Center for Medical Ethics and Health Policy Staff Publications
Publication Date
8-5-2022
Journal
The Oncologist
DOI
10.1093/oncolo/oyac004
PMID
35429391
PMCID
PMC9355812
PubMedCentral® Posted Date
4-16-2022
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Keywords
Acquired Immunodeficiency Syndrome, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Cytochrome P-450 CYP3A Inhibitors, HIV Infections, Humans, Neoplasms, Paclitaxel, HIV, paclitaxel, carboplatin, ritonavir, antiretroviral
Abstract
Background: Persons living with human immunodeficiency virus are an underserved population for evidence-based cancer treatment. Paclitaxel and carboplatin (PCb) is an active regimen against a variety of solid tumors, including several seen in excess in patients with HIV infection. We performed a pilot trial to evaluate the safety of full-dose PCb in people living with human immunodeficiency virus and cancer.
Methods: Eligible patients, stratified by concurrent antiretroviral therapy (ART) that included CYP3A4 inhibitors or not, received paclitaxel (175 mg/m2) in combination with carboplatin (target AUC 6) intravenously every 3 weeks for up to 6 cycles.
Results: Sixteen evaluable patients received 64 cycles of PCb, including 6 patients treated with CYP3A4 inhibiting ART (ritonavir). The adverse event profile was consistent with the known toxicity profile of PCb, with no differences between the 2 strata. There were 4 partial responses (25%, 95% CI: 7%-52%), and overall, CD4+ lymphocyte count was similar after completion of therapy (median: 310/μL) compared with baseline values (median: 389/μL). Pharmacokinetic studies in 6 patients revealed no significant differences in Cmax or AUCinf for paclitaxel between the 2 cohorts.
Conclusion: Full doses of PCb chemotherapy are tolerable when given concurrently with ART in people living with human immunodeficiency virus with cancer, including patients receiving CYP3A4 inhibitors.
Clinicaltrials.gov identifier: NCT01249443.