We explored the impact of the relative volume of a tumor versus the entire breast on outcomes in patients undergoing breast conservation therapy (BCT) versus mastectomy and reconstruction (M + R). We hypothesized that there would be a threshold tumor:breast ratio (TBR) below which patient-reported outcomes (PRO) would favor BCT and above which would favor M + R.
We conducted a prospective cohort study of patients with ductal carcinoma in situ (DCIS) or invasive breast cancers undergoing BCT or M + R. A prerequisite for inclusion, analysis of tumor and breast volumes was conducted from three-dimensional magnetic resonance imaging reconstructions to calculate the TBR. Three-dimensional photography was utilized to calculate pre- and postoperative volumes and assess symmetry. Oncologic, surgical, and patient-reported outcome data were obtained from relevant BREAST-Q modules administered pre- and postoperatively.
The BCT cohort had significantly smaller tumor volumes (p = 0.001) and lower TBRs (p = 0.001) than patients undergoing M + R overall. The M + R group, however, comprised a broader range of TBRs, characterized at lower values by patients opting for contralateral prophylactic mastectomy. Postoperative satisfaction with breasts, psychosocial, and sexual well-being scores were significantly higher in the BCT cohort, while physical well-being significantly favored the M + R cohort 480.2 ± 286.3 and 453.1 ± 392.7 days later, respectively.
Relative to BCT, M + R was used to manage a broad range of TBRs. The relative importance of oncologic and surgical risk reduction, symmetry, and number of procedures can vary considerably and may limit the utility of TBR as a guide for deciding between BCT and M + R.
Clinical Trial StatementThis study was registered with clinicaltrials.gov as “A Prospective Trial to Assess Tumor:Breast Ratio and Patient Satisfaction Following Lumpectomy Versus Mastectomy With Reconstruction”, Identifier: NCT02216136.
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The authors are grateful to Colleen Kilbourne-Glynn, Corrine Merrill, and Darlene Bird for data organization, IRB management, and administration of patient-reported outcome questionnaires throughout the study period. We are grateful to Tracey Guthrie and Annette Irving for providing compliance and administrative support and to information technology support at Washington University related to three-dimensional photography. We are grateful to Allergan Inc. for awarding the investigator-initiated grant (IIT-2017-10075) that funded this work.
This study was funded by an investigator-initiated grant from Allergan Inc. to Dr. Myckatyn (IIT-2017-10075). Dr. Myckatyn receives grant funding, consultant, and advisory board fees from Allergan, and investigator-initiated grant funding and consultant fees from RTI. Dr. Tenenbaum receives grant funding and consultant fees from Allergan, grant funding from Mentor, and advisory board and consulting fees from RTI. Dr. Appleton received consulting income from WhiteRabbit Inc. There are no other relevant disclosures for any of the authors.
Conflict of interest
Marissa M. Tenenbaum has received speaker honoraria and advisory board fees from Allergan, inc. in the last 2 years. She has received advisory board fees from RTI in the last year. Catherine Appleton declares consulting income from WhiteRabbit, Inc. Terence M. Myckatyn has received speaker honoraria and advisory board fees from Allergan, inc. in the last 2 years. Allergan is the company that funded this study via an investigator-initiated grant to Dr. Myckatyn as disclosed above. Dr. Myckatyn has also received advisory board fees from RTI in the last year and also has an active investigator-initiated research grant from RTI which is not related to this work other than the fact that, like the grant from Allergan, investigates topics under the umbrella of breast reconstruction research. Dr. Myckatyn is also a Co-Investigator on a an award from the National Institutes of Health, Agency for Health Care Research and Quality (AHRQ), R18 HS026699-01 “Implementing a breast reconstruction decision support tool in diverse practice settings.” This grant is also under the general umbrella of breast reconstruction research but not directly related to topic matter herein. The remaining authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional committee (the Human Research Protection Office (#201404004) at the Washington University School of Medicine) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study as regulated by the Human Research Protection Office (#201404004) at the Washington University School of Medicine.
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Dolen, U., Thornton, M., Tenenbaum, M.M. et al. A prospective cohort study to analyze the interaction of tumor-to-breast volume in breast conservation therapy versus mastectomy with reconstruction. Breast Cancer Res Treat 181, 611–621 (2020). https://doi.org/10.1007/s10549-020-05639-w
- Post-mastectomy reconstruction
- Patient-reported outcomes