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Recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) is a challenging disease, requiring personalized management by a multidisciplinary team. The aim of this retrospective multicentric study was to characterize real-world healthcare resource use and patient care for R/M HNSCC in Portugal during the first year after diagnosis. A total of 377 patients ineligible for curative treatment were included, mostly male (92.8%), aged 50-69 years (74.5%), with heavy alcohol (72.7%) or smoking habits (89.3%). Oropharynx (33.2%) and oral cavity (28.7%) were primary tumor locations, with lung metastases being the most common (61.4%). Eligible patients for systemic treatment with palliative intent (80.6%) received up to four treatment lines, with varied regimens. Platinum-based combination chemotherapy dominated first-line treatment (>70%), while single-agent chemotherapy and anti-PD1 immunotherapy were prevalent in later lines. Treatment approaches were uniform across disease stages and primary tumor locations but varied geographically. Treated patients received more multidisciplinary support than those who were ineligible. This study provides the first Portuguese real-world description of R/M HNSCC patient characteristics, treatment patterns, and supportive care during the year after diagnosis, highlighting population heterogeneity and aiming to improve patient management.
Subject(s)
Head and Neck Neoplasms , Neoplasm Recurrence, Local , Squamous Cell Carcinoma of Head and Neck , Humans , Male , Female , Portugal , Middle Aged , Aged , Head and Neck Neoplasms/therapy , Squamous Cell Carcinoma of Head and Neck/therapy , Retrospective Studies , Neoplasm Metastasis , Health Resources/statistics & numerical dataABSTRACT
BACKGROUND: A cardio-oncology rehabilitation model among cancer survivors showed superior results comparing to a community-based exercise intervention. However, questions remain about its cost-effectiveness. AIMS: To assess the cost-effectiveness of a center-based cardiac rehabilitation (CBCR) program when compared to usual care encompassing a community-based exercise training (CBET), among cancer survivors with high cardiovascular risk. METHODS: The CORE study was a single-center, prospective, randomized controlled trial; 80 adult cancer survivors with previous exposure to cardiotoxic cancer treatment and/or with previous cardiovascular disease were assigned (1:1 ratio) to an 8-week CBCR or CBET, twice/week. Cost-effectiveness was a pre-specified secondary endpoint. Outcomes included healthcare resource use and costs, quality-adjusted life-years (QALYs) and cost-effectiveness; incremental cost-effectiveness ratio (ICER) was computed from a societal perspective. RESULTS: 75 patients completed the study (CBCR N=38; CBET N=37). The CBCR had significantly higher cost per patient (477.76 ± 39.08) compared to CBET group (339.32 ± 53.88), with a significant between-group difference 138.44 (95% CI, 116.82 to 160.05, p<0.01). A between-group difference by 0.100 points in QALYs was observed, favouring the CBCR (95% CI, -0.163 to -0.037, p=0.002). When CBCR was compared with CBET, the ICER was 1,383.24 per QALY gained; at a willingness-to-pay threshold of 5,000 per QALY, the probability of CBCR being cost-effective was 99.9% (95% CI, 99.4 to 100.0). CONCLUSION: The CORE trial shows that a CBCR is a cost-effective intervention in the management of cancer survivors with high cardiovascular risk, reinforcing the potential benefits of this multidisciplinary approach in supportive care of this specific subset of cancer patients.
The CORE study was a randomized clinical trial including 80 cancer survivors with high cardiovascular risk; an 8-week cardio-oncology rehabilitation framework promoted superior results on cardiorespiratory fitness (peak oxygen consumption) and quality of life, but questions remained about the cost-effectiveness of this option. This study findings suggest that: a center-based cardiac rehabilitation proved to be cost-effective, when compared to usual care encompassing community-based exercise training the value-added of a comprehensive approach delivered in an oncological setting reinforce the potential benefits of including this intervention in supportive care of a specific subset of cancer patients, within existing contemporary cardiac rehabilitation resources and infrastructures.
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PURPOSE: Physical exercise has positive effects on clinical outcomes of breast cancer survivors such as quality of life, fatigue, anxiety, depression, body mass index, and physical fitness. We aimed to study its impact on immune, inflammatory, cardiometabolic, and fatty acids (FA) biomarkers. METHODS: An exploratory sub-analysis of the MAMA_MOVE Gaia After Treatment trial (NCT04024280, registered July 18, 2019) was performed. Blood sample collections occurred during the control phase and at eight weeks of the intervention phase. Samples were subjected to complete leukocyte counts, cytokine, and cardiometabolic marker evaluation using flow cytometry, enzyme-linked immunoassays, and gas chromatography. RESULTS: Ninety-three percent of the 15 participants had body mass index ≥ 25 kg/m2. We observed a decrease of the plasmatic saturated FA C20:0 [median difference - 0.08% (p = 0.048); mean difference - 0.1 (95%CI - 0.1, - 0.0)], positively associated with younger ages. A tendency to increase the saturated FA C18:0 and the ratio of unsaturated/saturated FA and a tendency to decrease neutrophils (within the normal range) and interferon-gamma were observed. CONCLUSIONS: Positive trends of physical exercise on circulating immune cells, inflammatory cytokines, and plasmatic FA were observed. Larger studies will further elucidate the implications of physical exercise on metabolism. These exploratory findings may contribute to future hypothesis-driven research and contribute to meta-analyses.
