Comparative Effectiveness Research

The Impact of Biologic Agents in Ethnic Minorities With Metastatic Colorectal Cancer

Sanjay Goel, Abdissa Negassa, Ashish Khot, Dharmendra Goyal, Shuang Guo, Amara Nandikolla, Kamila Bakirhan, Rahul Polineni, Umang Shah, Imran Chaudhary, Mohammad H. Ghalib, Lakshmi Rajdev, Andreas Kaubisch, Jennifer W. Chuy, Santiago Aparo

Research output: Contribution to journalArticle

Abstract

Background: Biologic agents have improved the outcomes of patients with metastatic colorectal cancer (mCRC). However, the clinical trials included a predominately white population (85%), with Hispanic and black patients underrepresented. Thus, the real world benefit for the latter remains unknown. Comparative effectiveness research is a tool allowing for this exploration. Patients and Methods: The demographic and clinical characteristics of patients treated for mCRC from 2000 to 2011 were extracted from the medical records of Montefiore Medical Center. A semiparametric accelerated failure time model was used to assess the survival differences between patients receiving chemotherapy (CT) alone versus CT plus biologic agents (CBT). Results: Of the 290 patients (black, 45.9%; Hispanic, 26.2%; and white, 27.9%), 53.8% received biologic agents. The median overall survival was 15.2 months in the CT-alone group and 25.6 months in CBT group (P = .004). On univariate analysis, a lower number of metastatic sites, carcinoembryonic antigen < 41 ng/mL, and more lines of CT were associated with improved overall survival. In a propensity score-based analysis of the entire cohort, CBT offered a survival benefit compared with CT alone (increased median survival, 1.44-fold; 95% confidence interval [CI], 1.11-1.86; P = .038). The results of the subgroup analysis suggested a survival benefit for white patients (2.01; 95% CI, 1.26-3.23; P = .031) but not for Hispanic (1.42; 95% CI, 0.91-2.20; P = .370) or black (1.12; 95% CI, 0.76-1.66; P = .596) patients. Conclusion: In the present cohort, CBT was associated with longer survival, with the effect mainly driven by the outcomes for white patients, with black patients not appearing to benefit. These data are provocative and warrant further confirmation. Efforts to increase ethnic minority patients' enrollment in clinical trials is required to prospectively define the benefit from novel therapies.

Original languageEnglish (US)
JournalClinical Colorectal Cancer
DOIs
StateAccepted/In press - Sep 19 2016

Fingerprint

Comparative Effectiveness Research
Biological Factors
Colorectal Neoplasms
Survival
Drug Therapy
Hispanic Americans
Confidence Intervals
Clinical Trials
Propensity Score
Carcinoembryonic Antigen
Medical Records

Keywords

  • Biologic therapy
  • Chemotherapy
  • Colorectal cancer
  • Comparative effectiveness research
  • Race

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

Comparative Effectiveness Research : The Impact of Biologic Agents in Ethnic Minorities With Metastatic Colorectal Cancer. / Goel, Sanjay; Negassa, Abdissa; Khot, Ashish; Goyal, Dharmendra; Guo, Shuang; Nandikolla, Amara; Bakirhan, Kamila; Polineni, Rahul; Shah, Umang; Chaudhary, Imran; Ghalib, Mohammad H.; Rajdev, Lakshmi; Kaubisch, Andreas; Chuy, Jennifer W.; Aparo, Santiago.

In: Clinical Colorectal Cancer, 19.09.2016.

Research output: Contribution to journalArticle

Goel, Sanjay ; Negassa, Abdissa ; Khot, Ashish ; Goyal, Dharmendra ; Guo, Shuang ; Nandikolla, Amara ; Bakirhan, Kamila ; Polineni, Rahul ; Shah, Umang ; Chaudhary, Imran ; Ghalib, Mohammad H. ; Rajdev, Lakshmi ; Kaubisch, Andreas ; Chuy, Jennifer W. ; Aparo, Santiago. / Comparative Effectiveness Research : The Impact of Biologic Agents in Ethnic Minorities With Metastatic Colorectal Cancer. In: Clinical Colorectal Cancer. 2016.
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abstract = "Background: Biologic agents have improved the outcomes of patients with metastatic colorectal cancer (mCRC). However, the clinical trials included a predominately white population (85{\%}), with Hispanic and black patients underrepresented. Thus, the real world benefit for the latter remains unknown. Comparative effectiveness research is a tool allowing for this exploration. Patients and Methods: The demographic and clinical characteristics of patients treated for mCRC from 2000 to 2011 were extracted from the medical records of Montefiore Medical Center. A semiparametric accelerated failure time model was used to assess the survival differences between patients receiving chemotherapy (CT) alone versus CT plus biologic agents (CBT). Results: Of the 290 patients (black, 45.9{\%}; Hispanic, 26.2{\%}; and white, 27.9{\%}), 53.8{\%} received biologic agents. The median overall survival was 15.2 months in the CT-alone group and 25.6 months in CBT group (P = .004). On univariate analysis, a lower number of metastatic sites, carcinoembryonic antigen < 41 ng/mL, and more lines of CT were associated with improved overall survival. In a propensity score-based analysis of the entire cohort, CBT offered a survival benefit compared with CT alone (increased median survival, 1.44-fold; 95{\%} confidence interval [CI], 1.11-1.86; P = .038). The results of the subgroup analysis suggested a survival benefit for white patients (2.01; 95{\%} CI, 1.26-3.23; P = .031) but not for Hispanic (1.42; 95{\%} CI, 0.91-2.20; P = .370) or black (1.12; 95{\%} CI, 0.76-1.66; P = .596) patients. Conclusion: In the present cohort, CBT was associated with longer survival, with the effect mainly driven by the outcomes for white patients, with black patients not appearing to benefit. These data are provocative and warrant further confirmation. Efforts to increase ethnic minority patients' enrollment in clinical trials is required to prospectively define the benefit from novel therapies.",
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author = "Sanjay Goel and Abdissa Negassa and Ashish Khot and Dharmendra Goyal and Shuang Guo and Amara Nandikolla and Kamila Bakirhan and Rahul Polineni and Umang Shah and Imran Chaudhary and Ghalib, {Mohammad H.} and Lakshmi Rajdev and Andreas Kaubisch and Chuy, {Jennifer W.} and Santiago Aparo",
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T2 - The Impact of Biologic Agents in Ethnic Minorities With Metastatic Colorectal Cancer

