Lung cancer, the leading cause of cancer death in the U.S., takes a particularly heavy toll on African Americans. Despite their lower smoking rates, African Americans are more likely than Caucasians to develop and die from lung cancer.
Today, Eli Lilly and Company (NYSE: LLY) announced results of a prospective observational study that evaluated whether ethnicity affected outcome in stage IIIB/IV non-small cell lung cancer (NSCLC) patients treated with ALIMTA® (pemetrexed for injection) in the second-line setting. The study found that the disease control rate (one of the measures for evaluating the effectiveness of NSCLC therapies) among African Americans was non-inferior to that of Caucasians.
Results of the study were announced today at the American Association for Cancer Research (AACR) annual "Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved" meeting in Washington, D.C.
"Few prospective lung cancer studies have looked at the impact of race and ethnicity on clinical outcomes," said Lee Schwartzberg, M.D., FACP, president and chief medical officer at ACORN Research, LLC and one of the study's investigators. "But as cancer researchers, determining how ethnicity influences treatment should be just as important as discovering the role of a gene mutation in predicting therapeutic success."
Disease Control Rate, or DCR, is defined as the percentage of patients with a partial or complete response to a drug, plus the percentage of patients whose disease has stabilized. DCR could be a more powerful predictor of how a drug will affect survival than the traditional measure of tumor response to therapy (the sum of complete response plus partial response).
Information on DCR was available for 267 Caucasians and 59 African Americans. The unadjusted DCR, or raw data, was 45.8 percent (27 of 59 patients) for the African American study arm and 43.4 percent (116 of 267 patients) for the Caucasian arm. The odds ratio, a measure of whether a response is more likely in one population than another, indicated the proportions were similar. This was true on the raw data, as well as after adjustment for relevant factors such as age, gender, smoking status and income.
Median survival for African American patients in the study was 6.9 months (95% CI: 4.5, 8.9) compared with 6.7 months (95% CI: 5.7, 7.9) for Caucasian patients. In addition, African American patients achieved 3.0 months (95% CI: 2.3, 4.7) of median progression-free survival compared with 2.7 months (95% CI: 2.4, 3.4) for Caucasian patients. The results indicate that the DCR was non-inferior for African American compared to Caucasian NSCLC patients receiving ALIMTA in this study.
"Traditionally, the vast majority of lung cancer studies have involved Caucasians, so physicians had no way of knowing whether the same results would hold true for other ethnic groups, such as African Americans," said Coleman Obasaju, M.D., Ph.D., senior medical director at Lilly Oncology. "These kinds of studies help us begin to close this gap and improve health outcomes for all ethnicities."
As part of Lilly's goal to improve health outcomes for individual patients, the company is increasing enrollment of diverse populations in clinical trials and making it easier for patients in minority communities to participate. Lilly's clinical trial strategy includes forming partnerships with other organizations committed to the same goal, and making efforts to educate and encourage physicians and patients to understand the importance of diverse representation in clinical trials.