Role of new treatment approaches in defining treatment goals in multiple myeloma - the ultimate goal is extended survival

Cancer Treatment Reviews

Volumn 36, Issue SUPPL. 2, 2010, Pages

  Durie, Brian G M ^a,b  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b Aptium Oncology   (United States)

Author keywords

Bortezomib; Clinical trial endpoints; Complete response; Lenalidomide; Multiple myeloma; Survival; Thalidomide; Time to progression; Treatment goal

Indexed keywords

BORTEZOMIB; DEXAMETHASONE; DOXORUBICIN; LENALIDOMIDE; MELPHALAN; PLACEBO; POMALIDOMIDE; PREDNISONE; THALIDOMIDE;

AGE DISTRIBUTION; ANTIANGIOGENIC ACTIVITY; ANTINEOPLASTIC ACTIVITY; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; BONE MARROW SUPPRESSION; CANCER RELAPSE; CANCER SURVIVAL; CHROMOSOME DELETION; CHROMOSOME TRANSLOCATION 4; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG FATALITY; DRUG MEGADOSE; DRUG POTENCY; DRUG TOLERABILITY; FATIGUE; GASTROINTESTINAL SYMPTOM; HUMAN; IMMUNOMODULATION; INFECTION; MAINTENANCE THERAPY; MONOCLONAL IMMUNOGLOBULINEMIA; MONOTHERAPY; MULTIPLE MYELOMA; MYELOMA; NEUTROPENIA; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PROGRESSION FREE SURVIVAL; REFRACTORY PERIOD; SALVAGE THERAPY; SEDATION; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DISEASE; SOMNOLENCE; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT DURATION; TREATMENT RESPONSE; WEAKNESS;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; ENDPOINT DETERMINATION; HUMANS; MULTIPLE MYELOMA; REMISSION INDUCTION; SURVIVAL; TIME FACTORS;

EID: 77952827488     PISSN: 03057372     EISSN: 15321967     Source Type: Journal    
DOI: 10.1016/S0305-7372(10)70008-6     Document Type: Article

References (42)

