(ChemotherapyAdvisor)–Profound immunodeficiency and high HIV-1 viral load in patients with AIDS-related lymphoma “do not preclude attainment of complete response after rituximab plus pegylated liposomal doxorubicin with highly active antiretroviral therapy (HAART),” the AIDS Malignancy Consortium Study 047 concluded in the Journal of Clinical Oncology online November 19.
“The regimen is tolerable, and use of rituximab was not associated with death as a result of infection during treatment,” noted Alexandra M. Levine, MD, of City of Hope National Medical Center, Duarte, CA, and colleagues. “This approach may be useful in patients in whom the more intensive infusional regimens are impractical.”
By substituting long-acting pegylated liposomal doxorubicin in a regimen similar to R-CHOP, the investigators hoped to improve outcome in patients with newly diagnosed AIDS-related lymphoma, “while obviating the need for multiple-day continuous infusions.”
In the prospective, multi-institutional phase II trial, patients were administered pegylated liposomal doxorubicin 40mg/m2, rituximab 375mg/m2, cyclophosphamide 750mg/m2, vincristine 1.4mg/m2 (not >2 mg) on day 1 and prednisone 100mg orally on days 1 through 5 with concomitant HAART, which was required; zidovudine was prohibited. The specific HAART regimen was left to physician discretion.
In 40 evaluable patients, median CD4 cell count was 114/µL (range 5 to 1,026/µL), and median HIV-1 viral load was 25,000 copies/mL, 28% of whom had high or intermediate/high age-adjusted International Prognostic Index scores.
“Overall response was 67.5%, with complete remission in 47.5% (95% CI 31.5–63.9). Of 19 complete responders, 84% had extranodal disease, 47% had CD4 <100/µL, and 47% had VL >50,000 copies/mL; one relapsed,” they reported. At a median follow-up of 25.5-months, 62% of patients remained alive.
Sixteen patients (40%) had 22 infections; 2 (5%) grade 4; 1 had opportunistic infection.