medwireNews: The use of immune checkpoint inhibitors (ICIs) is not associated with excess toxicity in people living with HIV (PWH) and a concomitant diagnosis of cancer, indicate real-world results.
ICIs were also efficacious in this population, and although they showed “differential activity across cancer types,” the objective response rates (ORRs) followed the general trends seen in people without HIV, note the researchers in the Journal of Clinical Oncology.
They analyzed data from the multicenter CATCH-IT consortium on 390 PWH who had received at least one dose of ICI-based therapy for a solid or hematologic malignancy.
Participants were aged a median of 58 years and 85% were men. The most common tumor type in the cohort was non-small-cell lung cancer (NSCLC), in 28%, followed by hepatocellular carcinoma (HCC) and head and neck squamous cell carcinoma (HNSCC), in a respective 11% and 10% of participants.
All were receiving antiretroviral therapy prior to the initiation of ICIs, with 79% taking an integrase-strand transfer inhibitor as part of the regimen. Of the 216 individuals with available data on CD4+ T-cell counts, 70% had levels of 200 cells/µL or greater, while 63% of 146 with available data had a CD4:CD8 ratio of at least 0.4.
Abdul Rafeh Naqash (University of Oklahoma, Oklahoma City, USA) and co-authors found that immune-related adverse events (irAEs) of any grade occurred in 20.0% of the cohort, irAEs of at least grade 3 in 7.7%, and irAEs leading to hospitalization in 7.4%.
Colitis/diarrhea and pneumonitis were the most frequently observed irAEs of grade 3 or worse, each in 1.5% of PWH. And there was one fatal irAE attributed to ICI therapy, a case of grade 5 pneumonitis 16 days after one dose of nivolumab in a patient with SCLC.
Of note, individuals with CD4+ T-cell counts of at least 200 cells/µL and those with lower counts had a comparable incidence of both any-grade irAEs (16.0 vs 24.0%) and grade 3 or more severe irAEs (7.8 vs 9.9%).
“These data further endorse the need to abrogate arbitrary CD4 cutoffs when using ICIs in the appropriate setting for the treatment of PWH and subsequently reduce barriers to ICI access on the basis of their favorable benefit-to-risk profiles,” writes the team.
With regard to efficacy, the highest ORRs were observed among participants with nonmelanoma skin cancer, Hodgkin’s lymphoma, or Kaposi’s sarcoma, at 69%, 67%, and 60%, respectively, followed by rates of 47% among those with melanoma and 31% among those with NSCLC.
The lowest ORRs were seen in the HNSCC subgroup, at 11%, and the anal cancer and HCC subgroups, at an identical 16%.
The investigators also compared the outcomes of 61 PWH with those of 110 matched participants without HIV, all of whom received ICIs for metastatic NSCLC. After accounting for race, performance status, histology, smoking status, and PD-L1 levels, the restricted mean survival time difference at 42 months was a nonsignificant –0.06 months for progression-free survival and 2.23 months for overall survival.
The ORRs did not differ significantly between people with and without HIV (28 vs 36%) and the incidence of irAEs of any grade (20 vs 22%) and of at least grade 3 (12 vs 9%) was also comparable.
“[T]hese results add to the growing body of evidence supporting the use of ICIs among PWH to enhance their inclusion in ICI clinical studies,” conclude Rafeh Naqash and colleagues.
Commenting on the findings, Associate Editor of the journal Gary Schwartz (Columbia University, New York, USA) writes in the article that “[t]his study should reassure physicians that the use of ICIs is safe and effective in this patient population, even for those on [antiretroviral therapy].”
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