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Blood, 1 December 2005, Vol. 106, No. 12, pp. 3755-3759.
Prepublished online as a Blood First Edition Paper on August 16, 2005; DOI 10.1182/blood-2005-03-1301.
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CLINICAL TRIALS AND OBSERVATIONS
High-dose therapy intensification compared with continued standard chemotherapy in multiple myeloma patients responding to the initial chemotherapy: long-term results from a prospective randomized trial from the Spanish cooperative group PETHEMA
Joan Bladé,
Laura Rosiñol,
Ana Sureda,
Josep M. Ribera,
Joaquín Díaz-Mediavilla,
José García-Laraña,
M. Victoria Mateos,
Luis Palomera,
Javier Fernández-Calvo,
Josep M. Martí,
Pilar Giraldo,
Félix Carbonell,
Manel Callís,
Jesús Trujillo,
Santiago Gardella,
M. Jesús Moro,
Abelardo Barez,
Alfons Soler,
Llorenç Font,
Montserrat Fontanillas,
Jesús San Miguel, for Programa para el Estudio de la Terapéutica en Hemopatía Maligna (PETHEMA)
From the Hospital Clínic, IDIBAPS, Barcelona; Hospital de la Santa Creu i Sant Pau, Barcelona; Hospital Universitario Germans Trias i Pujol; Hospital Clínico, Madrid; Hospital Ramón y Cajal, Madrid; Hospital Clínico, Zaragoza; Hospital Clínico, Valladolid; Hospital Mutua de Terrasa; Hospital Miguel Servet, Zaragoza; Hospital General Universitario, Valencia; Hospital Vall d'Hebron, Barcelona; Hospital Carlos Haya, Málaga; Hospital Dr Josep Trueta, Girona; Hospital Virgen Blanca, León; Hospital Nuestra Señora de Sonsoles, Avila; Hospital Parc Taulí, Sabadell; Hospital Verge de la Cinta, Tortosa; and Hospital Clínico/Centro de Investigación del Cáncer, Salamanca, Spain.
The aim of the present randomized trial was to compare high-dose therapy (HDT) with continued conventional chemotherapy in patients with multiple myeloma (MM) who responded to the initial treatment. From May 1994 to October 1999, 216 patients (122 men/94 women; stage II or III; Eastern Cooperative Oncology Group [ECOG] score less than 3) entered the study. Initial chemotherapy consisted of 4 cycles of alternating vincristine, BCNU, melphalan, cyclophosphamide, prednisone/vincristine, BCNU, Adriamycin, dexamethasone (VBMCP/VBAD). Responding patients were randomly assigned to receive 8 additional cycles of VBMCP/VBAD, intensification with melphalan 200 mg/m2, or melphalan 140 mg/m2 plus 12 Gy fractionated total body irradiation (TBI). One-hundred sixty-four patients were randomly assigned, 83 to continued chemotherapy and 81 to HDT. The complete remission (CR) rate was significantly higher with HDT (30% vs 11%; P = .002). However, progression-free survival (PFS) was not significantly different between HDT and conventional therapy (median, 42 vs 33 months; P = not significant [NS]), and overall survival (OS) was similar in both groups (median, 61 vs 66 months). Finally, survival after relapse was identical in the 2 arms (15.9 vs 16.4 months). In conclusion, these results show that HDT intensification, when given to myeloma patients who have responded to the initial chemotherapy, significantly increases the CR rate but has no significant impact on PFS or OS.
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