Subject(s)
Breast Neoplasms , Cancer Survivors , Cardiovascular Diseases , Humans , Female , Breast Neoplasms/therapy , Quality of Life , Fatty Acids , Exercise , Biomarkers , CytokinesABSTRACT
PURPOSE: Health literacy is a current Public Health priority in Portugal. The participation of well-informed patients in their care and shared decision making are essential, especially in chronic aggressive and debilitating pathologies such as recurrent or metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC). AIMS: This study aimed to characterize R/M HNSCC patients' and caregivers' information needs identified by healthcare professionals (HCPs). METHODS: Two online Focus Groups, one with only medical doctors and the other with other HCPs involved in the treatment of R/M HNSCC patients, were conducted, using a modified Metaplan, Lean or adapted PDCA methodology. The discussions were audio recorded in full and content analysis was performed using ATLAS.ti qualitative data analysis software. RESULTS: Topics addressed were diagnosis, treatment, quality of life, and global evaluation. In general, all experts agreed that only essential information should be cautiously given, according to patients' and caregivers' wishes. It was consensual that patients are given the necessary information to adhere to treatment. Two main barriers were identified: one barrier was associated with verbal communication due to the lack of health literacy of these patients, and the other barrier regarded healthcare access. It was also considered important to remind patients of the daily and social activities that they could and should maintain, as well as providing sufficient social resources and problem-solving training to caregivers. CONCLUSIONS: This qualitative study highlights the complexity of R/M HNSCC patients' care. Immediate availability of psychologists and psychiatrists should be implemented in all centers that treat HNSCC patients. The differences found between the physicians' Focus Group and other HCPs' Focus Group in some of the addressed topics emphasize the importance of a multidisciplinary and holistic approach, in a biomedical model integrated with a biopsychosocial model.
Subject(s)
Head and Neck Neoplasms , Health Literacy , Humans , Squamous Cell Carcinoma of Head and Neck , Health Literacy/methods , Quality of Life/psychology , Neoplasm Recurrence, Local , Head and Neck Neoplasms/therapy , Patient Care TeamABSTRACT
PURPOSE: To examine the effectiveness of a supervised exercise training program (SETP) on health-related quality of life (HRQoL) and functional capacity in women with breast cancer (BC) undergoing chemotherapy. METHODS: Ninety-three women with early-stage BC were randomly allocated to a SETP plus usual care (exercise, n = 47) or usual care alone (UC, n = 46). The SETP included three sessions per week, combining aerobic and resistance training, conducted concurrently over the chemotherapy. The EORTC Cancer Quality-of-Life-Questionnaire-Core-30 (QLQ-C30) and the BC-specific module (QLQ-BR23) were used to assess HRQoL. Functional capacity was analyzed by maximum voluntary handgrip strength (MVHS) and by the 30-s chair sit-to-stand test (30-s CST). These endpoints were assessed at baseline (t0); middle (t1; after 8 or 12 wk of t0); and at the end of chemotherapy (t2; after 20 wk of t0). Mean changes from baseline were assessed by an intention-to-treat approach. RESULTS: Mixed linear model analyses showed that Exercise group experienced less deterioration in several domains of QLQ-C30 at t2, including in global health status/QoL (Δ = 9.39 units; P = 0.034), QLQ-C30 summary score (Δ = 8.08 units; P < 0.001), physical (Δ = 15.14 units; P < 0.001), role ( Δ = 21.81 units; P < 0.001), cognitive (Δ = 9.16 units; P = 0.032) and social functioning (Δ = 11.67 units; P = 0.038), compared with the UC group. Similarly, Exercise group exhibited significant lower levels of fatigue (Δ = -20.19 units; P < 0.001) and appetite loss (Δ = -13.69 units; P = 0.034), compared with the UC group. Significant between-group differences were observed on MVHS of the tumor/surgery upper limb side (Δ = 2.64 kg; P < 0.001) and contralateral limb (Δ = 2.22 kg; P < 0.001), and on the 30-s CST score (Δ = 3.56repetitions; P < 0.001), favoring the Exercise group. No differences were observed on QLQ-BR23 domains. CONCLUSIONS: Exercise training was an effective complementary therapy to prevent the deterioration of HRQoL and functional capacity during chemotherapy in women with early-stage BC.
