Breast Cancer Treatment Outcome Scale Research Articles

Pilot/Phase II Trial of Hypofractionated Radiation Therapy to the Whole Breast Alone Before Breast Conserving Surgery

PurposeOur purpose was to report the results of a phase II trial of patients with breast cancer treated with hypofractionated whole breast radiation therapy (RT) before breast-conserving surgery (BCS). Methods and MaterialsBetween 2019 and 2020, patients with cT0-T2, N0, M0 breast cancer were enrolled. Patients were treated with hypofractionated whole breast RT, 25 Gy in 5 fractions, 4 to 8 weeks before BCS. Pathologic assessment was performed using the residual cancer burden (RCB). Toxicities were assessed according to Common Terminology Criteria for Adverse Events (version 4). Quality of life was assessed with Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, The Breast Cancer Treatment Outcome Scale, Linear Analogue Self-Assessment, and Patient-Reported Outcomes Measurement Information System. ResultsTwenty-two patients were enrolled. Median follow-up was 7.6 months (range, 0.2-16.8). Seven (32%) and 2 (9%) patients experienced grade 2+ or 3 toxicities, respectively. Overall quality of life Linear Analogue Self-Assessment and Patient-Reported Outcomes Measurement Information System did not change significantly from baseline (P = .21 and P = .72, respectively). There was no clinically significant change (≥1 point) in any of The Breast Cancer Treatment Outcome Scale domains. Only 1 (5%) patient experienced a clinical deterioration that corresponded to a “fair” outcome on the Harvard Cosmesis Scale. At pathologic evaluation, 14 (64%) patients had RCB-0 or RCB-I, including 3 (14%) patients with a pathologic complete response (RCB-0). Eight patients (36%) had RCB-II. No local or distant recurrences have been observed. ConclusionsExtremely hypofractionated whole breast RT before BCS is a feasible approach. There were low rates of toxicities and good cosmesis. Further investigation into this approach with RT before BCS is warranted.

Outcomes and toxicities after proton partial breast radiotherapy for early stage, hormone receptor positive breast cancer: 3-Year results of a phase II multi-center trial

PurposeProton therapy (PT) for partial breast irradiation (PBI) in early-stage breast cancer can decrease morbidity versus photon PBI with superior organs-at-risk sparing. We report 3-year outcomes of the first prospective, multicenter, phase II trial of proton PBI. Methods and MaterialsThis Proton Collaborative Group phase II trial (PCG BRE007-12) recruited women ≥ 50 years with node-negative, estrogen receptor (ER)-positive, ≤3cm, invasive ductal carcinoma (IDC) or ductal carcinoma in situ undergoing breast conserving surgery followed by proton PBI (40 Gy(RBE), 10 daily fractions). Primary endpoint was freedom from ipsilateral breast cancer recurrence. Adverse events were prospectively graded using CTCAEv4.0. Breast Cancer Treatment Outcome Scale (BCTOS) assessed patient-reported quality of life (PRQOL). ResultsThirty-eight evaluable patients enrolled between 2/2013–11/2016. Median age was 67 years (range 50–79); 55 % had left-sided disease, and median tumor size was 0.9 cm. Treatment was delivered in ≥ 2 fields predominantly with uniform scanning PT (n = 37). At 35-month median follow-up (12–62), all patients were alive, and none had local, regional or distant disease progression. One patient developed an ER-negative contralateral IDC. Seven grade 2 adverse events occurred; no radiotherapy-related grade ≥ 3 toxicities occurred. Changes in BCTOS subdomain mean scores were maximum 0.36, indicating no meaningful change in PRQOL. Median heart volume receiving 5 Gy (V5Gy), lung V20Gy, and lung V10Gy were 0 %, 0 % and 0.19 %, respectively. ConclusionAt 3 years, proton PBI provided 100 % cancer control for early-stage, ER-positive breast cancer. Toxicities are minimal, and PRQOL remains acceptable with continued follow-up. These findings support PT as a safe and effective PBI delivery option.

MC1635: Randomized Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast After Breast Conserving Surgery

