Pamidronate versus observation in asymptomatic myeloma: Final results with long-term follow-up of a randomized study

Leukemia and Lymphoma

Volumn 52, Issue 5, 2011, Pages 771-775

  D'Arena, Giovanni ^a   Gobbi, Paolo G ^b   Broglia, Chiara ^c   Sacchi, Stefano ^d   Quarta, Giovanni ^e   Baldini, Luca ^f   Iannitto, Emilio ^g   Falcone, Antonietta ^a   Guariglia, Roberto ^h   Pietrantuono, Giuseppe ^h   Villani, Oreste ^h   Martorelli, Maria Carmen ^h   Mansueto, Giovanna ^h   Sanpaolo, Grazia ^a   Cascavilla, Nicola ^a   Musto, Pellegrino ^h  

^a CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

^b UNIVERSITY OF PAVIA   (Italy)

^c FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^d UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^e Di Summa Hospital   (Italy)

^f FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^g UNIVERSITY OF PALERMO   (Italy)

^h REFERRAL CANCER CENTER OF BASILICATA   (Italy)

Author keywords

asymptomatic myeloma; bisphosphonates; bone lesions; multiple myeloma; Pamidronate; zoledronate

Indexed keywords

CREATININE; HEMOGLOBIN; M PROTEIN; PAMIDRONIC ACID;

ADULT; AGED; ANEMIA; ARTICLE; ASYMPTOMATIC DISEASE; ASYMPTOMATIC MYELOMA; BONE ATROPHY; BONE MARROW CELL; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER RISK; CANCER SURVIVAL; CLINICAL OBSERVATION; CONTROLLED STUDY; DISEASE DURATION; DRUG DOSE INCREASE; DRUG EFFECT; DRUG SAFETY; FEMALE; FEVER; FOLLOW UP; GENERAL MALAISE; HUMAN; HYPERCALCEMIA; HYPOCALCEMIA; HYPOTENSION; INTERMETHOD COMPARISON; JAW OSTEONECROSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; MYELOMA; OPEN STUDY; OVERALL SURVIVAL; PATHOLOGIC FRACTURE; PHASE 3 CLINICAL TRIAL; PLASMA CELL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; UNSPECIFIED SIDE EFFECT;

ADULT; AGED; AGED, 80 AND OVER; BONE DENSITY CONSERVATION AGENTS; BONE DISEASES; DIPHOSPHONATES; DISEASE PROGRESSION; FOLLOW-UP STUDIES; HUMANS; MIDDLE AGED; MULTIPLE MYELOMA; SURVIVAL ANALYSIS; YOUNG ADULT;

EID: 79955064499     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.3109/10428194.2011.553000     Document Type: Article

References (27)

