期刊
BREAST
卷 53, 期 -, 页码 1-7出版社
CHURCHILL LIVINGSTONE
DOI: 10.1016/j.breast.2020.05.012
关键词
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资金
- International Breast Cancer Study Group (IBCSG)
- IBCSG includes: Frontier Science and Technology Research Foundation
- Swiss Group for Clinical Cancer Research (SAKK)
- Cancer Research Switzerland
- Oncosuisse
- Cancer League Switzerland
- Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK)
- IBCSG
- Southern Switzerland (FSE)
- BIG and Baillet Latour Fund, Belgium
- Pink Ribbon Switzerland
- Swiss Cancer League, Switzerland [KLS-3361-02]
- San Salvatore Foundation
- Rising Tide Foundation for Clinical Research, Switzerland [CCR-15-120]
- Gateway for Cancer Research, USA [G-15-1900]
- Breast Cancer Research Foundation (BCRF), USA
- Swiss Cancer Foundation, Switzerland
- Piajoh Fondazione di Famiglia, Switzerland
- Gruppo Giovani Pazienti Anna dai Capelli Corti , Switzerland
- Ba_arguf, Switzerland [UG1CA189823]
- United States National Cancer Institute, USA
- TEXT
- US National Institutes of Health
- Breast Cancer Research Foundation [16-185, 17-187, 18-003]
- AstraZeneca
- Pfizer
- IBCSG Statistical and Data Management Center [US NIH] [CA075362]
- Breast Cancer Trials Australia [NHMRC 351161, 510788, 1105058]
- Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) on behalf of the National Cancer Research Institute Breast Clinical Studies Group United Kingdom [A15955]
- National Institute for Health Research Royal Marsden/Institute of Cancer Research Biomedical Research Center
- Alliance for Clinical Trials in Oncology [US NIH] [CA180821]
- SWOG [US NIH] [CA32102]
- ECOG-ACRIN Cancer Research Group [US NIH] [CA21115, CA16116]
- NRG Oncology [US NIH] [U10CA180868, U10CA180822, UG1CA189867]
- Canadian Cancer Trials Group [US NIH] [CA077202]
- Canadian Cancer Society Research Institute [015469, 021039]
Background: Although randomized controlled clinical trials are optimal to evaluate the effect of an experimental therapy, single-arm trials are required whenever randomization is unethical or not feasible, such as de-escalation studies. We propose using prospectively identified historical controls to place results of single-arm, de-escalation trials into context. Methods: POSITIVE is a prospective, single-arm study in young women with hormone-receptor-positive early breast cancer to determine if temporarily interrupting adjuvant endocrine therapy in order to become pregnant increases the risk of a breast cancer event. After 272 women enrolled in POSITIVE, we identified a cohort of 1499 SOFT/TEXT patients potentially eligible to enroll in POSITIVE who did not interrupt endocrine therapy. Method I used the SOFT/TEXT cohort to calculate annualized hazard rates by a piecewise exponential model. Method II used the SOFT/TEXT cohort to group-match SOFT/TEXT patients to POSITIVE patients; sample sets of SOFT/TEXT patients were randomly drawn 5000 times to obtain sets having patient, disease, and treatment characteristics more balanced with POSITIVE participants. Results: Compared with SOFT/TEXT, POSITIVE participants were younger, less likely to be overweight/ obese, had fewer positive nodes, and fewer received aromatase inhibitor or chemotherapy. The estimated 3-year breast cancer free interval event rates were 9.5% (95% CI: 7.9%,11.1%) for Method I and 9.4% (95% CI: 7.8%,10.9%) for Method II, compared with 5.8% initially assumed when POSITIVE was designed. Conclusion: External control datasets should be identified before launching single-arm, de-escalation trials and methods applied during their conduct to provide context for interim monitoring and interpretation of the final analysis. (C) 2020 The Author(s). Published by Elsevier Ltd.
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