title: 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.
abstract: 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.
authors.affiliation: Hematology Department, Hospital Clínic, IDIBAPS, Villarroel 170, 08036 Barcelona, Spain. jblade@clinic.ub.es
authors.forename: Joan
authors.initials: J
authors.lastname: Bladé
authors.forename: Laura
authors.initials: L
authors.lastname: Rosiñol
authors.forename: Ana
authors.initials: A
authors.lastname: Sureda
authors.forename: Josep M
authors.initials: JM
authors.lastname: Ribera
authors.forename: Joaquín
authors.initials: J
authors.lastname: Díaz-Mediavilla
authors.forename: José
authors.initials: J
authors.lastname: García-Laraña
authors.forename: M Victoria
authors.initials: MV
authors.lastname: Mateos
authors.forename: Luis
authors.initials: L
authors.lastname: Palomera
authors.forename: Javier
authors.initials: J
authors.lastname: Fernández-Calvo
authors.forename: Josep M
authors.initials: JM
authors.lastname: Martí
authors.forename: Pilar
authors.initials: P
authors.lastname: Giraldo
authors.forename: Félix
authors.initials: F
authors.lastname: Carbonell
authors.forename: Manel
authors.initials: M
authors.lastname: Callís
authors.forename: Jesús
authors.initials: J
authors.lastname: Trujillo
authors.forename: Santiago
authors.initials: S
authors.lastname: Gardella
authors.forename: M Jesús
authors.initials: MJ
authors.lastname: Moro
authors.forename: Abelardo
authors.initials: A
authors.lastname: Barez
authors.forename: Alfons
authors.initials: A
authors.lastname: Soler
authors.forename: Llorenç
authors.initials: L
authors.lastname: Font
authors.forename: Montserrat
authors.initials: M
authors.lastname: Fontanillas
authors.forename: Jesús
authors.initials: J
authors.lastname: San Miguel
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000008:administration & dosage; D012074:Remission Induction; D013030:Spain; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D008558:Melphalan; D002330:Carmustine; D011241:Prednisone