Hypofractionated radiation therapy (RT) for localized breast cancer improves patient convenience and reduces treatment cost. Here, we report the early results of MC1635 randomized trial.Between 04/04/2018 and 02/11/2020, patients with localized breast cancer (T1-T3, N0-N1, M0) managed with breast conserving surgery (BCS) were enrolled. Patients were randomized to receive whole breast RT with moderate hypofractionation to 40 Gy in 15 fractions (Arm A) or extreme hypofractionation to 25 Gy in 5 fractions (Arm B). An optional concurrent integrated boost to 48 Gy on Arm A or 30 Gy on Arm B was allowed. All patients were treated daily (Monday-Friday). Analysis of early toxicity (< 3 months), late toxicity (> 3 months), quality of life (QOL), cosmesis, and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were done. QOL was assessed with patient-reported outcomes measurement information system (PROMIS), overall Linear Analogue Self-Assessment (LASA), and The Breast Cancer Treatment Outcome Scale (BCTOS). Deterioration of cosmesis was defined as going from excellent/good to fair/poor or from fair to poor according to the Harvard Cosmesis Scale.One hundred seven patients were randomized to either Arm A (n = 54) or Arm B (n = 53). Median follow-up was 20 months. Patient characteristics included: IDC 55%, ILC 20%, mixed 7%, DCIS 16%, other 3%; grade 1 or 2 72%, grade 3 28%; triple negative 9%, ER/PR+ 84%, and Her2+ 7%. Treatment characteristics included: sentinel lymph node biopsy 68%, axillary lymph node dissection 32%; spot scanned proton therapy 50%, 3D conformal x-rays 50%; and an integrated boost 21%. No significant differences in any characteristics were noted between the two arms. No grade 3 toxicities occurred on either arm. Grade 2 toxicities were seen in 7.4% of Arm A and 7.5% of Arm B. This primarily consisted of radiation dermatitis (6 patients) with 1 patient with fibrosis and 1 patient with lymphedema. Deterioration in cosmesis ≥ 3 months after RT was seen in 1.6% of Arm A and 1.7% of Arm B (P = 0.4). The average Harvard Cosmesis score was similar between arms at all timepoints. QOL was similar between arms, as well. Patient-reported radiation skin burns of 'moderate to severe' as assessed by PRO-CTCAE were more commonly reported in Arm A (58.7%) vs Arm B (27.9%) (odds ratio 3.7, CI 1.5-8.9; P = 0.004). Patient satisfaction with treatment was very high with more than 98% of patients in both arms saying that they would do RT again. No cancer recurrences or deaths have been seen in either arm.Our early analysis of our randomized study suggests that extreme hypofractionation using 25 Gy in 5 fractions is well-tolerated and as safe as moderate hypofractionation. Patient-reported radiation skin burns were 3.7 times less likely with 25 Gy in 5 fractions. Further follow-up is warranted.

MC1732: Pilot/Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery

To report the results of our phase II trial of breast cancer patients treated with hypofractionated whole breast radiation therapy (RT) prior to breast conserving surgery (BCS).Between 2019 and 2020, patients with cT0-T2, N0, M0 breast cancer were enrolled. Patients were treated with hypofractionated whole breast RT, 25 Gy in 5 fractions, 4-8 weeks prior to BCS. RT was delivered with proton beam therapy or photons and no RT boost or regional nodal irradiation was allowed. Pathologic assessment was performed using the Residual Cancer Burden (RCB). Toxicities were assessed according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4). Quality of life (QOL) was assessed with Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE), The Breast Cancer Treatment Outcome Scale (BCTOS), Linear Analogue Self-Assessment (LASA), and patient-reported outcomes measurement information system (PROMIS). Deterioration of cosmesis was defined as going from excellent/good to fair/poor or from fair to poor according to the Harvard Cosmesis Scale.Twenty-two patients were enrolled. Median follow-up was 7.1 months (range, 0.2-16.8). Median age at RT was 64.1 years (range, 44.3-76.7). Tumor characteristics included: IDC 68%, ILC 14%, DCIS 5%, other 14%; grade 1 55%, grade 2 36%, 5%; ER+HER2- 95%, ER+HER2+ 5%; right-sided 68%, left-sided 32%. The DCIS were all ER+. Pre-treatment tumor size include Tis 5% and T1 95%. Median time from RT to BCS was 8 weeks. Seven (32%) patients and 3 (14%) patients experienced grade 2+ or 3 toxicity, respectively. Overall QOL LASA and PROMIS did not change significantly from baseline (P = 0.21 and P = 0.72, respectively). There was no clinically significant change (≥1 point) in any of the BCTOS domains. Patient satisfaction with treatment was high with over 90% of patients saying they would do RT again. Only 1 (5%) patient experienced a clinical deterioration that corresponded to a 'Fair' outcome on the Harvard Cosmesis Scale. At pathologic evaluation, 14 (64%) patients had RCB-0 or RCB-1 including 3 (14%) patients with a pathologic complete response (RCB-0). No local or distant recurrences have been observed.Hypofractionated whole breast RT prior to BCS yielded excellent pathologic responses. There were low rates of toxicities and good cosmesis. Further investigation into this approach with RT before BCS is warranted.

Five-Year Longitudinal Analysis of Patient-Reported Outcomes and Cosmesis in a Randomized Trial of Conventionally Fractionated Versus Hypofractionated Whole-Breast Irradiation.

There are limited prospective data on predictors of patient-reported outcomes (PROs) after whole-breast irradiation (WBI) plus a boost. We sought to characterize longitudinal PROs and cosmesis in a randomized trial comparing conventionally fractionated (CF) versus hypofractionated (HF) WBI. From 2011 to 2014, women aged ≥40 years with Tis-T2 N0-N1a M0 breast cancer who underwent a lumpectomy with negative margins were randomized to CF-WBI (50 Gray [Gy]/25 fractions plus boost) versus HF-WBI (42.56 Gy/16 fractions plus boost). At baseline (pre-radiation), at 6 months, and yearly thereafter through 5 years, PROs included the Breast Cancer Treatment Outcome Scale (BCTOS), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Body Image Scale; cosmesis was reported by the treating physician using Radiation Therapy Oncology Group cosmesis values. Multivariable mixed-effects growth curve models evaluated associations of the treatment arm and patient factors with outcomes and tested for relevant interactions with the treatment arm. A total of 287 patients were randomized, completing a total of 14,801 PRO assessments. The median age was 60 years, 37% of patients had a bra cup size ≥D, 44% were obese, and 30% received chemotherapy. Through 5 years, there were no significant differences in PROs or cosmesis by treatment arm. A bra cup size ≥D was associated with worse BCTOS cosmesis (P < .001), BCTOS pain (P=.001), FACT-B Trial Outcome Index (P=.03), FACT-B Emotional Well-being (P=.03), and Body Image Scale (P=.003) scores. Physician-rated cosmesis was worse in patients who were overweight (P=.02) or obese (P < .001). No patient subsets experienced better PROs or cosmesis with CF-WBI. Both CF-WBI and HF-WBI confer similar longitudinal PROs and physician-rated cosmesis through 5 years of follow-up, with no relevant subsets that fared better with CF-WBI. This evidence supports broad adoption of hypofractionation with boost, including in patients receiving chemotherapy and in a population with a high prevalence of obesity. The associations of large breast size and obesity with adverse outcomes across multiple domains highlight the opportunity to engage at-risk patients in lifestyle intervention strategies, as well as to consider alternative radiation treatment regimens.

