Functional Assessment Of Cancer Therapy-Breast Research Articles

Quality of Life (QoL) in Postmenopausal Breast Cancer Patients Receiving Adjuvant Hormonal Therapy

The primary aim of this study was to compare quality of life of postmenopausal breast cancer women receiving adjuvant hormone therapy with those not receiving. The secondary aims were to investigate impact of vitamin D status and type of hormone therapy (letrozole vs tamoxifen) on quality of life. Tertiary care hospital, prospective study (March 2016 to September 2017). Study included postmenopausal non-metastatic breast cancer women. Patients were divided in two groups: group 1 (n=120) receiving adjuvant hormone therapy and group 2 (n=93) not receiving hormone therapy. Patients filled Functional Assessment of Cancer Therapy-Breast (FACT–B) QoL questionnaire at enrolment and 6 month later. The scores were compared between the groups. Overall basal FACT-G (p=0.004), FACT-B (p=0.003), and all other quality of life subscales scores barring social well-being were significantly better in group 2 {physical well-being (p=0.002), social well-being (p=0.037), emotional well-being (p=0.028), functional well-being (p=<0.001)}. Follow-up scores in all subscales within both group improved significantly (p=<0.001), but significant difference between two groups persisted only for FACT-G (p=0.04), physical well-being (p=0.02), and functional well-being (p=<0.001) subscale. Except for social well-being subscale, vitamin D sufficient patients had significantly better scores than deficient patients. There was no significant difference among patients receiving either letrozole or tamoxifen except for better functional well-being (p=0.005) score in those receiving previous. Adjuvant hormonal therapy irrespective of type and vitamin D deficiency contribute to inferior quality of life in postmenopausal breast cancer women.

Effects of Short-Term Unsupervised Exercise, Based on Smart Bracelet Monitoring, on Body Composition in Patients Recovering from Breast Cancer.

Objective:We aimed to investigate the effects of exercise, monitored and managed using smart bracelets, on body composition, and quality of life in breast cancer survivors.Methods:A before-and-after study was conducted in 109 patients who were in the recovery phase of breast cancer and attended the Breast Surgery Department of the Cancer Hospital of Fudan University up to December 2017. Patients were advised to adhere to at least 150 minutes of moderate-intensity exercise per week, and a smart bracelet was issued to each participant to record their daily exercise data for 3 months. Bioelectrical impedance analysis was used to observe the effects of short-term unsupervised exercise intervention on body composition in patients recovering from breast cancer. Patients completed the Functional Assessment of Cancer Therapy-Breast to assess health-related quality of life.Results:Weight, body mass index (BMI), body fat mass (BFM), fat mass index (FMI), percent body fat (PBF), arm circumference (AC), arm muscle circumference (AMC), and visceral fat area (VFA) were lower than baseline after exercising for 3 months based on data from the wearable devices (P < .05). The only significant improvement was found in the “additional concerns about breast cancer” category among the quality-of-life assessments (P < .05). The average walking time was negatively associated with BFM, PBF, and FMI, while the average calorie consumption due to running was positively associated with fat free mass (FFM).Conclusion:In this study, we demonstrated that short-term exercise may be beneficial for postoperative breast cancer survivors. A wearable device could help patients track physical data easily and promote a healthier and more positive life.

Health variations among breast-cancer patients from different disease states: evidence from China

BackgroundThis study aimed to obtain health utility parameters among Chinese breast cancer patients in different disease states for subsequent health economics model. In addition, we aimed to explore the feasibility of establishing a breast cancer health utility mapping model in China.MethodsMultiple patient-reported health attributes were assessed, including quality of life, which was measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument; health utility and self-rated health, which were measured by the EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire. Multivariate regression models, including a linear regression model, an ordinal logistic regression model and a Tobit model, were employed to analyze health differences among 446 breast cancer patients. Subgroup analyses were performed to examine differences in multiple dimensions of health derived from the FACT-B and EQ-5D-5L instruments. A mapping function was used to estimate health utility from quality of life. Rank correlation analyses were employed to examine the correlation between estimated and observed health utility values.ResultsA total of 446 breast cancer patients with different disease states were analyzed. The health utility values of breast cancer patients in the P state (without cancer recurrence and metastasis), R state (with cancer recurrence within a year), S state (with primary and recurrent breast cancer for the second year and above), and M state (metastatic cancer) were 0.81 (SD ± 0.23), 0.90 (SD ± 0.12), 0.78 (SD ± 0.31), and 0.74 (SD ± 0.27), respectively. There were positive correlations between all scores, including every domain of the FACT-B instrument (p < 0.001). Results from multivariate analysis suggested that patients in the R and M states had lower scores for overall quality of life (R, β = − 9.45, p < 0.01; M, β = − 6.72, p < 0.05). Patients in the M state had lower health utility values than patients in the P state (β = − 0.11, p < 0.05). Estimated health utility values, which were derived from quality of life by using a mapping function, were significantly correlated with directly measured health utility values (p < 0.001).ConclusionsWe obtained the health utility and health-related quality of life (HRQoL) scores of Chinese breast cancer patients in different disease states. Mapping health utility values from quality of life using four disease states could be feasible in health economic modelling, but the mapping function may need further revision.

