Information de reference pour ce titreAccession Number: | 00003715-201009000-00003.
|
Author: | Gay, Francesca 1,2; Rajkumar, Vincent S. 1; Falco, Patrizia 3; Kumar, Shaji 1; Dispenzieri, Angela 1; Petrucci, Maria Teresa 4; Gertz, Morie A. 1; Boccadoro, Mario 2; Keith Stewart, A. 5; Palumbo, Antonio 2
|
Institution: | (1)Department of Internal Medicine, Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN, USA (2)Divisione Universitaria di Ematologia, Universita di Torino, Azienda Ospedaliera S. Giovanni Battista, Torino, Italy (3)Day Hospital Di Ematologia - S.O.C. di Immunoematologia e Medicina Trasfusionale, Ospedale di Ivrea, Italy (4)Dipartimento di Biotecnologie e Ematologia, Universita La Sapienza, Roma, Italy (5)Division of Hematology/Oncology, Mayo Clinic College of Medicine, Scottsdale, AZ, USA
|
Title: | |
Source: | European Journal of Haematology. 85(3):200-208, September 2010.
|
Abstract: | Background: The goal of this retrospective study was to compare the efficacy and toxicity of lenalidomide-dexamethasone (len/dex) vs. melphalan-prednisone-lenalidomide (MPR) as upfront therapy for newly diagnosed elderly patients with myeloma.
Methods: Data from 51 patients enrolled in an Italian phase I/II trial and treated with MPR were analyzed and compared with data from 38 patients, seen at the Mayo Clinic, treated with len/dex and enrolled in phase II/III trials.
Results: On intention-to-treat analysis, time to progression (median: 24.7 vs. 27.5 months in MPR and len/dex groups, respectively, P = 0.903), progression-free survival (median: 24.7 vs. 27.5 months in MPR and len/dex groups, respectively, P = 0.926), and overall survival (2-yr overall survival: 86.2% in MPR vs. 89.1% in len/dex, P = 0.730) were not significantly different between the two groups. Results were confirmed when the analysis was restricted to MPR and len/dex matched pair mates. Hematologic grade 3-4 toxicities were more common with MPR (neutropenia: 66.7% vs. 21.1%, P < 0.001; thrombocytopenia: 31.4% vs. 2.6%, P < 0.001). Grade 3-4 gastrointestinal events (13.2% vs. 3.9%, P = 0.132), thrombotic events (13.2% vs. 5.9%, P = 0.279), and fatigue (10.5% vs. 3.9%, P = 0.395) were more common with len/dex.
Conclusions: Results show that both MPR and len/dex are efficacious regimens for elderly patients with myeloma. Randomized trials are needed to confirm these results.
Copyright (C) 2010 Blackwell Publishing Ltd.
|
Author Keywords: | myeloma; melphalan; lenalidomide; steroids.
|
References: | 1. Rajkumar SV, Kyle R. Plasma cell disorders. In: Goldman L, Ausiello D, eds. Cecil Textbook of Medicine, 23rd edn. Philadelphia: W. B. Saunders, 2008:1426-37.
2. Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med 2004;351:1860-73.
3. Richardson PG, Schlossman RL, Weller E, et al. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood 2002;100:3063-7.
4. Hideshima T, Chauhan D, Shima Y, et al. Thalidomide and its analogs overcome drug resistance of multiple myeloma cells to conventional therapy. Blood 2000;96:2943-50.
5. Weber DM, Chen C, Niesvizky R, et al.; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med 2007;357:2133-42.
6. Dimopoulos M, Spencer A, Attal M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med 2007;357:2123-32.
7. Zonder JA, Crowley J, Hussein MA, Bolejack V, Moore DF, Whittenberger BF, Abidi MH, Durie BG, Barlogie B. Superiority of lenalidomide (Len) plus high-dose dexamethasone (HD) compared to HD alone as treatment of Newly-Diagnosed Multiple Myeloma (NDMM): results of the randomized, double-blinded, placebo-controlled SWOG trial S0232. ASH Annu Meet Abstr 2007;110:77.
8. Rajkumar SV, Jacobus S, Callander NS, et al. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol 2010;11:29-37.
9. Palumbo A, Falco P, Corradini P, et al. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA Italian multiple myeloma network. J Clin Oncol 2007;25:4459-65.
10. Palumbo A, Falco P, Falcone A, et al. Melphalan, prednisone, and lenalidomide for newly diagnosed myeloma: kinetics of neutropenia and thrombocytopenia and time-to-event results. Clin Lymphoma Myeloma 2009;9:145-50.
11. Lacy MQ, Gertz MA, Dispenzieri AA, et al. Long-term results of response to therapy, time to progression, and survival with lenalidomide plus dexamethasone in newly diagnosed myeloma. Mayo Clin Proc 2007;82:1179-84.
12. Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia 2009;23:3-9.
13. National Cancer Institute: Common Terminology Criteria for Adverse Events, v3.0, (CTCAE) http://ctep.cancer.gov/protocolD...- ouverture dans une nouvelle fenêtre.
14. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
15. Facon T, Mary J-Y, Pegourie B, et al. Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood 2006;107:1292-8.
16. Facon T, Mary JY, Hulin C, et al. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet 2007;370:1209-18.
17. Palumbo A, Bringhen S, Caravita T, et al. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet 2006;367:825-31.
18. Hulin C, Facon T, Rodon P, et al. Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial. J Clin Oncol 2009;27:3664-70.
19. Waage A, Gimsing P, Juliusson G, Turesson I, Fayers P. Melphalan-prednisone-thalidomide to newly diagnosed patients with multiple myeloma: a placebo controlled randomised phase 3 trial. ASH Annu Meet Abstr 2007;110:78.
20. Wijermans P, Schaafsma M, van Norden Y, et al. Melphalan + prednisone versus melphalan + prednisone + thalidomide in induction therapy for multiple myeloma in elderly patients: final analysis of the Dutch Cooperative Group HOVON 49 Study. Blood (ASH Annu Meet Abstr) 2008;112:649.
21. Ludwig H, Hajek R, Tothova E, et al. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood 2009;113:3435-42.
22. Palumbo A, Dimopoulos MA, Delforge M, et al. A phase III study to determine the efficacy and safety of lenalidomide in combination with melphalan and prednisone (MPR) in elderly patients with newly diagnosed multiple myeloma. Blood (ASH Annual Meeting Abstract) 2009; abstract 613.
|
Language: | English.
|
Document Type: | Original Articles.
|
Journal Subset: | Clinical Medicine.
|
ISSN: | 0902-4441
|
NLM Journal Code: | erf, 8703985
|
DOI Number: | https://dx.doi.org/10.1111/j.160...- ouverture dans une nouvelle fenêtre
|
Annotation(s) | |
|
|