title: Pamidronate reduces skeletal events but does not improve progression-free survival in early-stage untreated myeloma: results of a randomized trial.
abstract: Ninety patients with untreated, stage I-II A myeloma, were randomised to receive or not monthly infusions of pamidronate (PMD) for 1 year, without additional therapies. Follow-up ranged from 36 to 72 months (median 51 months). Three years after the start of the treatment, the disease had progressed in 25% of PMD treated patients and in 26.8% of controls (p n.s). Median time-to-progression was 16 and 17.4 months, respectively (p n.s). Among the 21 patients who required chemo-radiotherapy, skeletal events (osteolytic lesions, pathological fractures and/or hypercalcemia) developed in 9/11 (81.8%) controls and in 4/10 (40%) of treated patients (p < 0.01). "Prophylactic" administration of PMD may decrease the development of skeletal events, but does not reduce the rate and the time of disease progression in early-stage myeloma.
authors.affiliation: Unit of Hematology and Stem Cell Transplantation, IRCCS Casa Sollievo della Sofferenza Hospital, 71013, S. Giovanni Rotondo, Italy. p.musto@tin.it
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Antonietta
authors.initials: A
authors.lastname: Falcone
authors.forename: Grazia
authors.initials: G
authors.lastname: Sanpaolo
authors.forename: Carlo
authors.initials: C
authors.lastname: Bodenizza
authors.forename: Nicola
authors.initials: N
authors.lastname: Cascavilla
authors.forename: Lorella
authors.initials: L
authors.lastname: Melillo
authors.forename: Potito Rosario
authors.initials: PR
authors.lastname: Scalzulli
authors.forename: Matteo
authors.initials: M
authors.lastname: Dell'Olio
authors.forename: Antonio
authors.initials: A
authors.lastname: La Sala
authors.forename: Saverio
authors.initials: S
authors.lastname: Mantuano
authors.forename: Michele
authors.initials: M
authors.lastname: Nobile
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D004164:Diphosphonates / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D005598:Fractures, Spontaneous / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D006934:Hypercalcemia / Q000188:drug therapy* / Q000209:etiology; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications* / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D009367:Neoplasm Staging; D010014:Osteolysis / Q000188:drug therapy* / Q000209:etiology; D000077268:Pamidronate; D016896:Treatment Outcome
chemical_list: D004164:Diphosphonates; D000077268:Pamidronate