The Impact of Breast-Conserving Surgery Re-excision on Patient-Reported Outcomes Using the BREAST-Q.

BACKGROUND: Approximately 14% of women undergoing breast-conserving surgery (BCS) require re-excision to achieve negative margins following the Society of Surgical Oncology (SSO) and American Society for Radiation Oncology (ASTRO) margin guidelines, which may influence patient-reported outcomes (PROs). Few studies have assessed the impact of re-excision on PROs following BCS. PATIENTS AND METHODS: Women with stage 0-III breast cancer undergoing BCS who completed a BREAST-Q PRO measure from 2010 to 2016 were identified from a prospective database. Baseline characteristics were compared between women who underwent one BCS and those who underwent ≥ 1 re-excision surgery for positive margins (R-BCS). Linear mixed models were used to analyze associations between number of excisions and BREAST-Q scores over time. RESULTS: Of 2543 eligible women, 1979 (78%) had one BCS and 564 (22%) had R-BCS. Younger age, lower BMI, surgery pre-SSO Invasive Guidelines issuance, ductal carcinoma in situ (DCIS), multifocal disease, radiation therapy receipt, and endocrine therapy omission were more common in the R-BCS group. Breast satisfaction and sexual well-being were lower in the R-BCS group 2 years postoperatively. There were no differences in psychosocial well-being between groups over 5 years. On multivariable analysis, re-excision was associated with lower breast satisfaction and sexual well-being (p= 0.007 and p= 0.049, respectively), but there was no difference in psychosocial well-being (p= 0.250). CONCLUSIONS: Women with R-BCS had lower breast satisfaction and sexual well-being 2 years postoperatively, but this difference did not remain long term. Psychosocial well-being in women who underwent one BCS were largely comparable over time to the R-BCS group. These findings may help in counseling women who are concerned about satisfaction and quality-of-life outcomes with BCS if re-excision is necessary.

Development and Validation of the BREAST-Q Breast-Conserving Therapy Module.

BACKGROUND: In breast cancer surgery, patient-reported outcome measures are needed to measure outcomes best reported by patients (e.g., psychosocial well-being). This study aimed to develop and validate a new BREAST-Q module to address the unique concerns of patients undergoing breast-conserving therapy (BCT). METHODS: Phase 1 involved qualitative and cognitive interviews with women who had BCT and clinical expert input to establish content for the BCT module. A field-test (phase 2) was performed, and Rasch measurement theory (RMT) analysis was used for item reduction and examination of reliability and validity. Validation of the item-reduced scales in a clinical sample (phase 3) was conducted for further assessment of their psychometric properties. RESULTS: Qualitative interviews with 24 women resulted in the addition of 15 new items across multiple existing BREAST-Q scales and the development of two new scales (Adverse Effects of Radiation and Satisfaction With Information-Radiation Therapy). Feedback from 15 patients and 5 clinical experts were used to refine the instructions, response options, and item wording. An RMT analysis of data from 3497 women resulted in item reduction. The final set of scales showed evidence of ordered response option thresholds, good item fit, and good reliability, except for the Adverse Effects of the Radiation Scale. Validity and reliability were further supported by the phase 3 data from 3125 women. CONCLUSIONS: The BREAST-Q BCT module can be used in research and clinical care to evaluate quality metrics and to compare surgical outcomes across all breast cancer surgery patients.

A Comparison of Patient-Reported Outcomes After Breast-Conserving Surgery and Mastectomy with Implant Breast Reconstruction.

