TY - JOUR
T1 - Effects of radiotherapy in early-stage, low-recurrence risk, hormone-sensitive breast cancer
AU - CISNET-BOLD Collaborative Group
AU - Jayasekera, Jinani
AU - Schechter, Clyde B.
AU - Sparano, Joseph A.
AU - Jagsi, Reshma
AU - White, Julia
AU - Chapman, Judith Anne W.
AU - Whelan, Timothy
AU - Anderson, Stewart J.
AU - Fyles, Anthony W.
AU - Sauerbrei, Willi
AU - Zellars, Richard C.
AU - Li, Yisheng
AU - Song, Juhee
AU - Huang, Xuelin
AU - Julian, Thomas B.
AU - Luta, George
AU - Berry, Donald A.
AU - Feuer, Eric J.
AU - Mandelblatt, Jeanne
N1 - Funding Information:
We acknowledge the generous funding from the National Institutes of Health under National Cancer Institute Grant
Funding Information:
Julia White received honoraria from Qfix. Joseph Sparano owns stock in Metastat, has served in an advisory role for Genentech/Roche, Novartis, AstraZeneca, Celgene, Lilly, Celldex, Pfizer, Prescient Therapeutics, Juno Therapeutics, and Merrimack, and has received research funding from Prescient Therapeutics, Deciphera, Genentech/Roche, Merck, Novartis, and Merrimack. Donald Berry is co-owner of Berry Consultants, LLC, a company that designs adaptive Bayesian clinical trials for pharmaceutical and medical device companies, NIH cooperative groups, international consortia, and patient advocacy groups.
Funding Information:
This work was supported by the National Institutes of Health under National Cancer Institute (NCI) Grants U01CA12958, U10CA180868, UG1CA189867, and U10CA180822. Supplemental funding was provided by NCI’s Coordinating Center For Clinical Trials and a Lombardi Comprehensive Cancer Center American Cancer Society Young Investigator Award (ACS IRG 92–152-20) and the Cancer Prevention Research Fellowship sponsored by the American Society of Preventive Oncology and Breast Cancer Research Foundation (ASPO-17–001) to Dr. Jayasekera.
Publisher Copyright:
© The Author(s) 2018.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Background: Radiotherapy after breast conservation has become the standard of care. Prior meta-analyses on effects of radiotherapy predated availability of gene expression profiling (GEP) to assess recurrence risk and/or did not include all relevant outcomes. This analysis used GEP information with pooled individual-level data to evaluate the impact of omitting radiotherapy on recurrence and mortality. Methods: We considered trials that evaluated or administered radiotherapy after lumpectomy in women with low-risk breast cancer. Women included had undergone lumpectomy and were treated with hormonal therapy for stage I, ERþ and/or PRþ, HER2 breast cancer with Oncotype scores no greater than 18. Recurrence-free interval (RFI), type of RFI (locoregional or distant), and breast cancer-specific and overall survival were compared between no radiotherapy and radiotherapy using adjusted Cox models. All statistical tests were two-sided. Results: The final sample included 1778 women from seven trials. Omission of radiotherapy was associated with an overall adjusted hazard ratio of 2.59 (95% confidence interval [CI] ¼ 1.38 to 4.89, P ¼ .003) for RFI. There was a statistically significant increase in any first locoregional recurrence (P ¼ .001), but not distant recurrence events (P ¼ .90), or breast cancer-specific (P ¼ .85) or overall survival (P ¼ .61). Five-year RFI rate was high (93.5% for no radiotherapy vs 97.9% for radiotherapy; absolute reduction ¼ 4.4%, 95% CI ¼ 0.7% to 8.1%, P ¼ .03). The effects of radiotherapy varied across subgroups, with lower RFI rates for those with Oncotype scores of less than 11 (vs 11-18), older (vs younger), and ERþ/PRþ status (vs other). Conclusions: Omission of radiotherapy in hormone-sensitive patients with low recurrence risk may lead to a modest increase in locoregional recurrence event rates, but does not appear to increase the rate of distant recurrence or death.
AB - Background: Radiotherapy after breast conservation has become the standard of care. Prior meta-analyses on effects of radiotherapy predated availability of gene expression profiling (GEP) to assess recurrence risk and/or did not include all relevant outcomes. This analysis used GEP information with pooled individual-level data to evaluate the impact of omitting radiotherapy on recurrence and mortality. Methods: We considered trials that evaluated or administered radiotherapy after lumpectomy in women with low-risk breast cancer. Women included had undergone lumpectomy and were treated with hormonal therapy for stage I, ERþ and/or PRþ, HER2 breast cancer with Oncotype scores no greater than 18. Recurrence-free interval (RFI), type of RFI (locoregional or distant), and breast cancer-specific and overall survival were compared between no radiotherapy and radiotherapy using adjusted Cox models. All statistical tests were two-sided. Results: The final sample included 1778 women from seven trials. Omission of radiotherapy was associated with an overall adjusted hazard ratio of 2.59 (95% confidence interval [CI] ¼ 1.38 to 4.89, P ¼ .003) for RFI. There was a statistically significant increase in any first locoregional recurrence (P ¼ .001), but not distant recurrence events (P ¼ .90), or breast cancer-specific (P ¼ .85) or overall survival (P ¼ .61). Five-year RFI rate was high (93.5% for no radiotherapy vs 97.9% for radiotherapy; absolute reduction ¼ 4.4%, 95% CI ¼ 0.7% to 8.1%, P ¼ .03). The effects of radiotherapy varied across subgroups, with lower RFI rates for those with Oncotype scores of less than 11 (vs 11-18), older (vs younger), and ERþ/PRþ status (vs other). Conclusions: Omission of radiotherapy in hormone-sensitive patients with low recurrence risk may lead to a modest increase in locoregional recurrence event rates, but does not appear to increase the rate of distant recurrence or death.
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U2 - 10.1093/jnci/djy128
DO - 10.1093/jnci/djy128
M3 - Article
C2 - 30239794
AN - SCOPUS:85058882310
VL - 110
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
SN - 0027-8874
IS - 12
M1 - djy128
ER -