Cost-effectiveness analysis of a cardio-oncology rehabilitation framework compared to an exercise intervention for cancer survivors with high cardiovascular risk.

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.

Effect of physical exercise on immune, inflammatory, cardiometabolic biomarkers, and fatty acids of breast cancer survivors: results from the MAMA_MOVE Gaia After Treatment trial.

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.

Exercise Training Benefits Health-Related Quality of Life and Functional Capacity during Breast Cancer Chemotherapy: A Randomized Controlled Trial.

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.

Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial.

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 (V̇o2) 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 V̇o2 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 V̇o2 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.

Effects of a Physical Exercise Program on Quality of Life and Physical Fitness of Breast Cancer Survivors: the MAMA_MOVE Gaia After Treatment Trial.

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.

Effects of walking football on adherence, safety, quality of life and physical fitness in patients with prostate cancer: Findings from the PROSTATA_MOVE randomized controlled trial.

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.

Multidisciplinary approach, continuous care and opioid management in cancer pain: case series and review of the literature.

Underlying cancer pain has heterogenous aetiologies and mechanisms. It requires detailed and comprehensive pain assessment, combined with personalized treatment. A multidisciplinary team is essential to providing the best management of cancer pain at every disease stage, improving the quality of life and outcomes in patients with cancer. This narrative literature review emphasizes the value of providing all patients with multidisciplinary pain management in their preferred care setting. Real-life experiences are also reported to witness the efforts of physicians to properly manage cancer pain. This article is part of the Management of breakthrough cancer pain Special Issue: https://www.drugsincontext.com/special_issues/management-of-breakthrough-cancer-pain.

Effects of exercise training on cardiac toxicity markers in women with breast cancer undergoing chemotherapy with anthracyclines: a randomized controlled trial.

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.

Evaluation of Current Antiemetic Therapy Response in Patients Undergoing MEC or HEC Regimens in Portugal.

Chemotherapy-induced nausea and vomiting (CINV) negatively impact cancer patients' quality of life and treatment outcomes. This study evaluated the achievement of complete response to CINV prophylaxis during the first five days after chemotherapy in adult outpatient cancer clinics with solid malignant tumours receiving Moderate or Highly Emetogenic Chemotherapy (MEC or HEC) in Portugal. During the study, patients completed three evaluations, and nausea severity and CINV impact on patients' daily life was assessed. A complete response (no emetic episodes, no use of rescue antiemetic medication, and no more than mild nausea) was observed in 72% of the cycles (N = 161) throughout the five days after chemotherapy. Amongst the patient population, 25% classified their CINV episodes as severe. Though more than half of the patients achieved a complete response, suggesting that a therapeutic effort is being made to minimise this side effect, the overall scenario is barely optimistic. Significantly, new CINV-control measures in MEC/HEC patients should be adopted, specifically avoiding the single use of dexamethasone and 5-HT3 and raising awareness of using NK1-RAs. Thus, it is critical to improve CINV prophylactic treatment and implement practical international antiemetic guidelines in Portuguese clinical practice, envisaging the improvement of supportive care for cancer patients.

Adherence, safety, and satisfaction of a cardio-oncology rehabilitation program framework versus community exercise training for cancer survivors: findings from the CORE trial.

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.

Impact of a COmprehensive cardiac REhabilitation framework among high cardiovascular risk cancer survivors: Protocol for the CORE trial.

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.

Impact of physical exercise programs in breast cancer survivors on health-related quality of life, physical fitness, and body composition: Evidence from systematic reviews and meta-analyses.

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.

Acute Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT.

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.

Medical management of malignant bowel obstruction in patients with advanced cancer: 2021 MASCC guideline update.

