Are There Disparities in Breast Reconstruction After Contralateral Prophylactic Mastectomy?

INTRODUCTION: Despite national guidelines against contralateral prophylactic mastectomy (CPM) in low- to moderate-risk breast cancer, CPM use continues to rise. Breast reconstruction improves health-related quality of life and satisfaction among women undergoing mastectomy. Given the lack of data regarding factors associated with reconstruction after CPM and the known benefits of reconstruction, we sought to investigate whether disparities exist in receipt of reconstruction after CPM. METHODS: The 2004-2017 National Cancer Database was queried to identify women diagnosed with breast cancer who underwent unilateral mastectomy with CPM. Patients were divided into two groups: those who underwent planned reconstruction at any timepoint and those who did not. A secondary analysis comparing types of reconstruction (tissue, implant, combined) was conducted. Patient, tumor, and demographic characteristics were analyzed using chi-square test and odds ratios were calculated using generalized estimating equations. RESULTS: The cohort included 1,73,249 women: 95,818 (55.3%) underwent reconstruction and 77,431 (45.7%) did not. Both the rate CPM and the proportion of women undergoing reconstruction after CPM increased between 2004 and 2017. Of the women who had reconstruction, 40,840 (51.7%) received implants, 29,807 (37.7%) had tissue, and 8352 (10.6%) had combined reconstruction. After adjusted analysis, factors associated with reconstruction were young age, Hispanic ethnicity, private insurance, and living in an area with the highest education and median income (P < 0.01). Patients who underwent reconstruction were less likely to have radiation (P < 0.01) and chemotherapy (P < 0.01), more likely to have stage I disease (P < 0.01), and to be treated at an integrated cancer center (P < 0.01). CONCLUSIONS: Reconstruction after CPM is disproportionately received by younger women, Hispanics, those with private insurance, and higher socioeconomic status and education. While the rate of reconstruction after CPM is increasing, there remain significant disparities. Conscious efforts must be made to eliminate these disparities, especially given the known benefits of reconstruction after mastectomy.

Factors Associated With Cosmetic Outcomes After Treatment With a Novel Form of Breast Intraoperative Radiation Therapy.

INTRODUCTION: Precision breast intraoperative radiation therapy (PB-IORT) incorporates computed tomography-guided treatment planning and high dose rate brachytherapy to deliver a single dose of highly conformal radiational therapy. The purpose of this study is to determine factors associated with poor cosmetic outcomes after treatment with PB-IORT. METHODS: The study included all consecutive participants enrolled in an ongoing phase II clinical trial that had completed a minimum of 12 mo of follow-up. A poor cosmetic outcome was defined as scoring "fair" or "poor" on the Harvard Cosmesis evaluation, or "some" or "very much" on any of the three general cosmesis categories. Statistical analysis was performed utilizing R. RESULTS: The final cohort included 201 participants, of which 181 (90%) had an overall good/excellent cosmetic outcome. Group 1 consisted of 162 (81%) participants who reported only excellent/good cosmetic outcomes. Group 2 consisted of 39 (19%) participants who reported some aspect of a poor cosmetic outcome. On multivariable analysis, participants with ductal carcinoma in situ were significantly more likely to experience a poor cosmetic outcome (odds ratio 2.45, 95% confidence interval 1.03-5.82, P = 0.04), and those who received subsequent whole breast irradiation were also more likely to have a poor cosmetic outcome (odds ratio 10.20, 95% confidence interval CI 1.04-99.95, P = 0.04). CONCLUSIONS: Patients with need for further radiation after PB-IORT are at increased risk for a poor cosmetic outcome. Larger balloon volume and distance between the skin do not have deleterious effects on cosmetic outcomes.

Impact of a High-Resolution Anoscopy Clinic on Management of Anal Dysplasia in Women Living With HIV.