Health‐related quality of life outcomes for the LEAP study—CALGB 70305 (Alliance): A lymphedema prevention intervention trial for newly diagnosed breast cancer patients

Lymphedema is an adverse effect of breast cancer treatment that causes swelling and pain in the arm and hand. We tested 2 lymphedema prevention interventions and their impact on health-related quality of life (HRQOL) in a group-randomized trial at 38 cooperative group sites within the United States. Patients were recruited before breast surgery. Sites were randomly assigned to education-only (EO) lymphedema prevention or education plus exercise and physical therapy (LEAP). Lymphedema was defined as a ≥10% difference in arm volume at any time from baseline to 18 months postsurgery. HRQOL was assessed using the Functional Assessment of Cancer Therapy-Breast plus 4 lymphedema items (FACT-B+4). Longitudinal mixed model regression analysis, adjusting for key demographic and clinical variables, examined participants' HRQOL by intervention group and lymphedema status. A total of 547 patients (56% LEAP) were enrolled and completed HRQOL assessments. The results revealed no differences between the interventions in preventing lymphedema (P = .37) or HRQOL (FACT-B+4 total score; P = .8777). At 18 months, the presence of lymphedema was associated with HRQOL at borderline significance (P = .0825). However, African American patients reported greater lymphedema symptoms (P = .0002) and better emotional functioning (P = .0335) than patients of other races or ethnicities. Lower HRQOL during the intervention was associated with younger age (P ≤ .0001), Eastern Cooperative Oncology Group performance status >0 (P = .0002), ≥1 positive lymph nodes (P = .0009), having no education beyond high school (P < .0001), having undergone chemotherapy (P = .0242), and having had only axillary node dissection or sentinel node biopsy versus both (P = .0007). The tested interventions did not differ in preventing lymphedema or in HRQOL outcomes. African American women reported greater HRQOL impacts due to lymphedema symptoms than women of other races or ethnicities.

Quality of Life Indicators in Patients Operated on for Breast Cancer in Relation to the Type of Surgery-A Retrospective Cohort Study of Women in Serbia.

Background and objectives: Quality of life (QoL) after breast cancer surgery is an important public health issue. The aim of this study was to determine the relationship between the levels of perceived quality of life in patients operated on for breast cancer in relation to the type of surgery, using the standardized questionnaires. Materials and Methods: We assessed 425 women after surgery for breast cancer. The assessment included the application of the WHOQOL-bref (The World Health Organization Quality of Life-Bref), and FACT-B (Functional Assessment of Cancer Therapy-Breast) questionnaires. The statistical analysis of the data included multiple linear regression and correlation tests. Results: Multiple linear regression analysis found that education, existence of comorbidities, time elapsed since surgery, and type of surgery were significant predictors of overall quality of life. Women’s overall quality of life and general health has increased by 0.16 times for each subsequent year of surgery, and by 0.34 times for each subsequent higher education level. Breast-conserving surgery or mastectomy with breast reconstruction were statistically significant (β = 0.18) compared to total mastectomy. Conclusions: There is a significant difference in the quality of life perceived by patients in whom the breast has been preserved or reconstructed in relation to patients in whom total mastectomy has been performed.

Mapping the cancer-specific FACT-B onto the generic SF-6Dv2.

