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Structured Abstract
Objectives:
To evaluate the comparative effectiveness and harms of partial breast irradiation (PBI) compared with whole breast irradiation (WBI) for early-stage breast cancer, and how differences in effectiveness and harms may be influenced by patient, tumor, and treatment factors, including treatment modality, target volume, dose, and fractionation. We also evaluated the relative financial toxicity of PBI versus WBI.
Data sources:
MEDLINE®, Embase®, Cochrane Central Registrar of Controlled Trials, Cochrane Database of Systematic Reviews, Scopus, and various grey literature sources from database inception to June 30, 2022.
Review methods:
We included randomized clinical trials (RCTs) and observational studies that enrolled adult women with early-stage breast cancer who received one of six PBI modalities: multi-catheter interstitial brachytherapy, single-entry catheter brachytherapy (also known as intracavitary brachytherapy), 3-dimensional conformal external beam radiation therapy (3DCRT), intensity-modulated radiation therapy (IMRT), proton radiation therapy, intraoperative radiotherapy (IORT). Pairs of independent reviewers screened and appraised studies.
Results:
Twenty-three original studies with 17,510 patients evaluated the comparative effectiveness of PBI, including 14 RCTs, 6 comparative observational studies, and 3 single-arm observational studies. PBI was not significantly different from WBI in terms of ipsilateral breast recurrence (IBR), overall survival, or cancer-free survival at 5 and 10 years (high strength of evidence [SOE]). Evidence for cosmetic outcomes was insufficient. Results were generally consistent when PBI modalities were compared with WBI, whether compared individually or combined. These PBI approaches included 3DCRT, IMRT, and multi-catheter interstitial brachytherapy. Compared with WBI, 3DCRT showed no difference in IBR, overall survival, or cancer-free survival at 5 and 10 years (moderate to high SOE); IMRT showed no difference in IBR or overall survival at 5 and 10 years (low SOE); multi-catheter interstitial brachytherapy showed no difference in IBR, overall survival, or cancer-free survival at 5 years (low SOE). Compared with WBI, IORT was associated with a higher IBR rate at 5, 10, and over 10 years (high SOE), with no difference in overall survival, cancer-free survival, or mastectomy-free survival (low to high SOE). There were significantly fewer acute adverse events (AEs) with PBI compared with WBI, with no apparent difference in late AEs (moderate SOE). Data about quality of life were limited. Head-to-head comparisons between the different PBI modalities showed insufficient evidence to estimate an effect on main outcomes. There were no significant differences in IBR or other outcomes according to patient, tumor, and treatment characteristics; however, data for subgroups were insufficient to draw conclusions. Eight studies addressed concepts closely related to financial toxicity. Compared with conventionally fractionated WBI, accelerated PBI was associated with lower transportation costs and days away from work. PBI was also associated with less subjective financial difficulty at various time points after radiotherapy.
Conclusions:
Clinical trials that compared PBI with WBI demonstrate no significant difference in the risk of IBR. PBI is associated with fewer acute AEs and may be associated with less financial toxicity. The current evidence supports the use of PBI in appropriately selected patients with early-stage breast cancer. Further investigation is needed to evaluate the outcomes of PBI in patients with various clinical and tumor characteristics, and to define optimal radiation treatment dose and technique for PBI.
Contents
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- 1. Introduction
- 2. Methods
- 2.1. Review Approach
- 2.2. Key Questions and Contextual Question
- 2.3. Analytic Framework
- 2.4. Study Selection
- 2.5. Data Extraction
- 2.6. Risk of Bias Assessment
- 2.7. Data Synthesis and Analyses
- 2.8. Grading the Strength of Evidence for Major Comparisons and Outcomes
- 2.9. Assessing Applicability
- 2.10. Peer Review and Public Commentary
- 3. Results
- 4. Discussion
- References
- Abbreviations and Acronyms
- Appendixes
- Appendix A. Search Strategy
- Appendix B. Flow Chart
- Appendix C. Excluded Studies
- Appendix D. Characteristics of Included Studies
- Appendix E. Characteristics of Interventions
- Appendix F. Risk of Bias
- Appendix G. Results From Included Studies
- Appendix H. Studies With Multimodalities in the PBI Arms
- Appendix I. Specific Adverse Events and Adverse Events by Grade
- Appendix J. Subgroup Analysis
- Appendix K. Comparison by Risk of Bias
- Appendix L. Sensitivity Analysis
- Appendix M. Additional Relevant Studies
- Appendix N. Appendix References
Suggested citation:
Shumway DA, Corbin KS, Farah MH, Viola KE, Nayfeh T, Saadi S, Shah V, Hasan B, Shah S, Mohammed K, Riaz IB, Prokop LJ, Wang Z, Murad MH. Partial Breast Irradiation for Breast Cancer. Comparative Effectiveness Review No. 259. (Prepared by the Mayo Clinic Evidence-based Practice Center under Contract No. 75Q80120D00005.) AHRQ Publication No. 23-EHC001. Rockville, MD: Agency for Healthcare Research and Quality; January 2023. DOI: https://doi.org/10.23970/AHRQEPCCER259. Posted final reports are located on the Effective Health Care Program search page.
