PARMA international protocol: Pilot study on 50 patients and preliminary analysis of the ongoing randomized study (62 patients)

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Abstract
Fifty patients with intermediate- or high-grade non-Hodgkin's lymphoma who had relapsed following a complete remission (CR) induced by a doxorubicin-containing chemotherapy regimen participated in the PARMA pilot study. The patients ranged in age from 16 to 60 years (median age, 42). All patients received DHAP (dexamethasone/high-dose cytarabine/cisplatin) for two courses at 3- to 4-week intervals. Patients achieving a partial response (PR) or CR were scheduled to receive involved-field radiotherapy and high-dose BEAC (carmustine/etoposide/cytarabine/cyclophosphamide) followed by autologous bone marrow transplantation (ABMT). Of 48 evaluable DHAP-treated patients (one patient was lost to follow-up and one had no measurable disease), seven achieved CR, 21 PR, and 20 patients had no response or progressive disease. One responder died from treatment-related toxicity, and six others declined ABMT. The patient with no measurable disease did not progress on DHAP and received ABMT. In all, 22 patients underwent ABMT (20 with BEAC and two with cyclophosphamide plus total body irradiation); two patients (9%) died from toxicity and ten (45%) relapsed. One patient in continuous CR committed suicide 28 months post-ABMT, and nine are alive and disease-free 24 to 32 months (median, 30) post-ABMT. The actuarial 2-year event-free survival for patients undergoing transplantation is 40%. This prospective multicenter trial documented the ability of DHAP followed by ABMT to produce durable CR in a significant proportion of patients with relapsed aggressive non-Hodgkin's lymphoma (NHL). Forty-four percent of all study patients with relapsed lymphoma actually underwent ABMT, and 20% of the total group are projected to be long-term disease-free survivors. This is in contrast to the 0% to 5% long-term diseasefree survivors in multiple studies using only traditional-dose chemotherapy to treat relapses. A total of 128 patients with intermediate- or high-grade NHL, defined with the same criteria, are currently enrolled in the ongoing randomized PARMA study. As expected, the response to DHAP is 55.5% (71 responders, with 44 PR and 27 CR). Patients who relapsed while receiving therapy had a lower response rate to the protocol regimen than did patients who relapsed off therapy (9% v 57%, P < 0.0001). Among these 71 patients, 62 were randomly assigned to four additional courses of DHAP (n= 34) or BEAC (n =28). No statistical difference in toxic death rate is evident between the two arms. Results of survival in the two groups are not yet available, and the PARMA study is still open.

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