The health-related quality of life (HRQoL) data extracted from cancer-specific questionnaires are often non-preference based, while patient preference-based utility data are required for health economic evaluation. This study aimed to map Functional Assessment of Cancer Therapy-Breast (FACT-B) subscales onto the Short Form six Dimension as an independent instrument (SF-6Dv2ind-6) using the data gathered from patients with breast cancer. Data for 420 inpatient and outpatient patients with breast cancer were gathered from the largest academic center for cancer patients in Iran. The OLS and Tobit models were used to predict the values of the SF-6Dv2ind-6 with regard to the FACT-B subscales. Prediction accuracy of the models was determined by calculating the rootmeansquareerror(RMSE) and mean absolute error(MAE). The relationship between the fitted and observed SF-6Dv2ind-6 values was examined using the Intraclass Correlation Coefficients (ICC). Goodness of fit of models was assessed using the predicted R2 (Pred R2) and adjusted R2 (Adj R2). A tenfold cross-validation method was used for validation of models. Data of 416 patients with breast cancer were entered into final analysis. The model included main effects of FACT-B subscales, and statistically significant clinical and demographic variables were the best predictor for SF-6Dv2ind-6 (Model S3 of OLS with Adj R2 = 61.02%, Pred R2 = 59.25%, MAE = 0.0465, RMSE = 0.0621, ICC = 0.678, AIC = -831.324, BIC = -815.871). The best algorithm developed for SF-6Dv2ind-6 enables researchers to convert cancer-specific instruments scores into preference-based scores when the data are gathered using cancer-specific instruments.

Quality of life and related risk factors after breast reconstruction in breast cancer patients.

Breast cancer is the most frequently occurring cancer in women globally, using radical mastectomy as the main clinical treatment. This study aims to investigate the quality of life and related factors in patients after breast reconstruction. Female patients undergoing breast reconstruction after radical mastectomy between February 20, 2014 and February 20, 2019 in the Department of Tumor or the Department of Thyroid and Breast Surgery in the Affiliated Hospital of North Sichuan Medical College and Nanchong Central Hospital were surveyed. The patients' basic information was collected using a questionnaire prepared by the research team, and the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire was used to assess the patients' quality of life. Multivariate linear regression analysis was performed to explore the factors impacting the change of FACT-B scores one year after surgery. A total of 150 patients were included. 143 of them had complete data, and 7 patients were lost to follow-up. Compared with the preoperative results, the scores of all dimensions of the FACT-B scale and the overall health status of the patients were significantly reduced at 3 months after surgery, which recovered to the preoperative level at 6 months after surgery (P<0.05), and significantly increased at 12 months after surgery (P<0.05). The results showed that age ≥40 years, menopause, postoperative complications, and endocrine therapy were risk factors for decreased quality of life at 12 months after breast reconstruction. Meanwhile, tumor stage 0 or stage I and immediate breast reconstruction were protective factors for quality of life at 12 months after breast reconstruction (P<0.05). The postoperative quality of life of patients with breast reconstruction is relatively high. Older age, post-menopause, postoperative complications, endocrine therapy, advanced tumor stage, and delayed reconstruction are all risk factors for decreased quality of life of patients. Targeted measures should be taken to improve the postoperative life quality of patients, such as paying more attention to the older or post-menopausal patients, as well as those with postoperative complications, endocrine therapy, high tumor stage, or delayed breast reconstruction.

ABREAST: a prospective, real-world study on the effect of nab-paclitaxel treatment on clinical outcomes and quality of life of patients with metastatic breast cancer.

The efficacy of nab-paclitaxel in patients with metastatic breast cancer (MBC) has been demonstrated in randomized clinical trials. However, real-world evidence on effectiveness remains limited. The primary objective of this multicenter prospective study was to assess the overall response rate (ORR) of patients with MBC treated with nab-paclitaxel. Secondary objectives included progression-free survival (PFS), overall survival (OS) and quality of life, assessed with the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. Eligible patients (N = 150; 36% with de novo MBC presentation) with a median age of 64.5years were enrolled (86% were ER+, 33.3% (50/150) were ≥ 70years of age and 53% were treated in the third or later line of treatment). A median of 6 cycles were administered but 26% of patients required dose reduction due to toxicity. The ORR was 26.7% [95% confidence interval (CI) 19.6-33.7], the median PFS was 6.2months (95% CI 5.2-7.3), and the median OS 21.1months (95% CI 17.2-not estimable). There was no statistical significant difference in the median PFS of patients < and ≥ 70years of age. The patients' baseline FACT-B total score remained unchanged. The serious and non-serious adverse event incidence rates were 13% and 48%, respectively. This prospective study provides further evidence on quality of life, efficacy, and safety of nab-paclitaxel in patients with MBC and sheds more light in special subpopulations such as the elderly and those treated beyond the second line.

