HIGH-DOSE THERAPY AND AUTOLOGOUS STEM-CELL TRANSPLANTATION VS CONVENTIONAL THERAPY FOR PATIENTS WITH ADVANCED HODGKINS-DISEASE RESPONDING TO FIRST-LINE THERAPY - ANALYSIS OF CLINICAL CHARACTERISTICS OF 51 PATIENTS ENROLLED IN THE HD01 PROTOCOL

Whether high-dose therapy (HDT) plus autologous stem cell transplantat ion (ASCT) ought to be included in the initial treatment plan for thos e patients with unfavourable Hodgkin's disease, a wide cooperative stu dy (HD01 protocol) was approved, comparing HDT followed by ASCT vs con ventional chemotherapy (CT). Patients were eligible for the study if t hey had at least two of the following adverse prognostic factors: high serum LDH levels, mediastinal mass >0.45, more than one extranodal in volved site, low hematocrit (<34% for women and <38% for men), and ing uinal involvement. Those patients achieving complete or partial remiss ion with four courses of ABVD or ABVD-containing chemotherapy were ran domized to receive either HDT plus ASCT or four additional courses of chemotherapy, followed by ASCT in second remission, if appropriate. Be tween April 1993 and September 1995, 55 patients from 14 different cen ters have been enrolled into the trial. Twenty patients (45%) were in stage IV, and 37 patients (84%) had systemic symptoms. Twenty-seven pa tients (61%) had two adverse prognostic factors, and 17 patients (39%) had three or more risk factors. After four cycles of ABVD-containing CT, 44 patients were assessable for response. Overall 12 patients achi eved CR (27%), 25 obtained a PR (57%) and seven patients failed to res pond (16%). Thirty-six patients were randomized between ASCT (20 patie nts) or four additional cycles of conventional CT (16 patients). With a median follow-up after ASCT of 13 months (range 1-23 months), no maj or ASCT-related toxicity has been reported to the trial office. In con clusion, the first 44 patients registered in the HD01 trial and assess able for response, had a very aggressive disease and responded poorly to conventional CT, thus warranting a more aggressive approach, such a s HDT followed by ASCT.