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Treatment Intensification With Autologous Stem Cell Transplantation and Lenalidomide Maintenance Improves Survival Outcomes of Patients With Newly Diagnosed Multiple Myeloma in Complete Response
R. Mina, MT. Petrucci, P. Corradini, S. Spada, F. Patriarca, C. Cerrato, L. De Paoli, N. Pescosta, R. Ria, A. Malfitano, P. Musto, L. Baldini, T. Guglielmelli, B. Gamberi, D. Mannina, G. Benevolo, R. Zambello, AP. Falcone, A. Palumbo, A. Nagler,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu srovnávací studie, časopisecké články
- MeSH
- adjuvantní chemoterapie MeSH
- alkylační protinádorové látky aplikace a dávkování škodlivé účinky MeSH
- autologní transplantace MeSH
- časové faktory MeSH
- doba přežití bez progrese choroby MeSH
- klinické zkoušky, fáze III jako téma MeSH
- konsolidační chemoterapie MeSH
- lenalidomid aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom diagnóza mortalita terapie MeSH
- multicentrické studie jako téma MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- randomizované kontrolované studie jako téma MeSH
- reziduální nádor MeSH
- rizikové faktory MeSH
- transplantace kmenových buněk * škodlivé účinky mortalita MeSH
- udržovací chemoterapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
BACKGROUND: High-dose therapy with autologous stem cell transplantation (HDT-ASCT) and maintenance treatment with novel agents are the best options for patients with newly diagnosed multiple myeloma, increasing the rate of complete response (CR) and prolonging progression-free survival (PFS) and overall survival (OS). Indeed, the achievement of a CR is a predictor of long-term survival among transplant-eligible patients. However, it is unclear whether patients reaching a CR after induction treatment could receive less intense consolidation or avoid maintenance therapy. PATIENTS AND METHODS: We analyzed CR patients treated in 2 phase III trials, GIMEMA-RV-MM-PI-209 and RV-MM-EMN-441, to compare HDT-ASCT with an R-Alk (lenalidomide, alkylator) regimen as consolidation, and lenalidomide (R) maintenance with no maintenance. The primary endpoints were PFS, second PFS (PFS2), and OS from consolidation and maintenance (_m). RESULTS: Overall, the data from 166 patients in CR were analyzed, 95 in the HDT-ASCT group and 71 in the R-Alk group. The CR patients who received HDT-ASCT had a better PFS (hazard ratio [HR], 0.55; P = .01), PFS2 (HR, 0.46; P = .02), and OS (HR, 0.42; P = .03) compared with patients randomized to R-Alk. The survival benefit with HDT-ASCT was confirmed among all the subgroups, according to age, International Staging System (ISS stage, cytogenetic profile, and receipt of maintenance therapy. CR patients who received lenalidomide maintenance had a better PFS_m (4 years: 54% vs. 19%; HR, 0.43; P = .02) compared with those who received no maintenance. However, no difference was observed in terms of PFS2_m (4 years: 72% vs. 58%; HR, 0.83; P = .67) and OS_m (4 years: 79% vs. 72%; HR, 0.82; P = .73) with maintenance therapy. CONCLUSION: Even in CR patients, outcomes were improved by an intensified approach with HDT-ASCT consolidation and lenalidomide-based maintenance therapy.
Clinica Ematologica Azienda Sanitaria Universitaria Integrata DAME Università di Udine Udine Italy
Department of Haematology Alfred Health Monash University Melbourne Victoria Australia
Department of Oncology and Hematology University of Milano Milano Italy
Dipartimento di Medicina Ematologia e Immunologia Clinica Padua Italy
Division of Hematology AOU Policlinico OVE University of Catania Catania Italy
Division of Hematology Chaim Sheba Medical Center Tel Hashomer Israel
Ematologia AUSL IRCCS Reggio Emilia Italy
Ematologia Casa Sollievo Della Sofferenza IRCCS Hospital San Giovanni Rotondo Italy
Ematologia Ospedale San Luigi Gonzaga Orbassano Italy
Reparto Ematologia e Centro TMO Ospedale Centrale Bolzano Bolzano Italy
SC Hematology AO Città della Salute e della Scienza Turin Italy
Scientific Direction IRCCS CROB Referral Cancer Center of Basilicata Rionero in Vulture Italy
Citace poskytuje Crossref.org
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