Difficulties in identifying and describing feelings, social constraints, affect, and functional well-being among Chinese breast cancer patients: A mediation model.

Functional well-being (i.e., individuals' functioning in daily living activities and social roles; FWB) is often an understudied aspect of quality of life among breast cancer patients (BCP). Previous research has suggested that patients' emotional experience is associated with their FWB. However, little is known about how intrapersonal and interpersonal barriers of emotional processing and expression (i.e., social constraints, difficulties in identifying and expressing emotions) associated with FWB among Chinese BCP, plus how positive/negative affect might explain such associations. Chinese BCP (N=327) in Weifang, Shandong province, China completed a cross-sectional survey. The Functional Well-Being subscale from the Chinese version of the Functional Assessment of Cancer Therapy-Breast (FACT-B), the Social Constraints Scale, the Difficulty in Identifying Feelings (DIF; 7 items) and the Difficulty in Describing Feelings (DDF; 5 items) subscales from the Toronto Alexithymia Scale and the Positive Affect and Negative Affect Schedule were used as assessment scales. Path analyses results supported the proposed mediation model with satisfactory fit indices (χ2(5)=5.12, p=.40, CFI=1.00; IFI=1.00; RMSEA=0.01). Specifically, difficulty in describing emotions was associated with poorer functional well-being through increased negative affect (β=-0.06, 95%CI=-0.10, -0.03); difficulty in identifying emotions was associated with poorer functional well-being through reduced positive affect (β=-0.04, 95%CI=-0.09, -0.003). Social constraints were associated with poorer functional well-being through both increased negative affect and decreased positive affect (β=-0.16, 95%CI=-0.22, -0.10). After considering the mediators, difficulties in describing emotions still contributed significantly to functional well-being (β=-0.20, 95%CI=-0.31, -0.08). Our results indicated that positive/negative affect could mediate between barriers of emotional processing/expression and FWB. This study was unique in revealing how intrapersonal and interpersonal barriers of emotional processing and expression could be associated with Chinese BCPs' FWB through varied mechanisms. Practitioners should consider strategies to reduce those barriers through interventions.

Correlation analysis between mental health and symptom distress in breast cancer patients

Objective To investigate the correlation between mental health and symptom distress in breast cancer patients. Methods The clinical data of 110 female breast cancer patients at Shanxi Bethune Hospital from June 2017 to March 2018 were collected. The patients were assessed for symptomatic distress with depression self-rating scale (SDS). Functional assessment of cancer therapy-breast (FACT-B) and the functional assessment of chronic illness therapy-spiritual well-being (FACIT-SP) were used to make the mental assessment. Multiple linear regression analysis was used to analyze the effect of symptom distress on the mental health of the patients. Results The scores of symptom distress, mental health, FACT-B and FACIT-SP were (19.94±5.78), (50.68±10.64), (16.85±4.75), (33.83±8.33), respectively. Multivariate analysis showed that mental health score of the patients with symptom distress > 18 scores was reduced by 5.15 points (P=0.01) compared with the patients with symptom distress≤18 scores. Compared with the patients with annual household income < 50 000 yuan, the mental health score of patients with annual household income of 50 000-79 000 yuan was increased by 9.46 points (P < 0.01), and the mental health score of patients with annual family income ≥ 80 000 yuan was increased by 5.92 points (P < 0.01); compared with the patients in phase I, the mental health score of the patients in phaseⅡwas decreased by 2.62 points (P=0.02), and the mental health score of the patients in phase Ⅲ was decreased by 4.98 points (P < 0.01). Conclusions Symptom distress is an independent risk factor for affecting mental health of breast cancer patients. Solving symptom distress of patients can improve mental health status of the patients. Key words: Breast neoplasms; Mental health; Symptom distress

Abstract P5-12-09: Patient-reported outcomes (PROs) during one year of adjuvant enzalutamide for the treatment of early stage androgen receptor positive (AR+) triple negative breast cancer

