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Objectives: Many trials conclude "no clinically meaningful detriment" to health-related quality of life (HRQL) or function between arms, even when notable differential toxicity is observed. Mean change from baseline analyses of function or HRQL can possibly obscure important change in subgroups experiencing symptomatic toxicity. We evaluate the impact of diarrhea, a key treatment arm toxicity, on patient-reported HRQL and functioning in clinical trials submitted to US Food and Drug Administration.Methods: This study used 4 randomized, breast cancer trials (adjuvant to late-line metastatic) as case examples. Diarrhea, physical functioning (PF), and global health status and quality of life (GHS/QoL) from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 were analyzed at baseline and approximately 3 and 6 months.Results: Generally, patients reporting very much diarrhea at months 3 and 6 had worse PF (9-19 points lower) and GHS/QoL (16-19 points lower) than patients reporting no diarrhea regardless of treatment arm. In the change from baseline analysis, patients reporting very much diarrhea also experienced a greater decrease in PF (6-13 points) and GHS/QoL (6-16 points) versus patients reporting no diarrhea in both arms.Conclusions: In trials with moderate to large differences in symptomatic toxicity by arm, reporting "no meaningful difference in functioning and HRQL between arms" based on mean change from baseline analysis is insufficient and may obscure important impacts on subgroups experiencing symptomatic adverse events. Additional exploratory analyses with simple data visualizations evaluating functioning or HRQL in patient subgroups experiencing expected symptomatic toxicities can further inform the safety and tolerability of an investigational agent. [ABSTRACT FROM AUTHOR]

Effects of exercise in patients with breast cancer have been thoroughly investigated. The aim was to explore differences in effects regarding type, delivery mode and extensiveness (e.g. intensity; volume) of the interventions. We searched for randomised controlled trials including patients with breast cancer receiving systemic treatment, exercise-based interventions, and measures on patient reported- and objectively measured outcomes. Exercise showed significant and moderate effects on the primary outcomes quality of life and physical function, Standardised Mean Difference: 0.52 (95 % CI 0.38–0.65) and 0.52 (95 % CI 0.38–0.66), respectively. Type of exercise had little influence on the effects, however combined aerobic- and resistance exercise seemed superior for increasing physical function, compared to aerobic or resistance exercise. Supervised interventions were superior to partly and unsupervised. Extensiveness of the intervention only influenced physical function. Supervised interventions, more than type or extensiveness of interventions, seem to increase effects. [Display omitted] • Exercise effectively increases quality of life, irrespective of exercise type. • Supervised exercise interventions are most effective. • Extensiveness of exercise interventions has very little influence on the effects. [ABSTRACT FROM AUTHOR]

Treatments for early breast cancer have side effects that affect quality of life (QoL) and cause deconditioning. Physical exercise might have a supportive and coadjuvant role in the rehabilitation of breast cancer survivors. We aimed to analyse the preliminary results of a community-based supervised exercise training program on QoL and muscle strength in breast cancer survivors. Twenty breast cancer female survivors were recruited to a single-arm clinical trial consisting of sequential 16 weeks (wk) of control phase (CP) and 16 wk intervention phase (IP). Four evaluations were carried out: M1 (8 wk on CP), M2 (immediately previous IP), M3 (8 wk CP) and M4 (16 wk IP). The IP consisted of 3 sessions per week of combined aerobic and strength exercise (60min) at moderate to vigorous exercise (65-85% of maximum heart rate or 6-8 points on OMNI scale). The primary endpoint was QoL, which was evaluated by EORTC QLQ-C30 questionnaire. Secondary endpoints included handgrip strength and sit-to-stand (STS) test. Of the 20 recruited women, 19 initiated and 15 concluded the program, with a mean compliance to the exercise intervention of 63.6%. The median age was 59 years old (39-72). All but 3 were diagnosed with invasive carcinoma. After surgery, 13 (62%) underwent radiotherapy, 15 (71%) chemotherapy and 18 (86%) were under hormonotherapy. During the control phase, no significant differences were observed in the efficacy variables. There was no changes over time for any domain of QoL, except for physical functioning scale (p = 0.038), where it was observed a trend to increase between M2 and M3 (77.3±14.0 to 85.3±10.1, p = 0.051). A significant increase in handgrip strength of non-operated (22.2±3.9 to 25.6±5.3 kg.f, p = 0.004) and operated limb (22.6±4.7 to 26.9±6.6 kg.f, p = 0.001) was shown after exercise training. Similar results were also observed for STS test [12 (11-13.5) to 17 (13-21) repetitions, p = 0.002]. An exercise program appears to be beneficial for QoL, particularly in the physical functioning of breast cancer survivors. Moreover, it seems to have an important role on strength levels. Associação de Investigação e Cuidados de Suporte em Oncologia. Liga Portuguesa Contra o Cancro. All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]

In this study we aimed to examine the independent effect of baseline QoL and persistent CRT among pts with early BC. We included data stage I-III BC pts treated with chemotherapy who were included in the CANTO prospective cohort study (NCT-01993498) from 03/2012 to 12/2014. The primary outcome was CRT defined as the presence at 3-6 months after the end of treatment, of any of the following toxicities (NCI-CTC-AE): infection, venous or arterial thrombosis, neurological G2-4, digestive G3-4 or pulmonary toxicities G3-4). Treatment deliver including chemotherapy dose reductions were also examined. The independent variable of this study was baseline Qol defined by the EORTC QLQ-C30 subscales of general global health status (GHS) (< or ≥ 70) and physical functioning PF (< or ≥ 90). The defined cutoffs correspond to the average values in the French general population. Clinical relevant adjustment covariates included stage, age, performance status (PS), body mass index (BMI), HR and HER2 status, baseline lymphopenia, albumin, creatinine clearance, alcohol consumption, and smoking status. Multivariable logistic models were performed. Among 3079 BC pts included in this analysis, 33% received neoadjuvant and 77% adjuvant treatment. Median age at diagnosis was 53 years, median BMI= 25 kg/m2, 94% of patients had a PS = 0 and 83% stage I-II disease. Pts reported on average a good GHS = 68 (±19) and PF = 90 (±14). GHS and PF were higher in women with better performance status PS = 0 vs 1+, (68 vs 60 p < 0.001) and 91 vs 78 p < 0.001) respectively. 952 (31%) BC pts developed ≥1 CRT: 23% had an infection, 7% thrombosis, 0.3% G3-4 diarrhea, nausea or vomiting, 4% G2-4 neurological and 0.2% G3-4 pulmonary toxicities. 16% had chemotherapy dose reduction. Pts with a baseline GHS <70 had 19 % higher odds of CRT vs to those with GHS≥70, OR = 1.19 [95% CI 1.02-1.41] and similarly those with a PF < 90 had a 23% higher odds of CRT when compared to those with PF ≥ 90 (OR = 1.23 [95% CI 1.03-1.49]). Global and physical QoL before BC treatments are independently associated with CRT. QoL should be assessed before any treatment to identify patients at risk CRT. NCT01993498. UNICANCER/Villejuif, France, 94805 Principal Investigator: Fabrice André Gustave Roussy – Villejuif. Has not received any funding. All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]