Subject(s)
Breast Neoplasms , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/psychology , Quality of Life/psychology , Hand Strength , Health Status , ExerciseABSTRACT
Importance: Cardiovascular disease is a leading cause of morbidity in cancer survivors, which makes strategies aimed at mitigating cardiovascular risk a subject of major contemporary importance. Objective: To assess whether a center-based cardiac rehabilitation (CBCR) framework compared with usual care encompassing community-based exercise training (CBET) is superior for cardiorespiratory fitness improvement and cardiovascular risk factor control among cancer survivors with high cardiovascular risk. Design, Setting, and Participants: This prospective, single-center, randomized clinical trial (CORE trial) included adult cancer survivors who had exposure to cardiotoxic cancer treatment and/or previous cardiovascular disease. Enrollment took place from March 1, 2021, to March 31, 2022. End points were assessed at baseline and after the 8-week intervention. Interventions: Participants were randomly assigned in a 1:1 ratio to 8 weeks of CBCR or CBET. The combined aerobic and resistance exercise sessions were performed twice a week. Main Outcomes and Measures: The powered primary efficacy measure was change in peak oxygen consumption (VÌo2) at 2 months. Secondary outcomes included handgrip maximal strength, functional performance, blood pressure (BP), body composition, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), lipid profile, plasma biomarker levels, physical activity (PA) levels, psychological distress, quality of life (QOL), and health literacy. Results: A total of 75 participants completed the study (mean [SD] age, 53.6 [12.3] years; 58 [77.3%] female), with 38 in the CBCR group and 37 in the CBET group. Participants in CBCR achieved a greater mean (SD) increase in peak VÌo2 than those in CBET (2.1 [2.8] mL/kg/min vs 0.8 [2.5] mL/kg/min), with a between-group mean difference of 1.3 mL/kg/min (95% CI, 0.1-2.6 mL/kg/min; P = .03). Compared with the CBET group, the CBCR group also attained a greater mean (SD) reduction in systolic BP (-12.3 [11.8] mm Hg vs -1.9 [12.9] mm Hg; P < .001), diastolic BP (-5.0 [5.7] mm Hg vs -0.5 [7.0] mm Hg; P = .003), and BMI (-1.2 [0.9] vs 0.2 [0.7]; P < .001) and greater mean (SD) improvements in PA levels (1035.2 [735.7] metabolic equivalents [METs]/min/wk vs 34.1 [424.4] METs/min/wk; P < .001), QOL (14.0 [10.0] points vs 0.4 [12.9] points; P < .001), and health literacy scores (2.7 [1.6] points vs 0.1 [1.4] points; P < .001). Exercise adherence was significantly higher in the CBCR group than in the CBET group (mean [SD] sessions completed, 90.3% [11.8%] vs 68.4% [22.1%]; P < .001). Conclusion and Relevance: The CORE trial showed that a cardio-oncology rehabilitation model among cancer survivors with high cardiovascular risk was associated with greater improvements in peak VÌo2 compared with usual care encompassing an exercise intervention in a community setting. The CBCR also showed superior results in exercise adherence, cardiovascular risk factor control, QOL, and health literacy. Trial Registration: ClinicalTrials.gov Identifier: NCT05132998.
Subject(s)
Cancer Survivors , Cardiovascular Diseases , Neoplasms , Adult , Humans , Female , Middle Aged , Male , Quality of Life , Prospective Studies , Hand Strength , Quality Improvement , Risk Factors , Heart Disease Risk FactorsABSTRACT
To assess the effects of a group class physical exercise program on health-related quality of life (HRQOL), physical fitness and activity, and safety in early breast cancer women after treatment, a double-phase trial [16-week control phase (CP) followed by a 16-week intervention phase (IP)] was designed. Outcomes were evaluated at baseline (T1), 8 (T2) and 16 (T3) weeks (CP), and 24 (T4) and 32 (T5) weeks (IP). The primary endpoint was global health status. Out of 82 enrolled patients, 37 completed the IP. Global health status decreased (-10,1; 95% CI -19.8 to -0.4; p = 0.040) during the CP and stabilized during the IP. Physical and sexual functioning increased during the IP (p = 0.008; p = 0.017), while cardiorespiratory fitness increased in the CP (p = 0.004). Upper limb strength and lower limb functionality increased during both phases [CP: p < 0.0001, p = 0.001 (surgical and nonsurgical arm), p = 0.028; IP: p < 0.0001, p = 0.002, p = 0.009]. Body mass index decreased in the IP (p = 0.026). Waist circumference increased in the CP (p = 0.001) and decreased in the IP (p = 0.010); sedentary behaviours and moderate and vigorous physical activity did not change. Adherence to 70% of the sessions was reported in 54% of patients. No serious adverse events related to the intervention were reported. In conclusion, the physical exercise program was able to prevent the decline in global health status and to improve other domains of HRQOL and physical fitness. As physical exercise is not the standard of care in many countries, the implementation of group class programs might be an option.
