RESUMEN
Pembrolizumab has received approval in the UK as first-line monotherapy for recurrent and/or metastatic HNSCC (R/M HNSCC) following the results of the KEYNOTE-048 trial, which demonstrated a longer overall survival (OS) in comparison to the EXTREME chemotherapy regimen in patients with a combined positive score (CPS) ≥1. In this article, we provide retrospective real-world data on the role of pembrolizumab monotherapy as first-line systemic therapy for HNSCC across 18 centers in the UK from March 20, 2020 to May 31, 2021. 211 patients were included, and in the efficacy analysis, the objective response rate (ORR) was 24.7%, the median progression-free survival (PFS) was 4.8 months (95% confidence interval [CI]: 3.6-6.1), and the median OS was 10.8 months (95% CI 9.0-12.5). Pembrolizumab monotherapy was well tolerated, with 18 patients having to stop treatment owing to immune-related adverse events (irAEs). 53 patients proceeded to second-line treatment with a median PFS2 of 10.2 months (95% CI: 8.8-11.5). Moreover, patients with documented irAEs had a statistically significant longer median PFS (11.3 vs. 3.3 months; log-rank p value = <.001) and median OS (18.8 vs. 8.9 months; log-rank p value <.001). The efficacy and safety of pembrolizumab first-line monotherapy for HNSCC has been validated using real-world data.
Asunto(s)
Anticuerpos Monoclonales Humanizados , Neoplasias de Cabeza y Cuello , Carcinoma de Células Escamosas de Cabeza y Cuello , Humanos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Masculino , Femenino , Carcinoma de Células Escamosas de Cabeza y Cuello/tratamiento farmacológico , Carcinoma de Células Escamosas de Cabeza y Cuello/mortalidad , Persona de Mediana Edad , Anciano , Estudios Retrospectivos , Reino Unido/epidemiología , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/patología , Neoplasias de Cabeza y Cuello/mortalidad , Adulto , Anciano de 80 o más Años , Antineoplásicos Inmunológicos/uso terapéutico , Antineoplásicos Inmunológicos/efectos adversos , Supervivencia sin ProgresiónRESUMEN
OBJECTIVES: This rapid review aims to evaluate the impact of the COVID-19 pandemic on incidence of head and neck cancer (HNC) and stage distribution at diagnosis. DESIGN: Rapid review and meta-analysis. PARTICIPANTS: Comparative data for new HNC patients between a pre-pandemic cohort (before March 2020) and a pandemic cohort (after March 2020 during the lockdown period). MAIN OUTCOMES MEASURED: Data on tumour stage, incidence, referral pathway (number of new patient referrals), or workload levels (number of HNC treatments). Data on stage were summarised as odds ratios (OR) with 95% confidence intervals (CI), and data related to changes in numbers of diagnoses, referrals, and workload levels were summarised as a narrative synthesis. RESULTS: A total of 31 reports were included in this review. Individually 16 out of 23 studies did not show a significant impact on stage relative to the pre-pandemic period. However, the meta-analysis revealed that patients diagnosed with HNC during the pandemic were 16% more likely to have nodal involvement (OR = 1.16; 95% CI 1.00-1.35), 17% more likely to have a late overall stage (OR = 1.17; 95% CI 1.01-1.36), and 32% more likely to present with advanced tumour extent (T3 and T4 stage) (OR = 1.32; 95% CI 1.08-1.62). Data on incidence was extremely limited and not currently sufficient to assess trends in burden of disease. CONCLUSIONS: This review indicates that during the COVID-19 pandemic, there was upstaging of HNC at diagnosis, suggesting the provision of care to HNC patients was significantly affected.
Asunto(s)
COVID-19 , Neoplasias de Cabeza y Cuello , Estadificación de Neoplasias , SARS-CoV-2 , Humanos , COVID-19/epidemiología , Neoplasias de Cabeza y Cuello/epidemiología , Incidencia , PandemiasRESUMEN
OBJECTIVE: To evaluate the impact of persistent precarious employment (lasting 12+ months) on the health of working age adults, compared with more stable employment. Persistent precarity reflects a shift towards less secure forms of employment and may be particularly important for health. METHODS: Nine databases were systematically searched to identify quantitative studies that assessed the relationship between persistent precarious employment and health outcomes. Risk of bias (RoB) was assessed using an adaptation of the Effective Public Health Practice Project tool. Narrative synthesis and random effects meta-analysis were conducted. Certainty of evidence was assessed using the Grades of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS: Of 12 940 records screened, 50 studies met the inclusion criteria and 29 were included in meta-analyses. RoB was generally high (n=18). The most reported outcome domain was mental health; with evidence also reported relating to general health, physical health,and health behaviours. Of GRADE assessed outcomes, persistent precarious employment was associated with increased risk of poor self-rated health (OR 1.53, 95% CI 1.09 to 2.14, I2=80%) and mental health symptoms (OR 1.44, 95% CI 1.23 to 1.70, I2=65%). The association with all-cause mortality was imprecisely estimated (OR 1.10, 5% CI 0.91 to 1.33, I2=73%). There was very low GRADE certainty across all outcomes. CONCLUSIONS: Persistent precarious employment is associated with poorer health, particularly for outcomes with short time lags, though associations are small and causality is highly uncertain. Further research using more robust methods is needed but given potential health harms of persistent precarious employment, exploration of precautionary labour regulations and employment policies is warranted.