Exclusion of patients living with HIV from cancer immune checkpoint inhibitor trials
| Autor: | Mark M. Awad, Biagio Ricciuti, Kruti Vora |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Science Immune checkpoint inhibitors Population Clinical Decision-Making Human immunodeficiency virus (HIV) Antineoplastic Agents HIV Infections medicine.disease_cause Article 03 medical and health sciences 0302 clinical medicine Internal medicine Neoplasms Antineoplastic Combined Chemotherapy Protocols medicine Humans 030212 general & internal medicine Prospective cohort study education Immune Checkpoint Inhibitors education.field_of_study Clinical Trials as Topic Multidisciplinary business.industry Health care Cancer Disease Management Trial Phase medicine.disease Exact test Oncology 030220 oncology & carcinogenesis Cohort Medicine business |
| Zdroj: | Scientific Reports Scientific Reports, Vol 11, Iss 1, Pp 1-6 (2021) |
| ISSN: | 2045-2322 |
| Popis: | Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency virus (PLWH), however this high-cancer-risk population has often been excluded from groundbreaking cancer ICI trials. Our study aimed to characterize the current rate of exclusion and conditional inclusion of PLWH in cancer ICI trials by tumor type, trial phase, and year. ClinicalTrials.gov cancer ICI trials with planned starts between 1/1/2019 and 10/20/2020 were identified. Based on trial eligibility criteria, trials were categorized as “excluded” if PLWH could not enroll, “conditionally included” if only PLWH with adequate immune function were allowed, or “included/not specified” if HIV was not mentioned in the eligibility criteria. Trials from 2014 were separately collected for comparison over time. The number of trials excluding PLWH were compared to the included/not specified group using Fisher’s exact test. Of 809 trials analyzed from 2019 to 2020, 74.4% excluded, 6.9% conditionally included, and 18.7% included/did not specify PLWH. Early phase trials excluded PLWH more frequently than late phase trials. The 2019–2020 trial cohort showed no significant change in exclusion of PLWH compared to 2014. Despite increasing evidence for safe and effective ICI use for PLWH, most cancer ICI trials exclude PLWH and few studies permit PLWH to participate, even if HIV is well-controlled. |
| Databáze: | OpenAIRE |
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