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Medullary thyroid carcinoma (MTC) is a rare type of neuroendocrine tumor, accounting for 3%-4% of all thyroid cancers. Seventy-five percent are sporadic, of which 60% have pathogenic REarranged during Transfection (RET) somatic mutations. The sporadic RET-mutated MTC poses novel challenges for targeted treatment. The authors present a case of a 60-year-old male diagnosed in 2018 with MTC who underwent total thyroidectomy with sternotomy and bilateral cervical lymph node dissection - pT3N1b R1 L1 V1 Pn0 cM1 (hepatic and lung metastasis). According to the decisions made by the multidisciplinary tumor board, the patient received multiple palliative systemic treatments. Despite an initial response, vandetanib was accompanied by grade 3 high blood pressure and progression after 14 months of treatment. The patient also received cabozantinib, which led to an initial response, but with grade 3 hypertension and skin toxicity. The patient progressed, including symptomatic bone metastasis, after 15 months of treatment. Following the next sequencing genome result, which showed a somatic mutation in the RET M918T gene, the patient was treated with selpercatinib, a highly selective and potent RET inhibitor. The treatment led to clinical and radiological responses without significant toxicities. The objective of this case report is to highlight the impact of innovative treatment and precision medicine on the management of cancer patients, which not only has a direct effect on their survival but also on their quality of life.
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BACKGROUND: Xentuzumab is a humanised monoclonal antibody that binds to IGF-1 and IGF-2, neutralising their proliferative activity and restoring inhibition of AKT by everolimus. This study evaluated the addition of xentuzumab to everolimus and exemestane in patients with advanced breast cancer with non-visceral disease. METHODS: This double-blind, randomised, Phase II study was undertaken in female patients with hormone-receptor (HR)-positive/human epidermal growth factor 2 (HER2)-negative advanced breast cancer with non-visceral disease who had received prior endocrine therapy with or without CDK4/6 inhibitors. Patients received a weekly intravenous infusion of xentuzumab (1000 mg) or placebo in combination with everolimus (10 mg/day orally) and exemestane (25 mg/day orally). The primary endpoint was progression-free survival (PFS) per independent review. RESULTS: A total of 103 patients were randomised and 101 were treated (n = 50 in the xentuzumab arm and n = 51 in the placebo arm). The trial was unblinded early due to high rates of discordance between independent and investigator assessment of PFS. Per independent assessment, median PFS was 12.7 (95% CI 6.8-29.3) months with xentuzumab and 11.0 (7.7-19.5) months with placebo (hazard ratio 1.19; 95% CI 0.55-2.59; p = 0.6534). Per investigator assessment, median PFS was 7.4 (6.8-9.7) months with xentuzumab and 9.2 (5.6-14.4) months with placebo (hazard ratio 1.23; 95% CI 0.69-2.20; p = 0.4800). Tolerability was similar between the arms, with diarrhoea (33.3-56.0%), fatigue (33.3-44.0%) and headache (21.6-40.0%) being the most common treatment-emergent adverse events. The incidence of grade ≥ 3 hyperglycaemia was similar between the xentuzumab (2.0%) and placebo (5.9%) arms. CONCLUSIONS: While this study demonstrated that xentuzumab could be safely combined with everolimus and exemestane in patients with HR-positive/HER2-negative advanced breast cancer with non-visceral disease, there was no PFS benefit with the addition of xentuzumab. Trial registration ClinicalTrials.gov, NCT03659136. Prospectively registered, September 6, 2018.
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Breast Neoplasms , Humans , Female , Everolimus , AndrostadienesABSTRACT
Aims: To analyze the feasibility and impact of a walking football (WF) program on quality of life (QoL), cardiorespiratory fitness (CRF), muscle strength, and balance program in men with prostate cancer under androgen deprivation therapy (ADT). Methods: Fifty patients with prostate cancer (stages IIb-IVb) under ADT were randomized to a 16-week WF program plus usual care (n=25) or usual care control group (n=25). The WF program consisted of three 90-minute sessions per week. Recruitment, withdrawal, adherence, enjoyment rate, and safety of the intervention were recorded throughout the study. Cardiorespiratory fitness was assessed before and after the interventions, while handgrip strength, lower limb muscle strength, static balance, and QoL were assessed before, during (week 8), and after (week 16) the interventions. Adverse events during sessions were also recorded. Results: The WF group showed high levels of adherence (81.6 ± 15.9%) and enjoyment rate (4.5 ± 0.5 out of 5 points). In the intention-to-treat analysis, the WF group showed an improvement in chair sit-to-stand (p=0.035) compared to the control group. Within-group comparisons showed that handgrip strength in the dominant upper limb (p=0.024), maximal isometric muscle strength in the non-dominant lower limb (p=0.006), and balance in the dominant limb (p=0.009) improved over time in the WF group but not in the usual care group. The results obtained from the per-protocol analysis indicate that CRF improved significantly in the WF group as compared to the control group (p=0.035). Within-group analysis revealed that CRF (p=0.036), muscle strength in dominant (p=0.006) and non-dominant (p=0.001) lower limbs, and balance in the non-dominant lower limb (p=0.023) improved after 16 weeks of WF, but not in the control group. One major traumatic injury (muscle tear) was reported with a complete recovery before the end of the intervention. Conclusion: This study suggests that WF is feasible, safe, and enjoyable in patients with prostate cancer under hormonal therapy. Furthermore, patients who adhere to the WF program can expect cardiorespiratory fitness, muscle strength, and balance improvements. Clinical trials registration: clinicaltrials.gov, identifier NCT04062162.
