Feasibility and outcomes of a goal-directed physical therapy program for patients with metastatic breast cancer.

Results of a self-management program added to standard physical therapy in chronic neck pain

Objective: to determine the effectiveness of a physical therapy program for patients with obesity by the indicators of Functional Movement Screen test exercises.
 Materials and methods. A total of 114 people of the second adulthood with alimentary-constitutional obesity of the I-III degrees were examined. They were divided according to the level of compliance into two groups. The comparison group consisted of individuals with a low level of compliance; they did not go through a rehabilitation program, but were informed about the risks of obesity; acquainted with the basic principles of hypocaloric nutrition and physical activity. The main group consisted of individuals with a high level of compliance; they underwent a developed program for correcting body weight using measures to maintain a high level of compliance, nutrition modification, increased physical activity, lymphatic drainage procedures, and elements of behavioral psychocorrection. The control group consisted of 60 people with no signs of obesity. A survey of the test exercises Functional Movement Screen was conducted in dynamics before and after the one-year period of implementation of the rehabilitation program.
 Results. During the initial examination in obese patients, all the obtained parameters of the Functional Movement Screen exercises were statistically significantly worse than in individuals with normal body weight (p <0.05). Re-examination of patients with low compliance showed that no statistically significant positive changes occurred in any test test (p> 0.05). When analyzing the results of test exercises of patients with a high level of compliance under the influence of a physical therapy program, a statistically significant improvement was achieved in all studied parameters relative to the initial level (p <0.05).
 Conclusions: Diagnostics of mobility based on test exercises Functional Movement Screen in physical therapy programs for obese patients is a modern, simple and affordable method of rehabilitation examination. To achieve the target level of the control group for the studied parameters by patients of II-III degree of obesity, the rehabilitation program should be long for one year.

Aim: The aim is to elaborate a physical therapy program for patients affected by ischemic stroke and prove its usability. Materials and Methods: Comparative analysis of motor activity indicators obtained by diagnosing and monitoring the functional state of ischemic stroke patients using clinical tools. The participants of the experiment are male patients aged between 50-71 years affected by an ischemic stroke. Results: Elaborated on ischemic stroke physical therapy constitutes the set of therapeutic programs for the period of rehabilitation of patients affected by ischemic stroke, which is realized gradually and consists of 3 components: therapeutic exercises, electric stimulation of one’s shoulders and psychological assistance. As a result of the application of the authorial physical therapy program for patients affected by ischemic stroke, there is the occurrence of positive changes in the functional and psychological state of the patients. Experimental data was verified by the comparison of the level of motional activity of the patient before the implementation of a physical therapy program for the patients affected by ischemic stroke, as well as after scientific research. Conclusions: The usability of physical therapy programs for patients affected by ischemic stroke is statistically proven with the positive shifting of the functional state of the patients.

The literature emphasizes that a consideration of patients' perspectives is an important part of the assessment process; however, it is ignored by many clinicians because they believe physical impairment measures can reflect patients' perspectives about their symptoms. But the relevance of changes in physical impairments to changes in patient-reported outcome scores in rotator cuff disease is ambiguous. The purpose of this study is to determine the relationship between changes in glenohumeral range of motion (ROM) and shoulder muscle strength and changes in pain, disability, and health-related quality of life scores before and after physical therapy in patients with rotator cuff disease. This was a retrospective study of thirty-nine patients with unilateral rotator cuff disease. All patients received a 6-week physical therapy program. The outcome measures were glenohumeral ROM, shoulder muscle strength, pain and disability using the Shoulder Pain and Disability Index (SPADI), and health-related quality of life as measured by the Western Ontario Rotator Cuff Index. All outcomes were measured before and after the treatment period. There were weak correlations between the changes in abduction ROM and the SPADI-total score (r = - 0.32, p < 0.05), and the changes in external rotation strength and the SPADI-disability score (r = - 0.32, p < 0.05). There was no correlation between the changes in the other parameters. This study implies that the changes in glenohumeral ROM and shoulder muscle strength do not represent the changes in patients' perspectives in pain, disability, and health-related quality of life after the physical therapy program in patients with rotator cuff disease.

