Treatment outcomes were similar between Black and non-black patients with triple-negative breast cancer who received neoadjuvant durvalumab (Imfinzi) and chemotherapy, according to results of a phase I/II clinical trial published in Clinical Cancer Research.
Triple breast cancer is a serious form of breast cancer cancer which is more common among Black people. However, Black patients are often underrepresented in clinical trials of research methods, said Lajos Pusztai, MD, DPhil, professor of medicine; co-chair of Genetics, Genomics, and Epigenetics; and scientific director of the Yale Cancer Center at Yale School of Medicine.
“Small groups of ethnic minorities, especially Black Americans, in the clinical trials it’s problematic for a number of reasons,” he said. “One, it means black patients are not being given equal access to new life-saving treatments early on. Second, it limits our ability to study potential differences in drug metabolism, toxicity, and efficacy between different populations and ancestries.”
Durvalumab is an immunotherapeutic that targets the PD-1/PD-L1 immune system. The results of a previously published clinical trial by Pusztai and colleagues showed that the administration of durvalumab in combination with chemotherapy before surgery benefited the patients. triple negative breast cancer. However, the initial study population did not show the racial/ethnicity of the surrounding areas or the prevalence of the disease, Pusztai said.
To better understand the efficacy of this treatment in Black patients, Pusztai and colleagues put together a research team to recruit more Black patients into the trial. With the extension group, the trial included 67 patients, of which 21 (31 percent) identified as Black, bringing the number of Black patients close to that of the local population. Forty patients identified as non-Hispanic white, three as Hispanic/Latino, and three as Asian. Patient characteristics and baseline tumor characteristics did not differ significantly by race.
Of the 67 patients enrolled in the trial, 31 (46 percent) achieved a complete disease response (pCR) to neoadjuvant durvalumab plus chemotherapy. There were no significant differences by race: 43 percent of Black patients had a pCR compared with 48 percent of non-Black patients.
Similarly, no significant differences were found between blacks and patients for metastatic recurrence rates (14 percent vs. 17 percent), three-year overall survival (81 percent vs. 87 percent), and three-year event-free survival (71.4 percent vs. 78.3 percent).
In the Black and non-Black groups, patients who had a pCR had longer event-free survival and overall survival than those who did not have a pCR. The three-year overall survival rate was 96.8 percent for patients with pCR and 81.8 percent for those without. Party for three years-free survival rate they were 90.3 percent and 66.7 percent in those with and without pCR, respectively.
Neither PD-L1 status nor adverse events differed significantly by race.
“Our research shows that when patients are given similar treatment and similar follow-up, the disparity in outcomes between Black and white patients is reduced,” Pusztai said. “By improvisation access to health care and giving, we can reduce some of the health disparities that exist in our community.”
Limitations of the study include small sample size and entering the only institution.
Clinical Outcomes and Clinical Trials in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-TNBC, Clinical Cancer Research (2022). DOI: 10.1158/1078-0432.CCR-22-0862
American Association for Cancer Research
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