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AIMS: Exercise training has been suggested to prevent anthracycline-related cardiac dysfunction, but clinicalbased evidence is scarce. We investigated the effects of a supervised exercise training programme (SETP) on cardiac toxicity markers in women with breast cancer (BC) receiving anthracycline-containing chemotherapy. METHODS AND RESULTS: Ninety-three women with early-stage breast cancer were randomly allocated to a supervised exercise training programme (SETP) plus usual care group (Exercise, n = 47) or usual care alone group (UC, n = 46). The SETP consisted of three sessions per week, combining aerobic and resistance training, conducted concurrently across the anthracycline-containing chemotherapy length. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to the end of anthracycline cycles. Secondary endpoints included global longitudinal strain (GLS) and other conventional echocardiographic parameters, cardiorespiratory fitness (estimated peak VO2), circulating biomarkers (NT-proBNP, hs-TnT), and safety of the SETP. The study endpoints were also assessed 3 months after the end of anthracycline cycles. All patients were prescribed four cycles of doxorubicin plus cyclophosphamide (AC). No significant between-group differences in LVEF change were seen at the end of AC [mean difference: 0.7%; 95% confidence interval (CI): -0.8, 2.3; P = 0.349] and 3 months after AC (1.1%; 95% CI: -0.5, 2.6; P = 0.196). Compared to the usual care (UC) group, the estimated peak VO2 increased in the Exercise group at the end of AC (1.6 mL O2·kg-1·min-1; 95% CI: 0.06, 3.1; P = 0.041) and 3 months after AC (3.1 mL O2·kg-1·min-1; 95% CI: 1.4, 4.7; P < 0.001). No between-group differences were found in the remaining secondary endpoints. No serious adverse events were observed during SETP. CONCLUSION: Exercise training was safe during chemotherapy and significantly improved cardiorespiratory fitness. No significant effects were seen on cardiac toxicity markers (LVEF or GLS) as compared to the usual care. TRIAL REGISTRATION: Mama Move Gaia on treatment trial ISRCTN32617901.
Breast cancer patients are often treated with chemotherapy. Despite the clinical benefit, some of these drugs increase the risk of cardiac toxicity and impair patients' cardiorespiratory fitness. Exercise training has been proposed as a preventive approach, but clinical-based evidence is scarce. The results of this trial showed that an exercise training programme, combining aerobic training and resistance training, conducted during chemotherapy, did not significantly attenuate the decline in conventional cardiac function parameters when compared to usual care. However, the results of this trial showed that the training programme was safe and significantly improved cardiorespiratory fitness.
Subject(s)
Breast Neoplasms , Humans , Female , Breast Neoplasms/drug therapy , Anthracyclines/adverse effects , Cardiotoxicity , Stroke Volume , Ventricular Function, Left , ExerciseABSTRACT
PURPOSE: To assess safety, satisfaction, and overall adherence of a center-based cardiac rehabilitation (CBCR) program for cancer survivors at increased cardiovascular (CV) risk, compared to community-based exercise training (CBET). METHODS: The CORE study was a single-center, prospective, randomized controlled trial enrolling cancer survivors exposed to cardiotoxic cancer treatment and/or with previous CV disease. Participants were randomized to an 8-week CBCR program or CBET, twice a week. Overall feasibility (consent, retention, and completion rates), intervention adherence (percentage of exercise sessions attended), and safety were assessed. Adverse events (AEs) were registered, and participants' satisfaction was measured at the end of the study. RESULTS: Eighty out of 116 potentially eligible individuals were included; consent rate was 72.4%, and 77 (96.2%) started the study (retention rate 100% in CBCR vs 92.5% in CBET); completion rate was 92.5%. Intervention adherence was higher in CBCR (90.3 ± 11.8% vs 68.4 ± 22.1%, p < 0.001). Exercise-related AEs were mainly related to musculoskeletal conditions in both groups (7 in CBCR vs 20 in CBET, p < 0.001), accounting for exercise prescription modification in 47 sessions (18 (3.3%) in CBCR vs 29 (7.2%) in CBET, p = 0.006), none motivating exercise discontinuation. No participants reported major CV events. Overall, the satisfaction with the different aspects of the programs (e.g., expectations, monitoring) was higher in the CBCR. CONCLUSION: This exploratory analysis of the CORE trial suggests that both exercise-based interventions are feasible and safe in this setting. The higher intervention adherence and patient satisfaction in CBCR suggest that this comprehensive approach could be of interest in this population.