BackgroundMusculoskeletal disorders are major causes of morbidity in the world, and these conditions have a strong negative influence in terms of health-related quality of life. The purpose of this study was to evaluate the effect of an 8-week multimodal physical therapy program on general health state and health-related quality of life in patients with chronic musculoskeletal disorders.MethodsThere were 244 participants in this prospective cohort analysis with 8-week follow-up. The primary outcome was general health state (physical and mental components), determined with the Short Form-12 Health Survey (SF-12). The secondary outcome was health related quality of life, determined with the EuroQoL-5D and VAS. The intervention was evaluated by comparing pre- and post-outcome measurements. T-tests were performed for paired data.ResultsDifferences were statistically significant for physical health state: +1.68 (p < 0.05) (baseline: 42.38); mental health state: +3.15 (p < 0.001) (baseline: 46.57); and health related quality of life: +0.18 (EuroQoL 5D) (baseline: 46.57) and +7.22 (EuroQoL_VAS) (p < 0.001) (baseline: 60.81). Intervention resulted in clinically relevant changes in terms of percentage improvement from baseline scores.ConclusionsEight weeks of a Multimodal Physical Therapy Program seemed to moderately enhance the general health state and HRQoL of patients with chronic musculoskeletal diseases. This kind of therapeutic exercise can be recommended to patients with chronic low back pain, chronic neck pain and osteoarthritis, at least in the short term.

Background: Improved progression-free survival is considered as treatment goal for patients with metastatic breast cancer (MBC) since it is assumed to delay or prevent deterioration of quality of life.Aim of our analysis was to examine the influence of disease progression on health-related quality of life (HRQoL). Methods: The PRAEGNANT study comprises a real-life registry for patients with MBC. HRQoL was assessed with the EORTC-QLQ-C30 Version 3.0 questionnaire at study entry and every 3 months thereafter. The primary endpoint was minimally important deterioration (MID) in global HRQoL score by ≥ five points between baseline and any follow-up assessment. A logistic regression model was built with MID (yes/no) at a follow-up timepoint as outcome variable and several covariates as predictors. Results: In total, 329 patients were included in this analysis, with disease progression in 63 patients. Concerning the primary study aim, progression status predicted MID of global HRQoL status in addition to the other covariates. The adjusted odds ratio for the effect of progression status on MID was 2.22 (95% CI: 1.04 – 4.73). Comparisons of mean differences of QoL domains/scales yielded no differences. Conclusions: We provide evidence that disease progression in patients with metastatic breast cancer in a real-world registry has a significant negative impact on HRQoL as measured by MID of HRQoL. This study emphasizes the relevance of avoiding progression and prolonging PFS to maintain QoL. Citation Format: Wallwiener M, Nabieva N, Haeberle L, Taran FA, Hartkopf AD, Volz B, Overkamp F, Brandl AL, Kolberg H-C, Hadji P, Tesch H, Ettl J, Lux MP, Lueftner D, Belleville E, Fasching PA, Janni W, Beckmann MW, Wimberger P, Hielscher C, Fehm T, Brucker SY, Wallwiener D, Schneeweiss A, Mueller V. Impact of disease progression on health-related quality of life in patients with metastatic breast cancer in the PRAEGNANT breast cancer registry [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-10.

