Ch1VPP 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 cycles of prednisolone, Adriamycin (doxorubicin), bleomycin, vincristine (Oncovin) and etoposide (PABIOE) with 3 cycles of PABIOE that alternate with 3 cycles of chlorambucil vinblastine, procarbazine and prednisone (ChlVPP) in patients 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 protocol requirements on review and were excluded from further analysis, most of these being reclassified as NHL on histological review. Of the remaining 638 patients, 319 were allocated to receive PABIOE and 319 were allocated 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 radiotherapy to residual masses. The CR rates changed from 78% to 88% for ChlVPP/PABIOE and from 64% to 77% for PABIOE when re-evaluated in this manner (treatment difference still significant, P = 0.0002). The treatment associated mortality in the PABIOE arm was 2.2% (7 deaths), while there were no such deaths in the ChlVPP/PABIOE arm (P = 0.015). The failure-free survival was significantly 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 years were 77% and 91% in the ChlVPP/PABIOE arm, compared with 58% and 85% in the PABIOE arm, respectively These results indicate that ChlVPP alternating with PABIOE is superior to PABIOE alone as initial treatment for advanced Hodgkin's disease. (C) 2001 Cancer Research Campaign.