Subject(s)
Cancer Survivors , Neoplasms , Humans , Prospective Studies , Exercise , Exercise Therapy , Neoplasms/rehabilitation , Personal SatisfactionABSTRACT
INTRODUCTION: Head and neck cancers remain a significant health burden worldwide. Standardizing the care provided to these patients through the systematic measurement of established indicators is key to improve their outcomes. The aim of this study was to establish a relevant set of outcome indicators in this condition and identify measurement tools and requirements to do so. MATERIAL AND METHODS: One scientific committee and two regional working groups worked in a stepwise manner to narrow down an initial list of potential outcome indicators retrieved from an exhaustive literature review to a smaller set of outcome indicators according to their clinical practice. This was assessed by one representative of a head and neck cancer patient association until a final set of indicators was reached. RESULTS: A total of 164 outcome indicators comprising case-mix, outcomes, and adverse events dimensions were retrieved from the literature. These were reduced to a working set of 79 outcome indicators by the Scientific Committee and divided into seven categories including demographics, clinical status, tumor-related parameters, nutritional status, treatment, health and quality of life parameters and survival. Subsequently, these indicators were further reduced to a set of 50 indicators by the regional working groups and to a set of 49 indicators by the final Scientific Committee assessment. Finally, the discussed indicators were appraised by a head and neck cancer patient association, which added the 'rehabilitation' category, a key parameter to these patients. CONCLUSION: An initial set of outcome indicators for head and neck cancer was systematically developed aiming to standardize the care provided to these patients across institutions at national level and identify measurement tools and requirements to measure those indicators. This standard set should be continuously improved and consistently adopted in the different clinical and national settings.
Subject(s)
Head and Neck Neoplasms , Patient Outcome Assessment , Patient-Centered Care , Humans , Delphi Technique , Head and Neck Neoplasms/therapy , Outcome Assessment, Health Care , Quality of LifeABSTRACT
BACKGROUND: Cancer survivors are challenging patients, as they often present increased cardiovascular risk. In this background, cardio-oncology rehabilitation frameworks for specific cancer patients have been proposed. However, optimal program designs, as well as their overall safety and efficacy in different subsets of patients, are not fully ascertained. DESIGN: Single-center, pragmatic, prospective, randomized controlled trial performed in Portugal aiming to evaluate the impact of a center-based cardiac rehabilitation program, consisting of exercise training, nutritional counselling, psychosocial management and lifestyle behavior change, compared to community-based exercise training, in cancer survivors. METHODS: Adult cancer survivors (N = 80) exposed to cardiotoxic cancer treatment and/or with previous cardiovascular disease will be randomized (1:1) to receive either an eight-week cardiac rehabilitation program or community-based exercise training. Primary endpoint is cardiorespiratory fitness; secondary endpoints are physical activity, psychosocial parameters, blood pressure, body composition, lipids and inflammatory parameters. Physical function, quality of life, fatigue, health literacy, and feasibility will be assessed; a cost-effectiveness evaluation will also be performed. Between-group differences at baseline and in the change from baseline to the end of the study will be tested with unpaired t-tests or Mann-Whitney U test. Paired t-tests or Wilcoxon signed-rank test will be performed for within-group comparisons. CONCLUSION: This trial will address the overall impact of a contemporary cardiac rehabilitation program framework in cancer survivors, as compared to a community-based exercise training. Given the higher cardiovascular risk in several groups of cancer patients, our results could provide novel insights into optimized preventive strategies in this complex patient population.
