Treatments Matched to Genomic Analysis Improved Outcomes for Certain Patients With Metastatic Breast Cancer


Genomic analyses show promise for patients with metastatic breast cancer, reinforcing genomics as a part of the pathway of care.

Using multigene sequencing as a therapeutic decision tool was associated with improved outcomes for patients with metastatic breast cancer when the genomic alterations identified were ranked in the I/II tiers of the ESMO Scale for clinical actionability of molecular targets (ESCAT), according to the results of the SAFIR02-BREAST trial, presented at the 2021 San Antonio Breast Cancer Symposium.

Investigators were able to simultaneously sequence multiple genes to establish the mutational profile of a patient’s tumors using next-generation genome analysis technologies. According to the study authors, this method can assist in targeting the identified gene alterations with therapeutics that may not be the standard of care for that disease.

“Multigene sequencing has been widely implemented but its clinical impact and the best framework for its use are unclear,” said Fabrice André, MD, PhD, research director at Gustave Roussy Cancer Campus, in a press release. “The main purpose of our study was to test whether genomic analyses are useful for patients with metastatic breast cancer, and how we can best analyze the results.”

SAFIR02-BREAST, a phase 2 trial enrolling patients with metastatic, human epidermal growth factor receptor 2-negative breast cancer who had received no more than 2 lines of chemotherapy or 1 of the targeted therapies evaluated, was designed to analyze whether targeted therapies guided by multigene sequencing improve progression-free survival (PFS) for these patients compared to maintenance chemotherapy.

The investigators performed genomic analysis on 1462 patients, assigning 238 who carried known genomic alterations with stable disease following 6 to 8 cycles of chemotherapy to receive either targeted therapies matched to their mutation or maintenance chemotherapy. According to the results of the study, among 115 patients presenting an ESCAT I/II genomic alteration, the median PFS was 9.1 months in the matched targeted therapy groups compared to 2.8 months in the maintenance chemotherapy arms.

However, there was no significant difference in PFS between these 2 cohorts in the overall study population. Further, targeted therapies were not effective when matched to alterations that did not rank as ESCAT I/II, indicating that ESCAT classification may be highly predictive of which patients will benefit from targeted therapies, according to the study.

“Our study showed that genomic analysis improves the outcome of patients with metastatic breast cancer if they carry alterations classified as ESCATI/II,” André said in the release. “These findings suggest that genomics should be a part of the pathway of care, but it has no impact if the results are not interpreted using a validated framework of actionability of the gene alterations identified.”


Using genomics to match treatments improved outcomes for certain patients with metastatic breast cancer [news release]. San Antonio Breast Cancer Symposium; December 7, 2021. Accessed December 2, 2021.

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