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Randomized Controlled Trial
. 2024 Aug 7;31(8):4531-4545.
doi: 10.3390/curroncol31080338.

A Randomized Trial Comparing Concurrent versus Sequential Radiation and Endocrine Therapy in Early-Stage, Hormone-Responsive Breast Cancer

Sharon F McGee  1   2 , Mark Clemons  1   2 , Gregory Pond  3 , Jean-Michel Caudrelier  1 , Michelle Liu  2 , Mashari Jemaan Alzahrani  1 , Terry L Ng  1   2 , Arif A Awan  1   2 , Sandeep Sehdev  1 , John Hilton  1   2 , Marie-France Savard  1   2 , Lesley Fallowfield  4 , Vikaash Kumar  5 , Orit Freedman  6 , Lisa Vandermeer  2 , Brian Hutton  2 , Jean-Marc Bourque  1   7
Affiliations
Randomized Controlled Trial

A Randomized Trial Comparing Concurrent versus Sequential Radiation and Endocrine Therapy in Early-Stage, Hormone-Responsive Breast Cancer

Sharon F McGee et al. Curr Oncol. .

Abstract

Concerns exist regarding increased toxicities, including endocrine therapy toxicity, with concurrent radiation and endocrine therapy in early breast cancer (EBC). We present a pragmatic, randomized trial comparing concurrent versus sequential endocrine and radiotherapy in hormone-responsive EBC. In this multicenter trial, patients were randomized to receive adjuvant endocrine therapy concurrent with, or sequential to, radiotherapy. The primary outcome was change in endocrine therapy toxicity from baseline to 3 months post radiotherapy using the Functional Assessment of Cancer Therapy-Endocrine Symptom (FACT-ES) score. From September 2019 to January 2021, 133 patients were randomized to concurrent endocrine and radiotherapy, and 127 to sequential treatment. Most patients were post-menopausal (72.7%, 189/260) with stage 1 disease (65.8%, 171/260). Tamoxifen was the endocrine therapy of choice for 69.6% (181/260) of patients, and an aromatase inhibitor for the remainder. The median total radiation dose and fractions were 40.1 Gray (range 26-50) and 15 fractions (range 5-25), respectively. For the primary outcome of change in endocrine therapy toxicity per FACT-ES scores from baseline to 3 months post radiotherapy, no significant difference was found between the groups (median [range] = -4.9 (-82, 38.8) for concurrent and -5.1 (-42, 40) for sequential, p = 0.87). This is the first trial to investigate the impact of concurrent versus sequential adjuvant endocrine and radiotherapy on endocrine therapy-related toxicities. The findings provide further support to allow the optimal timing of radiation and endocrine therapy to be tailored for the individual patient.

Keywords: breast cancer; endocrine therapy; quality of life; radiotherapy; toxicity; treatment sequence.

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Conflict of interest statement

G.P. has received honoraria/consulting fees from Takeda, Merck, AstraZeneca, and Profound Medical and reports an immediate family member who is employed at Roche Canada and who owns stock in Roche Ltd. T.L.N. has received honoraria/consulting fees from Novartis Oncology, Knight Therapeutics, and Eli Lilly. A.A. reports participation on advisory boards for AstraZeneca, Eli Lilly, Exact Sciences, Exactis, Gilead, Novartis, Pfizer, Roche and has received honoraria/consulting fees from Apotex, AstraZeneca, Eli Lilly, Exactis, Novartis, OncologyEducation, and Roche. S.S. has received honoraria/consulting fees from Novartis, Knight, Lilly, AstraZeneca, Seagen, Pfizer, Gilead, Abbvie, and Roche. J.H. reports participation on advisory committees for BMS, AstraZeneca, Novartis, Merck, and Lilly. L.F. has received honoraria from Voluntis, Genomic Health/Exact Sciences, Nanostring Technologies, Novartis, Pfizer, MSD, Abbvie, Clovis Oncology, Puma Biotechnology, AstraZeneca, Takeda, Lilly, Seagen, and Roche. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT 2010 flow diagram.
See this image and copyright information in PMC

References

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