Patients' perspectives on the relevance of biosimilars' outcomes in oncology: qualitative study with nominal group technique.

PURPOSE: We aimed to rate the importance of outcomes from a systematic review about biosimilars in oncology from patients' perspective. METHODS: This is a qualitative research with nominal group technique. Patients with cancer were selected by convenience sampling and invited for two mediated virtual meetings in 2022. Twelve outcomes from a systematic review on biosimilars for oncology developed following a protocol were explained in plain language to participants who classified them as critical, important, or not important according to the Grading of Recommendations Assessment, Development and Evaluation approach. We employed Iramuteq software for lexical categorization of the meeting transcripts, and content analysis for interpretation. RESULTS: Five women participated (three had metastatic cancer, one non-metastatic, one recurrent). Six outcomes were classified as critical: duration of response, progression-free survival, pathological complete response, overall survival, severe adverse events, and quality of life; three as important: mortality, event-free survival, and objective response; and three as non-important: neutralizing anti-drug antibody, any adverse event, and non-neutralizing anti-drug antibody. Duration of response, pathological complete response, severe adverse events, and quality of life were considered secondary in the review protocol, but critical by the patients. The main themes influencing the importance classification were related to the disease (progression and control) and treatment (recognition and healthcare setting). CONCLUSION: Patients rated most outcomes as critical or important, some of them previously regarded as secondary by the researchers, which reinforces the need to include stakeholders' perspectives in oncology research. Aspects of the disease progression and treatment effects influenced participants' judgment on outcomes' relevance.

Potential interactions between antineoplastic agents and medicines used to treat Covid-19.

INTRODUCTION: Cancer patients with Covid-19 are exposed to treatment combinations that can potentially result in interactions that adversely affect patient outcomes. This study aimed to identify potential drug-drug interactions between antineoplastic agents and medicines used to treat Covid-19. METHODS: We conducted a search for potential interactions between 201 antineoplastic agents and 26 medicines used to treat Covid-19 on the Lexicomp® and Micromedex® databases. The following data were extracted: interaction severity ("major" and "contraindicated") and interaction effects (pharmacokinetic and pharmacodynamic). We also sought to identify the therapeutic indication of the antineoplastic drugs involved in the potential drug-drug interactions. RESULTS: A total of 388 "major" or "contraindicated" drug-drug interactions were detected. Eight drugs or combinations (baricitinib, lopinavir/ritonavir, atazanavir, darunavir, azithromycin, chloroquine, hydroxychloroquine, and sirolimus) accounted for 91.5% of these interactions. The class of antineoplastic agents with the greatest potential for interaction was tyrosine kinase inhibitors (accounting for 46.4% of all interactions). The findings show that atazanavir, baricitinib, and lopinavir/ritonavir can affect the treatment of all common types of cancer. The most common pharmacokinetic effect of the potential drug-drug interactions was increased plasma concentration of the antineoplastic medicine (39.4%). CONCLUSIONS: Covid-19 is a recent disease and pharmacological interventions are undergoing constant modification. This study identified a considerable number of potential drug-drug interactions. In view of the vulnerability of patients with cancer, it is vital that health professionals carefully assess the risks and benefits of drug combinations.

International Society of Oncology Pharmacy Practitioners global position on the use of biosimilars in cancer treatment and supportive care.

With the development of innovative cancer treatments over recent decades, the cost of cancer care has risen exponentially, limiting patient access to patented originator biotherapeutics in many countries. The introduction of biosimilars to the market has created new opportunities as well the need for changes in practice within healthcare institutions. A 'biosimilar' is a biotherapeutic product which is highly similar in terms of quality, safety and efficacy to an already licensed originator product. Although biosimilars lack clinically meaningful differences in therapeutic activity as compared to the originator product, these complex biological molecules are not considered identical chemical copies, unlike generics, and minor differences in molecular structure and inactive compounds may exist. A thorough understanding of these differences and their clinical implications is necessary for optimising medicines-use practices involving biosimilars. This position statement, developed by the International Society of Oncology Pharmacy Practitioners Biosimilars Taskforce, aims to provide the global oncology pharmacy community with guidance to support decisions around biosimilar use. The 11 statements cover the regulation and evaluation of biosimilars, practical issues around local implementation, the education of healthcare staff and patients, and the requirement for ongoing pharmacovigilance and outcome monitoring.

Late adverse effects related to treatment in a cohort of survivors of childhood and adolescent cancer.

Taking into consideration the progress in cancer treatment, an increase in the number of adult survivors of childhood cancer is expected. These survivors will have received treatment that predisposes them to late morbidity and increased risk of early mortality. The aim of this single-center retrospective cohort study was to describe the frequency and identify risk factors associated with late adverse events related to cancer treatment in survivors of childhood and adolescent cancer.Patients were recruited from 2010 to 2014. All possible late adverse effects identified, were classified according to CTCAE grading system version 4.0. The variables were characterized and stratified according to the presence or not of late effects. Odds ratio was used as a measure of association in bivariate analysis to identify characteristics associated with the late effects of treatment. Among 111 potentially eligible participants, 62 survivors met the inclusion criteria; 17 (27.4%) had abnormal test results observed in the systems: 8 (47%) in the endocrine and metabolic, 7 (41.2%) in the cardiovascular, 5 (29.4%) in the musculoskeletal, and 1 (5.9%) in auditory and renal systems. Frequency and severity of late adverse events were not affected by treatments employed; except for radiotherapy which was associated with a higher risk of late adverse effect occurrences.