Alemtuzumab plus CHOP as front-line chemotherapy for patients with peripheral T-cell lymphomas: a phase II study

PURPOSE: The present study was conducted to evaluate the safety and efficacy of alemtuzumab plus CHOP chemotherapy for patients with peripheral T-cell lymphomas (PTCLs). PATIENTS AND METHODS: Twenty patients with newly diagnosed PTCLs were enrolled. The treatment consisted of classical CHOP plus alemtuzumab (10 mg i.v. on day 1 and 20 mg i.v. on day 2 in the first cycle, then 30 mg i.v. on day 1 in the subsequent cycles) based on 3-week intervals. RESULTS: Thirteen complete responses (65.0%) and three partial responses (15.0%) were confirmed, giving an overall response rate of 80.0%. The estimated event-free survival at 1 year was 43.3%. The most severe hematologic adverse event was neutropenia, which occurred with a grade-4 intensity in 18 patients (90.0%). Also, febrile neutropenia was observed in 11 patients (55.0%). Five patients (25%) experienced cytomegalovirus (CMV) reactivation, while three patients developed CMV diseases, such as pneumonitis or retinitis. There were two treatment-related deaths. Based on the high incidence of the adverse infectious and hematologic events, the current study was closed after 20 of the planned 43 patients had been enrolled. CONCLUSION: The alemtuzumab plus CHOP chemotherapy seemed to produce active antitumor activity in terms of the complete response rates in patients with PTCLs. However, since high infectious and hematologic toxicities were observed, careful monitoring and early treatment are needed to prevent treatment-related mortality.