Abstract BACKGROUND: A subset of TNBC expresses a luminal signature and demonstrates AR-dependence. Enzalutamide (ENZA), an AR-antagonist, has activity with metastatic AR+ TNBC, with a clinical benefit rate of 33% (Traina et al, JCO 2018). We recently demonstrated that one year (y) of adjuvant ENZA is feasible in early stage, AR+ TNBC, with no new safety signals observed (Traina ASCO 2019). Fatigue was the most common, treatment (tx)-related, adverse event of any grade according to investigator assessment (24%). Here we report per-protocol planned secondary analyses of PROs during one year of ENZA including quality of life (QoL), fatigue, and self-reported physical activity (NCT02750358). METHODS: Eligible patients have Stage I-III, ER/PR &amp;lt;1%, HER2(-), AR ≥1% breast cancer and completed all planned standard of care surgery, chemotherapy and radiation within 6 months of study start. Tx = ENZA 160mg orally daily for 1y with the option to extend tx to 2y as per patient preference. Clinician-reported toxicities (NCI CTCAEv4) were assessed every 4 weeks for 12 weeks, then every 3 months. Total study N=50 patients. PROs were assessed every 12 weeks. We examined serial changes in overall QoL (functional assessment of cancer therapy – breast (FACT-B), fatigue (FACIT-fatigue) and exercise behavior (total exercise minutes/week over past 7 days) from pre-treatment and every 3 months thereafter until month 12. All analyses are exploratory and consist of descriptive summaries. RESULTS: Between 5/2016 and 6/2018, 50 patients were enrolled. As of 6/27/19, 34 patients completed 1y of ENZA; 15 patients are off tx: recurrence (3), toxicity (5), nonadherence (4), and consent withdrawal (3). Patients evaluable for PRO (N): baseline (50), 12 weeks (43) and 52 weeks (34). Median scores on FACT-B and fatigue scales remained stable over the course of adjuvant ENZA in the 1st year of therapy (Table). Self-reported exercise increased during this period. Table. Median scores (range) for PROs during 1 year of adjuvant ENZATime PointBaselineWeek 12Week 52FACT-G88.0 (53.5-105.0)82.0 (36.4-105.0)89.5 (58.0-105.0)Breast Cancer Subscale28.5 (15.6-39.0)29.0 (9.0-40.0)29.0 (19.0-40.0)Total118.0 (77.0-141.0)111.0 (45.4-145.0)121.0 (83.0-145.0)FACT-B trial outcome index73.0 (43.0-92.0)73.0 (25.7-96.0)76.9 (51.0-96.0)FACIT43.0 (17.0-52.0)39.0 (10.0-52.0)43.0 (11.0-52.0)Total Exercise (min/week)120 (0-1260)152 (0-3120)180 (0-2580) CONCLUSIONS: Patient reported outcomes of health related QOL remain stable when ENZA is administered for 1 year in the adjuvant setting. Self-reported time spent engaged in physical exercise increased numerically during 1y of therapy. During presentation, additional analyses will be reported including QOL at additional time points, relationship of FACT-B score with FACIT fatigue score and exercise, and QOL changes in relation to relative dose intensity of ENZA, toxicity and off study reason. Citation Format: Tiffany A Traina, Lee W Jones, Victoria Blinder, Jessica Scott, Leigh Ann Boyle, Artavazd Arumov, Tina Alano, Sujata Patil, Patricia DeFusco, Nicholas Lamparella, Mark Robson, Ayca Gucalp. Patient-reported outcomes (PROs) during one year of adjuvant enzalutamide for the treatment of early stage androgen receptor positive (AR+) triple negative breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-12-09.

Abstract P2-15-07: Real-world multicenter, prospective study of the effects of nab-paclitaxel on clinical outcomes and quality of life of patients with metastatic breast cancer in Greece. The ‘ABReast’ study