Ribociclib Plus Endocrine Therapy in Premenopausal Women

Background: Advances in screening and treatment have led to increase in breast cancer (BC) survival in recent years but prognoses for metastatic BC remain poor with poorer outcomes as health-related quality of life (HRQOL). Treatment as bevacizumab and paclitaxel for metastatic BC, although that can increase time to progression of disease, often carry toxicity and is not curative but rather palliative in intent with the goal to improve or maintain HRQOL. The aim of this work was to assess impact of clinical factors such as disease progression, toxicity on HRQOL. Methods: COMET study is a multicenter prospective single-arm cohort study in France whose main objective was to identify biological factor that could predict the clinical benefit of bevacizumab-paclitaxel combination therapy as first treatment in HER2 negative metastatic BC. HRQOL was assessed at baseline, at every cycle (every for 4 weeks) until progression and then every 3 months up to death using the EORTC QLQ-C30 questionnaire and its BC specific module, the EORTC QLQ-BR23. In this ancillary study, we targeted 5 dimensions HRQOL for the primary analyses: Global health status (GHS), physical functioning (PF), Emotional functioning (EF), fatigue (FA) and pain (PA). The primary endpoint was time until definitive deterioration (TUDD) in HRQOL scales that defined as time between inclusion and the first decrease HRQOL score ≥ 5 points compared to baseline score, with no further improvement of at least 5 points. Multivariable Cox model with time dependent covariate was performed to assess clinical factors associated with TUDD for each of the 5 target dimensions HRQOL. We performed 3 models for each dimension: model 1 including all covariate with p&amp;lt; 0.10 in univariable; model 2 including model 1 and adjusted on cancer subtype and model 3 included model 1 stratified by cancer subtype. P value &amp;lt; 0.01 were considered statistically significant. Results: Out of 510 patients included in COMET study, 432 patients with available HRQOL data were analyzed in this study. Median age at inclusion was 58 years (range: 29-83), and 24.4% of patients had triple negative tumor subtype. About 79 % of cancers were invasive ductal carcinoma and 43 % patients had least 3 metastasis sites at baseline. At baseline, patients reported a mean score for GHS of 57.6 (SD=22.7), for PF of 75.8 (23.2), for EF of 62.2 (25.8), for FA of 42.2 (29.60) and for PA of 38.1 (31.5). The Median TUDDs for the 5 targeted dimensions was 10.1 months [7.5-16.9] for GHS, 6.1 months [4.1-8.9] for PF, 21.6 [18.7-31.2] for EF, 10.8 [6.2-16.6] for FA and 13.6[10.1-22.5] months for PA. In multivariable analyses, Disease Progression was associated with TUDD of GHS (HR [99%CI] =2.4 [1.2-4.9] and TUDD of PF (2.1 [1.1-3.7]). After adjusted on cancer subtype, association persisted with TUDD of GHS (p=0.009). Performance Status was associated with TUDD of PF (1.6 [1.2-2.3]), and TUDD of Pain (1.6 [1.1-2.3]). Performance Status association with TUDD of PF continued after adjustment on cancer subtype (p=0.0003). Prior endocrine therapy was associated with TUDD of pain in patients with tumor with positive hormone receptor (HR+) (2.4 [1.2-4.7]). There was no factor associated with TUDD of EF and TUDD of FA. Conclusion: Results of this study have shown that among the 5 targeted dimensions HRQOL, Physical Functioning was deteriorated in the shortest time. Disease progression, base line performance status and prior endocrine therapy for HR+ subtype, are clinical factors that could influence HRQOL in HER2 negative metastatic BC treated with first line chemotherapy. Citation Format: Oumar Billa, Sandrine Dabakuyo, Marion Chevrier, Franck Bonnetain, Isabelle Desmoulins, William Jacot, Olivier Trédan, Marc Debled, Christelle Levy, Anthony Gonçalves, Jean-Marc Ferrero, Florence Dalenc, Christelle Jouannaud, Marie-Ange Mouret-Reynier, Mireille Mousseau, Julien Grenier, Jean-Philippe Jacquin, Fatima-Zohra Toumi, Frédérique Berger, Jérôme Lemonnier, Jean-Yves Pierga. Health related quality of life of patients treated with bevacizumab and paclitaxel as first-line treatment for HER2 negative metastatic breast cancer: impact of clinical factors [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-54.