Validity and reliability of the Turkish version of the Breast Cancer Treatment Outcome Scale

Amaç: Bu araştırmanın amacı koruyucu meme cerrahisi geçiren hastalarda Meme Kanseri Tedavi Sonuçları Ölçeği (MKTSÖ) Türkçe versiyonunun, geçerlik ve güvenirliğini araştırmaktı. Yöntem: Çalışmaya, tek taraflı koruyucu meme cerrahisi geçirmiş 50 meme kanseri hastası dahil edildi. Anketin Türkçeye çevrilmesinin ardından güvenirliği ve iç tutarlılığı test edildi. Test-tekrar test güvenirliğini değerlendirmek ve sınıf içi korelasyon katsayısını (ICC) hesaplamak amacıyla anket tüm hastalara iki kez uygulandı. Cronbach alfa değeri anketin iç tutarlılığını belirlemek için hesaplandı. Ölçeğin kriter geçerliğinin belirlenebilmesi için MKTSÖ alt ölçekleri ile Avrupa Kanser Tedavisi ve Araştırmaları Örgütü-Hayat Kalitesi Ölçeği (EORTC-QLQ C30-BR23) alt ölçekleri korelasyonuna bakıldı. Bulgular: Anketin iç tutarlılığının analizinde, alt ölçekler için Cronbach alfa katsayıları 0,604-0,882 arasında bulundu. Test tekrar test güvenirliği mükemmel (ICC 0,941-1,000 arasında (%95 güven aralığında)) olarak bulundu. MKTSÖ ile EORTC-QLQ C30-BR23 alt ölçekleri arasında orta seviyeden yüksek seviyeye (r=-0,324-r=0,812 aralığında) korelasyon bulundu. En yüksek korelasyon kol semptomları ve MKTSÖ fonksiyonel seviye alt ölçekleri arasında bulundu (r: 0,812). C30 Emosyonel durum ve BR23 seksüel fonskiyon alt ölçekleri ile MKTSÖ’nin hiçbir alt ölçeği arasında korelasyon bulunmadı. Sonuç: Çalışmanın sonuçları MKTSÖ Türkçe versiyonunun, koruyucu meme cerrahisi geçirmiş hastalarda tedavi sonuçlarını fonksiyonel ve kozmetik açıdan değerlendirmede geçerli ve güvenilir bir ölçüm aracı olduğunu göstermektedir.

Patient reported cosmetic outcome after vacuum assisted excision of benign breast lesions: a cross-sectional study.

Better cosmetic outcome after vacuum assisted excision (VAE) compared to surgical excision of benign breast lesions is suggested in previous studies but has never been evaluated with validated outcome measures. In this study, patient reported cosmetic outcome after VAE was evaluated. Patients who underwent VAE between July 2017 and December 2018 were invited to complete the cosmetic subscale of the Dutch Breast Cancer Treatment Outcome Scale, comparing the treated with the untreated breast. Response mode ranged from 1 (no difference) to 4 (large difference) and cosmetic outcome was calculated as the unweighted mean. Clinical outcomes included: tumor size, number of cores, complications, residual lesions and recurrences. Response rate was 73.4% (47 of 64 patients). Median tumor size was 15 mm (range 5-51 mm) and median number of cores 6.5 (range 1-85), complete excision was confirmed in all but two patients. Mean cosmetic outcome was good (mean score ≤1.75) in 74% of patients and no patients reported a poor cosmetic outcome (mean score >3.25). A hematoma occurred in five patients (one needed aspiration) and a skin rash in one patient, no patients developed an infection or seroma. In this study VAE is safe and effective for tumors up to 5 cm and patient reported cosmetic outcome was good. Patients with benign lesions could benefit from VAE as an alternative for surgical excision. A formal quantitative measurement of cosmetic outcome after vacuum assisted excision for benign breast lesions was still lacking. This study shows that this cosmetic outcome is overall good in benign lesions up to 5 cm.