Abstract Introduction: Nanoparticle albumin-bound (nab)-paclitaxel (nab-P) is approved for the treatment of patients with metastatic breast cancer (MBC) who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Real-world evidence on the effectiveness of nab-P is sparse. From this perspective, this non-interventional study was designed to assess the impact of nab-P on the clinical outcomes and the quality of life of patients with MBC in the routine care of Greece. Materials and methods: This multicenter prospective study enrolled consented females with MBC initiated (≤7 days prior to enrollment) on nab-P according to physicians decision. Clinicopathologic parameters and patient-reported outcomes [Functional Assessment of Cancer Therapy-Breast (FACT-B)] were collected at approximately 9-week intervals during the first 12 months of study participation and approximately every 18 weeks thereafter, until the end of the study observation period (maximum 30 months). Results: Between April 2016 and October 2017, 150 eligible patients (99.3% Caucasian) were enrolled in the study in 16 oncology centers. The patients’ median age was 64.5 years (range: 30.7-84.0) and ECOG performance status was 0 in 66.4% and 1 in 26.2%. 45.3% of patients had ≥1 comorbidity (21.3% cardiovascular diseases). The median time elapsed since MBC diagnosis was 22.4 months, while 36.0% of patients were de novo metastatic. The distribution of hormone receptor (HR)/human epidermal growth factor receptor 2 (HER2) status was 74.6% HR+/HER2-, 11.9% HR-/HER2-, 11.2% HR+/HER2+, and 2.2% HR-/HER2+. Most commonly occurring metastatic sites were the bones (55.3%), lung (50.0%), and liver (40.0%). Prior taxane-based therapy was annotated in 40.0% of patients. Of the patients, 11.3% received nab-P as first, 36.0% as second, 23.3% as third, and 29.3% as fourth or further treatment line. A median of 6 cycles (range: 1-33) was administered; 42.7% of the patients completed &amp;gt;6 and 22.0% &amp;gt;8 cycles. Dose reductions were required for 26.0% of the patients, mainly due to toxicity. The objective response rate was 26.7% and the clinical benefit rate was 44.0%. After a median follow-up of 19.3 months, 92 patients had progressed and 57 had died (14 without progression). The median progression-free survival (PFS) was 6.2 months [95% confidence interval (CI): 5.2-7.3]. The 6- and 12-month PFS rates were 50.6% and 30.5%, respectively. The median overall survival was 21.1 months (95% CI: 17.2-not estimable). Liver [hazard ratio (HR): 1.81; 95% CI: 1.24-2.66] and lung (HR: 1.53; 95% CI: 1.04-2.25) metastases were associated with a higher risk of progression or death. No statistically significant change in the patients’ baseline FACT-B total score (median: 93.0) was observed. The serious and non-serious adverse event (AE) incidence rates were 12.7% and 48.0%, respectively with a total of 37 grade ≥3 AEs (not including disease progression) reported. Conclusion: This study generated real-world evidence on the effectiveness of nab-paclitaxel; no new safety signals emerged. Citation Format: Anna Koumarianou, Paris Makrantonakis, Flora Zagouri, Christos Papadimitriou, Athina Christopoulou, Epaminontas Samantas, Christos Christodoulou, Amanda Psyrri, Dimitris Bafaloukos, Gerasimos Aravantinos, Pavlos Papakotoulas, Sofia Baka, Charalampos Andreadis, Athanasios Alexopoulos, Iliada Bombolaki, Katerina Kampoli, Sofia Liori, Kiki Karvounis, Alexandros Ardavanis. Real-world multicenter, prospective study of the effects of nab-paclitaxel on clinical outcomes and quality of life of patients with metastatic breast cancer in Greece. The ‘ABReast’ study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-07.

Abstract P2-12-11: Does goserelin have an effect on quality of life in women who have chemotherapy for early breast cancer? Results from the OPTION randomised trial

Abstract The OPTION trial examined whether or not premenopausal women with early breast cancer receiving chemotherapy benefited from ovarian function protection with goserelin. This trial showed some preservation of ovarian function and fertility in women aged 40 years or less*. Additionally the OPTION trial examined the immediate and late impact of treatments on patients’ Quality of Life (QoL) over a 5 year period. Patients and Methods: In the OPTION trial 227 pre-menopausal patients with early stage breast cancer were randomly assigned to chemotherapy with or without goserelin. Patients were stratified by age into ≤40 years and &amp;gt; 40 years of age. QoL was assessed with the Functional Assessment of Cancer Therapy - Breast (FACT-B) and Endocrine Symptom checklist(ES) at baseline (pre- treatment), 3, 6, 12, 18 and 24 months, then annually to 5 years. Results:-Two hundred and thirteen patients were available for analysis of QoL results. There was a temporary increase in endocrine symptoms of menopause in the goserelin group that was statistically higher than in the controls (P = 0.02) and was associated with a decrease in the main outcome measure of global QoL, TOI. This contrasted with a longer term outcome favouring the intervention in terms of QoL and fewer adverse endocrine symptoms, though these later findings were not statistically significant. Conclusions: Cytotoxic chemotherapy with or without goserelin causes a short term decrement in QoL for up to 6 months in otherwise well women.* Ann Onc 2017 28 1811-1816. Citation Format: Robert CF Leonard, Janine Mansi, Ann Yellowlees, Lesley Fallowfield, Valerie Jenkins. Does goserelin have an effect on quality of life in women who have chemotherapy for early breast cancer? Results from the OPTION randomised trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-12-11.

