Pegfilgrastim support for full delivery of BEACOPP-14 chemotherapy for patients with high-risk Hodgkin's lymphoma: results of a phase II study.

The primary endpoint of this feasibility study was to determine whether pegfilgrastim support could enable the delivery of the full dose of BEACOPP chemotherapy every 14 days on schedule. Forty-one patients with high-risk Hodgkin's lymphoma were randomized to receive pegfilgrastim (6 mg) on day 4 or 8 of each cycle. Eighty-one percent of cycles administered were delivered at full dose and on schedule (FDOS). Response was retrospectively assessed in 27 patients at 6 months; 23 of these 27 patients (85%) achieved a complete response and one (4%) achieved a partial response. Toxicities were mostly moderate in intensity. These results support the feasibility of delivering full dose, on schedule BEACOPP-14, chemotherapy with pegfilgrastim support.

RCT Entities:   Population Interventions Outcomes