ChlVPP alternating with PABIOE is superior to PABIOE alone in the initial treatment of advanced Hodgkin's disease: results of a British National Lymphoma Investigation/Central Lymphoma Group randomized controlled trial

The purpose of this randomized trial was to compare the efficacy of 6 cycle s of prednisolone, Adriamycin (doxorubicin), bleomycin, vincristine (Oncovi n) and etoposide (PABIOE) with 3 cycles of PABIOE that alternate with 3 cyc les of chlorambucil vinblastine, procarbazine and prednisone (ChlVPP) in pa tients with advanced Hodgkin's disease. Between October 1992 and April 1996 , 679 patients were entered onto the study. 41 of these did not match the p rotocol requirements on review and were excluded from further analysis, mos t of these being reclassified as NHL on histological review. Of the remaini ng 638 patients, 319 were allocated to receive PABIOE and 319 were allocate d to receive ChlVPP/PABIOE. The complete remission (CR) rates were 78% and 64%, for ChlVPP/PABIOE and PABIOE respectively after initial chemotherapy ( P < 0.0001). 124 patients were re-evaluated subsequently following radiothe rapy to residual masses. The CR rates changed from 78% to 88% for ChlVPP/PA BIOE and from 64% to 77% for PABIOE when re-evaluated in this manner (treat ment difference still significant, P = 0.0002). The treatment associated mo rtality in the PABIOE arm was 2.2% (7 deaths), while there were no such dea ths in the ChlVPP/PABIOE arm (P = 0.015). The failure-free survival was sig nificantly greater in the ChlVPP/PABIOE arm (P < 0.0001) as was the overall survival (P = 0.01). The failure-free and overall survival rates at 3 year s were 77% and 91% in the ChlVPP/PABIOE arm, compared with 58% and 85% in t he PABIOE arm, respectively These results indicate that ChlVPP alternating with PABIOE is superior to PABIOE alone as initial treatment for advanced H odgkin's disease. (C) 2001 Cancer Research Campaign.