LOS ANGELES--The final report of the Parma study, presented at the American Society of Clinical Oncology meeting, confirms the superiority of dose intensification with autologous bone marrow transplantation (ABMT) over conventional chemotherapy in patients with relapsed diffuse non-Hodgkin's lymphoma (NHL).
"High-dose chemotherapy with ABMT increases both event-free survival and overall survival and can be considered as standard treatment of high- and intermediate-grade NHL in sensitive relapse," Thierry O. Philip, MD, director of the Centre Leon Berard, Lyon, France, said in his report at the plenary session.
Although ABMT has been widely used in these patients for nearly two decades, results of previous studies had been questioned primarily because of lack of uniform patient selection criteria and inability to prove survival benefit. At a 1985 meeting in Parma, Italy, a protocol for a definitive prospective randomized multicenter study was developed.
The criteria were designed to select patients most likely to be cured with chemotherapy, Dr. Philip said. The protocol was open to patients with diffuse high- or intermediate-grade lymphoma in first or second relapse who had a previous complete response with an Adriamycin-containing regimen. Patients over 60 years of age and those with CNS or bone marrow involvement were excluded from the trial.
The study began with 216 patients who received two courses of DHAP (dexamethasone, ara-C, and cisplatin(Drug information on cisplatin)). Those in partial or complete response were then defined as sensitive relapses, and all others were defined as resistant relapses and were excluded from the study.
Those patients in sensitive relapse (109 eligible) were then randomized to receive either conventional treatment (four additional courses of DHAP followed by involved-field radiotherapy) or dose-intensive therapy consisting of involved-field radiotherapy plus high-dose chemotherapy--BCNU, etoposide, ara-C, and cyclophosphamide(Drug information on cyclophosphamide) (BEAC)--followed by ABMT. In both arms, patients received radiotherapy only if one or more relapsed tumor sites measured more than 5 cm.
Response rates were significantly higher with ABMT (84% versus 45% for conventional DHAP), as were complete responses (78% vs 40%). At a median of 63 months of follow-up, disease-free survival was 46% for the transplant patients, compared with 12% for the DHAP group.