Subject(s)
Cancer Survivors , Cardiac Rehabilitation , Cardiovascular Diseases , Neoplasms , Adult , Humans , Cardiac Rehabilitation/psychology , Quality of Life , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Prospective Studies , Risk Factors , Neoplasms/epidemiology , Heart Disease Risk Factors , Exercise Therapy/methods , Randomized Controlled Trials as TopicABSTRACT
Background: Breast cancer is the most common cancer worldwide, and despite remarkable progress in its treatment, the survivors' quality of life is hampered by treatment-related side effects that impair psychosocial and physiological outcomes. Several studies have established the benefits of physical exercise in breast cancer survivors in recent years. Physical exercise reduces the impact of treatment-related adverse events to promote a better quality of life and functional outcomes. Aim: This study aims to provide an overview of systematic reviews and meta-analyses on the effect of physical exercise on the health-related quality of life, cardiorespiratory fitness, muscle strength, and body composition of breast cancer survivors. Methods: PubMed and Cochrane databases were searched for systematic reviews and meta-analyses from January 2010 to October 2022. The main focus was ascertaining the effectiveness of physical exercise in breast cancer survivors undergoing curative treatment (surgery and/or radiotherapy and/or chemotherapy). Two reviewers independently screened the literature, extracted the data, and assessed the risk of bias in the included studies. Results: A total of 101 studies were identified, and 12 were yielded for final analysis. The eligible studies included nine systematic reviews/meta-analyses, one meta-analysis/meta-regression, and two systematic reviews. The number of randomised clinical trials included in each review varied from 11 to 63, and the number of participants was from 214 to 5761. A positive and significant effect of different physical exercise interventions on health-related quality of life was reported in 83.3% (10 studies) of the eligible studies. Physical exercise also improved cardiorespiratory fitness (3 studies; 25%) and showed to be effective in reducing body weight (3 studies; 25%) and waist circumference (4 studies; 33.3%). Conclusions: Our results suggest that physical exercise is an effective strategy that positively affects breast cancer survivors' quality of life, cardiorespiratory fitness, and body composition. Healthcare professionals should foster the adoption of physical exercise interventions to achieve better health outcomes following breast cancer treatments. Systematic review registration: https://inplasy.com/inplasy-2022-11-0053/, identifier INPLASY2022110053.
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Head and neck cancer (HNC) treatment's toxicities impact several health domains. Exercise training (ET) may be beneficial. This prospective observational study (NCT04996147) aimed to analyse the acute impact of HNC curative multimodal treatment on health-related quality of life (HRQoL), nutritional status, physical and cognitive functions, and ET preferences. Eighteen patients with stage III/IV HNC were evaluated at baseline (T0), and 10 patients were evaluated at the end of treatment (T1), 7 of them after radical chemoradiotherapy (rCRT). At T0, the majority referred a good HRQoL on the EORTC QLQ-C30 questionnaire (median score: 70.8), were moderately malnourished or at risk of malnutrition (78%), recognized the benefits of an ET program, and were willing to participate (78%). After rCRT, there was worsening in HRQoL (75 vs. 50 score, p = 0.014), dysphagia severity (Eating Assessment Tool: 7 vs. 31, p = 0.027; Functional Oral Intake Scale: 6 vs. 4, p = 0.041), handgrip strength (dominant: 40.9 vs. 35.8 kgf, p = 0.027; nondominant: 37.2 vs. 33.9 kgf, p = 0.043), and nutritional status (Patient-Generated Subjective Global Assessment: 7 vs. 18, p = 0.028). HNC patients subjected to radical treatment represent a vulnerable population that might benefit from multimodal supportive care strategies including an ET program.
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Metaplastic breast carcinoma (MBC) is a rare and aggressive histologic subtype of cancer. Because of its rarity and heterogeneity, the management of these patients is challenging. Here, we present the case of a rapidly progressive MBC with mesenchymal differentiation in a 37-year-old female, treated with trimodal therapy consisting of neoadjuvant chemotherapy with paclitaxel and carboplatin, followed by dose-dense cyclophosphamide and doxorubicin (ddAC), modified radical left mastectomy, and adjuvant radiotherapy. Despite the need to anticipate the surgery after the first cycle of ddAC, because of a life-treating adverse event, there was a pathologic complete response. Nevertheless, 6.2 months after completing adjuvant radiotherapy, the patient had a recurrence on the central nervous system (CNS) (two lesions), which was managed with excisional biopsy and stereotactic body radiation therapy. The patient also started "complementary" chemotherapy with capecitabine. Still, 18 months after being diagnosed, she died due to CNS disease progression.
ABSTRACT
BACKGROUND: Cardiotoxicity is a known complication and one of the most adverse effects from the use of conventional treatments such as anthracyclines and trastuzumab in breast cancer (BC) care. This phenomenon has been associated with the restriction of therapeutic options and the increase of cardiovascular complications, which may compromise the survival of patients. Implementation of preventive strategies is an important approach for the management of this issue. Physical exercise has been proposed as a non-pharmacological strategy to counteracting cardiotoxicity. The aim of this protocol is to describe the rationale and methods for a systematic review of published randomized controlled trials (RCTs) that have analysed the effects of physical exercise on outcomes of cardiac (dys)function in women with BC undergoing neoadjuvant or adjuvant treatment containing anthracyclines and/or trastuzumab. METHODS AND ANALYSIS: This is a protocol for a systematic review reported according to the PRISMA-P 2015 checklist. Randomized controlled trials (RCTs) will be included. The literature will be screened on MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, ISI Web of Science and Scopus. The risk of bias of the included RCTs will be assessed using the Cochrane Collaboration's tool. The primary outcomes will be systolic function (left ventricular ejection fraction), diastolic function (E/A' ratio, deceleration time of early left ventricular filling, isovolumetric relaxation time, E/E' septal and lateral ratio) and myocardial deformation imaging outcomes (strain and strain rate [measured in longitudinal, radial, or circumferential directions]). Secondary outcomes will be cardiac biomarkers (troponin I or T, high-sensitivity troponin I or T, brain natriuretic peptide, amino terminal of B-type natriuretic peptide). Data will be descriptively reported, and quantitative synthesis will also be considered if the included studies are sufficiently homogenous. DISCUSSION: This systematic review will help to understand the effectiveness of physical exercise on counteracting cardiotoxicity related to anticancer therapies in women with BC. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018096060.
