patients, including CD86 (2.8-fold increase in classic monocytes, p¼0.06) and CCR2 (2.9-fold in intermediate monocytes, p¼0.17; 11-fold in non-classic monocytes, p¼0.03). Conclusions:In cancer patients presenting with severe SARS-CoV-2 positive pneumonia, the infection may cause a hypercoagulable state, as suggested by higher levels of D-dimer, and unleash a pro-inflammatory response. Marked CD4 + T lymphocytopenia and NK expansion may reflect lymphocyte exhaustion and dysregulated cytotoxicity. Monocyte activation and recruitment also seem to be strongly upregulated.Legal entity responsible for the study: Hospital Clínico San Carlos.
Purpose: Chemotherapy-induced nausea and vomiting is a highly prevalent adverse event that could lead to worse treatment adherence and decreased quality of life1,2. To our knowledge, total dexamethasone omission from any regimen to prevent nausea and vomiting has not been evaluated2-4. This study aimed to address the efficacy of a three-drug protocol in preventing nausea and vomiting, with no corticosteroids included. Methods: This was a prospective single-arm phase II study designed to evaluate the efficacy of olanzapine, netupitant, and palonosetron in controlling nausea and vomiting induced by highly emetogenic chemotherapy. Patients were assigned to take olanzapine on Days 1–5 and netupitant and palonosetron on Day 1. No corticosteroid use was allowed. The primary endpoint was complete control of nausea in the first 5 days after chemotherapy administration. Secondary endpoints were complete emesis control (no emesis and no use of rescue medication) and complete control (no emesis, no rescue, and no nausea). Results: For the primary endpoint, the complete nausea control rate was 46% (CI 32–59%), with p < 0.0001. The emesis control rate was 68% (IC 55–80%), and the overall control rate was 46% (IC 32–59%). Conclusion: Omitting dexamethasone for highly emetogenic chemotherapy is feasible and showed a nausea and vomiting control rate that was similar to that of the standard four-drug protocol. Trial registered by the number NCT04669132, on December 16, 2020, on clinicaltrials.gov platform.
Objective To evaluate the severity of COVID-19 in cancer patients to describe clinical and epidemiological factors associated with poor outcomes (mortality and need of intensive care unit admission or mechanical ventilation). Methods Retrospective data from patients with cancer and laboratory diagnosis of COVID-19, obtained between March 16 and May 29, 2020, were retrieved out of a cancer center database. Data analyzed included patient history, age, sex, comorbidities, types of cancer and anticancer therapy. Results This sample comprised 105 patients aged 18-92 years, 80.9% of whom were females. Dyspnea was the most prevalent initial symptom (30.4%) among patients who died (p<0.0001). Overall, 57.1% of patients had metastatic disease and 60% had poor performance status (Eastern Cooperative Oncologic Group ≥2) at the time of COVID-19 diagnosis. The overall mortality rate was 40.95%. Mortality rates were higher in male patients and those with poor performance status (p<0.0001). Conclusion This cohort is one of the largest Brazilian studies describing clinical and epidemiological features of patients with cancer and concurrent COVID-19. Findings of this study emphasize the vulnerability of cancer patients in the current pandemic, and indicate high mortality from COVID-19 among male cancer patients and cancer patients with poor performance status. This analysis may assist the selection of patients who may benefit from strict isolation and eventual discontinuation of anticancer therapy to reduce exposure to infection.
e24057 Background: The number of breast cancer survivors has grown worldwide in recent years due to advances in treatments, however, increased survival lead to the appearance of signs and symptoms after the end of treatment that affect the quality of life of these patients in the long term. Methods: Women aged 20-60 years with a diagnosis of breast cancer and primary treatment for at least 1 year were selected. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire was used and sociodemographic data, life habits and clinical conditions of the participants were collected. The primary end point was to identify the main repercussions of breast cancer and its treatments. Results: A total of 87 women were enrolled for this study. The mean age was 48.5 years. The main symptoms identified were pain (15.48%), nausea (13.10%), fatigue (11.90%), hot flashes (9.52%) and insomnia (5.95%). The total FACT-B+4 score was 110.75 (SD 20.02). No statistically significant variables were identified as predictors of worsening quality of life. Conclusions: The main residual problems in breast cancer survivors 1 year after curative treatment at Hospital São Camilo Oncologia were identified, however, it was not possible to establish significant predictors of worsening quality of life. We will conduct a new interview in 1 year using others quality of life assessment instruments.
12104 Background: Chemotherapy induced nausea and vomiting (CINV) is a highly prevalent adverse event1,2 that can result in decreased quality of life, dose reduction and interruptions of treatment.3 Four drug protocol including Olanzapine, 5-hydroxytryptamine type 3 receptor (5HT3) antagonist, a neurokinin 1 receptor (NK1) antagonist and dexamethasone is the current standard of care for highly emetogenic chemotherapy (HEC) 2,4-6. Corticosteroids are associated with side effects like insomnia and weight gain. To our knowledge, total Dexamethasone omission has not been addressed previously. Methods: This is a prospective single arm phase II study designed to evaluate the efficacy of Olanzapine, Netupitant and Palonosetron in controlling nausea and vomiting induced by highly emetogenic chemotherapy. Eligible patients were women with histologic confirmed breast cancer, planned to start treatment with Doxorubicin and Cyclophosphamide. Exclusion criteria included use of opioids or antipsychotic medications, medical condition that could potentially cause vomiting or inability to take oral medications. Patients were assigned to take Olanzapine 5mg QD, days 1 – 5, Netupitant 300mg and Palonosetron 0.5mg on day one. No corticosteroid use was allowed. The null hypothesis considered that the scheme containing Olanzapine, Netupitant and Palonosetron could not effectively control nausea. Based on a previous phase III study with Olanzapine (Navari et al.), we set the control of nausea at 20% and the expected control rate at 40% for the present study. To reach 5% (two-sided) significance and 80% statistical power, we calculated that a minimum sample size of 50 patients was required, assuming a 5% dropout rate. We used the one-sample T-test of proportion to analyze the data, based on intent-to-treat (ITT) The primary endpoint was complete control of nausea in the first 5 days after chemotherapy administration. Secondary endpoints were complete emesis control (no emesis, no use of rescue medication) and complete control (no emesis, no rescue and no nausea) Results: Fifty patients were enrolled from January 2020 to December 2021. The median age was 47.6 years-old (range: 29 – 78 years) and 48 patients (96%) received chemotherapy with curative intent. For the primary endpoint, complete nausea control rate was 46% (IC 32 – 59%) and p < 0.0001. The emesis control rate was 68% (IC 55 – 80%) and overall control rate was 46% (IC 32 – 59%). One patient dropped out for dizziness and drowsiness following administration of Olanzapine. Conclusions: Omitting Dexamethasone for highly emetogenic chemotherapy is feasible and showed similar control of nausea and vomiting compared to standard four-drug protocol. This could be a potential prophylactic regimen of choice for patients who have a contraindication for Dexamethasone use. Clinical trial information: NCT04669132.
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