ASCO Reading Room | Erica Mayer, MD, on Updated HER2- Breast Cancer Guidelines

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ASCO has published two sets of updated guidelines for patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer, both in Journal of Clinical Oncology.

One update (Burstein et al.) covers endocrine therapy and targeted therapy for patients with hormone receptor-positive (HR) cancer. Another update (Moy et al.) covers chemotherapy and targeted therapy for patients with HR-negative disease or those already treated with endocrine therapy.

In the following interview, Erica Meyer, MD, ASCO’s Cancer Communications Committee, summarizes some of the important changes and key themes of the new recommendations. Mayer is an oncologist and clinical investigator at the Dana-Farber Cancer Institute in Boston.

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Update by Burstein et al. Genotyping by tumor tissue or circulating tumor DNA is favored for all patients. What is the point of this recommendation?

Mayer: We’ve had the technology to obtain tumor genomic profiling for years, but until recently this information was of scientific interest in breast cancer, but not clinically feasible. As described by Borstein et al. Supported by the SOLAR-1 study, approval of alpelisib [Piqray] For patients with metastatic ER+/HER2-PIK3CA-mutated carcinomas, the need to obtain genotyping of all patients with advanced ER+/HER2- disease supports the identification of the best candidates for alpelisib. It is hoped that with further scientific progress, additional actionable genetic mutations will be identified as well.

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This update also supports the use of endocrine therapy in conjunction with targeted therapies, including CDK4/6 inhibitors and alpelisib. How has this approach affected the treatment of HER2-negative breast cancer?

Mayer: Historically, ER+/HER2 breast cancer patients received endocrine therapies as sequential monotherapy. However, there are now large clinical trial data showing better survival outcomes by partnering endocrine agents with a target agent, including CDK4/6 inhibitors in the first-line or pre-treated setting, and the PI3 kinase inhibitor alpelisib in the ER+/ HER2-PIK3CA mutated breast cancer.

In general, patients with metastatic ER+/HER2 breast cancer live longer than ever before due to the benefits gained from adding targeted agents, and new ASCO guidelines fully support this approach.

Update by Moy et al. It includes many new agents that are becoming available. Can you tell us about some of these indicators and their implications?

Mayer: Management of triple-negative breast cancer – TNBC, ER/PR receptor-negative and HER2-positive cancers – has primarily involved the use of chemotherapy. However, as described by Moi et al., there are now newer agents that improve outcomes for patients with this subgroup of disease.

A subset of TNBC expresses the PD-L1 receptor, and as shown in the KEYNOTE-355 study, outcomes are improved when the PD-L1 inhibitor pembrolizumab is added to chemotherapy as part of a first-line setting. In patients with metastatic TNBC and at least two previous lines of therapy for advanced disease, conjugation of sacituzumab govitecan antibody and drug significantly improves survival outcomes and is recommended.

Finally, in patients with BRCA1/2 germline mutations, PARP inhibitors, such as olaparib or talazoparib, may be used in first-line or pretreatment of HER2-positive breast cancer. In general, a move away from chemotherapy alone and towards models of treatment with targeted agents is welcome for this subgroup of disease.

Are there any general or general topics in these updated Guidelines?

Mayer: It has been incredibly encouraging to see advances from the Cancer Biology Laboratory, including the ability to identify tumor mutations in real time and understand the mechanistic impact of genetic changes, and translate them into clinically effective tools that provide benefit to patients with advanced breast cancer.

Recent guidelines highlight the importance of learning as much as possible about each patient’s tumor, and then designing a treatment model with appropriate factors included. It is hoped that future drug approvals and guidelines will continue to reflect this successful translational science and the ability to continue to tailor therapeutic strategies to each patient.

Read the study here.

Mayer reports that he is a consultant to Lilly, Novartis, Gilead and AstraZeneca.

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