This report is based on research conducted by the Mayo Clinic Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 75Q80120D00005). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. Most AHRQ documents are publicly available to use for noncommercial purposes (research, clinical or patient education, quality improvement projects) in the United States, and do not need specific permission to be reprinted and used unless they contain material that is copyrighted by others. Specific written permission is needed for commercial use (reprinting for sale, incorporation into software, incorporation into for-profit training courses) or for use outside of the U.S. If organizational policies require permission to adapt or use these materials, AHRQ will provide such permission in writing.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
A representative from AHRQ served as a Contracting Officer’s Representative and reviewed the contract deliverables for adherence to contract requirements and quality. AHRQ did not directly participate in the literature search, determination of study eligibility criteria, data analysis, interpretation of data, or preparation or drafting of this report.
AHRQ appreciates appropriate acknowledgment and citation of its work. Suggested language for acknowledgment: This work was based on an evidence report, Partial Breast Irradiation for Breast Cancer, by the Evidence-based Practice Center Program at the Agency for Healthcare Research and Quality (AHRQ).
- NLM CatalogRelated NLM Catalog Entries
- Partial breast irradiation compared with whole breast irradiation: a systematic review and meta-analysis.[J Natl Cancer Inst. 2023]Partial breast irradiation compared with whole breast irradiation: a systematic review and meta-analysis.Shumway DA, Corbin KS, Farah MH, Viola KE, Nayfeh T, Saadi S, Shah V, Hasan B, Shah S, Mohammed K, et al. J Natl Cancer Inst. 2023 Sep 7; 115(9):1011-1019.
- Partial Breast Irradiation for Patients With Early-Stage Invasive Breast Cancer or Ductal Carcinoma In Situ: An ASTRO Clinical Practice Guideline.[Pract Radiat Oncol. 2024]Partial Breast Irradiation for Patients With Early-Stage Invasive Breast Cancer or Ductal Carcinoma In Situ: An ASTRO Clinical Practice Guideline.Shaitelman SF, Anderson BM, Arthur DW, Bazan JG, Bellon JR, Bradfield L, Coles CE, Gerber NK, Kathpal M, Kim L, et al. Pract Radiat Oncol. 2024 Mar-Apr; 14(2):112-132. Epub 2023 Nov 15.
- Review Partial breast irradiation for early breast cancer.[Cochrane Database Syst Rev. 2016]Review Partial breast irradiation for early breast cancer.Hickey BE, Lehman M, Francis DP, See AM. Cochrane Database Syst Rev. 2016 Jul 18; 7(7):CD007077. Epub 2016 Jul 18.
- Review Comparison of partial-breast irradiation and intraoperative radiation to whole-breast irradiation in early-stage breast cancer patients: a Kaplan-Meier-derived patient data meta-analysis.[Breast Cancer Res Treat. 2024]Review Comparison of partial-breast irradiation and intraoperative radiation to whole-breast irradiation in early-stage breast cancer patients: a Kaplan-Meier-derived patient data meta-analysis.Ravani LV, Calomeni P, Wang M, Deng D, Speers C, Zaorsky NG, Shah C. Breast Cancer Res Treat. 2024 Jan; 203(1):1-12. Epub 2023 Sep 22.
- Comparison of adverse events in partial- or whole breast radiotherapy: investigation of cosmesis, toxicities and quality of life in a meta-analysis of randomized trials.[Radiat Oncol. 2023]Comparison of adverse events in partial- or whole breast radiotherapy: investigation of cosmesis, toxicities and quality of life in a meta-analysis of randomized trials.Haussmann J, Budach W, Corradini S, Krug D, Jazmati D, Tamaskovics B, Bölke E, Pedotoa A, Kammers K, Matuschek C. Radiat Oncol. 2023 Nov 2; 18(1):181. Epub 2023 Nov 2.
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