Prospective study of rituximab in chemotherapy-dependent human immunodeficiency virus-associated multicentric Castleman's disease:: ANRS 117 CastlemaB trial

Purpose Single-agent chemotherapy is usually effective in HIV-associated multicentric Castleman's disease ( MCD). However, in most patients, chemotherapy cannot be discontinued. Patients and Methods To evaluate the efficacy of four weekly rituximab infusions ( 375 mg/ m(2)) after discontinuation of chemotherapy in HIV-associated MCD, 24 patients were enrolled onto a prospective open-label trial. Results At study entry, the median time from MCD diagnosis was 21 months. All patients had stable disease on chemotherapy and were dependent on chemotherapy for a median time of 13 months. The median CD4 cell count was 270 x 106/ L, and the plasma HIV RNA was less than 50 copies/ mL in 18 patients. One patient died with progressive disease at day 15, and 23 patients completed the four cycles of rituximab. Sustained remission ( SR) off treatment at day 60 ( primary end point) was achieved in 22 patients ( 92%). From day 60 to day 365, one patient died with acute respiratory failure of undetermined origin, and four patients experienced relapse. Seventeen patients ( 71%) were alive in SR at day 365 without specific treatment, and the overall survival rate was 92% ( 95% Cl, 71% to 98%). Rituximab was well tolerated, and the majority of adverse events were mild to moderate infections. Mild exacerbation of Kaposi's sarcoma ( KS) lesions was observed in eight of 12 patients with previous KS. Conclusion Rituximab was both effective and safe in HIV-infected patients with chemotherapy-dependent MCD.