The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis

GJ Morgan; WM Gregory; FE Davies; SE Bell; AJ Szubert; JM Brown; NN Coy; G Cook; NH Russell; C Rudin; H Roddie; Mark Drayson; RG Owen; FM Ross; GH Jackson; JA Child

doi:10.1182/blood-2011-06-357038

The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis

GJ Morgan, WM Gregory, FE Davies, SE Bell, AJ Szubert, JM Brown, NN Coy, G Cook, NH Russell, C Rudin, H Roddie, Mark Drayson, RG Owen, FM Ross, GH Jackson, JA Child

Immunology and Immunotherapy

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Abstract

Thalidomide maintenance has the potential to modulate residual multiple myeloma (MM) after an initial response. This trial compared the effect of thalidomide maintenance and no maintenance on progression-free survival (PFS) and overall survival (OS) in MM patients. After intensive or nonintensive induction therapy, 820 newly diagnosed MM patients were randomized to open-label thalidomide maintenance until progression, or no maintenance. Interphase FISH (iFISH) analysis was performed at study entry. Median PFS was significantly longer with thalidomide maintenance (log-rank P <.001). Median OS was similar between regimens (log-rank P = .40). Patients with favorable iFISH showed improved PFS (P = .004) and a trend toward a late survival benefit. Patients with adverse iFISH receiving thalidomide showed no significant PFS benefit and worse OS (P = .009). Effective relapse therapy enhanced survival after progression, translating into a significant OS benefit. Meta-analysis of this and other studies show a significant late OS benefit (P <.001, 7-year difference hazard ratio = 12.3; 95% confidence interval, 5.5-19.0). Thalidomide maintenance significantly improves PFS and can be associated with improved OS. iFISH testing is important in assessing the clinical impact of maintenance therapy. Overview analysis demonstrated that thalidomide maintenance was associated with a significant late OS benefit. This trial was registered at www.isrctn.orgas #ISRCTN68454111. (Blood. 2012; 119(1): 7-15)

Original language	English
Pages (from-to)	7-15
Number of pages	9
Journal	Blood
Volume	119
Issue number	1
DOIs	https://doi.org/10.1182/blood-2011-06-357038
Publication status	Published - 1 Jan 2012

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10.1182/blood-2011-06-357038

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Morgan, GJ., Gregory, WM., Davies, FE., Bell, SE., Szubert, AJ., Brown, JM., Coy, NN., Cook, G., Russell, NH., Rudin, C., Roddie, H., Drayson, M., Owen, RG., Ross, FM., Jackson, GH., & Child, JA. (2012). The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis. Blood, 119(1), 7-15. https://doi.org/10.1182/blood-2011-06-357038

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title = "The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis",

abstract = "Thalidomide maintenance has the potential to modulate residual multiple myeloma (MM) after an initial response. This trial compared the effect of thalidomide maintenance and no maintenance on progression-free survival (PFS) and overall survival (OS) in MM patients. After intensive or nonintensive induction therapy, 820 newly diagnosed MM patients were randomized to open-label thalidomide maintenance until progression, or no maintenance. Interphase FISH (iFISH) analysis was performed at study entry. Median PFS was significantly longer with thalidomide maintenance (log-rank P <.001). Median OS was similar between regimens (log-rank P = .40). Patients with favorable iFISH showed improved PFS (P = .004) and a trend toward a late survival benefit. Patients with adverse iFISH receiving thalidomide showed no significant PFS benefit and worse OS (P = .009). Effective relapse therapy enhanced survival after progression, translating into a significant OS benefit. Meta-analysis of this and other studies show a significant late OS benefit (P <.001, 7-year difference hazard ratio = 12.3; 95% confidence interval, 5.5-19.0). Thalidomide maintenance significantly improves PFS and can be associated with improved OS. iFISH testing is important in assessing the clinical impact of maintenance therapy. Overview analysis demonstrated that thalidomide maintenance was associated with a significant late OS benefit. This trial was registered at www.isrctn.orgas #ISRCTN68454111. (Blood. 2012; 119(1): 7-15)",

author = "GJ Morgan and WM Gregory and FE Davies and SE Bell and AJ Szubert and JM Brown and NN Coy and G Cook and NH Russell and C Rudin and H Roddie and Mark Drayson and RG Owen and FM Ross and GH Jackson and JA Child",