BACKGROUND: The rate of anal squamous cell cancer (aSCC) is increasing among women living with HIV. Treatment of precursor high grade squamous intraepithelial lesions (HSIL) may reduce the risk of progression to aSCC. The objective of this study was to examine effects of a dedicated high-resolution anoscopy (HRA) clinic on management of HSIL in women with HIV. METHODS: Women living with HIV who underwent anal dysplasia screening at a single institution between 2006 and 2020 were reviewed. Those who underwent screening before (Group A) and after (Group B) the implementation of an HRA program in 2017 were compared. The primary outcome of interest was the successful detection and treatment of HSIL. RESULTS: A total of 201 women living with HIV underwent anal dysplasia screening between 2006 and 2020. Seventy-seven patients were found to have abnormal anal cytology requiring further treatment: 43 (55.8%) in Group A and 34 (44.2%) patients in Group B. Of the patients with abnormal anal cytology, 76.7% of patients in Group A received further biopsy and treatment, whereas 79.4% of Group B patients underwent subsequent biopsy and treatment. In propensity score weighting logistic regression analysis, the Group B was 4.6 times as likely to diagnosis HSIL on biopsy compared to Group A (OR = 4.60, 95% CI: 1.15 to 18.38, P = .03). CONCLUSIONS: Anal dysplasia is common among women living with HIV. The establishment of a HRA program was associated with increased identification and treatment of HSIL among women living with HIV, which may prevent the progression to aSCC.

Residents as Leaders: Using a Delphi Process to Conduct an Institutional Preoperative Patient Optimization Quality Improvement Initiative.

BACKGROUND: Many residency programs struggle to meet the ACGME requirement for resident participation in quality improvement initiatives. STUDY DESIGN: As part of an institutional quality improvement effort, trainees from the Departments of Surgery and Anesthesiology at a single academic medical center were teamed with institutional content experts in 7 key risk factor areas within preoperative patient optimization. A systematic review of each subject matter area was performed using the MEDLINE database. Institutional recommendations for the screening and management of each risk factor were developed and approved using modified Delphi consensus methodology. Upon project completion, an electronic survey was administered to all individuals who participated in the process to assess the perceived value of participation. RESULTS: Fifty-one perioperative stakeholders participated in recommendation development: 26 trainees and 25 content experts. Residents led 6 out of 7 groups specific to a subject area within preoperative optimization. A total of 4,649 abstracts were identified, of which 456 full-text articles were selected for inclusion in recommendation development. Seventeen out of 26 (65.4%) trainees completed the survey. The vast majority of trainees reported increased understanding of their preoperative optimization subject area (15/17 [88.2%]) as well as the Delphi consensus method (14/17 [82.4%]) after participation in the project. Fourteen out of 17 (82.4%) trainees stated that they would participate in a similar quality improvement initiative again. CONCLUSIONS: We demonstrate a novel way to involve trainees in an institutional quality initiative that served to educate trainees in quality improvement, the systematic review process, Delphi methodology, and preoperative optimization. This study provides a framework that other residency programs can use to engage residents in institutional quality improvement efforts.

A comparative study using time-driven activity-based costing in single-fraction breast high-dose rate brachytherapy: An integrated brachytherapy suite vs. decentralized workflow.

INTRODUCTION: Precision breast intraoperative radiation therapy (PB-IORT) is a novel approach to adjuvant radiation therapy for early-stage breast cancer performed as part of a phase II clinical trial at two institutions. One institution performs the entire procedure in an integrated brachytherapy suite which contains a CT-on-rails imaging unit and full anesthesia capabilities. At the other, breast conserving surgery and radiation therapy take place in two separate locations. Here, we utilize time-driven activity-based costing (TDABC) to compare these two models for the delivery of PB-IORT. METHODS: Process maps were created to describe each step required to deliver PB-IORT at each institution, including personnel, equipment, and supplies. Time investment was estimated for each step. The capacity cost rate was determined for each resource, and total costs of care were then calculated by multiplying the capacity cost rates by the time estimate for the process step and adding any additional product costs. RESULTS: PB-IORT costs less to deliver at a distributed facility, as is more commonly available, than an integrated brachytherapy suite ($3,262.22 vs. $3,996.01). The largest source of costs in both settings ($2,400) was consumable supplies, including the brachytherapy balloon applicator. The difference in costs for the two facility types was driven by personnel costs ($1,263.41 vs. $764.89). In the integrated facility, increased time required by radiation oncology nursing and the anesthesia attending translated to the greatest increases in cost. Equipment costs were also slightly higher in the integrated suite setting ($332.60 vs. $97.33). CONCLUSIONS: The overall cost of care is higher when utilizing an integrated brachytherapy suite to deliver PB-IORT. This was primarily driven by additional personnel costs from nursing and anesthesia, although the greatest cost of delivery in both settings was the disposable brachytherapy applicator. These differences in cost must be balanced against the potential impact on patient experience with these approaches.

