Real-World Data (RWD) studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice for novel cancer drugs. However, few studies have systematically appraised their quality or compared outcomes to pivotal trials. Methods: All RWD studies (2010e2019) for drugs approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) from 2010 to 2015 for solid organ tumours in the non-curative setting were identified. Quality assessment was undertaken using the Newcastle Ottawa Scale. Survival differences between each RWD study and the pivotal trial were determined using a related sample Wilcoxon signed-rank test. Results: 293 RWD studies for 45 of the 57 drug indications approved by the FDA/EMA were identified. The most common tumour types were prostate cancer (29%, n Z 86) and melanoma (15%, n Z 43). A quarter of the studies had industry funding. No high-quality studies were identified, and 78% were low quality. Comparative survival analysis between RWD and

Nivolumab is an anti-PD-1 monoclonal antibody currently used as immunotherapy for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) with evidence of disease progression after platinum-based chemotherapy. This study evaluates real-world safety and treatment outcomes of non-trial nivolumab use. A retrospective multicenter cohort study of patients with recurrent/metastatic HNSCC treated with nivolumab between January 2017 and March 2020 was performed. Overall, 123 patients were included. The median age was 64 years, the majority of patients were male (80.5%) and had a smoking history (69.9%). Primary outcomes included overall response rate (ORR) of 19.3%, median progression-free survival (PFS) of 3.9 months, 1-year PFS rate of 16.8%, a median overall survival (OS) of 6.5 months and 1-year OS rate of 28.6%. These results are comparable to the CHECKMATE-141 study. Of 27 patients who had PD-L1 status tested, positive PD-L1 status did not significantly affect PFS (p = 0.86) or OS (p = 0.84). Nivolumab was well tolerated with only 15.1% experiencing immune-related toxicities (IRT) and only 6.7% of patients stopping due to toxicity. The occurrence of IRT appeared to significantly affect PFS (p = 0.01) but not OS (p = 0.07). Nivolumab in recurrent/metastatic HNSCC is well tolerated and may be more efficacious in patients who develop IRT.

Blood cultures are important tools for the evaluation of sepsis in febrile neutropenia (FN) patients. Febrile neutropenia remains a serious complication of anticancer systemic chemotherapy with increased mortality worldwide. NICE (National Institute of Clinical Excellence) UK issued clinical practice guideline to prevent and manage febrile neutropenia in cancer patients [1]. There was also a genuine concern about diagnostic dilemma and management of febrile neutropenia during recent pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) associated disease COVID-19 [2]. Healthcare resources were already limited and were overwhelmed rapidly by large influx of patients [3]. Routine medical care including management of cancer patient was severely disrupted [4]. This led to the developments of rapid guidelines to manage cancer patients across the world [5]. NICE and other bodies issued rapid guidelines to manage febrile neutropenia during COVID-19 period [6]. Majority of guidelines consider blood culture an essential part in assessment of sepsis in febrile neutropenia [1]. This prospective study was done in hospitalized patients who developed febrile neutropenia while on chemotherapy, looking at various factors and their impact on outcome. The objective of this study was to evaluate whether antibiotic choice is affected by blood culture utilization in febrile neutropenia [7].

No abstract

No abstract