Oncoplastic Surgery in Breast-Conserving Treatment: Patient Profile and Impact on Quality of Life

Background: Breast-conserving treatment (BCT) provides better quality of life (QL) than mastectomy without reconstruction. Oncoplastic surgery (OS) encompasses a series of surgical techniques, increasing the indications for BCT, but few studies have evaluated the impact on QL in patients who undergo BCT with OS. Materials and Methods: A prospective, cross-sectional study was conducted in women who underwent BCT. We evaluated the characteristics of patients who underwent BCT with and without OS and the associated QL. QL was assessed through the EORTC QLQ-30, EORTC QLQ-BR23, and Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. Results: A total of 300 patients underwent BCT, 72 underwent breast OS, and 37 underwent bilateral surgery. Patients who underwent OS were younger (p = 0.004), had a higher level of education (p = 0.01), had a smaller time interval since the end of treatment (p = 0.02), had tumours with greater dimensions (p = 0.003), and were more likely to receive neoadjuvant chemotherapy (p = 0.05). Based on the QL questionnaires, no difference was observed between the groups. Breast symmetry was not associated with high patient satisfaction (p = 0.55). Conclusion: Despite the fact that OS was performed in patients with worse tumour conditions and in more demanding patients, OS allowed similar cosmetic results to classical BCT.

Quantitative 3-Dimensional Photographic Assessment of Breast Cosmesis After Whole Breast Irradiation for Early Stage Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial

PurposeOur purpose was to use 3-dimensional (3D) surface photography to quantitatively measure breast cosmesis within the framework of a randomized clinical trial of conventionally fractionated (CF) and hypofractionated (HF) whole breast irradiation (WBI); to identify how 3D measurements are associated with patient- and physician-reported cosmesis; and to determine whether objective measures of breast symmetry varied by WBI treatment arm or transforming growth factor β 1 (TGFβ1) status. Methods and MaterialsFrom 2011 to 2014, 287 women age ≥40 with ductal carcinoma in situ or early-stage invasive breast cancer were enrolled in a multicenter trial and randomized to HF-WBI or CF-WBI with a boost. Three-dimensional surface photography was performed at 3 years posttreatment. Patient-reported cosmetic outcomes were recorded with the Breast Cancer Treatment Outcome Scale. Physician-reported cosmetic outcomes were assessed by the Radiation Therapy Oncology Group scale. Volume ratios and 6 quantitative measures of breast symmetry, termed F1-6C, were calculated using the breast contour and fiducial points assessed on 3D surface images. Associations between all metrics, patient- and physician-reported cosmesis, treatment arm, and TGFβ1 genotype were performed using the Kruskal-Wallis test and multivariable logistic regression models. ResultsAmong 77 (39 CF-WBI and 38 HF-WBI) evaluable patients, both patient- and physician-reported cosmetic outcomes were significantly associated with the F1C vertical symmetry measure (both P < .05). Higher dichotomized F1C and volumetric symmetry measures were associated with improved patient- and physician-reported cosmesis on multivariable logistic regression (both P ≤ .05). There were no statistically significant differences in vertical symmetry or volume measures between treatment arms. Increased F6C horizontal symmetry was observed in the CF-WBI arm (P = .05). Patients with the TGFβ1 C-509T variant allele had lower F2C vertical symmetry measures (P = .02). ConclusionsQuantitative 3D image-derived measures revealed comparable cosmetic outcomes with HF-WBI compared with CF-WBI. Our findings suggest that 3D surface imaging may be a more sensitive method for measuring subtle cosmetic changes than global patient- or physician-reported assessments.

Patient-Reported Outcomes and Cosmesis After Once-Weekly Hypofractionated Breast Irradiation in Medically Underserved Patients

To evaluate patient-reported outcomes (PROs) and cosmesis from a phase 2 trial of once-weekly hypofractionated breast irradiation (WH-WBI) after breast-conserving surgery (BCS). Patients had stage 0-II breast cancer treated with BCS and negative margins. WH-WBI was 28.5 to 30 Gy in 5 weekly fractions of 5.7 to 6 Gy delivered with or without a boost. PROs were collected for 3 years after treatment using the Breast Cancer Treatment Outcome Scale (BCTOS) and European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). Physicians rated cosmetic outcome with the Global Cosmesis Score. Longitudinal growth models were used to assess changes in BCTOS across time, and baseline values and changes between time points were correlated with patient and treatment factors. From 2011 to 2015, 158 women received WH-WBI, and 148 were eligible for analysis after a median follow-up of 39.3 months. Adverse changes (P < .001) in global BCTOS score and breast pain and arm function subscores were observed 6 months after radiation therapy, followed by improvement to near-baseline values at years 1 and 3. Adverse changes in BCTOS cosmetic subscore were also detected at 6 months (P < .001), with no significant improvement at 1 (P = .385) and 3 (P = .644) years. No effect was detected for longitudinal changes in BCTOS scoring for age, body mass index, diabetes, smoking, breast volume, tumor size, seroma volume, dosimetric factors, dose, boost, or systemic therapy. Physician-rated cosmesis at 3 years was excellent/good in 89% and fair/poor in 11%. WH-WBI was associated with transient worsening in arm function and breast pain but persistent adverse changes in cosmetic PROs that were typically mild or moderate in severity. Physician-rated cosmetic outcomes were acceptable.