Effects of a novel form of intraoperative radiation therapy on quality of life among patients with early-stage breast cancer.

PURPOSE: To investigate patient-perceived quality of life (QOL) among patients treated with a novel form of breast intraoperative radiation therapy (PB-IORT). METHODS AND MATERIALS: Patients treated with PB-IORT as part of a phase II clinical trial from 2013 to 2020 were identified. Patients were given the European Organization for Research and Treatment of Cancer (EORTC) core 30-item Quality of Life Questionnaire (QLQ-C30) encompassing global health, functionality, and symptomatology at baseline, 1-month, 6-months, 12-months, and 24-months after PB-IORT. Scores were on a 100-point scale with change greater than 10 considered clinically significant. Scores at interval follow-up were compared to baseline using repeated measure modeling with an unstructured covariance matrix. RESULTS: The cohort consisted of 303 patients, a majority of which were White (84.2%) with a median age of 64 years (IQR: 52, 76). One month after PB-IORT, a decline from baseline in physical (-2.5, 95% CI: -4.4 - -0.55, p = 0.01), role (-7.6, 95% CI: -11.7 - -3.5, p < 0.001), and social functioning (-3.0, 95% CI: -5.5 - -0.42, p = 0.02) were observed, which correlated with increased fatigue (8.4, 95% CI: 5.5-11.3, p < 0.001). At 6 months, nearly all QOL measures returned to baseline or improved. There were no statistically or clinically significant differences from baseline in overall global health. All functional and symptom scale differences were less than 10, indicating minimal clinical significance. CONCLUSIONS: PB-IORT has minimal negative impact on QOL, further supporting this patient-centered treatment approach for early-stage breast cancer.

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer.

Checkpoint-blockade therapy (CBT) is approved for select colorectal cancer (CRC) patents, but additional immunotherapeutic options are needed. We hypothesized that vaccination with carcinoembryonic antigen (CEA) and Her2/neu (Her2) peptides would be immunogenic and well tolerated by participants with advanced CRC. A pilot clinical trial (NCT00091286) was conducted in HLA-A2+ or -A3+ Stage IIIC-IV CRC patients. Participants were vaccinated weekly with CEA and Her2 peptides plus tetanus peptide and GM-CSF emulsified in Montanide ISA-51 adjuvant for 3 weeks. Adverse events (AEs) were recorded per NIH Common Terminology Criteria for Adverse Events version 3. Immunogenicity was evaluated by interferon-gamma ELISpot assay of in vitro sensitized peripheral blood mononuclear cells and lymphocytes from the sentinel immunized node. Eleven participants were enrolled and treated; one was retrospectively found to be ineligible due to HLA type. All 11 participants were included in AEs and survival analyses, and the 10 eligible participants were evaluated for immunogenicity. All participants reported AEs: 82% were Grade 1-2, most commonly fatigue or injection site reactions. Two participants (18%) experienced treatment-related dose-limiting Grade 3 AEs; both were self-limiting. Immune responses to Her2 or CEA peptides were detected in 70% of participants. Median overall survival (OS) was 16 months; among those enrolled with no evidence of disease (n = 3), median OS was not reached after 10 years of follow-up. These data demonstrate that vaccination with CEA or Her2 peptides is well tolerated and immunogenic. Further study is warranted to assess potential clinical benefits of vaccination in advanced CRC either alone or in combination with CBT.