BACKGROUND: Many factors influence decisions regarding choice of breast-conserving surgery (BCS) versus mastectomy with reconstruction for early invasive breast cancer. The purpose of this study was to compare patient satisfaction following BCS and mastectomy with implant reconstruction (M-iR) utilizing the BREAST-Q patient-reported outcome measure. METHODS: Women with stage I or II breast cancer undergoing BCS or M-iR who completed a BREAST-Q from 2010 to 2016 were identified by retrospective review of a prospective database. Baseline characteristics were compared, and linear mixed models were used to analyze associations with BREAST-Q scores over time. RESULTS: Our study group was composed of 3233 women; 2026 (63%) had BCS, 123 (3.8%) had nipple-sparing mastectomy, and 1084 (34%) had skin-sparing or total mastectomy. Median time from surgery to BREAST-Q was 205 days for BCS and 639 days for M-iR (p < 0.001). Regardless of type of surgery, breast satisfaction scores decreased significantly over time (p < 0.001), whereas psychosocial (p = 0.001) and sexual (p = 0.004) well-being scores increased significantly over time. BCS was associated with significantly higher scores over time compared with M-iR across all subscales (all p < 0.001). Radiation was significantly associated with decreased scores over time across all subscales (all p < 0.05). CONCLUSIONS: Breast satisfaction and quality-of-life scores were higher for BCS compared with M-iR in early-stage invasive breast cancer. These findings may help in counseling women who have a choice for surgical treatment. Breast satisfaction scores decreased over time in all women, highlighting the need for further evaluation with longer follow-up.

Early Adoption of the SSO-ASTRO Consensus Guidelines on Margins for Breast-Conserving Surgery with Whole-Breast Irradiation in Stage I and II Invasive Breast Cancer: Initial Experience from Memorial Sloan Kettering Cancer Center.

BACKGROUND: Reexcision rates in patients undergoing breast-conserving surgery (BCS) for early-stage invasive breast cancer are highly variable. The Society of Surgical Oncology (SSO) and American Society for Radiation Oncology (ASTRO) published consensus guidelines to help standardize practice. We sought to determine reexcision rates before and after guideline adoption at our institution. METHODS: We identified patients with stage I or II invasive breast cancer initially treated with BCS between June 1, 2013, and October 31, 2014. Margins were defined as positive (tumor on ink), close (≤1 mm), or negative (>1 mm), and were recorded for both invasive cancer and ductal carcinoma-in situ (DCIS) components. Reexcision rates were quantified, characteristics were compared between groups, and multivariable logistic regression was performed. RESULTS: A total of 1205 patients were identified, 504 before and 701 after the guideline adoption (January 1, 2014). Clinical and pathologic characteristics were similar between time periods. Reexcision rates significantly declined from 21.4 to 15.1 % (p = 0.006) after guideline adoption. A multivariable model identified extensive intraductal component (odds ratio [OR] 2.5, 95 % confidence interval [CI] 1.2-5.2), multifocality (OR 2.0, 95 % CI 1.2-3.6), positive (OR 844.4, 95 % CI 226.3-5562.5) and close (OR 38.3, 95 % CI 21.5-71.8) ductal carcinoma-in situ margin, positive (OR 174.2, 95 % CI 66.2-530.0) and close (OR 6.4, 95 % CI 3.0-13.6) invasive margin, and time period (OR 0.5, 95 % CI 0.3-0.9 for post vs. pre) as independently associated with reexcision. CONCLUSIONS: Overall reexcision rates declined significantly after guideline adoption. Close invasive margins were associated with higher rates of reexcision than negative invasive margins in both time periods; however, the effect diminished in the postguideline adoption period. Thus, we expect continued decline in reexcision rates as adherence to guidelines becomes more uniform.

Rectal cancer patients' quality of life with a temporary stoma: shifting perspectives.

BACKGROUND: Patients with rectal cancer who have a temporary ostomy report good quality of life despite identifying a number of stoma-related difficulties. OBJECTIVE: This study aimed to qualitatively explore the experiences of patients with rectal cancer who have a temporary ileostomy to better understand the discordant findings of previous quantitative quality-of-life studies. DESIGN/SETTING: We conducted in-depth qualitative interviews with patients with stage I to III rectal cancer who underwent sphincter-preserving surgery that resulted in a temporary ileostomy. PATIENTS: Twenty-six patients (54% male, median age 54) participated. Sixty-five percent had stage III disease, and 88% received neoadjuvant therapy. MAIN OUTCOME MEASURES: Interviews examined preoperative expectations, overall experience, and stoma impact on quality of life. With the use of grounded theory, 2 investigators independently performed line-by-line content analysis to identify key themes. Analysis continued until data saturation. RESULTS: Two major themes were identified: stoma-related difficulties and perceived response shift. Patients reported difficulty in exercise, sleep, social activities, sexuality, and clothing. Patients' perception of quality of life with a temporary stoma appears to have undergone a response shift through recalibration of their standards for measuring quality of life (internal measurement scale altered by side effects of neoadjuvant/adjuvant treatment, temporary nature of stoma, and accommodation to stoma) and reconceptualization of what "good quality of life" is (stoma difficulties were felt to be less important in comparison with cancer-related mortality). LIMITATIONS: Although qualitative research is, by design, not generalizable, these data support our previous quantitative work. This convergence of findings suggests that our data may be representative. CONCLUSIONS: A temporary ileostomy represents significant difficulties for patients with rectal cancer. However, because of response shift, these difficulties may not be perceived as important to overall quality of life when considered within the context of the cancer experience. Our results can inform preoperative consultations with patients who have rectal cancer to assist in aligning patient expectations of what life with a temporary ileostomy may be like.