Introduction: In recent years, patient reported outcomes have become increasingly a focus in clinical investigations. Health related quality of life (HRQoL) is now regularly evaluated in clinical trials, yet data on HRQoL in postmenopausal women receiving adjuvant aromatase inhibitor treatment for early breast cancer (EBC) is limited. Here, we present the 12 months results on HRQoL and patient satisfaction from PACT, a program which aims to increase awareness, motivation and adherence to adjuvant anastrozole therapy in routine clinical practice by adding regular standardized information (brochures and motivational letters) to standard clinical care. Methods: PACT is a prospective, randomised, two-arm parallel-group study with 60 months follow-up (NCT00555867, sponsored by AstraZeneca Germany). Postmenopausal women on anastrozole for hormone-receptor positive (HR+) EBC were randomized to routine clinical care alone or additional regular standardized information (educational arm) for the first year of adjuvant endocrine therapy. Primary endpoint was the compliance rate in the educational vs. routine arm after 12 months. Secondary endpoints include HRQoL and patient satisfaction, evaluated via EORTC IN-PATSAT32, QLQ-C30, and QLQ-BR23. The present analysis focuses on differences in HRQoL and patient satisfaction between the standard and educational arm and between compliant and non-compliant patients at 12 months after treatment initiation. Results: 4,923 patients were enrolled into PACT by Nov. 2008. Of these, 2,707 were evaluable for analysis of the primary endpoint compliance and the secondary endpoints patient satisfaction and HRQoL. Analysis of HRQoL and patient satisfaction scores showed no differences between the standard and the educational arm at 12 months. When comparing compliant vs. non-compliant patients, however, compliant patients reached significantly higher (=better) patient satisfaction scores in all domains. In addition, compliant patients achieved significantly higher (=better) scores in the HRQoL domains of physical functioning (p=0.04), emotional functioning (p=0.018), cognitive functioning (p=0.004), social functioning (p=0.005), and sexual enjoyment (p=0.047), as well as lower (=better) scores in the domains of fatigue (p=0.01), systemic therapy (p=0.003), and arm symptoms (p=0.03). After correction for multiple testing, statistically significant differences favouring compliant patients were retained in the areas of information provision and availability (p=0.0008 and p=0.0005, respectively). Conclusion: In postmenopausal patients with HR+ EBC assigned to adjuvant endocrine treatment with an aromatase inhibitor (anastrozole), HRQoL and patient satisfaction were not affected by the intervention. However, analysis of compliant vs. non-compliant patients revealed improved scores for patient satisfaction in multivariate analysis favouring compliant patients at 12 months after treatment initiation. PACT represents an important project in health outcomes research regarding adjuvant endocrine therapy in postmenopausal patients with HR+ EBC. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-11-12.