1. Kyle RA, Yee GC, Somerfield MR, et al. American Society of Clinical Oncology 2007 clinical practice guideline update on the role of bisphosphonates in multiple myeloma. J Clin Oncol 2007;25:2464-2472. (Pubitemid 46999218)
2. Terpos E, Sezer O, Croucher PI, et al. The use of bisphosphonates in multiple myeloma: recommendations of an expert panel on behalf of the Euroepan Myeloma Network. Ann Oncol 2009;20:1303-1317.
3. Berenson JR. Therapeutic options in the management of myeloma bone disease. Semin Oncol 2010;37(Suppl. 1): S20-S29.
4. Lahtinen R, Laakso M, Palva L, Virkkunen P, Elomaa I. Randomized, placebo-controlled multicentre trial of clodro-nate in multiple myeloma. Lancet 1992;340:1049-1052.
5. Berenson J, Lichtenstein A, Porter L, et al. Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. J Clin Oncol 1998;16:593-602. (Pubitemid 28135605)
6. Berenson JR, Rosen LS, Howell A, et al. Zoledronic acid reduces skeletal-related events in patients with osteolytic metastases: a double blind, randomized dose-response study. Cancer 2001;91:1191-1200. (Pubitemid 32267028)
7. McCloskey EV, Dunn JA, Kanis JA, McLennan IC, Drayson MT. Long-term follow-up of a prospective double-blind, placebo-controlled tyrial of clodronate in multiple myeloma. Br J Haematol 2001;113:1035-1043. (Pubitemid 32634773)
8. Rosen LS, Gordon D, Kaminski M, et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial. Cancer J 2001;7:377-387. (Pubitemid 33759002)
9. Rosen LS, Gordon D, Kaminski M, et al. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer 2003;98:1735-1744. (Pubitemid 37238631)
10. Avilés A, Nambo MJ, Neri N, Castañeda C, Cleto S, Huerta-Guzmán J. Antitumor effect of zoledronic acid in previously untreated patients with multiple myeloma. Med Oncol 2007;24:227-230. (Pubitemid 350135975)
11. Morgan G, Davies F, Gregory W, et al. Evaluating the effects of zoledronic acid (ZOL) on overall survival (OS) in patients (Pts) with multiple myeloma (MM): results of the Medical Research Council (MRC) Myeloma IX study. J Clin Oncol 2010;28(15 Suppl.): Abstract 8021.
12. Mauri D, Valachis A, Polyzos NP, et al. Does adjuvant bisphosphonate in early breast cancer modify the natural course of the disease? A meta-analysis of randomized controlled trials. J Natl Compr Cancer Network 2010;8: 279-286.
13. Moschetta M, Di Pietro G, Ria R, et al. Bortezomib and zoledronic acid on angiogenic and vasculogenic activities of bone marrow macrophages in patients with multiple myeloma. Eur J Cancer 2010;46:420-429.
14. Neville-Webbe HL, Gnant M, Coleman RE. Potential antic-ancer properties of bisphosphonates. Semin Oncol 2010; 37(Suppl. 1): S53-S65.
15. Santini D, Virzi V, Fratto ME, et al. Can we consider zoledronic acid a new antitumor agent? Recent evidence in clinical setting. Curr Cancer Drug Targets 2010;10:46-54.
16. Kyle RA, Remstein ED, Therneau TM, et al. Clinical course and prognosis in smoldering (asymptomatic) multiple myeloma. N Engl J Med 2007;316:2582-2590. (Pubitemid 46961003)
17. International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. Br J Haematol 2003;121:749-757.
18. Patriarca F, Petrucci MT, Bringhen S, et al. Considerations in the treatment of multiple myeloma: a consensus statement from Italian experts. Eur J Haematol 2009;82:93-105.
19. NCCN Guidelines TM, version 1. 2011, Multiple myeloma [internet]. [Accessed 29 August 2010]. Available from: www.nccn.org/professionals/physician- gls/f-guidelines.asp.
20. Martin A, Garcia-Sanz R, Hernandez J, et al. Pamidronate induces bone formation in patients with smouldering or indolent myeloma, with no significant anti-tumor effect. Br J Haematol 2002;188:239-242. (Pubitemid 34779542)
21. Musto P, Falcone A, Sanpaolo G, et al. Pamidronate reduces skeletal events but does not improve progression-free survival in early-stage untreated myeloma: results of a randomized trial. Leuk Lymphoma 2003;44:1545-1548. (Pubitemid 36833970)
22. Musto P, Petrucci MT, Bringhen S, et al. A multicenter, randomized clinical trial comparing zoledronic acid versus observation in patients with asymptomatic myeloma. Cancer 2008;113:1588-1595.
23. Greipp PR, San Miguel J, Durie BG, et al. International staging system for multiple myeloma. J Clin Oncol 2005;23: 3412-3420.
24. Kaplan EL, Meier P. Non parametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-481.
25. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized trials requiring prolonged observation of each patient. Br J Cancer 1977;35:1-39. (Pubitemid 8018922)
26. Badros A, Weikel D, Salama A, et al. Osteonecrosis of the jaw in multiple myeloma patients: clinical features and risk factors. J Clin Oncol 2006;24:945-952. (Pubitemid 46638849)
27. Rustemeyer J, Bremerich A. Bisphosphonate-associated osteonecrosis of the jaw: what do we currently know? A survey of knowledge given in the recent literature. Clin Oral Invest 2010;14:59-64.