BACKGROUND: Malignant bowel obstruction (MBO) is a frequent complication in patients with advanced cancer, particularly colon or gynecological malignancies. MASCC previously published a guideline for symptom management of MBO in 2017. This is a 5-year update. METHOD: A systematic search and review of relevant literature includes a review published in 2010 and 2017. The guideline update used the same literature search process as followed in 2015. The dates of the new search included 2015 up to February 2, 2021. The guidelines involved the pharmacologic management of nausea and vomiting in malignant bowel obstruction (MBO) only. Only randomized trials were included in the updated guideline as evidence. The evidence was reviewed by the panel and the MASCC criteria for establishing a guideline were followed using MASCC level of grading and category of evidence. RESULTS: There was one systematic review and 3 randomized trials accepted as evidence from 257 abstracts. Octreotide is effective in reducing gastrointestinal secretions and colic and thereby reduces nausea and vomiting caused by MBO. Scopolamine butylbromide is inferior to octreotide in the doses used in the comparison study. Olanzapine or metoclopramide may be effective in reducing nausea and vomiting secondary to partial bowel obstructions. The panel suggests using either drug. Additional studies are needed to clarify benefits. Haloperidol has been used by convention as an antiemetic but has not been subjected to a randomized comparison. Ranitidine plus dexamethasone may be effective in reducing nausea and vomiting from MBO but cannot be recommended until there is a comparison with octreotide. DISCUSSION: Octreotide remains the drug of choice in managing MBO. Ranitidine was used in one randomized trial in all participants and so its effectiveness as a single drug is not known until there is a randomized comparison with octreotide. Antiemetics such as metoclopramide and olanzapine may be effective, but we have very few randomized trials of antiemetics in MBO. CONCLUSION: The panel recommends octreotide in non-operable MBO. Randomized trials are needed to clarify ranitidine and antiemetic choices.

MASCC antiemetics in advanced cancer updated guideline.

BACKGROUND: Nausea and vomiting are a common clinical symptom in the advanced cancer patient. Pharmacologic management is important. Evidence for drug choices and guidelines are needed to help clinicians manage nausea and vomiting in this population METHODS: Evidence from a systematic review published in 2010, initial MASCC guidelines developed from a systematic review of literature to 2015, and a new systematic review of randomized trials published between 2015 and February 2, 2021, was combined to establish a new guideline. RESULTS: A search of the literature between 2015 and February 2, 2021, revealed 257 abstracts of which there was one systematic review and 4 randomized trials which were used to modify the guideline. The new guideline is as follows: First Line: Metoclopramide (II) multiple small RCTs including a placebo-controlled trial, haloperidol (II) multiple non-placebo-controlled RCTs, high consensus. Second line: Methotrimeprazine (II) 1 well-powered non-placebo-controlled RCT, olanzapine (II) 1 placebo-controlled pilot RCT, high consensus. Third line: Tropisetron (II) large unblinded lower quality non-placebo-controlled RCT, levosulpiride (II) 1 blinded non-placebo-controlled pilot RCT, high consensus. DISCUSSION: Haloperidol, metoclopramide, methotrimeprazine, olanzapine tropisetron, and levosulpiride have been antiemetics used in randomized trials with antiemetic activity demonstrated. There are only three placebo-controlled randomized trials we could find in our literature review. Placebo responses varied significantly between two randomized trials. More randomized placebo-controlled trials with either metoclopramide or haloperidol rescue are needed to clarify antiemetic choices in advanced cancer. CONCLUSION: First-line antiemetics for nausea and vomiting in advanced cancer are metoclopramide and haloperidol, and second-line medications are methotrimeprazine and olanzapine.

Ferric Carboxymaltose in the treatment of chemotherapy-induced anaemia: an effective, safe and cost- sparing alternative to blood transfusion.

Anaemia is highly prevalent in cancer patients, adversely affects quality of life and impacts survival. The pathogenesis is multifactorial, with iron deficiency being a major and potentially treatable contributor. This study aimed to assess the effectiveness and economic impact of ferric carboxymaltose in chemotherapy-induced anaemia. This prospective cohort study between 2015-2016 of chemotherapy-treated patients for solid tumours, grade ≥2 anaemia and iron deficiency evaluated hematopoietic response four weeks after ferric carboxymaltose treatment. Transfusion rate of all cancer patients treated at our ambulatory unit during the two-year study period (2015-2016) was compared to a retrospective cohort (2013-2014) who received blood transfusion only. Between 2015-2016, 99 patients were included and treated with ferric carboxymaltose, the majority of whom (n = 81) had relative iron deficiency. Mean haemoglobin concentrations improved from 9.2 [6.7-10.8] g/dL to 10.6 [7.8-14.2] g/dL four weeks after treatment. A 26% reduction in the transfusion rate was observed from control retrospective to the prospective study group including ferric carboxymaltose treated patients [relative risk 0.74 (95% CI:0.66-0.83)]. The cost analysis showed a benefit for the use of ferric carboxymaltose in chemotherapy-induced anaemia. This study shows that ferric carboxymaltose is an effective, cost-saving support treatment, reducing the need for allogeneic transfusions saving blood units which are a limited resource.