Background: Within the past 3 years, PARPi have demonstrated improved progression-free survival and favorable PROs compared with chemotherapy in randomized clinical trials in patients with gBRCA1/2mut HER2- ABC. These agents are now available in multiple countries for the treatment of gBRCA1/2mut HER2- locally advanced and/or metastatic breast cancer. Limited information is available on physician/patient satisfaction with PARPi from the RW. We assessed RW physician/patient treatment satisfaction among adult patients with gBRCA1/2mut HER2- ABC in Germany, France, Italy, Spain (EU4), US, and Israel. Methods: Oncologist were recruited to abstract data from medical records (2019/2020) for patients with gBRCA1/2mut HER2- ABC. Physicians were asked to rank (1=very dissatisfied to 5=very satisfied) their satisfaction with their patient’s current ABC treatment. The scores were dichotomized to a 0/1 variable (0=very dissatisfied/ dissatisfied/moderately satisfied; 1=satisfied/very satisfied). A subset of patients completed the Cancer Treatment Satisfaction Questionnaire, a validated instrument that was used to measure patient’s satisfaction with their current therapy. The physician and patient sample were matched. Physician/patient satisfaction scores were compared between chemotherapy and PARPi monotherapy utilizing inverse probability weighted regression adjustment controlling for age at therapy initiation, Charlson Comorbidity Index at time of data collection, baseline symptoms, hormone receptor (HR) status, ECOG score at therapy initiation, stage of therapy initiation (locally advanced breast cancer or metastatic breast cancer) and number of lines of ABC treatment. Results: Overall 96 adult female patients participated; mean age was 51 years. Tumor characteristics were: 34.4% HR+/HER2-, 65.6% triple negative breast cancer. Chemotherapy (n=58) was received among 60.4% of pts [n=29 (50.0%) platinum based, n=29 (50.0%) non-platinum based], and PARPi monotherapy (n=38) was received among 39.6% of pts. Physicians were significantly more likely to be satisfied or very satisfied with PARPi in comparison with chemotherapy (95.4% vs. 40.8%, p&amp;lt;0.001). Mean patient satisfactions scores were numerically higher with PARPi vs. chemotherapy: expectation of therapy 81.3 vs. 72.0 (p=0.13), feelings about side effects 55.7 vs. 51.4 (p=0.30), satisfaction with therapy 74.0 vs. 68.5 (p=0.13). Conclusions: PARPi have demonstrated superior efficacy and favorable PROs vs. chemotherapy in randomized controlled trials. In this RW study, physicians reported significantly higher satisfaction with PARPi vs. chemotherapy; patients reported numerically higher satisfaction scores with PARPi vs. chemotherapy across all domains. These findings further support the value of PARPi in patients with gBRCA1/2mut HER2- ABC. Additional studies to validate these findings are planned. Funding: Pfizer Citation Format: Michael Patrick Lux, Alexander Niyazov, Katie Lewis, James Pike, Alex Rider, Bhakti Arondekar, Reshma Mahtani. Physician and patient satisfaction with poly(ADP-ribose) polymerase inhibitors (PARPi) versus chemotherapy in adult patients with germline BRCA1/2 mutated (gBRCA1/2mut) HER2- advanced breast cancer (ABC): Results from a multi-country real-world (RW) study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS10-47.

Mortality, morbidity, and health-related quality of life (HRQoL) are patient-relevant end points generally considered in the early benefit assessments of new cancer treatments. Progression-related end points, such as time to progression or progression-free survival, are not included, although patients and physicians testify to the detrimental association of disease progression with HRQoL. To examine the association of disease progression and HRQoL in 4 prevalent solid-cancer entities in routine clinical practice. This cohort study evaluated data from 4 prospective, nonintervention, multicenter registries collected between 2011 and 2018 in 203 centers in Germany. Patients' HRQoL was assessed regularly for up to 5 years. The change in HRQoL scores after disease progression was examined with linear mixed models, adjusting for demographic and clinical covariates. Patients with metastatic breast, pancreatic, lung, and colorectal cancer were recruited at the start of systemic first-line treatment. Data analysis was performed from February 2019 to April 2019. All patients received systemic, palliative first-line treatment according to their physician's choice. The primary outcome was deterioration of HRQoL associated with disease progression, as measured by 4 validated questionnaires: Functional Assessment of Cancer Therapy-General version 4, European Organization for Research and Treatment of Cancer QLQ-C30 version 3.0, European Organization for Research and Treatment of Cancer QLQ-C15-PAL version 1, and Hospital Anxiety and Depression Scale. More than 8000 questionnaires from 2314 patients with 2562 documented disease progressions were analyzed. In total, 464 patients had breast cancer (464 [100.0%] female; median [range] age, 61.6 [26.4-90.1] years), 807 patients had pancreatic cancer (352 [43.6%] female; median [range] age, 70.0 [39.0-93.0] years), 341 patients had lung cancer (118 [34.6%] female; median [range] age, 65.9 [28.4-88.2] years), and 702 patients had colorectal cancer (248 [35.3%] female; median [range] age, 66.9 [26.9-92.1] years). The first disease progression was associated with a statistically significant worsening of 37 of 45 HRQoL scales; for 17 of these scales, the worsening was clinically meaningful. Scale scores for appetite loss (pancreatic cancer, 10.2 points [95% CI, 6.8-13.5 points]; lung cancer, 10.8 points [95% CI, 5.4-16.2 points]; colorectal cancer, 8.8 points [95% CI, 5.5-12.2]; all P < .001), physical functioning (pancreatic cancer, 6.2 points [95% CI, 3.8-8.5 points]; lung cancer, 8.4 points [95% CI, 5.4-11.5 points]; colorectal cancer, 5.0 points [95% CI, 3.0-7.0 points]; all P < .001), and fatigue (pancreatic cancer, 5.5 points [95% CI, 3.0-7.9 points]; lung cancer, 7.7 points [95% CI, 4.3-11.1]; colorectal cancer, 4.5 points [95% CI, 2.1-6.9 points]; all P < .001) were most affected, irrespective of the type of cancer. The association with global HRQoL was most pronounced in lung cancer (6.7 points [95% CI, 3.5-9.9 points]; P < .001) and pancreatic cancer (5.4 points [95% CI, 3.3-7.5 points]; P < .001) and less in colorectal cancer (3.5 points [95% CI, 1.3-5.7 points]; P = .002) and breast cancer (2.4 points [95% CI, 1.0-3.9 points]; P = .001). The second progression was associated with an even larger decrease in HRQoL. These findings suggest that disease progression is associated with a deterioration in HRQoL among patients with metastatic breast, pancreatic, lung, and colorectal cancer. This evidence highlights the importance of progression-related end points, such as time to progression and progression-free survival, as additional patient-relevant end points when evaluating the benefit of new treatments for patients with metastatic cancer.

