TY - JOUR
T1 - Arandomized phase 3 trial of thalidomide and prednisone as maintenance therapy afterASCT in patients withMMwith a quality-of-life assessment
T2 - The national cancer Institute of Canada clinicals trials group myeloma 10 trial
AU - Stewart, A. Keith
AU - Trudel, Suzanne
AU - Bahlis, Nizar J.
AU - White, Darrell
AU - Sabry, Waleed
AU - Belch, Andrew
AU - Reiman, Tony
AU - Roy, Jean
AU - Shustik, Chaim
AU - Kovacs, Michael J.
AU - Rubinger, Morel
AU - Cantin, Guy
AU - Song, Kevin
AU - Tompkins, Kirsty A.
AU - Marcellus, Deb C.
AU - Lacy, Martha Q.
AU - Sussman, Jonathan
AU - Reece, Donna
AU - Brundage, Michael
AU - Harnett, Erica L.
AU - Shepherd, Lois
AU - Chapman, Judy Anne W.
AU - Meyer, Ralph M.
PY - 2013/2/28
Y1 - 2013/2/28
N2 - We conducted a randomized, controlled trial comparing thalidomide- prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival, progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide- prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P < .0001) and more frequent venous thromboembolism (7.3% vs none; P = .0004). Median survival after first disease recurrence was 27.7 months with thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomideprednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit.
AB - We conducted a randomized, controlled trial comparing thalidomide- prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival, progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide- prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P < .0001) and more frequent venous thromboembolism (7.3% vs none; P = .0004). Median survival after first disease recurrence was 27.7 months with thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomideprednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit.
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U2 - 10.1182/blood-2012-09-451872
DO - 10.1182/blood-2012-09-451872
M3 - Article
C2 - 23297129
AN - SCOPUS:84876494741
SN - 0006-4971
VL - 121
SP - 1517
EP - 1523
JO - Blood
JF - Blood
IS - 9
ER -