A phase 2 study of first-line nivolumab in patients with locally advanced or metastatic cutaneous squamous-cell carcinoma.

BACKGROUND: Cutaneous squamous-cell carcinoma (CSCC) is among the most frequent malignancies worldwide. For those not amenable to treatment with curative intent, immune checkpoint inhibition (ICI) with anti-programmed death receptor 1 (PD-1) antibodies has emerged as a novel therapeutic option. In this study, the authors sought to investigate the activity of the anti-PD-1 agent nivolumab in patients with advanced CSCC (aCSCC). METHODS: CA209-9JC was an open-label, single-arm, phase 2 study to evaluate the safety and/or efficacy of nivolumab in systemic treatment-naive patients with aCSCC. Nivolumab (3 mg/kg) was administered every 2 weeks until disease progression, unacceptable toxicity, or 12 months of treatment. The primary end point was the best objective response rate (BORR) as per RECIST 1.1 criteria. Secondary end points included safety, progression-free survival (PFS), and overall survival (OS). RESULTS: Twenty-four patients with aCSCC were enrolled with a median age of 74 years (range, 48-93). Among the 24 patients evaluable for response, the BORR was 58.3% (14/24); there were no complete responses. With a median follow-up of 17.6 months, median duration of response has not been reached, and the estimated median PFS and OS were 12.7 and 20.7 months, respectively. Prior exposure to radiotherapy was associated with worse outcomes (p = .035, univariate analysis). Treatment-related adverse events of any grade and grade ≥ 3 occurred in 21 (87.5%) and six (25%) patients, respectively, and one patient discontinued nivolumab due to toxicities. CONCLUSIONS: Nivolumab resulted in robust antitumor activity, sustained responses, and good tolerability in systemic treatment-naive patients with aCSCC. These data provide further evidence to support the use of ICI as the standard treatment of aCSCC.

Readmissão precoce em hospital público de alta complexidade em cardiologia / Early readmission in a high complexity public hospital in cardiology

Avaliar a readmissão precoce de pacientes em hospital público de alta complexidade em cardiologia.Métodos: estudo descritivo, documental e retrospectivo, realizado em instituição pública hospitalar. Resultados:dos 9.218 pacientes internados, em 2012, 729 foram readmitidos, destes, 47,9% reinternaram dentro de 30dias após a alta hospitalar, sendo 61% homens, idade média de 57 anos, tendo o principal diagnóstico médico de doenças cardíacas (insuficiência cardíaca, tratamento de síndrome coronariana aguda, entre outros) na admissão (44,7%) e na readmissão (45,8%). A maioria foi readmitida pela mesma razão médica que motivou a primeira hospitalização. Conclusão: em consideração ao perfil da população admitida e readmitida na instituição, acredita-se que a taxa de readmissões se deve, principalmente, ao perfil dos pacientes, ponderando a alta prevalência de doenças crônicas não transmissíveis, e doença arterial coronariana considerada inabordável para tratamento percutâneo ou cirúrgico na admissão.

Objective: to evaluate the early readmission of patients in a high complexity public hospital in cardiology. Methods: this is a descriptive, documental and retrospective study, carried out in a public hospital. Results: in 2012, 729 of the 9,218 hospitalized patients were readmitted, 47.9% of them were readmitted within 30 days after discharge, 61% were men, with a mean age of 57 years old, with the main medical diagnosis of heart disease (heart failure, treatment of acute coronary syndrome, among others) on admission (44.7%) and readmission (45.8%). Most were readmitted for the same medical reason that led to their first hospitalization. Conclusion: considering the profile of the population admitted and readmitted to the institution, it is believed that the rate of readmission is mainly due to the profile of the patients, considering the high prevalence of non-communicable chronic diseases, and coronary artery disease considered unapproachable for percutaneous or surgical when hospitalized.

Assessment of the health status in Brazilian burn victims five to seven months after hospital discharge.

PURPOSE: To evaluate health status, impact of event, anxiety, and depression in burn victims at five-to-seven months after hospital discharge, and to explore the association between those variables with age, body surface area burn (BSA), sex, and marital status. METHODS: Cross-sectional study involving 73 adults who were interviewed for general health status (BSHS-R), impact of event (IES), and anxiety and depression (HADS). RESULTS: Participants were mostly men (68.5%), with mean age 38.4 years (SD = 14.5), and mean hospital length of stay (LOS) 24.5 days (SD = 25.3). Mean scores were: 128.1 (SD = 18.9) for BSHS-R, 62.1(SD = 35.8) for IES, 5.5 (SD = 4.1) for anxiety, and 3.9 (SD = 3.9) for depression. Health status was highly and inversely correlated with impact of event, depression, anxiety, LOS, number of surgeries, and BSA. Men and women differed in the BSHS-R affect and body image domains, and depression. Individuals with larger BSA reported worse scores for BSHS-R (work domain). CONCLUSION: Burn victims reported good health status on average, which was negatively correlated with reported depression, anxiety, impact of event, LOS, number of operations, and BSA. These findings suggest that general health might be improved by interventions that target modifiable behavioral factors, such as support groups and cognitive behavioral therapies.