Effect of a pre-operative web-based dietary self-management intervention on patient satisfaction, body weight and quality of life of esophageal cancer patients: A prospective, observational study

Background: The FDA approved neratinib (N), an irreversible pan-HER tyrosine kinase inhibitor, in combination with capecitabine (C) for patients with HER2+ advanced or metastatic breast cancer who have received ≥2 prior HER2-directed regimens in the metastatic setting based on the NALA clinical study, where N+C significantly improved PFS vs. lapatinib (L)+C. Characterizing HRQoL associated with this regimen can help inform treatment decision-making for these patients. The objective of this analysis was to characterize HRQoL among patients with HER2+ metastatic breast cancer from the NALA clinical study. Methods: NALA was a multinational, randomized, open-label, phase III clinical study of N+C vs. L+C in patients with HER2+ metastatic breast cancer and ≥2 prior HER2-directed regimens. From May 2013 to July 2017, patients were randomized 1:1 to N (240 mg qd) + C (750 mg/m2 bid 14d/21d) with loperamide prophylaxis during the first cycle, or to L (1250 mg qd) + C (1000 mg/m2 bid 14d/21d). HRQoL, a prespecified secondary endpoint of the NALA study, was measured using the EORTC QLQ-C30 and the breast cancer-specific QLQ-BR23 at baseline and every 6 weeks (±3 days) until the end of treatment (data collection through treatment cycle 19, 12.5 months). The QLQ-C30 summary and global health status scores range from 0 (worst) to 100 (best) and the systemic therapy side-effects scores range from 0 (best) to 100 (worst). Patients were included in the analysis for a particular scale if they had a baseline assessment and at least 1 follow-up assessment. For these analyses, a change of ≥10 points was considered to be clinically meaningful. Descriptive statistics summarized observed scores and changes from baseline, Kaplan-Meier and log-rank tests were used for time-to-deterioration (TTD) of ≥10 points and mixed models estimated the change over time for 7 prespecified scales: QLQ-C30 summary score, global health status, physical functioning, fatigue, constipation and diarrhea, and the EORTC QLQ-BR23 systemic therapy side effects subscale. No adjustments for multiplicity were performed. Results: 621 patients from 28 countries were randomized (307 N+C; 314 L+C). The mean completion rate of the QLQ-C30 over the course of the study was 91% for both treatment arms. Discontinuation due to any treatment-emergent adverse event (TEAE) was lower in the N+C vs. L+C arm (14% vs. 18%). At baseline, the mean (SD) QLQ-C30 summary scores were 79.8 (14.1) for N+C and 79.9 (15.7) for L+C. After 19 treatment cycles, the mean (SD) QLQ-C30 summary scores were similar to baseline scores: 81.8 (16.7) for N+C and 81.3 (15.3) for L+C. There were no differences in TTD of ≥10 points for the QLQ-C30 summary score between treatment arms; the HR for N+C vs. L+C was 0.94 (95% CI 0.63-1.40). All prespecified HRQoL subscales had similar statistically non-significant results for TTD with the exception of diarrhea (HR=1.71; 95% CI 1.32-2.23). The mixed models analyzing change in HRQoL from baseline did not demonstrate persistent declines nor meaningful differences between the treatment arms. Conclusion: In these results from the NALA study, among patients with HER2+ metastatic breast cancer, at study end and throughout most of the study, there were no differences observed between the two treatment arms in HRQoL scores. HRQoL was sustained over the study period despite the early transient presence of diarrhea in some patients. Discontinuation due to any TEAE was lower in the N+C vs. the L+C arm. These results may help guide healthcare providers, patients and carers in selection of optimal treatment for HER2+ metastatic breast cancer. Citation Format: Beverly Moy, Mafalda Oliveira, Cristina Saura, William Gradishar, Sung-Bae Kim, Adam Brufsky, Sara Hurvitz, Larisa Ryvo, Daniele Fagnani, Nancy Chan, Sujith R Kalmadi, Paula Silverman, Suzette Delaloge, Richard Bryce, Kiana Keyvanjah, Judith Bebchuk, Bo Zhang, Nina Oestreicher, Ron Bose. Neratinib + capecitabine sustains health-related quality of life (HRQoL) while improving progression-free survival (PFS) in patients with HER2+ metastatic breast cancer and ≥2 prior HER2-directed regimens [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-02.

