Safety and efficacy of cyclophosphamide, adriamycin, vincristine, prednisone and rituximab in patients with human immunodeficiency virus‐associated diffuse large B‐cell lymphoma: results of a phase II trial

Immunochemotherapy with cyclophosphamide, adriamycin, vincristine, prednisone and rituximab (R‐CHOP) is the standard treatment in non‐immunosuppressed patients with diffuse large B‐cell lymphoma (DLBCL), but its adequacy has not been definitively established in patients with human immunodeficiency virus (HIV)‐related lymphoma. This phase II trial aimed to evaluate the safety and efficacy of six cycles of R‐CHOP in patients with HIV‐related DLBCL and to determine whether response to highly active antiretroviral therapy (HAART) had prognostic impact. Patients were eligible if they had performance status <3 and absence of active opportunistic infections. Eighty‐one patients were enrolled, 57 in stages III or IV, International Prognostic Index (IPI) 0 or 1 (n = 26), 2 (n = 19), 3 (n = 20) and 4 or 5 (n = 16), and median CD4 lymphocyte count of 0·158 × 109/l. The main adverse events were neutropenia (48% of cycles) and infections (10% of cycles), which were fatal in seven patients. Complete response was achieved in 55 (69%) patients, with an estimated 3‐year disease‐free survival of 77% and 3‐year overall survival of 56%. IPI score and virological response to HAART were the prognostic parameters for response and survival. In HIV‐related DLBCL R‐CHOP is feasible, safe and effective. The prognosis depends on lymphoma‐related parameters and on the response to HAART.