When the clipped node goes missing, CT guided SAVI SCOUT placement: A novel approach for localizing soft tissue targets.

Axillary staging in breast cancer is performed with physical exam and axillary imaging. Suspicious lymph nodes are biopsied and clipped prior to surgery to identify the previously biopsied node during surgery. Conventional mapping techniques of blue dye and radioisotope do not always accurately identify the clipped lymph node and therefore many techniques have been described to improve the identification of the clipped lymph node. Most of these techniques rely on axillary ultrasound to identify the previously biopsied lymph node or previously placed clip. A marker such as a fiducial reflector is then placed percutaneously. In this case report we describe a novel technique of Computed tomography (CT) identification of a previously clipped lymph node with CT guided placement of a fiducial reflector (SAVI SCOUT). The SAVI SCOUT was then identified and successfully excised with the previously biopsied lymph node. A PRECIS: CT guided placement of SAVI SCOUT is a novel technique for the identification and retrieval of a previously biopsied axillary lymph node in breast cancer patients.

Impact of a temporary stoma on the quality of life of rectal cancer patients undergoing treatment.

BACKGROUND: Data from randomized controlled trials support use of a diverting stoma in rectal cancer patients with low anastomoses, but there is little data on how this impacts patient quality of life (QOL). This study prospectively evaluates QOL in stage I-III rectal cancer patients undergoing sphincter-preserving surgery (SPS) with a temporary diverting stoma. MATERIALS AND METHODS: Patents were identified from a prospective single-institution study of stage I-III rectal cancer patients undergoing SPS. Patients completed the EORTC C30/CR38 QOL scale preoperatively, at stoma closure, and at 6 months. The Stoma Quality of Life (SQOL) was administered at stoma closure. Subscales of the EORTC hypothesized to be affected by a diverting stoma were identified a priori. Longitudinal trends were analyzed using repeated measures ANOVA. Frequencies for responses on specific SQOL items were tabulated, and correlations between SQOL subscales and EORTC Global QOL assessed with Pearson correlation coefficient. RESULTS: Global QOL was reportedly good (mean score 70.2) and did not change with a temporary stoma (P = .83). Physical (P = .33), role (P = .07), and social function (P = .48) were also stable. Decreased body image was observed (P = .03). Stoma-related difficulties identified by the SQOL included sexual activity (53%), leakage (39%), discomfort in clothing (34%), concerns regarding privacy to empty pouch (32%), and feeling unattractive (31%). "Overall satisfaction with life," Work/social function (P < .001), sexuality/body image (P = .01), and stoma function (P = .01) subscales of the SQOL correlated strongly with the EORTC Global QOL score (P < .001). CONCLUSION: In this longitudinal study of QOL in rectal cancer patients with a temporary stoma, Global QOL was good despite significant stoma-related difficulties. Use of alternative research methodology is necessary to provide insight into why this contradiction exists.

Expectations of breast-conserving therapy: a qualitative study.