[Oncocytic tumors of the adrenal gland]. / Tumores oncocíticos da supra-renal.

The oncocytic tumors of the adrenal gland are rare. To date there's only 147 cases published. The authors present a case of a 34 year-old man admitted to the hospital with lumbar pain and fever. At medical examination a mass was found in the left upper quadrant of the abdomen. The hormonal measurements of the adrenal gland were normal and the abdominal angio CT showed a left retroperitoneal lesion measuring 145 x 157 x 128 mm with extensive necrotic and hemorrhagic areas. The patient underwent a complete surgical resection of the lesion. The mass weighted 1495g and the histological exam revealed an oncocytic tumor of the adrenal gland with uncertain potential. Most of the oncocytic tumors are non functioning and must be considered in the differential diagnosis of adrenocortical tumors. The biologic behavior and the prognosis of these tumors are variable and still need a better definition. Due to the rarity of these tumors the authors made a revision on the published bibliography.

Os tumores oncocíticos da supra-renal são neoplasias pouco frequentes. Atualmente existem 147 casos publicados. Os autores descrevem o caso de um homem de 34 anos admitido no hospital por lombalgias e febre. À observação identificava-se massa no quadrante superior esquerdo do abdomen. Os doseamentos das hormonas da supra-renal foram normais e a angiotomografia abdominal mostrou lesão retroperitoneal esquerda com 145 x 157 x 128 mm com extensas áreas necrosadas e hemorrágicas. O doente foi submetido a ressecção cirúrgica completa da lesão. O tumor pesava 1495 g e o exame anatomo-patológico concluiu tratar-se de tumor oncocítico da supra-renal com potencial maligno incerto. A maioria dos tumores oncocíticos é não funcionante e devem ser considerados no diagnóstico diferencial de tumores do córtex da supra-renal. O comportamento biológico e o seu prognóstico são variáveis e ainda estão mal estabelecidos. A propósito da raridade deste tipo de tumores os autores fazem uma revisão da bibliografia publicada.

[Hypokalemic paralysis: the first presentation of primary Sjögren's syndrome]. / Paralisia Por Hipocaliémia: Manifestação Inaugural da Síndrome de Sjögren Primário.

The Sjögren's syndrome is a systemic autoimmune disorder characterized by chronic inflammation of the exocrine glands with extraglandular manifestations in up to 25% patients. Renal involvement occurs in 18.4-67% of cases, with tubulointerstitial nephritis being the most frequent pathology. We present the case of a 37 year-old woman admitted because of generalized grade 2 muscle weakness which developed over a week. We detected: hypokalemia, rhabdomyolysis, urinary pH 6.5, proteinuria and metabolic acidemia. The laboratory tests suggestive of distal renal tubular acidosis with hypokalaemia led to the diagnosis of lymphoplasmocytic tubulointerstitial nephritis, which was confirmed by renal biopsy, and to a clinical suspicion of Sjögren's syndrome. Primary Sjögren's syndrome was diagnosed in this patient based on the following criteria: xerophthalmia, xerostomia, sialadenitis, positive anti-SSA and anti-SSB antibodies, and absence of criteria for lupus and rheumatoid arthritis. During hospitalization, the patient developed deep vein thrombosis. Tests showed positive antiphospholipid antibodies and the diagnosis of secondary antiphospholipid syndrome was made. She was treated with potassium, bicarbonate, steroids, ramipril and warfarin. The authors wish to highlight the extraglandular manifestations and in particular the rarity of hypokalemic paralysis as the presenting manifestation of primary Sjögren's syndrome.