Abstract P2-12-03: A yoga program for breast cancer patients undergoing chemotherapy: Effects on quality of life and chemotherapy-associated symptoms

Abstract Background: Patients undergoing chemotherapy for breast cancer (BC) report side effects such as nausea, fatigue and sleep disturbance, which can be exacerbated by stress and anxiety commonly associated with the diagnosis and treatment of BC. Effective management of these symptoms is limited. With yoga as an increasingly popular mind-body practice among Americans today, we conducted a pilot randomized controlled study to evaluate the feasibility and efficacy of yoga on chemotherapy-related symptoms and quality of life (QOL) in patients receiving neoadjuvant or adjuvant chemotherapy. Methods: Women with stage I-III BC scheduled to undergo neoadjuvant or adjuvant chemotherapy at Mount Sinai Chelsea Cancer Center were randomized to start yoga immediately (yoga group) or in 3 months (waitlist control group). The intervention consisted of 12 weekly 60-minute yoga classes. Demographic, clinical, ad treatment related factors were collected. All patients completed self-reported questionnaires including Functional Assessment of Cancer Therapy-Breast (FACT-Breast), Anxiety and Depression Scale (HADS), and Pittsburgh sleep quality inventory (PSQI) at the start, 6 weeks, and 12 weeks after being randomized. Between group analyses were performed using two-sample t-test for baseline, 6 and 12-week time-points. Results: Among the 50 patients enrolled, median age at diagnosis was 51 (range 34-74). The patient population was diverse, with 36% (18) African Americans, 20% (10) Hispanics, 20% (10) Asians, 20% (10) white, and 2 patients of unknown race. Sixty-six percent of the patients had no prior yoga experience, and the average class participation rate was 55%. There was a significant reduction in reported nausea at 12 weeks in the yoga group compared to the control group (p=0.014). In addition, there were trends towards statistical significance in improvement in sleep efficiency (p=0.075) and overall physical well-being (p=0.090) at 12 weeks in the yoga group compared to the control group. Furthermore, in patients with poorer quality of life at baseline, there was a significant improvement in severity of depression (p = 0.050) at 6 weeks, and a trend towards improvement in overall physical well-being at 12 weeks (0.094) in the yoga group compared to the control group. Conclusions: Our study showed that weekly yoga participation is feasible in BC patients receiving adjuvant or neoadjuvant chemotherapy. Yoga intervention led to a significant reduction in nausea, as well as trends towards improvement in sleep efficiency, severity of depression, and overall physical well-being during chemotherapy. Larger studies are warranted to further assess the efficacy of yoga in reducing chemotherapy-associated symptoms in patients with early stage breast cancer. Citation Format: Tiffany Chen, Paula Klein, Tiffany Xing, Theresa Shao. A yoga program for breast cancer patients undergoing chemotherapy: Effects on quality of life and chemotherapy-associated symptoms [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-12-03.

Cancer Survivorship Program: Implementation for Individuals With Recurrent Breast Cancer.

Patients are living longer with recurrent breast cancer, but survivorship programs for these individuals are lacking. The aims were to implement a survivorship program for individuals with recurrent breast cancer, increase their quality of life (QOL), and evaluate patient satisfaction with the program. Survivors were referred for a one-hour coaching intervention tailored to their needs based on results of the Functional Assessment of Cancer Therapy-Breast (FACT-B) survey. Satisfaction was assessed immediately and two weeks postintervention. A paired t test was used to evaluate QOL scores before and two weeks following participation. Statistically significant (p = 0.000) improvements were observed overall and in each subscale of the FACT-B survey. Patient satisfaction was high immediately postintervention and remained high at the two-week assessment.

A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy.

Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group (P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group (P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.

A randomized, placebo-controlled trial evaluating changes in peripheral neuropathy and quality of life by using low-frequency electrostimulation on breast cancer patients treated with chemotherapy

Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group (P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group (P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.