123P Cosmetic outcome after vacuum-assisted excision is good and independent of the amount of resected tissue

A better cosmetic outcome after vacuum-assisted excision is suggested in previous studies, but it has, to the best of our knowledge, never been formally evaluated nor demonstrated. While, providing more insight in patient reported outcomes is especially important for treatment decision making of this non-malignant disease. Therefore, we aimed to evaluate patient reported cosmetic outcome and the contributing variables after vacuum-assisted excision. In this cross-sectional study, patients who underwent vacuum assisted excision were invited to complete the cosmetic subscale of the Dutch Breast Cancer Treatment Outcome Scale (BCTOS-cs). For each patient, the mean cosmetic outcome was calculated and cosmetic outcome was dichotomized as either good or suboptimal. All clinically relevant variables were independently tested for the impact on cosmetic outcome. Variables that were possibly associated with cosmetic outcome (univariate p<0.2) were included in a multivariable regression analysis. The BCTOS-cs was completed by 46 of 64 (73.4%) contacted patients. Mean cosmetic outcome was 1.5 (good) and was not related to the number of resected cores and weight of the specimen (r=0.248, p=0.093 and r=0.221, p=0.131 respectively). Cosmetic outcome was not significantly different between tumors ≥3cm and <3cm (respectively mean 1.74 ± 0.66 vs. 1.53 ± 0.45, p=0.36). The absence of follow-up complications was the only significant factor associated with a better mean cosmetic outcome score (β= 0.367, SE=0.152, p=0.02) and with the dichotomized cosmetic outcome (OR=13.5, 95% CI 1.13-162.0, p=0.04) in the multiple regression analyses. It was already known that vacuum-assisted excision of benign lesions is safe and effective and now this study confirms that the patient reported cosmetic outcome after vacuum-assisted excision is good and independent of tumor size and resected specimen. The absence of complications was the only factor that contributed to a better cosmetic outcome. All recurrent lesions occurred in tumors < 3cm and no severe complications occurred in lesions > 3cm. Thus, vacuum-assisted excision could also be beneficial in patients with larger (> 3cm) benign breast tumors.

Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial

BIG 3-07/TROG 07.01 is an international, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofractionation in patients with non-low-risk ductal carcinoma in situ following breast-conserving surgery and whole breast radiotherapy. Here, we report the effects of diagnosis and treatment on health-related quality of life (HRQOL) at 2 years. The BIG 3-07/TROG 07.01 trial is ongoing at 118 hospitals in 11 countries. Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ were randomly assigned, by use of a minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy using one of three randomisation categories. Category A was a 4-arm randomisation of tumour bed boost versus no boost following conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy (42·5 Gy in 16 fractions over 3·5 weeks). Category B was a 2-arm randomisation between tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy. Stratification factors were age at diagnosis, planned endocrine therapy, and treating centre. The primary endpoint, time to local recurrence, will be reported when participants have completed 5 years of follow-up. The HRQOL statistical analysis plan prespecified eight aspects of HRQOL, assessed by four questionnaires at baseline, end of treatment, and at 6, 12, and 24 months after radiotherapy: fatigue and physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question). For each of these measures, tumour bed boost was compared with no boost, and conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy, by use of generalised estimating equation models. Analyses were by intention to treat, with Hochberg adjustment for multiple testing. This trial is registered with ClinicalTrials.gov, NCT00470236. Between June 1, 2007, and Aug 14, 2013, 1208 women were enrolled and randomly assigned to receive no tumour bed boost (n=605) or tumour bed boost (n=603). 396 of 1208 women were assigned to category A: conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost (n=100). 447 were assigned to category B: conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost (n=224). 365 were assigned to category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost (n=183). All patients were followed up at 2 years for the HRQOL analysis. 1098 (91%) of 1208 patients received their allocated treatment, and most completed their scheduled HRQOL assessments (1147 [95%] of 1208 at baseline; 988 [87%] of 1141 at 2 years). Cosmetic status was worse with tumour bed boost than with no boost across all timepoints (difference 0·10 [95% CI 0·05-0·15], global p=0·00014, Hochberg-adjusted p=0·0016); at the end of treatment, the estimated difference between tumour bed boost and no boost was 0·13 (95% CI 0·06-0·20; p=0·00021), persisting at 24 months (0·13 [0·06-0·20]; p=0·00021). Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08 [95% CI 0·03-0·13], global p=0·0033, Hochberg adjusted p=0·045); the difference between tumour bed boost and no boost at the end of treatment was 0·08 (0·01 to 0·15, p=0·021), and did not persist at 24 months (0·04 [-0·03 to 0·11], p=0·29). None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. Conventional whole breast radiotherapy was associated with worse body image than hypofractionated whole breast radiotherapy at the end of treatment (difference -1·10 [95% CI -1·79 to -0·42], p=0·0016). No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy. Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending. National Health and Medical Research Council, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society.

Psychometric validation of the Breast Cancer Treatment Outcome Scale (BCTOS-12): a prospective cohort study.

The Breast Cancer Treatment Outcome Scale (BCTOS) is a questionnaire to evaluate the aesthetic and functional outcome after breast conserving surgery (BCS). The original BCTOS with its 22 items on three subscales was refined to a shorter, improved, and easier to administer patient-reported outcome measure, the BCTOS-12. The BCTOS-12 consists of 12 items on two distinct subscales, the Functional Status and the Aesthetic Status. The aim of this study was to validate the BCTOS-12 in a prospective cohort. For this study, 239 breast cancer patients were included preoperatively, and 204 patients completed the BCTOS-12 and EORTC QLQ C30 BR23 shortly after their BCS, corresponding to a follow-up rate of 85%. The item-factor structure was examined by confirmatory factor analysis. The reliability was calculated by McDonald's Omega for estimating internal consistency. The convergent validity was assessed by Spearman's rank correlation coefficients between the related scales of the questionnaires. The BCTOS-12 showed a robust item-factor structure and a good internal consistency with McDonald's Omega of 0.89 for the Aesthetic Status and 0.90 for the Functional Status. A high convergent and divergent validity was indicated by correlations between the subscales of the EORTC QLQ C30 BR23 and the BCTOS-12. Overall, the results demonstrate a successful psychometric validation of the BCTOS-12. The BCTOS-12 is a refined, improved, and now validated, instrument. It can be used in clinical studies and routine management for the evaluation of the aesthetic and functional outcome after BCS.