1. Chin R, Lee BR Principles and practice of clinical trial medicine 2008, Academic Press, Philadelphia (PA).
2. Pazdur R Endpoints for assessing drug activity in clinical trials. Oncologist 2008, 13(Suppl 2):19-21.
3. Bladé J, Samson D, Reece D, et al. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Br J Haematol 1998, 102:1115-1123.
4. Durie BG, Harousseau JL, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia 2006, 20:1467-1473.
5. Rajkumar SV Treatment of myeloma: cure vs control. Mayo Clin Proc 2008, 83:1142-1145.
6. 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.
7. Fox E, Curt GA, Balis FM Clinical trial design for target-based therapy. Oncologist 2002, 7:401-409.
8. Harousseau JL, Attal M, Avet-Loiseau H The role of complete response in multiple myeloma. Blood 2009, 114:3139-3146.
9. San Miguel JF, Schlag R, Khuageva NK, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med 2008, 359:906-917.
10. Attal M, Harousseau JL, Facon T, et al. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med 2003, 349:2495-2502.
11. 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, 370:1209-1218.
12. Ludwig H, Hajek R, Tóthová E, et al. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood 2009, 113:3435-3442.
13. Pineda-Roman M, Bolejack V, Arzoumanian V, et al. Complete response in myeloma extends survival without, but not with history of prior monoclonal gammopathy of undetermined significance or smouldering disease. Br J Haematol 2007, 136:393-399.
14. Zhan F, Barlogie B, Arzoumanian V, et al. Gene-expression signature of benign monoclonal gammopathy evident in multiple myeloma is linked to good prognosis. Blood 2007, 109:1692-1700.
15. Harousseau JL, Avet-Loiseau H, Attal M, et al. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 trials. J Clin Oncol 2009, 27:5720-5726.
16. Avet-Loiseau H, Attal M, Moreau P, et al. Genetic abnormalities and survival in multiple myeloma: the experience of the Intergroupe Francophone du Myélome. Blood 2007, 109:3489-3495.
17. Haessler J, Shaughnessy JD, Zhan F, et al. Benefit of complete response in multiple myeloma limited to high-risk subgroup identified by gene expression profiling. Clin Cancer Res 2007, 13:7073-7079.
18. Barlogie B, Pineda-Roman M, van Rhee F, et al. Thalidomide arm of Total Therapy 2 improves complete remission duration and survival in myeloma patients with metaphase cytogenetic abnormalities. Blood 2008, 112:3115-3121.
19. Ladetto M, Pagliano G, Ferrero S, et al. Major shrinking of residual tumor cell burden and achievement of molecular remissions in myeloma patients undergoing post-transplant consolidation with bortezomib, thalidomide and dexamethasone: a qualitative and quantitative PCR study [abstract]. Blood 2008, 112. abstract 3683.
20. San Miguel J, Dimopoulos M, Bravo M-L, Weber D Longer duration of treatment and maintenance of best response with lenalidomide + dexamethasone increases overall survival (OS) in patients with relapsed/refractory multiple myeloma (RRMM) [abstract]. Haematologica 2009, 94(Suppl 2):382. (abstract 0949).
21. D'Amato RJ, Loughnan MS, Flynn E, Folkman J Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci USA 1994, 91:4082-4085.
22. Haslett PA, Corral LG, Albert M, Kaplan G Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytotoxic responses in the CD8+ subset. J Exp Med 1998, 187:1885-1892.
23. Singhal S, Mehta J, Desikan R, et al. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med 1999, 341:1565-1571.
24. Bartlett JB, Dredge K, Dalgleish AG The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer 2004, 4:314-322.
25. Hideshima T, Anderson KC Molecular mechanisms of novel therapeutic approaches for multiple myeloma. Nat Rev Cancer 2002, 2:927-937.
26. Weber DM, Chen C, Niesvizky R, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med 2007, 357:2133-2142.
27. Dimopoulos M, Spencer A, Attal M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med 2007, 357:2123-2132.
28. Lacy MQ, Rajkumar SV Pomalidomide: a new IMiD with remarkable activity in both multiple myeloma and myelofibrosis. Am J Hematol 2010, 85:95-96.
29. Lacy MQ, Hayman SR, Gertz MA, et al. Pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma. J Clin Oncol 2009, 27:5008-5014.
30. Palombella VJ, Rando OJ, Goldberg AL, Maniatis T The ubiquitin-proteasome pathway is required for processing the NF-kappa B1 precursor protein and the activation of NF-kappa B. Cell 1994, 78:773-785.
31. Chauhan D, Uchiyama H, Akbarali Y, et al. Multiple myeloma cell adhesion-induced interleukin-6 expression in bone marrow stromal cells involves activation of NF-kappa B. Blood 1996, 87:1104-1112.
32. Anderson KC Proteasome inhibitors in multiple myeloma. Semin Oncol 2009, 36(Suppl 1):S20-S26.
33. Richardson PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 2005, 352:2487-2498.
34. Kumar SK, Rajkumar SV, Dispenzieri A, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood 2008, 111:2516-2520.
35. Dimopoulos MA, Chen C, Spencer A, et al. Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Leukemia 2009, 23:2147-2152.
36. Orlowski RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol 2007, 25:3892-3901.
37. Rajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR, Eastern Cooperative Oncology Group Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol 2006, 24:431-436.
38. 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, 367:825-831.
39. Zonder JA, Crowley J, Hussein MA, et al. 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 [abstract]. Blood 2007, 110. abstract 77.
40. 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, 27:3664-3670.
41. Palumbo A, Bringhen S, Liberati AM, et al. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood 2008, 112:3107-3114.
42. Harousseau JL, Weber D, Dimopoulos MA, et al. Relapsed/refractory multiple myeloma patients treated with lenalidomide/dexamethasone who achieve a complete or near complete response have longer overall survival and time to progression compared with patients achieving a partial response [abstract]. Blood 2007, 110. abstract 3598.