IFCT-1001 CHIVA trial: A phase II study of carboplatin (Ca) plus pemetrexed (P) followed by P maintenance, as first-line therapy for human immunodeficiency virus (HIV)-associated advanced non-squamous non-small-cell lung cancer (NS-NSCLC)
Lung cancer and especially nonsquamous non–small-cell lung cancer (NS-NSCLC) is the first cause of mortality by cancer in the HIV population, and the prognosis of lung cancer is worse in HIV-positive individuals.1
However, recommendations for treatment of advanced NSCLC are lacking in this population, as HIV seropositivity is an exclusion criterion from most trials. Lavole and colleagues conducted a multicenter phase 2 trial to evaluate the efficacy and safety of carboplatin plus pemetrexed (CaP) induction followed by pemetrexed maintenance, in HIV-associated advanced NS-NSCLC.2
Four cycles of CaP were administered, followed by pemetrexed until progression. The primary end point was a ≥30% disease control rate (DCR) after 12 weeks. Secondary end points were objective response rate, progression-free survival (PFS), and overall survival (OS), as well as the incidence of adverse events (AEs) and opportunistic infections. A total of 61 patients were enrolled with a median CD4 count at diagnosis and at a median nadir of 163 CD4+ T-cells/µL (range, 1-822). Median HIV viral load was 39 copies/µL (0-95499) and 96% of patients received antiretroviral treatment. DCR after 4 cycles was 50.8 % (95% confidence interval, 38.3-63.4); of these, 29.5% were partial responses and 21.3% had stable disease. After a median follow-up of 26 months, median PFS was 3.5 months (range, 2.7-4.4) and median OS was 7.6 months (range, 5.7-13.2). Grade ≥3 hematologic AEs during cycles 1 to 4 included leukopenia (3.3%), neutropenia/febrile neutropenia (53.3%/6.7%), anemia (30%), and thrombocytopenia (35%). A global quality of life (QOL) survey showed that after 4 cycles of therapy, the average QOL score improved in 26% of the patients from baseline, remained stable in 50%, and declined in 13% of the patients. Grade ≥3 nonhematologic AEs included nausea (5%), vomiting (5%), renal failure (<1%), paresthesia (<1%), and infection (6.6%). Two deaths related to sepsis were observed, but no opportunistic infections were noted. The authors concluded that 4 cycles of CaP induction, followed by pemetrexed maintenance, were effective and reasonably well-tolerated as first-line therapy of HIV-infected patients with NS-NSCLC.
- Lavole A, et al. Rev Mal Respir. 2014;31:133-141.
- Lavole A, et al. ASCO 2016. Abstract 9076.