Combined Patients and Medical Related Cosmetic Breast Cancer Outcomes—A Preferred Approach to Outcomes Assessment

Introduction: Reducing positive margins and need for re-excision yet maintaining cosmesis is key in breast cancer surgery. This study describes the evaluation of early outcomes of a combined cosmetic assessment programme following breast conservation surgery (BCS). Methods: An ethically approved prospective study was conducted at Letterkenny University Hospital and a 15-month timeframe was chosen. All consecutive patients undergoing conservative breast surgery with complete local excision, from July 2015 to October 2016, were entered into the study. Patients undergoing mastectomy and reconstruction with either implant or autologous tissue were not included. 41 patients undergoing BCS were analysed. Objective and subjective cosmetic evaluations were carried out. Assessments used were the Breast Cancer Conservative Treatment—cosmetic results [BCCT.core 2.0] Software, a panel of 4 experts in breast surgery and the Breast Cancer Treatment Outcome Scale (BCTOS). Demographic and pathological data, breast excision weight, % breast volume excised (BVE), margin positivity, complications and re-excision were documented. Data was expressed as mean and standard deviation for normally distributed data and medians and inter quartile range for non-normal data. Scores were also dichotomised to excellent/good and fair/poor and results were analysed. Results: 41 patients’ mean age is 55 ± 13 years. Mean breast volume was 768.3 cm3 ± 440; BVE weighed 78.6g ± 42.6 (18.9 - 214.4) and %BVE 11.3% ± 5.2% (5.1 - 23.3). Re-excision rate was 2/41 (4.9%) all for positive margins. 0/41 infections or haematomas occurred. Cosmetic status of 10 - 14 days post surgery was excellent or good by BCCT.core Software 78%, Expert panel 82.9%, BCTOS scale (92.7%), and fair or poor in 22%, 17.1% and 7.3% respectively. Conclusion: This study successfully evaluated objective and subjective cosmetic related outcomes following breast conserving surgery, incorporating both patient and surgeon in these assessments. The encouraging results show that despite low re-excision rates, acceptable cosmetic outcomes were achieved.

Development and psychometric evaluation of a Dutch-translated shorter Breast Cancer Treatment Outcome Scale (Dutch BCTOS-13)

PurposeTo create a Dutch translated short version of the Breast Cancer Treatment Outcome Scale (BCTOS) and validate it in patients who have completed both breast conserving surgery and adjuvant radiotherapy.MethodsThe BCTOS consists of items comparing the treated with the untreated breast. After forward and backward translation, we tested the BCTOS-12 plus 5 additional items. Two-hundred breast cancer patients treated with breast conserving therapy (BCT) between January 2016 and December 2017, were asked to complete the BCTOS items twice with a 2 week interval. The EORTC QLQ-BR23 breast and arm symptoms subscales were completed once in parallel. Feasibility was assessed by missing or non-unique answer rates and content validity with floor and ceiling effect analysis. Construct validity was evaluated with 1) principal component analysis (PCA) 2) convergent validity and 3) known groups comparison (clinical validity differentiating between patients with and without locoregional side effects). From all potential items with good feasibility, content and construct validity, items were selected for the Dutch BCTOS based on clinical validity. The relation to the EORTC QLQ-BR23 subscales and reliability was tested for the new Dutch BCTOS.ResultsHundred and one of 200 (50.5%) approached patients participated in this study, with follow-up after surgery ranging from 5 to 29 months. Feasibility was high (1.5% missing answers). Content validity testing showed a floor effect > 20% in all 17 items. PCA showed that all items loaded well (> 0.4) into the assigned subscale and revealed two distinct subscales: cosmesis and function. Based on clinical validity, item “breast shape” was replaced by “breast elevation/position” and “overall skin appearance”. Very good clinical validity (Cohen’s d = 1.38) was found for the new Dutch BCTOS-13. Correlation to the EORTC QLQ-BR23 subscales was high (ICC = 0.65–0.85) for both subscales. Test-retest reliability (Cohen’s d = 0.105) and internal consistency (Cronbach’s α =0.90) were excellent.ConclusionsPsychometric evaluation of a newly developed Dutch BCTOS-13 questionnaire in BCT patients showed excellent results, that were slightly better than the original BCTOS-22 and the shortened BCTOS-12. The good clinical validity makes the BCTOS-13 a useful tool to identify patients with unfavourable cosmetic and functional outcomes, requiring specific attention.

Improved long-term patient-reported health and well-being outcomes of early-stage breast cancer treated with partial breast proton therapy.

