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

作者：Obasaju Coleman K^*; Ansari Rafat H; Socinski Mark A; Chen Ruqin; Monberg Matthew J; Catalano Robert B; Marinucci Donna M; Liles Darla K; Ribeiro Maria Jose; Comis Robert L; Treat Joseph

来源：Journal of Thoracic Oncology, 2010, 5(7): 993-1000.

DOI：10.1097/JTO.0b013e3181e29cf3

• NSCLC
• Phase III
• African American
• Nonplatinum doublets
• Accrual
• Race

Purpose: 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: Chemonaive 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 gemcitabine-carboplatin (n = 47), 10.5 months (95% CI: 7.1-15.4) for gemcitabine- paclitaxel (n = 42), and 10.2 months (95% CI: 8.5-13.2) for paclitaxel-carboplatin (n = 49).
Conclusion: Whites and African Americans had similar outcomes, although there was some variability in survival among African Americans across the three treatment groups.

• 出版日期2010-7