New findings suggest that docetaxel may be considered the preferred treatment over paclitaxel for Black patients with early-stage breast cancer. While the EAZ171 trial focused specifically on Black people, the results highlight the need to personalize therapy to minimize toxicity. Importantly, this study offers a blueprint for how to design and recruit for a study focusing on a minority or underserved patient population. The research was presented by Ballinger et al at the 2024 ASCO Annual Meeting (Abstract LBA503) and simultaneously published in the Journal of Clinical Oncology.
About the EAZ171 Study
Previous research from the laboratory of Bryan P. Schneider, MD, Vera Bradley Professor of Oncology at Indiana University School of Medicine, found that Black patients with breast cancer experience significantly more treatment-induced peripheral neuropathy compared to patients of other races and that specific genetic differences could modify the risk of neuropathy. Higher rates of neuropathy are associated with chemotherapy dose reductions and lower cure rates.
The ECOG-ACRIN Cancer Research Group designed the EAZ171 trial to validate genetic predictors of neuropathy and to determine the optimal taxane based on side effects and potential dose reductions for Black patients with early-stage breast cancer.
The design of the trial and recruitment of patients was done in collaboration with Black patient advocates, including a local group in Indianapolis called Pink-4-Ever Ending Disparities. A strong social media campaign was designed for recruitment with help from these advocates and featured Black women with breast cancer. Many enrolled patients came from sites in the National Cancer Institute’s Community Oncology Research Program, or NCORP, rather than solely from academic settings.
Woman with early-stage breast cancer who self-identified as Black received treatment with either weekly paclitaxel or docetaxel every 3 weeks. A total of 249 patients were enrolled in the trial, with 121 receiving at least one dose of paclitaxel and 118 receiving one dose of docetaxel.
Key Findings
Black patients with breast cancer treated with docetaxel had less treatment-induced peripheral neuropathy and fewer dose reductions compared to those who received paclitaxel. Patients receiving paclitaxel required more dose reductions due to peripheral neuropathy (28% vs 9%) or due to any cause (39% vs 25%) compared to patients receiving docetaxel.
Inherited gene alterations were more common in patients who developed treatment-induced peripheral neuropathy, but this outcome did not reach statistical significance. Physician-reported grade 2 to 4 peripheral neuropathy was not significantly different in the high- vs low-risk gene-alteration groups for either treatment arm. However, grade 2 to 4 peripheral neuropathy was significantly higher in patients receiving paclitaxel than those receiving docetaxel both by physician report (44% vs 29%) and patient report (40% vs 24%).
“Clinical trials in the United States have suffered from a disproportionate lack of Black patient enrollment. Lack of representation is problematic given significant disparities in cancer outcomes by race. Specifically, Black patients with breast cancer are significantly more likely to die of the disease and to experience significant toxicity. We sought to not just describe disparities, but to expand our understanding of them so that we can improve equity in breast cancer care,” said lead study author Tarah Ballinger, MD, a breast cancer investigator at the Indiana University Melvin and Bren Comprehensive Cancer Center, and the Vera Bradley Foundation Scholar in Breast Cancer Research and Associate Professor of Clinical Medicine at the Indiana University School of Medicine, Indianapolis.
Next Steps
The researchers are planning another trial that will look to further optimize therapy for Black patients with breast cancer.
ASCO Perspective
Julie R. Gralow, MD, FACP, FASCO
“Racial and ethnic differences in chemotherapy toxicity have been observed, but most have not been subjected to detailed studies, primarily due to low numbers of enrollees from minority populations in clinical trials. This study shows that it is possible to achieve successful enrollment to a prospective study restricted to women of African ancestry with early-stage breast cancer in order to evaluate a proposed germline predictor of taxane-induced peripheral neuropathy, and to compare toxicity between two different taxane drugs in this population. While these drugs may cause additional toxicities, this research finds that docetaxel can be considered the preferred treatment for Black patients with early-stage breast cancer compared to paclitaxel,” said Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer of ASCO.
Disclosure: This study was funded by the National Cancer Institute. Additional support was provided by Susan G. Komen and the Vera Bradley Foundation for Breast Cancer. For full disclosures of the study authors, visit coi.asco.org.
