TY - JOUR
T1 - Pamidronate versus observation in asymptomatic myeloma
T2 - Final results with long-term follow-up of a randomized study
AU - D'Arena, Giovanni
AU - Gobbi, Paolo G.
AU - Broglia, Chiara
AU - Sacchi, Stefano
AU - Quarta, Giovanni
AU - Baldini, Luca
AU - Iannitto, Emilio
AU - Falcone, Antonietta
AU - Guariglia, Roberto
AU - Pietrantuono, Giuseppe
AU - Villani, Oreste
AU - Martorelli, Maria Carmen
AU - Mansueto, Giovanna
AU - Sanpaolo, Grazia
AU - Cascavilla, Nicola
AU - Musto, Pellegrino
PY - 2011/5
Y1 - 2011/5
N2 - A prospective, multicenter, randomized trial comparing pamidronate administration (60-90 mg once a month for 1 year) versus simple observation in 177 patients with asymptomatic myeloma was performed to explore whether the administration of this drug reduces the rate of and/or the time to progression to overt, symptomatic disease. No relevant side effects were recorded in pamidronate-treated patients. With a minimum follow-up of 5 years for live patients, there were 56/89 (62.9%) progressions in the pamidronate-treated group and 55/88 (62.5%) within the controls (p = NS). Median time to progression was 46 and 48 months, respectively (p = NS). Overall survival was also similar between the two groups. Skeletal-related events at the time of progression were observed in 40/55 (72.7%) controls, but only in 22/56 (39.2%) pamidronate-treated patients (p = 0.009). In conclusion, the administration of pamidronate in asymptomatic myeloma, while reducing bone involvement at progression, did not decrease the risk of transformation and the time to progression into overt myeloma.
AB - A prospective, multicenter, randomized trial comparing pamidronate administration (60-90 mg once a month for 1 year) versus simple observation in 177 patients with asymptomatic myeloma was performed to explore whether the administration of this drug reduces the rate of and/or the time to progression to overt, symptomatic disease. No relevant side effects were recorded in pamidronate-treated patients. With a minimum follow-up of 5 years for live patients, there were 56/89 (62.9%) progressions in the pamidronate-treated group and 55/88 (62.5%) within the controls (p = NS). Median time to progression was 46 and 48 months, respectively (p = NS). Overall survival was also similar between the two groups. Skeletal-related events at the time of progression were observed in 40/55 (72.7%) controls, but only in 22/56 (39.2%) pamidronate-treated patients (p = 0.009). In conclusion, the administration of pamidronate in asymptomatic myeloma, while reducing bone involvement at progression, did not decrease the risk of transformation and the time to progression into overt myeloma.
KW - asymptomatic myeloma
KW - bisphosphonates
KW - bone lesions
KW - multiple myeloma
KW - Pamidronate
KW - zoledronate
UR - http://www.scopus.com/inward/record.url?scp=79955064499&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79955064499&partnerID=8YFLogxK
U2 - 10.3109/10428194.2011.553000
DO - 10.3109/10428194.2011.553000
M3 - Article
C2 - 21299465
AN - SCOPUS:79955064499
VL - 52
SP - 771
EP - 775
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
SN - 1042-8194
IS - 5
ER -