Exercise for improving outcomes after osteoporotic vertebral fracture.

SummaryThe purpose of this study was to assess the association of GI events with HRQoL and treatment satisfaction. The effect of baseline GI events persisted through 1 year of follow-up, as indicated by lower EQ-5D, OPAQ-SV, and treatment satisfaction scores among patients with vs without baseline GI events. The presence of GI events is an independent predictor of decreased HRQoL and treatment satisfaction in patients being treated for osteoporosis.IntroductionThe goal of this study was to assess the association of gastrointestinal (GI) events with health-related quality of life (HRQoL) and treatment satisfaction in patients being treated for osteoporosis.MethodsMUSIC OS was a multinational, prospective, observational study examining the impact of GI events on osteoporosis management in postmenopausal women. In this analysis, HRQoL and treatment satisfaction were assessed at baseline, 6, and 12 months and compared between patients with and without GI events. Covariate-adjusted scores were calculated using multivariate least-squares regression analysis, and differences between the mean scores of patients with and without baseline and post-baseline GI events were determined.ResultsAmong the 2959 patients in the analysis, unadjusted scores at each time point were lower (i.e., worse) for patients with GI events than patients without GI events. In adjusted analyses, the effect of baseline GI events persisted through 1 year of follow-up, as indicated by lower EQ-5D and OPAQ-SV scores at 12 months among patients with vs without baseline GI events (−0.04 for the EQ-5D utility score, −5.07 for the EQ-5D visual analog scale, −3.35 for OPAQ physical function, −4.60 for OPAQ emotional status, and −8.50 for OPAQ back pain; P ≤ 0.001 for all values). Decrements in month 12 treatment satisfaction scores were −6.46 for patients with baseline GI events and −7.88 for patients with post-baseline GI events.ConclusionsThe presence of GI events is an independent predictor of decreased HRQoL and treatment satisfaction in patients being treated for osteoporosis.