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Study Including Only Black Patients with Breast Cancer Finds Less Treatment-Induced Neuropathy from Docetaxel Compared to Paclitaxel, Offers Blueprint for Future Study Designs

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06/07/2024
society.asco.org

ASCO Perspective Quote

“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.” – Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer of the American Society of Clinical Oncology.   

Study at-a-Glance

Focus

Treatment-induced neuropathy in Black patients with breast cancer

Population

249 Black patients with early-stage breast cancer

Main Takeaway

Black patients with breast cancer treated with docetaxel had less taxane-induced peripheral neuropathy (TIPN) and less dose reductions compared to those who received paclitaxel, and two inherited gene alterations did not statistically predict which women would have less TIPN.

Significance

  • According to the authors, this is one of the first National Cancer Institute-cooperative group trials to focus enrollment solely on a minority population where there are disparate outcomes.
  • Unlike many trials focused on the efficacy of a given therapy, this trial focused on drug-induced toxicity—specifically peripheral neuropathy, which substantially impacts both quality of life and the ability to deliver planned doses of curative chemotherapy.

ALEXANDRIA, Va. — New study findings suggest that docetaxel may be considered the preferred treatment for Black patients with early-stage breast cancer compared to paclitaxel. While the trial focused specifically on Black people, the results highlight the need to personalize therapy in order 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 will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4 in Chicago, Illinois.

About the Study

“Clinical trials in the U.S. 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.

Previous research from the laboratory of Dr. Bryan Schneider, Vera Bradley Professor of Oncology at Indiana University School of Medicine, found that Black people with breast cancer experience significantly more treatmentinduced peripheral neuropathy (TIPN) compared to other races and that specific genetic differences could modify the risk of neuropathy. Higher rates of neuropathy are associated with dose reductions of chemotherapy 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—a type of drug that blocks cell growth by stopping cell division—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 (NCORP) rather than solely from academic settings.

Woman with early-stage breast cancer who self-identified as Black received treatment with either paclitaxel weekly or docetaxel every three weeks. A total of 249 patients were enrolled, 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 TIPN and fewer dose reductions compared to those who received paclitaxel.
  • Inherited gene alterations were more common in patients who developed TIPN but this outcome did not reach statistical significance.
  • Physician-reported grade 2-4 peripheral neuropathy was not significantly different in the high vs. low-risk gene alteration groups for either treatment arm.
  • However, grade 2-4 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%).
  • 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. 

These findings will be simultaneously published in the Journal of Clinical Oncology.

Next Steps

The researchers are planning another trial that will look to further optimize therapy for Black patients with breast cancer.

This study was funded by the National Cancer Institute, part of the National Institutes of Health. Additional support was provided by Susan G. Komen and the Vera Bradley Foundation for Breast Cancer.

View the full embargoed abstract 

View author disclosures

View the News Planning Team disclosures:https://society.asco.org/sites/new-www.asco.org/files/content-files/about-asco/pdf/2024-am-ccc-disclosures.pdf

ATTRIBUTION TO THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING IS REQUESTED IN ALL COVERAGE.

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Schedule19 Jun 2024