A Randomized Trial of Fulvestrant, Everolimus, and Anastrozole for the Front-line Treatment of Patients with Advanced Hormone Receptor-positive Breast Cancer, SWOG S1222.

Autor:	Moore HCF; Cleveland Clinic, Cleveland, Ohio., Barlow WE; SWOG Statistics and Data Management Center, Seattle, Washington., Somlo G; City of Hope Medical Center, Duarte, California., Gralow JR; University of Washington School of Medicine/Seattle Cancer Care Alliance, Seattle, Washington., Schott AF; University of Michigan Rogel Cancer Center, Ann Arbor, Michigan., Hayes DF; University of Michigan Rogel Cancer Center, Ann Arbor, Michigan., Kuhn P; University of Southern California, Los Angeles, California., Hicks JB; University of Southern California, Los Angeles, California., Welter L; University of Southern California, Los Angeles, California., Dy PA; Crossroads Cancer Center (Cancer Care Specialists of Illinois), Heartland NCORP, Decatur, Illinois., Yeon CH; City of Hope, South Pasadena Cancer Center, South Pasadena, California., Conlin AK; Pacific Cancer Research ConsortiumNCORP, Portland, Oregon., Balcueva E; Michigan CRC NCORP, St. Mary's of Michigan, Saginaw, Michigan., Lew DL; SWOG Statistics and Data Management Center, Seattle, Washington., Tripathy D; The University of Texas MD Anderson Cancer Center, Houston, Texas., Pusztai L; Yale University, New Haven, Connecticut., Hortobagyi GN; The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Feb 15; Vol. 28 (4), pp. 611-617.
DOI:	10.1158/1078-0432.CCR-21-3131
Abstrakt:	Purpose: Metastatic hormone receptor (HR)-positive, HER2-negative breast cancer is an important cause of cancer mortality. Endocrine treatment with or without additional targeted therapies has been the mainstay of treatment. This trial was designed to evaluate the combination of fulvestrant plus everolimus versus fulvestrant, everolimus, and anastrozole compared with fulvestrant alone in the first-line treatment of advanced HR-positive, HER2-negative breast cancer. Patients and Methods: This randomized placebo-controlled trial included postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had received no prior systemic therapy for metastatic disease. Participants were randomized to one of three treatment arms and the primary outcome was progression-free survival (PFS), comparing combinations of fulvestrant and everolimus with or without anastrozole with fulvestrant alone. Circulating tumor cells (CTC), as measured with two different methods, and circulating tumor DNA (ctDNA) were evaluated serially prior to treatment and the beginning of the second cycle of therapy. Results: Due in part to changes in clinical practice, the study was closed after accruing only 37 participants. There was no evidence that everolimus-containing combination treatment improved PFS or overall survival relative to fulvestrant alone. When modeled continuously, an association was observed of baseline CTC and ctDNA with poorer survival. Conclusions: Although power of the study was limited, the findings were unable to support the routine use of everolimus combination endocrine therapy in the first-line treatment of advanced hormone-sensitive breast cancer. Prognostic impact of baseline ctDNA and copy-number variations in CTC was demonstrated. (©2021 American Association for Cancer Research.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu