Safety and Tolerability of Carboplatin and Paclitaxel in Cancer Patients with HIV (AMC-078), an AIDS Malignancy Consortium (AMC) Study

Missak Haigentz, Page Moore, Milan Bimali, Timothy Cooley, Joseph Sparano, Michelle Rudek, Lee Ratner, David Henry, Juan Ramos, John Deeken, Paul Rubinstein, Elizabeth Chiao, Missak Haigentz, Page Moore, Milan Bimali, Timothy Cooley, Joseph Sparano, Michelle Rudek, Lee Ratner, David Henry, Juan Ramos, John Deeken, Paul Rubinstein, Elizabeth Chiao

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.

Keywords: HIV; antiretroviral; carboplatin; paclitaxel; ritonavir.

© The Author(s) 2022. Published by Oxford University Press.

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