Résumé
SUMMARY OBJECTIVE: Anticipatory nausea and vomiting are unpleasant symptoms observed before undergoing chemotherapy sessions. Less is known about the occurrence of symptoms since the advent of the new neurokinin-1 antagonist. METHODS: This prospective cohort study was performed at a single Brazilian Institution. This study included breast cancer patients who received doxorubicin and cyclophosphamide chemotherapy and an appropriate antiemetic regimen (dexamethasone 10 mg, palonosetron 0.56 mg, and netupitant 300 mg in the D1 followed by dexamethasone 10 mg 12/12 h in D2 and D4). Patients used a diary to record nausea, vomiting, and use of rescue medication in the first two cycles of treatment. The prevalence of anticipatory nausea and vomiting was assessed before chemotherapy on day 1 of C2. RESULTS: From August 4, 2020, to August 12, 2021, 60 patients were screened, and 52 patients were enrolled. The mean age was 50.8 (28-69) years, most had stage III (53.8%), and most received chemotherapy with curative intent (94%). During the first cycle, the frequency of overall nausea and vomiting was 67.31%, and that of severe nausea and vomiting (defined as grade>4 on a 10-point visual scale or use of rescue medication) was 55.77%. Ten patients had anticipatory nausea and vomiting (19.23%). The occurrence of nausea and vomiting during C1 was the only statistically significant predictor of anticipatory nausea and vomiting (OR=16, 95%CI 2.4-670.9, p=0.0003). CONCLUSION: The prevalence of anticipatory nausea is still high in the era of neurokinin-1 antagonists, and failure of antiemetic control in C1 remains the main risk factor. All efforts should be made to control chemotherapy-induced nausea or nausea and vomiting on C1 to avoid anticipatory nausea.
Résumé
Para avaliar o papel da pregabalina na proteção das náuseas e vômitos induzidos pela quimioterapia, foi realizado um ensaio clínico de fase II, aleatorizado, duplamente cego, controlado por placebo, para investigar se a pregabalina poderia melhorar o controle completo das náuseas e vômitos (desfecho primário). Inscrevemos 82 pacientes virgens de quimioterapia, programados para receber quimioterapia moderadamente e altamente emetogênica. Todos os doentes receberam ondansetron 8mg por via intravenosa, dexametasona 10mg antes da quimioterapia no primeiro dia e, dexametasona 4 mg por via oral, b.d., nos dias dois e três. Os doentes foram distribuídos aleatoriamente para tomar pregabalina 75 mg ou placebo, bd, desde a noite anterior à quimioterapia até ao quinto dia. A resposta completa global não foi estatisticamente significativa entre os grupos (53,7 versus 48,8%, respetivamente, no grupo da pregabalina e no grupo de controlo (P=0,65)). Também não houve diferença estatística significativa durante a fase aguda (primeiras 24 horas) e a fase tardia (24-120h): 80,5% versus 82,9% (P=0,77), 53,7 versus 51,2% (P=0,82), respectivamente. Neste estudo não foi identificada ação da pregabalina na prevenção de náuseas e vômitos induzidos por quimioterapia. Número de registo no Clinicaltrial.gov: NCT04181346.
To evaluate the role of pregabalin in the protection of chemotherapy-induced nausea and vomiting, we performed a phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled 82 chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients received IV ondansetron 8mg, dexamethasone 10mg before chemotherapy on day one and oral dexamethasone 4mg, b.d., on days two and three. Patients were randomly assigned to take pregabalin 75mg or placebo, bd, from the night before chemotherapy to day five. The overall complete response was not statistically significant between the groups (53.7 versus 48.8%, respectively, in the pregabalin group and the control group (P=0.65)). There was also no significant difference during the acute phase (first 24 hours) and delayed phase (24-120h): 80.5% versus 82.9% (P=0.77), 53.7 versus 51.2% (P=0.82), respectively. There is no role for pregabalin preventing chemotherapy-induced nausea and vomiting. Clinicaltrial.gov registration number: NCT04181346.
Résumé
ABSTRACT 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.
RESUMO Objetivo Avaliar a gravidade da infecção por COVID-19 em pacientes oncológicos, determinando os aspectos clínicos e epidemiológicos associados ao pior desfecho, seja em termos de mortalidade, necessidade de internação em unidade de terapia intensiva ou ventilação mecânica. Métodos Pacientes com câncer e diagnóstico confirmado por laboratório de COVID-19 foram identificados nos bancos de dados de um hospital oncológico entre 16 de março e 29 de maio de 2020. Os dados coletados incluíram história, idade, sexo e comorbidades dos pacientes, além dos tipos de câncer e do tratamento anticâncer. Resultados Dentre os 105 pacientes analisados, a idade variou de 18 a 92 anos, e 80,9% eram do sexo feminino. Dispneia foi o sintoma inicial mais prevalente entre os que morreram (30,4%). No momento do diagnóstico da infecção, 57,1% apresentavam doença metastática e 60% performance status ruim (Eastern Cooperative Oncologic Group ≥2). A taxa de mortalidade geral foi 40,95% e superior entre os homens e pacientes com baixo nível de performance status (p<0,0001). Conclusão Este coorte é um dos estudos mais robustos do Brasil, descrevendo características clínicas e epidemiológicas de pacientes com câncer e COVID-19. Os achados do estudo alertam para a vulnerabilidade dos pacientes oncológicos na pandemia atual e demonstram alta mortalidade por COVID-19 em pacientes do sexo masculino e com pior performance status. Essa análise pode ajudar a selecionar os pacientes que podem se beneficiar de isolamento rigoroso e até mesmo da interrupção do tratamento, reduzindo a exposição à infecção.