Harold J Burstein1, Mark R Somerfield2, Debra L Barton3, Ali Dorris4, Lesley J Fallowfield5, Dharamvir Jain6, Stephen R D Johnston7, Larissa A Korde8, Jennifer K Litton9, Erin R Macrae10, Lindsay L Peterson11, Praveen Vikas12, Rachel L Yung13, Hope S Rugo14. 1. Dana Farber Cancer Institute, Boston, MA. 2. American Society of Clinical Oncology, Alexandria, VA. 3. University of Michigan School of Nursing, Ann Arbor, MI. 4. Lobular Breast Cancer Research Advocate, San Francisco, CA. 5. University of Sussex, Brighton, United Kingdom. 6. Houston Methodist Hospital and Health Care, Houston, TX. 7. Royal Marsden NHS Foundation Trust, London, United Kingdom. 8. Clinical Investigations Branch, CTEP, DCTD, National Cancer Institute, Bethesda, MD. 9. University of Texas MD Anderson Cancer Center, Houston, TX. 10. Columbus Oncology Associates, Columbus, OH. 11. Division of Medical Oncology, Washington University School of Medicine, Saint Louis, MO. 12. University of Iowa Holden Comprehensive Cancer Center, Iowa City, IA. 13. University of Washington, Seattle, WA. 14. University of California San Francisco Comprehensive Cancer Center, San Francisco, CA.
Abstract
PURPOSE: To update recommendations of the ASCO systemic therapy for hormone receptor (HR)-positive metastatic breast cancer (MBC) guideline. METHODS: An Expert Panel conducted a systematic review to identify new, potentially practice-changing data. RESULTS: Fifty-one articles met eligibility criteria and form the evidentiary basis for the recommendations. RECOMMENDATIONS: Alpelisib in combination with endocrine therapy (ET) should be offered to postmenopausal patients, and to male patients, with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, ABC, or MBC following prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Clinicians should use next-generation sequencing in tumor tissue or cell-free DNA in plasma to detect PIK3CA mutations. If no mutation is found in cell-free DNA, testing in tumor tissue, if available, should be used as this will detect a small number of additional patients with PIK3CA mutations. There are insufficient data at present to recommend routine testing for ESR1 mutations to guide therapy for HR-positive, HER2-negative MBC. For BRCA1 or BRCA2 mutation carriers with metastatic HER2-negative breast cancer, olaparib or talazoparib should be offered in the 1st-line through 3rd-line setting. A nonsteroidal aromatase inhibitor (AI) and a CDK4/6 inhibitor should be offered to postmenopausal women with treatment-naïve HR-positive MBC. Fulvestrant and a CDK4/6 inhibitor should be offered to patients with progressive disease during treatment with AIs (or who develop a recurrence within 1 year of adjuvant AI therapy) with or without one line of prior chemotherapy for metastatic disease, or as first-line therapy. Treatment should be limited to those without prior exposure to CDK4/6 inhibitors in the metastatic setting.Additional information can be found at www.asco.org/breast-cancer-guidelines.
PURPOSE: To update recommendations of the ASCO systemic therapy for hormone receptor (HR)-positive metastatic breast cancer (MBC) guideline. METHODS: An Expert Panel conducted a systematic review to identify new, potentially practice-changing data. RESULTS: Fifty-one articles met eligibility criteria and form the evidentiary basis for the recommendations. RECOMMENDATIONS: Alpelisib in combination with endocrine therapy (ET) should be offered to postmenopausal patients, and to male patients, with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, ABC, or MBC following prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Clinicians should use next-generation sequencing in tumor tissue or cell-free DNA in plasma to detect PIK3CA mutations. If no mutation is found in cell-free DNA, testing in tumor tissue, if available, should be used as this will detect a small number of additional patients with PIK3CA mutations. There are insufficient data at present to recommend routine testing for ESR1 mutations to guide therapy for HR-positive, HER2-negative MBC. For BRCA1 or BRCA2 mutation carriers with metastatic HER2-negative breast cancer, olaparib or talazoparib should be offered in the 1st-line through 3rd-line setting. A nonsteroidal aromatase inhibitor (AI) and a CDK4/6 inhibitor should be offered to postmenopausal women with treatment-naïve HR-positive MBC. Fulvestrant and a CDK4/6 inhibitor should be offered to patients with progressive disease during treatment with AIs (or who develop a recurrence within 1 year of adjuvant AI therapy) with or without one line of prior chemotherapy for metastatic disease, or as first-line therapy. Treatment should be limited to those without prior exposure to CDK4/6 inhibitors in the metastatic setting.Additional information can be found at www.asco.org/breast-cancer-guidelines.
Authors: L J Fallowfield; S L Catt; S F May; L Matthews; V M Shilling; R Simcock; S Westwell; V A Jenkins Journal: Support Care Cancer Date: 2016-09-13 Impact factor: 3.603
Authors: Mark Robson; Seock-Ah Im; Elżbieta Senkus; Binghe Xu; Susan M Domchek; Norikazu Masuda; Suzette Delaloge; Wei Li; Nadine Tung; Anne Armstrong; Wenting Wu; Carsten Goessl; Sarah Runswick; Pierfranco Conte Journal: N Engl J Med Date: 2017-06-04 Impact factor: 91.245
Authors: Joyce O'Shaughnessy; Katarina Petrakova; Gabe S Sonke; Pierfranco Conte; Carlos L Arteaga; David A Cameron; Lowell L Hart; Cristian Villanueva; Erik Jakobsen; Joseph T Beck; Deborah Lindquist; Farida Souami; Shoubhik Mondal; Caroline Germa; Gabriel N Hortobagyi Journal: Breast Cancer Res Treat Date: 2017-11-21 Impact factor: 4.872
Authors: N Harbeck; S Iyer; N Turner; M Cristofanilli; J Ro; F André; S Loi; S Verma; H Iwata; H Bhattacharyya; K Puyana Theall; C H Bartlett; S Loibl Journal: Ann Oncol Date: 2016-03-30 Impact factor: 32.976
Authors: Peter A Kaufman; Masakazu Toi; Patrick Neven; Joohyuk Sohn; Eva-Maria Grischke; Valerie Andre; Clemens Stoffregen; Sarah Shekarriz; Gregory L Price; Gebra Cuyun Carter; George W Sledge Journal: Oncologist Date: 2019-10-24
Authors: Ashley J Housten; Uzoma Charles Okere; Graham A Colditz; Cynthia Ma; Jingxia Liu; Courtney Harriss; Nancy U Lin; Melissa Rooney; Jennifer Dill; Muhammad Popalzai; Jennifer Badiu; Kan Huang; Casey Burton; Lindsay Peterson Journal: JMIR Res Protoc Date: 2022-07-25
Authors: Elisabeth K Trapp; Peter A Fasching; Tanja Fehm; Andreas Schneeweiss; Volkmar Mueller; Nadia Harbeck; Ralf Lorenz; Claudia Schumacher; Georg Heinrich; Fabienne Schochter; Amelie de Gregorio; Marie Tzschaschel; Brigitte Rack; Wolfgang Janni; Thomas W P Friedl Journal: Cancers (Basel) Date: 2022-08-16 Impact factor: 6.575
Authors: Georg Pfeiler; Angela DeMichele; Amylou C Dueck; Christian Fesl; Michael Gnant; Erica L Mayer Journal: Lancet Oncol Date: 2022-02 Impact factor: 41.316