Subject(s)
Anthracyclines/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Breast Neoplasms/drug therapy , Cardiotoxicity , Exercise/physiology , Randomized Controlled Trials as Topic , Trastuzumab/therapeutic use , Adult , Female , Humans , Ventricular Function, Left , Systematic Reviews as TopicABSTRACT
BACKGROUND: Anthracyclines are chemotherapeutic agents frequently used in breast cancer (BC) treatment. Although it improves disease-free and overall survival, the use of anthracyclines is associated with a cumulative risk of cardiac toxicity. Preventive strategies to optimize cardiac health are needed and exercise is proposed as a potential non-pharmacological approach for counteracting anthracycline-related cardiotoxicity (ARC). Most of the data on the effects of exercise to reduce ACT are from animal studies, with only a few studies in a limited number of patients indicating beneficial effects. To better understand the effectiveness of exercise in the mitigation of ARC, clinical, real-world trials claim require a larger sample size and more accurate and valuable clinical biomarkers. In this study, we intend to include a large sample and investigate cardiac function through serial measures of biomarkers and imaging techniques. METHODS: This protocol describes a two-arm, prospective, randomized controlled trial that will explore the cardioprotective effect of a structured exercise program in women with BC undergoing anthracycline-containing chemotherapy (ACT). Ninety adult women with early BC and recommended to receive ACT will be randomly assigned (1:1) to an intervention group or a control group. Patients allocated to the intervention group will perform a supervised exercise program three times per week, consisting of a combination of aerobic and resistance training with progressive intensity and volume, during the time period they receive ACT. The control group will receive standard BC care. Primary outcomes related to cardiac (dys)function will be circulating N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, resting left ventricular (LV) longitudinal strain, and resting LV ejection fraction. Secondary outcomes will include the assessment of resting blood pressure, resting heart rate (HR), resting HR variability (HRV), recovery HR, physical function outcomes, self-reported physical activity level, health-related quality of life, and fatigue. Data will be obtained at baseline (t0), after the end of anthracycline-treatment (t2), and 3 months after t2 (t3). Additionally, NT-proBNP will be measured 1-24 h prior to each anthracycline-treatment cycle (t1). DISCUSSION: The implementation of the present study design, using novel clinical biomarkers, will determine the effect of structured exercise interventions at mitigating ARC, with the overall aim of finding means to further improve BC care. TRIAL REGISTRATION: ISRCTN, ISRCTN32617901 . Registered on 24 October 2018. Last updated on 11 January 2019.
Subject(s)
Anthracyclines/adverse effects , Antibiotics, Antineoplastic/adverse effects , Breast Neoplasms/drug therapy , Heart Diseases/prevention & control , Resistance Training , Biomarkers/blood , Breast Neoplasms/pathology , Cardiotoxicity , Female , Health Status , Heart Diseases/chemically induced , Heart Diseases/diagnostic imaging , Heart Diseases/physiopathology , Hemodynamics/drug effects , Humans , Natriuretic Peptide, Brain/blood , Peptide Fragments/blood , Portugal , Prospective Studies , Randomized Controlled Trials as Topic , Resistance Training/adverse effects , Risk Factors , Time Factors , Treatment Outcome , Ventricular Function, Left/drug effectsABSTRACT
After breast cancer diagnosis (BCD), localized breast cancer (BC) patients are treated with curative intent by several therapeutic modalities. Despite the benefit of those therapies, the induction of side effects is acommon consequence affecting psychosocial and physiological outcomes. This quasi-experimental study compared physical fitness in recent-term (14-30 months; n= 11) and later-term (74-92 months; n= 8) BCD patients. After inclusion, recent-term BCD patients were engaged in asupervised exercise program and was explored its impact on physical fitness, health-related quality of life (HR-QOL) and fatigue. At baseline (M1) and after 8 (M2) and 16 weeks (M3) of this period, HR-QOL and fatigue were evaluated by the EORTC QLQ-C30 questionnaire and physical fitness through the estimation of maximum oxygen consumption (VO2max,ml.kg.min-1), handgrip force (kg) and sit-stand test. At baseline, women with later-term BCD have revealed better VO2max (p < 0.05) than recent-term BCD patients. There was asignificant time*group interaction for physical fitness outcomes and only the patients who have participated in the exercise program reported significant changes between baseline and at 16 weeks. The observed results demonstrated that performing regular exercise is associated with effective psychosocial and physiological recovery after BCD.