AU - Goel, Sanjay

AU - Negassa, Abdissa

AU - Khot, Ashish

AU - Goyal, Dharmendra

AU - Guo, Shuang

AU - Nandikolla, Amara

AU - Bakirhan, Kamila

AU - Polineni, Rahul

AU - Shah, Umang

AU - Chaudhary, Imran

AU - Ghalib, Mohammad H.

AU - Rajdev, Lakshmi

AU - Kaubisch, Andreas

AU - Chuy, Jennifer W.

AU - Aparo, Santiago

PY - 2016/9/19

Y1 - 2016/9/19

N2 - Background: Biologic agents have improved the outcomes of patients with metastatic colorectal cancer (mCRC). However, the clinical trials included a predominately white population (85%), with Hispanic and black patients underrepresented. Thus, the real world benefit for the latter remains unknown. Comparative effectiveness research is a tool allowing for this exploration. Patients and Methods: The demographic and clinical characteristics of patients treated for mCRC from 2000 to 2011 were extracted from the medical records of Montefiore Medical Center. A semiparametric accelerated failure time model was used to assess the survival differences between patients receiving chemotherapy (CT) alone versus CT plus biologic agents (CBT). Results: Of the 290 patients (black, 45.9%; Hispanic, 26.2%; and white, 27.9%), 53.8% received biologic agents. The median overall survival was 15.2 months in the CT-alone group and 25.6 months in CBT group (P = .004). On univariate analysis, a lower number of metastatic sites, carcinoembryonic antigen < 41 ng/mL, and more lines of CT were associated with improved overall survival. In a propensity score-based analysis of the entire cohort, CBT offered a survival benefit compared with CT alone (increased median survival, 1.44-fold; 95% confidence interval [CI], 1.11-1.86; P = .038). The results of the subgroup analysis suggested a survival benefit for white patients (2.01; 95% CI, 1.26-3.23; P = .031) but not for Hispanic (1.42; 95% CI, 0.91-2.20; P = .370) or black (1.12; 95% CI, 0.76-1.66; P = .596) patients. Conclusion: In the present cohort, CBT was associated with longer survival, with the effect mainly driven by the outcomes for white patients, with black patients not appearing to benefit. These data are provocative and warrant further confirmation. Efforts to increase ethnic minority patients' enrollment in clinical trials is required to prospectively define the benefit from novel therapies.

AB - Background: Biologic agents have improved the outcomes of patients with metastatic colorectal cancer (mCRC). However, the clinical trials included a predominately white population (85%), with Hispanic and black patients underrepresented. Thus, the real world benefit for the latter remains unknown. Comparative effectiveness research is a tool allowing for this exploration. Patients and Methods: The demographic and clinical characteristics of patients treated for mCRC from 2000 to 2011 were extracted from the medical records of Montefiore Medical Center. A semiparametric accelerated failure time model was used to assess the survival differences between patients receiving chemotherapy (CT) alone versus CT plus biologic agents (CBT). Results: Of the 290 patients (black, 45.9%; Hispanic, 26.2%; and white, 27.9%), 53.8% received biologic agents. The median overall survival was 15.2 months in the CT-alone group and 25.6 months in CBT group (P = .004). On univariate analysis, a lower number of metastatic sites, carcinoembryonic antigen < 41 ng/mL, and more lines of CT were associated with improved overall survival. In a propensity score-based analysis of the entire cohort, CBT offered a survival benefit compared with CT alone (increased median survival, 1.44-fold; 95% confidence interval [CI], 1.11-1.86; P = .038). The results of the subgroup analysis suggested a survival benefit for white patients (2.01; 95% CI, 1.26-3.23; P = .031) but not for Hispanic (1.42; 95% CI, 0.91-2.20; P = .370) or black (1.12; 95% CI, 0.76-1.66; P = .596) patients. Conclusion: In the present cohort, CBT was associated with longer survival, with the effect mainly driven by the outcomes for white patients, with black patients not appearing to benefit. These data are provocative and warrant further confirmation. Efforts to increase ethnic minority patients' enrollment in clinical trials is required to prospectively define the benefit from novel therapies.

KW - Biologic therapy

KW - Chemotherapy

KW - Colorectal cancer

KW - Comparative effectiveness research

KW - Race

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