The role of cognitive emotion regulation strategies in health related quality of life of breast cancer patients

Background/Aim. Breast cancer is often accompanied by patients? unpleasant emotional states, which can significantly affect both the undergoing treatment and the quality of life of patients. The aim of this study was to examine the mediating role of cognitive emotion regulation strategies in relation between emotional distress and various aspects of patients? quality of life, which would further indicate different psychotherapeutic interventions in psycho-oncological practice. Methods. The sample consisted of 97 breast cancer patients. Emotional distress was measured by the Depression Anxiety Stress Scale (DASS-21), cognitive emotion regulation strategies were measured using the Cognitive emotion Regulation Questionnaire (CERQ-36), while various aspects of health related quality of life were assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Multiple simultaneous mediations between variables were established using the process macro INDIRECT for SPSS. Results. Positive refocusing had positive effects both on physical [a = -0.83, b = 0.50, ab = - 0.42, standard error (SE) = 0.14; 95% confidence interval (CI) = 0.17 ? 0.83] and emotional well-being (a = -0.83, b = 0.29, ab = 0.24, SE = 0.13; 95% CI = -0.01 ? 0.58) of the patients. Rumination negatively affected emotional wellbeing (a = -0.75, b = -0.33, ab = -0.25, SE = 0.16; 95% CI = -0.71 ? -0.01) of the patients. Catastrophizing had a negative impact on social (a = 0.96, b = 0.12, ab = -0.12, SE = 0.13; 95% CI = -0.33 ? -0.13) and functional well-being of the patients (a = 0.96, b = -0.16, ab = -0.15, SE = 0.09; 95% CI = -0.32 ? -0.01). Conclusion. Positive refocusing, rumination and catastrophizing are significant cognitive coping strategies through which the intensity of emotional distress significantly changes, and this can be subsequently reflected in different aspects of patients? health related quality of life. The above mentioned implies potential benefits of implementation of cognitive-behavioral trainings and interventions directed towards acquiring adaptive cognitive emotion regulation strategies, in order to improve the quality of life of breast cancer patients.

Managing Cancer and Living Meaningfully (CALM) Intervention on Chemotherapy-Related Cognitive Impairment in Breast Cancer Survivors.

Objective: To evaluate the effectiveness and feasibility of Managing Cancer and Living Meaningfully (CALM), which is used to reduce chemotherapy-related cognitive impairment (CRCI), relieve psychological distress, and improve quality of life (QOL) in Chinese breast cancer survivors (BCs). Methods: Seventy-four BCs were enrolled in this study. All patients were randomly assigned to either the CALM group or the care as usual (CAU) group. All patients were evaluated by the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog), Distress Thermometer (DT), and the Functional Assessment of Cancer Therapy–Breast (FACT-B) before and after CALM or CAU application to BCs with CRCI. We compared the differences in all these scores between the CALM group and the control group and analyzed the correlation between cognitive function and QOL. Results: Compared with the CAU group, the performance of the CALM group on the FACT-Cog, DT, and FACT-B showed significant differences before and after CALM (t = −18.909, −5.180, −32.421, P = .000, .000, .000, respectively). Finally, there was a positive correlation between cognitive function and QOL in breast cancer patients before (r = 0.579, P = .000) and after (r = 0.797, P = .000) treatment. Conclusions: The present results indicated that CALM has salutary effects on the improvement of cognitive impairment and QOL and relieves psychological distress in breast cancer patients, which may be due to a positive correlation between psychological distress and cognitive function or QOL.

Stages of breast reconstruction and quality of life after breast cancer

Objective: To evaluate which stage of breast reconstruction promotes improved quality of life for women treated for breast cancer, and to verify the socioeconomic and clinical factors associated with better quality of life. Methods: A cross-sectional study was conducted with 70 women treated for breast cancer in the perioperative period of late breast reconstruction in the Federal District. To assess quality of life, the Functional Assessment of Cancer Therapy — Breast (FACT-B) instrument was used. Results: Half of the women were under 50 years old. Tumor removal surgery had occurred on average 5.4 years ago. Women with axillary dissection had greater impairment in the physical well-being domain (p=0.001) and the breast cancer subscale (p=0.016). Among women who had undergone surgery more than one year previously, there were higher domains of emotional (p=0.006) and functional (p=0.003) well-being. Women who underwent breast reconstruction had higher values in the social/family well-being (p&lt;0.001), emotional well-being (p=0.001), functional well-being (p=0.001), and breast cancer subscale (p=0.005) domains; and on the FACT-B score (p&lt;0.001), right after the first stage. Conclusions: Breast reconstruction favored better quality of life from the first stage, suggesting that this therapeutic modality should be offered promptly, whenever possible, and guaranteed for all women treated for breast cancer.