Author, as appears in the article.: Juan José Lahuerta; Maria Victoria Mateos; Joaquin Martínez-López; Carlos Grande; Javier de la Rubia; Laura Rosiñol; Anna Sureda; José García-Laraña; Joaquín Díaz-Mediavilla; Miguel T. Hernández-García; Dolores Carrera; Joan Besalduch; Felipe de Arriba; Albert Oriol; Lourdes Escoda; Javier García-Frade; Concepción Rivas-González; Adrían Alegre; Joan Bladé; Jesús F. San Miguel

Department: Medicina i Cirurgia

e-ISSN: 1592-8721

URV's Author/s: Escoda Teigell, Maria Lourdes

Abstract: Background The aim of this study was to compare the long-term safety and efficacy of oral busulfan 12 mg/kg plus melphalan 140 mg/m2 and melphalan 200 mg/m2 as conditioning regimens for autologous stem cell transplantation in newly diagnosed patients with multiple myeloma in the GEM2000 study.Design and Methods The first 225 patients received oral busulfan 12 mg/kg plus melphalan 140 mg/m2; because of a high frequency of veno-occlusive disease, the protocol was amended and a further 542 patients received melphalan 200 mg/m2.Results Engraftment and hospitalization times were similar in both groups. Oral busulfan 12 mg/kg plus melphalan 140 mg/m2 resulted in higher transplant-related mortality (8.4% versus 3.5%; P=0.002) due to the increased frequency of veno-occlusive disease in this group. Response rates were similar in both arms. With respective median follow-ups of 72 and 47 months, the median progression-free survival was significantly longer with busulfan plus melphalan (41 versus 31 months; P=0.009), although survival was similar to that in the melphalan 200 mg/m2 group. However, access to novel agents as salvage therapy after relapse/progression was significantly lower for patients receiving busulfan plus melphalan (43%) than for those receiving melphalan 200 mg/m2 (58%; P=0.01).Conclusions Conditioning with oral busulfan 12 mg/kg plus melphalan 140 mg/m2 was associated with longer progression-free survival but equivalent survival to that achieved with melphalan 200 mg/m2 but this should be counterbalanced against the higher frequency of veno-occlusive disease-related deaths. This latter fact together with the limited access to novel salvage therapies in patients conditioned with oral busulfan 12 mg/kg plus melphalan 140 mg/m2 may explain the absence of a survival difference. Oral busulfan was used in the present study; use of the intravenous formulation may reduce toxicity and result in greater efficacy, and warrants further investigation in myeloma patients. (Clinicaltrials.gov identifier: NCT00560053).

licence for use: https://creativecommons.org/licenses/by/3.0/es/

ISSN: 0390-6078

Author's mail: marialourdes.escoda@urv.cat

Record's date: 2023-09-30

Journal volume: 95

Papper version: info:eu-repo/semantics/publishedVersion

Link to the original source: https://haematologica.org/article/view/5788

Licence document URL: http://repositori.urv.cat/ca/proteccio-de-dades/

Papper original source: 95 (11): 1913-1920

APA: Juan José Lahuerta; Maria Victoria Mateos; Joaquin Martínez-López; Carlos Grande; Javier de la Rubia; Laura Rosiñol; Anna Sureda; José García-Laraña; (2010). Busulfan 12 mg/kg plus melphalan 140 mg/m(2) versus melphalan 200 mg/m(2) as conditioning regimens for autologous transplantation in newly diagnosed multiple myeloma patients included in the PETHEMA/GEM2000 study. Haematologica-The Hematology Journal, 95(11), 1913-1920

Article's DOI: 10.3324/haematol.2010.028027

Entity: Universitat Rovira i Virgili

Journal publication year: 2010

Publication Type: Journal Publications