ASCO's New Guideline for Endocrine Therapy in Breast Cancer

Roxanne Nelson

June 01, 2016

The American Society of Clinical Oncology (ASCO) has issued a new guideline for the use of endocrine therapy in the treatment of hormone receptor (HR)-positive metastatic breast cancer.

The guideline was published online May 23 in the Journal of Clinical Oncology.

The options for endocrine therapy have expanded in the past 2 decades as new and effective agents have become available, write Hope Rugo, MD, from the University of California, San Francisco Comprehensive Cancer, and her coauthors.

In addition, many of these drugs have now been incorporated into the treatment of early-stage disease. "The forward movement of new drugs from the advanced- to the early-stage setting has complicated choices for metastatic disease, increasing the importance of guidelines that summarize available evidence," the authors note.

A number of issues have arisen, such as the sequencing of hormonal agents, whether hormonal agents or chemotherapy should be used in the first-line setting, and whether hormonal agents should be combined with each other or with targeted agents.

The treatment of premenopausal women is also a particular challenge in relation to the timing of ovarian suppression and the optimal use of hormonal agents.

To address these concerns and others, ASCO convened an expert panel to conduct a systematic review of the literature from 2008 to 2015, and developed recommendations on the basis of that evidence.

Key Recommendations for Women With HR-Positive Metastatic Breast Cancer
Hormone therapy should be offered to patients whose tumors express any level of estrogen and/or progesterone receptors, and treatment recommendations should be based on factors such as the type of adjuvant treatment being administered, disease-free interval, and the extent of disease at the time of recurrence
Use of a specific agent can be repeated if recurrence happens more than 12 months after the last treatment
Endocrine therapy should be recommended as the initial treatment in this patient population, except in the case of immediate life-threatening disease or rapid disease recurrence during adjuvant endocrine therapy
The use of combination endocrine therapy and chemotherapy is not recommended
For first-line therapy
  Postmenopausal women should be offered aromatase inhibitors (AIs)
  Combination hormone therapy with a nonsteroidal AI and fulvestrant (Faslodex, AstraZeneca) 500 mg and with a loading-dose schedule can be offered to patients who have not previously used endocrine therapy
  Premenopausal women should be offered ovarian suppression or ablation and hormone therapy; current agents have only been studied in the postmenopausal population
For second-line therapy
  Sequential hormone therapy should be offered except for those with rapid progression and organ dysfunction
  If fulvestrant is given, a 500 mg dose should be used, and with a loading schedule
For targeted therapy
  Postmenopausal women can be offered a nonsteroidal AI and palbociclib (Ibrance, Pfizer)
  Exemestane (Aromasin, Pfizer) and everolimus (Afinitor, Novartis) can be offered to postmenopausal women who progressed with nonsteroidal AIs, either before or after treatment with fulvestrant
  Fulvestrant and palbociclib can be offered to patients who experienced progression with AIs, with or without prior chemotherapy
  Adding HER2-targeted therapy to first-line AIs should be offered to patients with HR-positive and HER2-positive disease if they are not candidates for chemotherapy
  Genomic or expression profiling should not be used at this time to select treatment for metastatic HR-positive breast cancer


"A number of questions have not been fully explored in the current era of treatment options, such as the comparison of chemotherapy versus hormone therapy on the basis of biologic subsets of disease and the sequential or combination use of ovarian suppression and hormone therapy in premenopausal women," the authors explain.

One major goal, for example, is to identify markers or signatures that can predict response to specific therapies. "To date, these studies have only confirmed prognostic markers that do not predict benefit from specific therapies," they write.

Several of the authors have disclosed financial relationships, as detailed in the publication.

J Clin Oncol. Published online May 23, 2016. Abstract


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