BACKGROUND: Early-stage breast cancer is often treated with breast-conserving therapy (BCT), including lumpectomy with radiation therapy. Patients' expectations of BCT remain largely unknown. Expectations affect perceptions of treatment-related experiences and health-related quality of life (HR-QOL) outcomes. Our primary aim was to describe expectations of BCT among patients with early breast cancer through qualitative methods. Our secondary aim was to inform preoperative patient education and improve the patient experience through knowledge. METHODS: We used a grounded-theory approach to investigate a convenience sample of 22 women with stage I and II breast cancer who were treated with BCT at a single hospital in New York City between May and August 2016. Semi-structured interviews were conducted in person and by telephone. Open-ended questions covered participants' expectations of treatment experiences and outcomes. Data was analyzed in a line-by-line approach to identify emergent themes related to patient expectations. Interviews continued until no new themes emerged. RESULTS: Analysis of data identified the following themes related to patient expectations of BCT: experience of cancer care, recovery, appearance, and HR-QOL. Despite preoperative informed consent and teaching, participants expressed few expectations preoperatively, owing to a lack of knowledge about the process of care. Lack of expectations preoperatively was compensated with available care and resources postoperatively. CONCLUSIONS: Patients in our sample had a surprisingly limited understanding of what to expect during treatment with BCT. Despite available information and preoperative teaching, patients have a clear knowledge gap regarding BCT. These findings suggest patients often undergo cancer treatment with trust rather than complete understanding of the process. This data may be used to enhance preoperative discussions aimed at preparing patients for surgery and treatment.

Validation of the electronic version of the BREAST-Q in the army of women study.

Women undergoing surgery for primary breast cancer can choose between breast conserving therapy and mastectomy (with or without breast reconstruction). Patients often turn to outcomes data to help guide the decision-making process. The BREAST-Q is a validated breast surgery-specific patient-reported outcome measure that evaluates satisfaction, quality of life, and patient experience. It was originally developed for paper-and-pencil administration. However, the BREAST-Q has increasingly been administered electronically. Therefore, the aim of this study was to evaluate the psychometric properties of an electronic version of the BREAST-Q in a large online survey. Women with a history of breast cancer surgery recruited from the Love/AVON Army of Women program completed an electronic version of the BREAST-Q in addition to the Impact of Cancer Survey and PTSD Checklist. Traditional psychometric analyses were performed on the collected data. BREAST-Q data were collected from 6748 women (3497 Breast Conserving Therapy module, 1295 Mastectomy module, 1956 Breast Reconstruction module). Acceptability was supported by a high response rate (82%), low frequency of missing data (<5%), and maximum endorsement frequencies (<80%) in all but 17 items. Scale reliability was supported by high Cronbach's α coefficients (≥0.78) and item-total correlations (range of means, 0.65-0.91). Validity was supported by interscale correlations, convergent and divergent hypotheses as well as clinical hypotheses. The electronically administered BREAST-Q yields highly reliable, clinically meaningful data for use in clinical outcomes research. The BREAST-Q can be used in the clinical setting, whether administered electronically or using paper-and-pencil, at the choice of the patient and surgeon.

Polyp Detection Rates among Body Mass Index Categories at First Screening Colonoscopy.

In the United States, obesity is an epidemic and colorectal cancer is the second deadliest cancer for men and women. A link between obesity and colorectal adenomas and carcinoma has been suggested but not proven. We sought out to determine if obesity was associated with increased rates of polyp formation. All patients undergoing a first screening colonoscopy by one of the participating endoscopists at Thomas Jefferson University Hospital from January 2012 to March 2015 were considered for the study. Their demographics, body mass index (BMI), and colonoscopy findings were recorded at the time of the procedure and prospectively maintained in our database. The final pathologic diagnosis was recorded for each participant as it became available. A total of 758 subjects were included. Of these, 22 per cent had a BMI <25 kg/m2, 29 per cent had a BMI between 25 and 29.9 kg/m2, and 49 per cent had a BMI of at least 30 kg/m2. Overall, 21.9 per cent of the participants were found to have at least one adenomatous polyp. The polyp detection rates were 24.4 per cent in the group with a BMI less than 25, 20.5 per cent in the overweight group, and 21.6 per cent in the obese group. Our study included 56 super obese individuals with a BMI ≥45 kg/m2. About 17.9 per cent of subjects in the super obese group had an adenomatous polyp. There were no differences in the incidence of adenomatous polyps between BMI categories in our study.