Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma

Haematologica

Volumn 95, Issue 9, 2010, Pages 1548-1554

  Ludwig, Heinz ^a   Adam, Zdenek ^b   Tóthová, Elena ^c   Hajek, Roman ^b   Labar, Boris ^d   Egyed, Miklós ^e   Spicka, Ivan ^f   Gisslinger, Heinz ^g   Drach, Johannes ^g   Kuhn, Ingrid ^h   Hinke, Axel ⁱ   Zojer, Niklas ^a  

^a WILHELMINEN HOSPITAL   (Austria)

^b UNIVERSITY HOSPITAL BRNO   (Czech Republic)

^c L PASTEUR UNIVERSITY HOSPITAL   (Slovakia)

^d KBC Zagreb   (Croatia)

^e Kaposi Mor Teaching Hospital   (Hungary)

^f CHARLES UNIVERSITY   (Czech Republic)

^g MEDICAL UNIVERSITY OF VIENNA   (Austria)

^h Schering Plough Inc   (Austria)

ⁱ WiSP Research Institute   (Germany)

Author keywords

Overall survival; Progression free survival; Thalidomide; Thalidomide interferon

Indexed keywords

ALPHA2B INTERFERON; DEXAMETHASONE; MELPHALAN; PREDNISOLONE; THALIDOMIDE;

ADULT; AGE; AGED; ANEMIA; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DRUG FEVER; DRUG RESPONSE; DYSPNEA; ELDERLY CARE; FATIGUE; FEMALE; HUMAN; INFECTION; KIDNEY DISEASE; LEUKOPENIA; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NAUSEA; NEUROLOGIC DISEASE; NEUROPATHY; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN TOXICITY; THROMBOCYTOPENIA; THROMBOEMBOLISM;

AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; INTERFERON-ALPHA; MALE; MIDDLE AGED; MULTIPLE MYELOMA; SURVIVAL RATE; THALIDOMIDE;

EID: 77956829463     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2009.020586     Document Type: Article

References (28)