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doi = "10.1182/blood-2011-06-357038",

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Morgan, GJ, Gregory, WM, Davies, FE, Bell, SE, Szubert, AJ, Brown, JM, Coy, NN, Cook, G, Russell, NH, Rudin, C, Roddie, H, Drayson, M, Owen, RG, Ross, FM, Jackson, GH & Child, JA 2012, 'The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis', Blood, vol. 119, no. 1, pp. 7-15. https://doi.org/10.1182/blood-2011-06-357038

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T1 - The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis

AU - Morgan, GJ

AU - Gregory, WM

AU - Davies, FE

AU - Bell, SE

AU - Szubert, AJ

AU - Brown, JM

AU - Coy, NN

AU - Cook, G

AU - Russell, NH

AU - Rudin, C

AU - Roddie, H

AU - Drayson, Mark

AU - Owen, RG

AU - Ross, FM

AU - Jackson, GH

AU - Child, JA

PY - 2012/1/1

Y1 - 2012/1/1

N2 - Thalidomide maintenance has the potential to modulate residual multiple myeloma (MM) after an initial response. This trial compared the effect of thalidomide maintenance and no maintenance on progression-free survival (PFS) and overall survival (OS) in MM patients. After intensive or nonintensive induction therapy, 820 newly diagnosed MM patients were randomized to open-label thalidomide maintenance until progression, or no maintenance. Interphase FISH (iFISH) analysis was performed at study entry. Median PFS was significantly longer with thalidomide maintenance (log-rank P <.001). Median OS was similar between regimens (log-rank P = .40). Patients with favorable iFISH showed improved PFS (P = .004) and a trend toward a late survival benefit. Patients with adverse iFISH receiving thalidomide showed no significant PFS benefit and worse OS (P = .009). Effective relapse therapy enhanced survival after progression, translating into a significant OS benefit. Meta-analysis of this and other studies show a significant late OS benefit (P <.001, 7-year difference hazard ratio = 12.3; 95% confidence interval, 5.5-19.0). Thalidomide maintenance significantly improves PFS and can be associated with improved OS. iFISH testing is important in assessing the clinical impact of maintenance therapy. Overview analysis demonstrated that thalidomide maintenance was associated with a significant late OS benefit. This trial was registered at www.isrctn.orgas #ISRCTN68454111. (Blood. 2012; 119(1): 7-15)

AB - Thalidomide maintenance has the potential to modulate residual multiple myeloma (MM) after an initial response. This trial compared the effect of thalidomide maintenance and no maintenance on progression-free survival (PFS) and overall survival (OS) in MM patients. After intensive or nonintensive induction therapy, 820 newly diagnosed MM patients were randomized to open-label thalidomide maintenance until progression, or no maintenance. Interphase FISH (iFISH) analysis was performed at study entry. Median PFS was significantly longer with thalidomide maintenance (log-rank P <.001). Median OS was similar between regimens (log-rank P = .40). Patients with favorable iFISH showed improved PFS (P = .004) and a trend toward a late survival benefit. Patients with adverse iFISH receiving thalidomide showed no significant PFS benefit and worse OS (P = .009). Effective relapse therapy enhanced survival after progression, translating into a significant OS benefit. Meta-analysis of this and other studies show a significant late OS benefit (P <.001, 7-year difference hazard ratio = 12.3; 95% confidence interval, 5.5-19.0). Thalidomide maintenance significantly improves PFS and can be associated with improved OS. iFISH testing is important in assessing the clinical impact of maintenance therapy. Overview analysis demonstrated that thalidomide maintenance was associated with a significant late OS benefit. This trial was registered at www.isrctn.orgas #ISRCTN68454111. (Blood. 2012; 119(1): 7-15)

U2 - 10.1182/blood-2011-06-357038

DO - 10.1182/blood-2011-06-357038

M3 - Article

C2 - 22021371

SN - 0006-4971

VL - 119

SP - 7

EP - 15

JO - Blood

JF - Blood

IS - 1

ER -

The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis

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