ABSTRACT
Background: Supervised exercise programs (SEP) have demonstrated an improvement in quality of life (QoL), cardiovascular health, treatment tolerance and disease outcomes in early breast cancer patients. In metastatic breast cancer (MBC), previous data suggest SEP are safe but no impact on QoL and a low adherence to programs were shown. These studies included a heterogenous population in terms of type of treatments received, numbers of previous lines or comorbidities. From our perspective, MBC profile that could benefit most from SEP needs to be explored. Thus, we conducted a pilot study to assess adherence, safety and impact on QoL of a combined SEP and nutritional program (NP) in a selected population of MBC of patients treated with cyclin-dependent kinase 4/6 inhibitors (iCDK 4/6). Method(s): This is a prospective, single center, single arm pilot study. SEP consisted in a 12-week intervention with twice a week in-person resistance exercise session. Patients also completed weekly aerobic exercise goals in self-managed sessions monitored with activity trackers. SEP was conducted by registered Physical Activity and Sports Science instructors that followed American College of Sports Medicine guidelines. In addition, participants had an initial nutritional assessment and personalized counselling by a qualified nutritionist. Adherence to treatment, biological variables and QoL assessments (FACIT-Fatigue and QLQ-C30 questionnaires) were collected at baseline (B) and week-12 (w12). Primary endpoint was global adherence (>=70% of attended sessions relative to scheduled sessions). Secondary endpoints included safety, changes in biological variables and QoL. Paired samples t-tests (Wilcoxon) were used to assess biological changes and QoL. Result(s): Patients (n=26) were recruited from October 2020 to November 2021. Median age was 47,5 years (45-55);84,6% of patients were ECOG 0. 42,3% of patients were receiving Abemaciclib;34,6% Ribociclib and 23,1% Palbociclib in first (73,1%) or second (26,9%) line treatment. Patients had bone (69,2%);visceral metastasis (57,7%) or both (30,8%). 2 patients did not start the intervention and additional 7 patients discontinued the program prematurely, the majority of them due to COVID-related concerns. Considering all patients who at least attended one session, global adherence was 66% (39-77,5%) and 45,8% of patients achieved an adherence of >= 70%. Patients reported an improvement in QoL [B global QLQ-C30 66,6 (50-75), w12 75 (66,6-83,3);p 0,0121] and fatigue [B FACIT-Fatigue 37 (30-44), w12 42 (38-48);p 0,0017]. Sit-to-stand repetitions in 30-second period also improved [(B 15 (12-17), 19 (15-23);p 0,0002]. Same benefits were seen in patients with adherence >= 70%. No statistically significant changes were seen in body fat or muscular composition and handgrip scores. Importantly, no safety issues related to study intervention were reported. Conclusion(s): Even though the study was conducted during COVID-19 pandemic, global adherence was 66%. For the first time in MBC, SEP and NP combined program demonstrated to be safe and improved QoL in patients with first or second line MBC treated with iCDK4/6. Further research is needed to identify strategies that improve QoL in MBC.
ABSTRACT
Background: The immune checkpoint inhibitors (ICI) have improved the prognosis of many cancers in the last years but concerning cardiovascular toxicity (CVtox) have been reported. Nowadays, specific surveillance protocols are lacking, and early diagnosis of toxicity may be challenging. Purpose: To characterize the cardiovascular (CV) effects of immunotherapy and to seek for the mechanisms of CVtox of ICI in a protocolize surveillance program of cardio-oncology. Methods: A multicentre national registry was developed by a research consortium of scientific societies of Cardiology and Oncology (SEC and SEOM) and the cardiovascular research centre (CNIC) in Spain (Figure 1). A total of 18 hospitals participate in recruiting since Q4 2021. A follow-up protocol was stablished with clinical, electrocardiographic (EKG), echocardiography, cardiac magnetic resonance (CMR) and laboratory assessment, including cardiac biomarkers, inflammatory panel and the expression of miR-721, a specific myocarditis biomarker. Toxicity management is performed at each institution following international guidelines. Results: 53 patients were currently included. Median age was 68 [59, 75] years-old, 79% were male. 83% had at least 1 CV-risk factor (75% smoking history, 20% diabetes mellitus, 50% hyperlipemia, 57% hypertension, 19% chronic kidney injury) and up to34% had previous CV disease. 93% had at least one dose of COVID19 vaccine. Dyspnoea was referred by 23% of patients, 28% have abnormal EKG findings and one-third (33%) abnormal cardiac biomarkers (median Troponin I-hs 5.30 [2.60, 11.00];NT-proBNP 199 [68, 736]). Mean LVEF (60% [56.15, 66.78]) and GLS (−18 [−19.75, −16]) were within the normal range but 26% showed LGE at baseline. Cancer characteristics are summarized in Table 1. Conclusion: Real-world SIR-CVT patients show a high CV risk profile and frequent pre-existing CV diseases before ICI treatment. The prospective follow-up of this cohort will help to develop personalized surveillance protocols according to baseline CVtox risk and to define different grades of cardiotoxicity. Funding Acknowledgement: Type of funding sources: None.Figure 1Table 1