lung cancer improved overall, with the gap closing by 2012 (EDD, 0.03 [95% CI, 0.00 to 0.06]; EDR, 1.07 [95% CI, 1.00 to 1.16]). Enrollment disparities persisted without significant improvement for elderly women, blacks, Asians/Pacific Islanders, and Hispanics. Conclusion: Under-representation in lung cancer trials improved significantly from 1990 to 2012 for elderly patients with non-small-cell lung cancer and for women, but ongoing efforts to improve the enrollment of elderly patients with SCLC and minorities are needed. Our study highlights the importance of addressing enrollment disparities by demographic and disease subgroups to better target under-represented groups of patients with lung cancer.

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