BackgroundBecause early‐stage breast cancer can be treated successfully by a variety of breast‐conservation approaches, long‐term quality of life (QoL) is an important consideration in assessing treatment outcomes for these patients. This study compares patient‐reported QoL outcomes among women with stage 0‐2 disease treated via lumpectomy followed by whole breast irradiation (WBI) or partial breast proton irradiation (PBPT).MethodsIn this cross‐sectional study, 129 participants evaluated QoL several years post‐treatment by responding to subjective instruments, including established scalar questionnaires and self‐report measures. Responses were averaged between the two groups.ResultsAt 6.5 years (median) postdiagnosis, participants’ demographic, and clinical characteristics were similar. Patient‐reported outcomes were reported as mean scale scores for the two groups, all displaying significant differences favoring PBPT, including: cosmetic breast cancer treatment outcome scale (BCTOS) (PBPT mean 1.45, WBI mean 1.88, P < 0.001); breast pain (PBPT mean 1.30, WBI mean 1.67, P < 0.05); breast texture (BPT mean 1.44, WBI mean 1.91, P < 0.001); clothing fit (PBPT mean 1.06, WBI 1.46, P < 0.001); fatigue (PBPT mean 2.24, WBI mean 3.77, P < 0.002); impact of daily life fatigue on personal relations (OBPT mean 0.83, WBI mean 2.15, P < 0.001); and self‐consciousness (appearance dissatisfaction) (PBPT mean 1.38, WBI mean 1.77, P < 0.004).ConclusionPatients’ responses suggest that PBPT is associated with improved overall QoL compared to standard whole breast treatment. These self‐perceptions are reported by patients who are 5‐10 years post‐treatment, and that PBPT may enhance QoL in a multitude of interrelated ways.

Comprehensive Validation Study of Quality-of-Life Questionnaire Using Objective Clinical Measures: Breast Cancer Treatment Outcome Scale (BCTOS), Brazilian Portuguese Version

IntroductionWhen evaluating a quality-of-life questionnaire (QLQ), many validation studies do not correlate quality-of-life scores with objective measurements of complications associated with treatment. Patients and MethodsWe performed a cross-sectional observational study with 300 patients submitted to breast-conserving therapy. The patients answered the European Organization for Research and Treatment of Cancer (EORTC) QLQs C-30 and BR23, as well as the Brazilian Portuguese version of the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire. Retest, internal consistency, factorial analysis, convergent/divergent analysis, and Rasch evaluation were performed. All patients underwent physical evaluations to assess lymphedema, handgrip strength, shoulder range of motion, breast cosmesis, and breast pain, and these groups were compared on the basis of BCTOS scores. Receiver operating characteristic curve determined the predictive value of BCTOS scores associated with clinical practice. ResultsThe internal consistencies of the BCTOS domains ranged from 0.785 to 0.895. Factor analysis grouped according to the original questionnaire. Convergent validation showed differences in the sexual functioning and sexual enjoyment domains of the EORTC BR23. Analysis of known groups found that in most domains, the scores were higher in patients with lymphedema, strength deficit, shoulder range-of-motion alteration, poor breast cosmesis, breast pain, and axillary lymphadenectomy. Using a cutoff of 1.26, lymphedema was associated with the edema domain; using a cutoff of 1.33, Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic pain was associated with the pain domain; and using a cutoff of 2.37, the cosmetic domain was associated with subjective cosmesis. ConclusionThe association of objective measurements in a validation study of quality of life qualified the study and allowed us to develop better parameters for comparisons of results of breast-conserving therapy between populations.

NRG Oncology/RTOG 1014: Patient Reported Outcomes (PRO) and Cosmesis From a Phase II Study of Repeat Breast Preserving Surgery and 3D Conformal (3D-CRT) Partial Breast Re-Irradiation (PBrI) for In-Breast Recurrence.

NRG/RTOG 1014 is a prospective phase II trial of 3D-CRT PBrI following repeat lumpectomy for in-breast recurrence following previous whole breast irradiation (WBI). This analysis focuses on patient reported and cosmetic outcomes. Eligible patients (pts) had in-breast recurrences presenting >1 year following WBI for initial lesion, were confirmed to be <3cm, unifocal and resected with negative margins. Prescription dose of 45 Gy was delivered as 1.5Gy BID for 30 treatments with 3D-CRT. PRO were collected using the Breast Cancer Treatment Outcome Scale (BCTOS) where change compared to the contralateral breast is graded as 1 = none, 2 = slight, 3 = moderate and 4 = large and analyzed in three domains: functional (e.g. shoulder or arm movement, stiffness, pain) , cosmetic (e.g. breast size, texture, shape, scar tissue ) and breast-specific pain (e.g. breast pain, tenderness, sensitivity). MD assessment was done using a four point NRG/RTOG established criteria scale. The BCTOS and MD Cosmetic Score were completed at baseline (prior to the start of PBrI, but after surgery), 12 months (mo), and 36 mo intervals. Of the 58 pts eligible and treated, 46 (79%) consented to the Quality of Life component. BCTOS mean + standard deviation (SD) at baseline, 12 and 36 mo in the table demonstrate that functional status was unchanged over the observation period, breast-specific pain improved and cosmesis worsened slightly at 12 mo and 36 mo.Abstract 84; TableBCTOS Mean + SDFunctionalCosmeticBreast-Specific PainBaseline (n=46)1.27 ± 0.421.95 ± 0.551.92 ± 0.5412-month (n=36)1.28 ± 0.432.05 ± 0.661.70 ± 0.6436-month (n=32)1.29 ± 0.472.12 ± 0.711.76 ± 0.83 Open table in a new tab MD-assessed fibrosis, volume loss, retraction and/or pigment change was scored as effecting cosmesis at baseline (n=44) in 9%, 41%, 28%, 7%, respectively; worsening to 21%, 49%, 36%, 8% at 12 mo (n=39); and, 43%, 57%, 53%, 7% at 36 mo (n=30), respectively. MD assessed cosmesis was excellent/good in 59%, 63% and 52% respectively and Fair/Poor 41%, 37% and 48% respectively at baseline (n=44), 12 mo (n=35) and 36 mo (n=27). When evaluating individual pts with all time points available, improvements and deteriorations in MD scoring were seen. BCTOS cosmetic status mean score correlated to the MD- assessed four point score at the 12 mo interval: BCTOS mean score of 1.67 ± 0.57, 1.88 ± 0.44, 2.19 ± 0.69, and 2.48 ± 1.21 corresponding to the MD assessment of excellent, good, fair, and poor, respectively. Based on PRO, repeat lumpectomy with PBrI had no impact on functional status, breast-specific pain improved over time, and there was a small worsening of cosmesis. MD assessment of cosmesis correlated with this trend. Fibrosis, volume loss, retraction, pigment change were the MD identified factors most commonly affecting cosmesis at 12 and 36 months.

