The lack of head-to-head randomised trials and the consequences for patients and national health service: The case of non-small cell lung cancer.

INTRODUCTION: To introduce a drug to the market, it's not mandatory for it to be more effective and safer than the current treatment for the same condition. Consequently, head-to-head studies between the two best treatments for the same condition are not required, and this could result in a lack of information for patients, clinicians, and decision-makers. This study aims to evaluate the presence of head-to-head studies among the drugs used for the treatment of non-small cell lung cancer (NSCLC). METHODS: Taking into account the National Comprehensive Cancer Network (NCCN) guidelines updated to 2022, which list all available treatments for each NSCLC subtype, the search engine Pubmed and the platform clinicaltrials.gov were consulted to find all completed and ongoing head-to-head studies among various treatments for NSCLC. RESULTS: Among the anti-EGFR (epidermal growth factor receptor) drugs, 7 studies were found, with 6 completed and 5 registrational for drug commercialisation. No completed study to date has compared osimertinib and afatinib. For anti-ALK (anaplastic lymphoma kinase) drugs, 7 studies were found, with 5 completed. Alectinib, brigatinib, and lorlatinib have no completed comparison studies, but all were compared with crizotinib. Among various immunotherapy-based regimens, 5 studies were found, with only 1 completed. Therapeutic regimens based on pembrolizumab, atezolizumab, or the combination of nivolumab/ipilimumab have not been compared in studies published to date. CONCLUSION: There are few head-to-head studies comparing treatments for NSCLC; there are no such studies between the latest generation of drugs. Consequently, ambiguous areas exist due to the lack of comparative studies among the available evidence, preventing the clinician's choice of the most effective treatment and risking the patient receiving suboptimal therapy. Simultaneously, the price of the drug cannot be determined correctly, relying only on indirect evaluations from different trials. To dispel this uncertainty, it would be desirable to initiate a process that brings together the demands derived from clinical practice and clinical research to provide clinicians and patients with the best possible evidence.

Increasing pharmacy productivity and reducing medication turnaround times in an Italian comprehensive cancer center by implementing robotic chemotherapy drugs compounding.

INTRODUCTION: The management of antineoplastic drugs used for chemotherapy is widely recognized as a high-risk activity. In 2018, our oncology pharmacy implemented workflow improvements to manage the growing workload due to the centralisation of activities from a hospital's satellite pharmacy, moving towards automated compounding of antineoplastic drugs.The aim of this study was to determine the impact of the centralization on the productivity of the pharmacy department and evaluate the performances of the robotic chemotherapy drugs compounding. MATERIAL AND METHODS: Data were collected from the hospital information system and the workflow management software, and examined over a 3-year period (2017-2019). The total annual throughput in terms of doses prepared and patients treated and the Medication Turnaround Time (MTAT) were determined. Productivity and dosage accuracy were calculated for the robotic system. RESULTS: In 2018, the number of patients treated increased by 16.6%, consequently, the overall number of intravenous preparations compounded in the pharmacy increased by 17.2%. Regarding manual compounding, the total number of antineoplastic preparations decreased by about 2%. Investigational treatments manually compounded increased by about 27%, in contrast to the non-investigational treatments, which decreased by 9.4%. Regarding robotic compounding, the annual production increased by 50.4%. In 2018, the MTAT decreased about 24%. The dosage accuracy and precision of the total amount of doses were -1.1% and 1.2%, respectively. CONCLUSION: This study indicates that in the effort to satisfy an ever-increasing workload, computerization and automation are essential instruments to maintain and ensuring high standards of quality.