Parma International Protocol: Pilot Study of DHAP Followed by Involved-Field Radiotherapy and BEAC With Autologous Bone Marrow Transplantation

• Published in: Blood 1991-04, Vol.77 (7), p.1587-1592
• Main Authors: Philip, T., Chauvin, F., Armitage, J., Bron, D., Hagenbeek, A., Biron, P., Spitzer, G., Velasquez, W., Weisenburger, D.D., Fernandez-Ranada, J., Somers, R., Rizzoli, V., Harousseau, J.L., Sotto, J.J., Cahn, J.Y., Guilhot, F., Biggs, J., Sonneveld, P., Misset, J.L., Manna, A., Jagannath, S., Guglielmi, C., Chevreau, C., Delmer, A., Santini, G., Coiffier, B.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Bone Marrow Transplantation; Cisplatin - administration & dosage; Combined Modality Therapy; Cytarabine - administration & dosage; Dexamethasone - administration & dosage; Drug Administration Schedule; Europe; Female; Hematologic and hematopoietic diseases; Humans; Lymphoma, Non-Hodgkin - drug therapy; Lymphoma, Non-Hodgkin - radiotherapy; Lymphoma, Non-Hodgkin - surgery; Lymphoma, Non-Hodgkin - therapy; Male; Medical sciences; Middle Aged; Pilot Projects; Radiotherapy - methods; Transplantation, Autologous
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V77.7.1587.1587

Fifty patients with intermediate- or high-grade non-Hodgkin's lymphoma (NHL) who had relapsed after a complete remission induced by an Adriamycin-containing chemotherapy regimen participated in this prospective pilot study. The patients ranged in age from 16 to 60 years (median 42 years). All patients received dexamethasone, high-dose cytarabine, and cisplatin (DHAP) for two courses at 3- to 4-week intervals. Patients achieving a partial or complete response were scheduled to receive involved-field radiotherapy and high-dose carmustine, etoposide, cytarabine, and cyclophosphamide (BEAC), followed by autologous bone marrow transplantation (ABMT). Among 48 evaluable patients (ie, 1 was lost to follow-up and 1 had no measurable disease) 7 patients obtained a complete response (CR) and another 21 patients achieved partial response (PR), whereas the remaining 20 patients failed. One responder died of treatment-related toxicity, and six others declined ABMT. The patient with no measurable disease did not progress on DHAP and was submitted to ABMT. Twenty-two patients underwent ABMT [20 with BEAC and 2 with cyclophosphamide plus total body irradiation (TBI)] of whom 2 (9%) died of toxicity and 10 relapsed. One patient was a suicide at 28 months post-ABMT in CCR and 9 are alive disease-free 24 months to 32 months (median 30 months) post-ABMT. The actuarial 2-year event-free survival for patients undergoing transplantation is 40%. This prospective multicenter trial documents the ability of DHAP followed by ABMT to produce durable complete remission in a significant proportion of patients with relapsed aggressive NHL. Forty-four percent of all patients with relapsed lymphoma who entered the study actually underwent ABMT and 20% of the total group are projected to be long-term disease-free survivors.