1. Wisløff F, Hjorth M. Health-related quality of life assessed before and during chemotherapy predicts for survival in multiple myeloma. Nordic Myeloma Study Group. Br J Haematol. 1997;97(1):29-37.
2. Quach H, Mileshkin L, Seymour JF, Milner A, Ritchie D, Harrison S, et al. Predicting durable remissions following thalidomide therapy for relapsed myeloma. Leuk Lymphoma. 2009;50(2):223-229.
3. Belch A, Shelley W, Bergsagel D, Wilson K, Klimo P, White D, et al. A randomized trial of maintenance versus no maintenance melphalan and prednisone in responding multiple myeloma patients. Br J Cancer. 1988;57(1):94-99.
4. Berenson JR, Crowley JJ, Grogan TM, Zangmeister J, Briggs AD, Mills GM, et al. Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients. Blood. 2002;99(9):3163-3168.
5. Shustik C, Belch A, Robinson S, Rubin SH, Dolan SP, Kovacs MJ, et al. A randomized comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7, Br J Haematol. 2007; 136(2):203-211.
6. Mellstedt H, Ahre A, Björkholm M. Interferon therapy in myelomatosis. Lancet 1979;1(8110):245-247.
7. Myeloma Trialists' Collaborative Group. Interferon as therapy for multiple myeloma: an individual patient data overview of 24 randomized trials and 4012 patients. Br J Haematol. 2001;113:1020-1034.
8. Fritz E, Ludwig H. Interferon-alpha treatment in multiple myeloma: meta-analysis of 30 randomised trials among 3948 patients. Ann Oncol. 2000;11(11):1427-1436.
9. Attal M, Harousseau JL, Leyvraz S, Doyen C, Hulin C, Benboubker L, et al. for the Inter-Groupe Francophone du Myélome (IFM). Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood. 2006;108(10): 3289-3294.
10. Spencer A, Prince HM, Roberts AW, Prosser IW, Bradstock KF, Coyle L, et al. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patientsundergoing a single autologous stem-cell transplantation procedure. J Clin Oncol. 2009;27(11):1788-1793.
11. Barlogie B, Tricot G, Anaissie E, Shaughnessy J, Rasmussen E, van Rhee F, et al. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N Engl J Med. 2006;354(10):1021-1030.
12. Lokhorst HM, van der Holt B, Zweegman S, Vellenga E, Croockewit S, van Oers MH, et al. A randomized phase 3 study on the effect of thalidomide combined with adriamycin, dexamethasone, and high-dose melphalan, followed by thalidomide maintenance in patients with multiple myeloma. Blood. 2010;115(6):1113-1120.
13. Morgan GJ, Jackson GH, Davies FE, Drayson MT, Owen RG, Gregory WM, et al. Maintenance thalidomide may improve progression free but not overall survival; Results from the Myeloma IX Maintenance Randomisation. Blood. (ASH Annual Meeting Abstracts) 112, 2008 (abstract 656).
14. Ludwig H, Hajek R, Tóthová E, Drach J, Adam Z, Labar B, et al. Thalidomide-dexamethasone compared with melphalanprednisolone in elderly patients with multiple myeloma. Blood. 2009;113(15):3435-3442.
15. Kyle RA, Yee GC, Somerfield MR, Flynn PJ, Halabi S, Jagannath S, et al. American Society of Clinical Oncology. American Society of Clinical Oncology 2007 clinical practice guideline update on the role of bisphosphonates in multiple myeloma. J Clin Oncol. 2007;25(17):2464-2472.
16. Blade J, Samson D, Reece D, Apperley J, Björkstrand B, Gahrton G, et al. Criteria for evaluating disease response and in patients with multiple myeloma treated with high dose chemotherapy and haematopoietic stem cell transplantation. Br J Haematol. 1998;102(5):1115-1123.
17. Common Toxicity Criteria Manual: Version 2.0, June 1, 1999, Available from http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcmanual_v4_10-4-99.pdf
18. Kaplan EL, P Meier. Nonparametric estimation from incomplete observations. J Am Stat Ass 1958;53:457-481.
19. Peto R, Peto J. Asymptotically efficient rank invariation test procedures (with discussion). J R Stat Soc A 1972;135:185-206.
20. Cox DR. Regression models and life tables. J Roy Stat Soc (B) 1972;34:187-202.
21. Offidani M, Corvatta L, Polloni C, Piersantelli MN, Gentili S, Galieni P, et al. Thalidomide-dexamethasone versus interferon- alpha-dexamethasone as maintenance treatment after ThaDD induction for multiple myeloma: a prospective, multicentre, randomised study. Br J Haematol. 2009;144(5):653-659.
22. Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, et al. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008;112(8):3107-3114.
23. Hulin C, Facon T, Rodon P, Pegourie B, Benboubker L, Doyen C, 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(22):3664-3670.
24. Moreira AL, Tsenova-Berkova L, Wang J, Laochumroonvorapong P, Freeman S, Freedman VH, et al. Effect of cytokine modulation by thalidomide on the granulomatous response in murine tuberculosis. Tuber Lung Dis 1997;78(1):47-55.
25. Rowland TL, McHugh SM, Deighton J, Dearman RJ, Ewan PW, Kimber I. Differential regulation by thalidomide and dexamethasone of cytokine expression in human peripheral blood mononuclear cells. Immunopharmacology 1998;40(1):11-20.
26. Rosiñol L, Cibeira T, Martínez J, Mateos MV, Terol MJ, de la Rubia J, et al. Thalidomide/Dexamethasone (TD) Versus Bortezomib (Velcade)/ Thalidomide/ Dexamethasone (VTD) Versus VB. International Myeloma Workshop, Washington, D.C. February 26 - March 1, 2009 (abstract A160).
27. Cavo M, Testoni N, Terragna C, Marzocchi G, Durante S, Zambello R, et al. Superior rate of complete response with up-front Velcade-Thalidomide-Dexamethasone versus Thalidomide-Dexamethasone in newly diagnosed multiple myeloma is not affected by adverse prognostic factors, including high-risk cytogenetic abnormalities. Blood (ASH Annual Meeting Abstracts) 112, 2008 (abstract 1662).
28. Barlogie B, Pineda-Roman M, van Rhee F, Haessler J, Anaissie E, Hollmig K, et al. Thalidomide arm of Total Therapy 2 improves complete remission duration and survival in myeloma patients with metaphase cytogenetic abnormalities. Blood 2008;112(8):3115-3121.