Eight‐year median survival in multiple myeloma after total therapy 2: roles of thalidomide and consolidation chemotherapy in the context of total therapy 1
Open Access
- 27 March 2008
- journal article
- research article
- Published by Wiley in British Journal of Haematology
- Vol. 141 (4) , 433-444
- https://doi.org/10.1111/j.1365-2141.2008.06982.x
Abstract
Summary: In comparison to total therapy 1 (TT1), the phase 3 trial total therapy 2 (TT2) evaluated the benefit of up‐front administration of thalidomide (THAL); TT2 also introduced post‐transplant consolidation chemotherapy. With median follow‐up times of 5 and 12 years, respectively, outcome comparisons were made of 668 patient’s enrolled on TT2 and 231 patients treated on TT1. Complete response (CR) rates were similar at 40% for TT1 and TT2 without THALversus60% on the THAL arm of TT2. CR durations were similar with either TT2 arm and both were superior to results of TT1. Event‐free and overall survivals were extended from 2·6 to 5·7 years, respectively, with TT1 to 4·8 and 8·0 years with TT2. TT2’s major advance vis‐à‐vis TT1 pertained to the subgroup without cytogenetic abnormalities (CA), supporting the role of post‐transplant consolidation therapy, whereas the improved survival of the CA subgroup on the experimentalversuscontrol arm of TT2 attests to the role of THAL in this setting. Adjusting for prognostic variables in multivariate and pair‐mate analyses, TT2 was superior to TT1 in terms of CR duration, event‐free and overall survival. These results provide a basis for the prospective evaluation of the consolidation strategy in a randomized clinical trial design.Keywords
This publication has 26 references indexed in Scilit:
- A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myelomaBlood, 2006
- Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 studyBlood, 2006
- Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trialThe Lancet, 2006
- 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 GroupJournal of Clinical Oncology, 2006
- PAD combination therapy (PS‐341/bortezomib, doxorubicin and dexamethasone) for previously untreated patients with multiple myelomaBritish Journal of Haematology, 2005
- Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignanciesBlood, 2005
- DTPACE: An Effective, Novel Combination Chemotherapy With Thalidomide for Previously Treated Patients With MyelomaJournal of Clinical Oncology, 2003
- Antitumor Activity of Thalidomide in Refractory Multiple MyelomaNew England Journal of Medicine, 1999
- Effective Treatment of Advanced Multiple Myeloma Refractory to Alkylating AgentsNew England Journal of Medicine, 1984
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958