Strategies to improve minority patient accrual to cancer clinical trials

Wujcik, Debra; Ikpeazu, Chukwuemeka; Chinratanalab, Wichai; Wolff, S. N.; Kinnard, Cheryl; McCullough, N.; Mason, Hyacinth R. C.; Stain, Steven C.

doi:10.1200/jco.2004.22.90140.6017

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“…Previous research has demonstrated that long-term meaningful improvement in minority representation must be a multifocal, cooperative effort between research sponsors, investigators, and the communities and institutions in which they serve. 37,38 In the overall analysis of efficacy parameters, median survival (8.3 months versus 9.1 months), TTP (4.6 months versus 4.3 months), and RR (29.1% versus 29.0%) were similar between white and African American patients, respectively. This is consistent with previous research that suggests that whites and African Americans who have uniform access to health care have similar outcomes in advanced NSCLC.…”

Section: Discussionmentioning

confidence: 98%

A Comparison of White and African American Outcomes from a Three-Arm, Randomized, Phase III Multicenter Trial of Advanced or Metastatic Non-small Cell Lung Cancer

Obasaju

Ansari

Socinski

et al. 2010

Journal of Thoracic Oncology

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To investigate the effect of race on the efficacy and safety of standard chemotherapy doublet regimens in African American patients, we conducted a subgroup analysis of a phase III randomized trial. Patients and Methods: Chemonaïve patients with a performance status of 0 or 1 and stage IIIB or IV non-small cell lung cancer were randomized to arm A: gemcitabine 1000 mg/m 2 on days 1 and 8 plus carboplatin area under the curve 5.5 on day 1; arm B: the same schedule of gemcitabine plus paclitaxel 200 mg/m 2 on day 1; or arm C: paclitaxel 225 mg/m 2 on day 1 plus carboplatin area under the curve 6.0 on day 1. Cycles were repeated every 21 days up to 6. A site selection tool identified institutions with potential to recruit a minority population. Outcome and toxicity data of white and African American patients were compared. Results: Of 1135 total patients, 972 were white (85.6%) and 138 were African American (12.2%). Median survival was 8.3 months for white patients (95% confidence interval [CI]: 7.7-9.3) and 9.1 months for African American patients (95% CI: 8.2-11.1). Response rates were 29.1 and 29.0%, respectively. Rates of grade 3 or 4 toxicities were comparable. Among African Americans, median survival was 7.2 months (95% CI: 5.1-10.1) for gemcitabinecarboplatin (n ϭ 47), 10.5 months (95% CI: 7.1-15.4) for gemcitabine-paclitaxel (n ϭ 42), and 10.2 months (95% CI: 8.5-13.2) for paclitaxel-carboplatin (n ϭ 49). Conclusion:Whites and African Americans had similar outcomes, although there was some variability in survival among African Americans across the three treatment groups.

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Section: Discussionmentioning

confidence: 98%