Treatment Intensification With Autologous Stem Cell Transplantation and Lenalidomide Maintenance Improves Survival Outcomes of Patients With Newly Diagnosed Multiple Myeloma in Complete Response

Roberto Mina, Maria Teresa Petrucci, Paolo Corradini, Stefano Spada, Francesca Patriarca, Chiara Cerrato, Lorenzo De Paoli, Norbert Pescosta, Roberto Ria, Alessandra Malfitano, Pellegrino Musto, Luca Baldini, Tommasina Guglielmelli, Barbara Gamberi, Donato Mannina, Giulia Benevolo, Renato Zambello, Antonietta Pia Falcone, Antonio Palumbo, Arnon NaglerValeria Calafiore, Roman Hájek, Andrew Spencer, Mario Boccadoro, Sara Bringhen

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)533-540
Number of pages8
JournalClinical Lymphoma, Myeloma and Leukemia
Volume18
Issue number8
DOIs
Publication statusPublished - Aug 2018

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Stem Cell Transplantation
Multiple Myeloma
Maintenance
Survival
Disease-Free Survival
Therapeutics
lenalidomide
Alkylating Agents
Cytogenetics
Transplants

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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. / Mina, Roberto; Petrucci, Maria Teresa; Corradini, Paolo; Spada, Stefano; Patriarca, Francesca; Cerrato, Chiara; De Paoli, Lorenzo; Pescosta, Norbert; Ria, Roberto; Malfitano, Alessandra; Musto, Pellegrino; Baldini, Luca; Guglielmelli, Tommasina; Gamberi, Barbara; Mannina, Donato; Benevolo, Giulia; Zambello, Renato; Falcone, Antonietta Pia; Palumbo, Antonio; Nagler, Arnon; Calafiore, Valeria; Hájek, Roman; Spencer, Andrew; Boccadoro, Mario; Bringhen, Sara.

In: Clinical Lymphoma, Myeloma and Leukemia, Vol. 18, No. 8, 08.2018, p. 533-540.

Research output: Contribution to journalArticle

Mina, R, Petrucci, MT, Corradini, P, Spada, S, Patriarca, F, Cerrato, C, De Paoli, L, Pescosta, N, Ria, R, Malfitano, A, Musto, P, Baldini, L, Guglielmelli, T, Gamberi, B, Mannina, D, Benevolo, G, Zambello, R, Falcone, AP, Palumbo, A, Nagler, A, Calafiore, V, Hájek, R, Spencer, A, Boccadoro, M & Bringhen, S 2018, 'Treatment Intensification With Autologous Stem Cell Transplantation and Lenalidomide Maintenance Improves Survival Outcomes of Patients With Newly Diagnosed Multiple Myeloma in Complete Response', Clinical Lymphoma, Myeloma and Leukemia, vol. 18, no. 8, pp. 533-540. https://doi.org/10.1016/j.clml.2018.05.019
Mina, Roberto ; Petrucci, Maria Teresa ; Corradini, Paolo ; Spada, Stefano ; Patriarca, Francesca ; Cerrato, Chiara ; De Paoli, Lorenzo ; Pescosta, Norbert ; Ria, Roberto ; Malfitano, Alessandra ; Musto, Pellegrino ; Baldini, Luca ; Guglielmelli, Tommasina ; Gamberi, Barbara ; Mannina, Donato ; Benevolo, Giulia ; Zambello, Renato ; Falcone, Antonietta Pia ; Palumbo, Antonio ; Nagler, Arnon ; Calafiore, Valeria ; Hájek, Roman ; Spencer, Andrew ; Boccadoro, Mario ; Bringhen, Sara. / Treatment Intensification With Autologous Stem Cell Transplantation and Lenalidomide Maintenance Improves Survival Outcomes of Patients With Newly Diagnosed Multiple Myeloma in Complete Response. In: Clinical Lymphoma, Myeloma and Leukemia. 2018 ; Vol. 18, No. 8. pp. 533-540.
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abstract = "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.",
author = "Roberto Mina and Petrucci, {Maria Teresa} and Paolo Corradini and Stefano Spada and Francesca Patriarca and Chiara Cerrato and {De Paoli}, Lorenzo and Norbert Pescosta and Roberto Ria and Alessandra Malfitano and Pellegrino Musto and Luca Baldini and Tommasina Guglielmelli and Barbara Gamberi and Donato Mannina and Giulia Benevolo and Renato Zambello and Falcone, {Antonietta Pia} and Antonio Palumbo and Arnon Nagler and Valeria Calafiore and Roman H{\'a}jek and Andrew Spencer and Mario Boccadoro and Sara Bringhen",
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TY - JOUR

T1 - Treatment Intensification With Autologous Stem Cell Transplantation and Lenalidomide Maintenance Improves Survival Outcomes of Patients With Newly Diagnosed Multiple Myeloma in Complete Response

AU - Mina, Roberto

AU - Petrucci, Maria Teresa

AU - Corradini, Paolo

AU - Spada, Stefano

AU - Patriarca, Francesca

AU - Cerrato, Chiara

AU - De Paoli, Lorenzo

AU - Pescosta, Norbert

AU - Ria, Roberto

AU - Malfitano, Alessandra

AU - Musto, Pellegrino

AU - Baldini, Luca

AU - Guglielmelli, Tommasina

AU - Gamberi, Barbara

AU - Mannina, Donato

AU - Benevolo, Giulia

AU - Zambello, Renato

AU - Falcone, Antonietta Pia

AU - Palumbo, Antonio

AU - Nagler, Arnon

AU - Calafiore, Valeria

AU - Hájek, Roman

AU - Spencer, Andrew

AU - Boccadoro, Mario

AU - Bringhen, Sara

N1 - Copyright © 2018 Elsevier Inc. All rights reserved.

PY - 2018/8

Y1 - 2018/8

N2 - 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.

AB - 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.

U2 - 10.1016/j.clml.2018.05.019

DO - 10.1016/j.clml.2018.05.019

M3 - Article

C2 - 29910180

VL - 18

SP - 533

EP - 540

JO - Clinical Lymphoma, Myeloma and Leukemia

JF - Clinical Lymphoma, Myeloma and Leukemia

SN - 2152-2669

IS - 8

ER -