Patient Reported Outcomes and Cosmesis Following Once Weekly Hypofractionated Breast Irradiation

Once weekly hypofractionated breast irradiation (WHBI) is a novel treatment in the setting of breast conservation, but data regarding cosmetic and functional outcomes are limited. We report physician and patient report outcomes (PROs) from a phase II trial to determine whether WHBI is associated with adverse cosmetic, functional, and pain outcomes. Women with stage 0-II breast cancer treated with breast conserving surgery and negative margins were enrolled on this institutional review board-approved, phase II trial. WHBI was 28.5-30 Gy in five weekly fractions of 5.7-6 Gy delivered with field-in-field tangents, with or without a boost. Regional nodal irradiation was not permitted. Ipsilateral breast tumor recurrence (primary endpoint), survival times, and acute toxicity have previously been reported. Physician reported cosmesis and patient reported quality of life outcomes were secondary endpoints and are reported herein. PROs were assessed at baseline, 6 months, 1 and 3 years using the Breast Cancer Treatment Outcome Scale (BCTOS) which includes three subscales of cosmetic changes, arm function, and breast pain. Physician rated cosmesis was assessed using the Harvard Scale and recorded at the same time points. BCTOS outcomes were compared with baseline values using a two sided t test with each patient serving as her own internal control. From January 2011 to October 2015, 158 women were enrolled, of whom 73% (n=115) had sentinel node biopsy, 12% (n=119) had axillary dissection, 21% (n=33) had re-excision of margins, and 29% (n=45) received chemotherapy. The median follow up for cosmetic and functional assessments was 30 months (range, 5-46). Eighty patients received 30 Gy, 78 patients received 28.5 Gy, and 28 (18%) received a boost. PROs indicate adverse changes in arm function (p=0.001) and breast pain (p=0.001) outcomes at 6 months post-treatment, however, no detectable adverse change when compared to baseline at 1 (function p=0.419, pain p=0.564) and 3 years (p=0.673, p=0.636). Adverse changes in cosmetic PROs were also detected at 6 months (p<0.001) and 1 year (p=0.008), with a trend towards significance at 3 years (p=0.06). At last follow up, the cosmetic PROs most commonly noted to be moderately or largely different than the untreated breast were breast size (26% moderate difference, 5% large difference), shape (21%, 9%), scar tissue (16%, 8%), texture (18%, 5%), and elevation (16%, 6%). Physician rated cosmesis was excellent/good in 84% (n=133) and fair/poor in 16% (n=25). The most common physician reported changes effecting cosmesis were volume loss in 21%, scarring in 21%, and retraction/contour defect in 14%. WHBI was associated with transient worsening in arm function and breast pain. Adverse changes in cosmetic PROs persisted longer following treatment but were typically mild or moderate in severity. Physician rated cosmetic outcomes were acceptable.

Translation and cultural adaptation of the Breast Cancer Treatment Outcome Scale (BCTOS) into Brazilian Portuguese.

Breast conservative treatment (BCT) is safe when it is performed in association with radiotherapy. The number of referral for BCT has increased, and it has become an important treatment modality. Patients who undergo BCT present some characteristics that are associated with better quality of life compared with patients who undergo mastectomy without reconstruction. Instruments that measure the quality of life specifically used in cases of BCT are limited. One of these instruments is the Breast Cancer Treatment Outcome Scale (BCTOS), which has not yet been translated into Brazilian Portuguese. It contains 22 questions and four domains (functional, aesthetic, breast sensitivity and oedema). We performed the translation and cultural adaptation process using Beaton's and EORTC translations process. In summary, the translation process is based on Portuguese translation, translation summary, reverse translation into English, expert committee, pre-test (10 patients), questionnaire review and test of the final version (6 patients). All 16 patients were submitted to quadrantectomy and mammary radiotherapy. Lymphedema was present in 4, altered strength in 5, and altered shoulder mobility in 6 patients. Considering the questionnaire, the reconciled version determined change in 2 items. Pre-test evaluation showed difficulties in 3 patients, but the questionnaire did not change. Test evaluation showed no problems. The translation of BCTOS into Portuguese will help us to evaluate the quality of life in BCT patients evaluating treatment-related sequelae and may be useful for oncoplastic surgery evaluation.