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Clinical Trial
. 2018 Jul;144(7):1357-1366.
doi: 10.1007/s00432-018-2641-5. Epub 2018 Apr 19.

Maintenance in myeloma patients achieving complete response after upfront therapy: a pooled analysis

Chiara Cerrato  1 , Francesco Di Raimondo  2 , Lorenzo De Paoli  3 , Stefano Spada  1 , Francesca Patriarca  4 , Claudia Crippa  5 , Roberto Mina  1 , Tommasina Guglielmelli  6 , Dina Ben-Yehuda  7 , Daniela Oddolo  1 , Chiara Nozzoli  8 , Emanuele Angelucci  9 , Nicola Cascavilla  10 , Rita Rizzi  11 , Stefano Rocco  12 , Luca Baldini  13 , Elena Ponticelli  1 , Magda Marcatti  14 , Clotilde Cangialosi  15 , Tommaso Caravita  16 , Giulia Benevolo  17 , Roberto Ria  18 , Arnon Nagler  19 , Pellegrino Musto  20 , Paola Tacchetti  21 , Paolo Corradini  22 , Massimo Offidani  23 , Antonio Palumbo  1   24 , Maria Teresa Petrucci  25 , Mario Boccadoro  1 , Francesca Gay  26
Affiliations
Clinical Trial

Maintenance in myeloma patients achieving complete response after upfront therapy: a pooled analysis

Chiara Cerrato et al. J Cancer Res Clin Oncol. 2018 Jul.

Abstract

Purpose: Maintenance demonstrated to improve survival in newly diagnosed multiple myeloma (NDMM) patients and the achievement of complete response (CR) is a strong predictor of survival. Nevertheless, the role of maintenance according to response after induction/consolidation has not been investigated so far. To evaluate the impact of maintenance according to response, we pooled together and retrospectively analyzed data from 955 NDMM patients enrolled in two trials (GIMEMA-MM-03-05 and RV-MM-PI-209).

Methods: Primary endpoints were progression-free survival (PFS)1, PFS2 and overall survival (OS) of CR patients randomized to maintenance and no maintenance. Secondary endpoints were PFS1, PFS2 and OS in very good partial response/partial response (VGPR/PR) patients.

Results: Overall, 213 patients obtained CR after induction/consolidation, 118 received maintenance and 95 no maintenance. In patients achieving CR, maintenance significantly improved PFS1 (HR 0.50, P < 0.001), PFS2 (HR 0.58, P 0.02) and OS (HR 0.51, P 0.02) compared with no maintenance; the advantage was maintained across all the analyzed subgroups according to age, International Staging System (ISS) stage, cytogenetic profile and treatment. Similar features were seen in VGPR/PR patients.

Conclusion: Maintenance prolonged survival in CR and in VGPR/PR patients. The benefit in CR patients suggests the importance of continuing treatment in patients with chemo-sensitive disease.

Trial registration: The two source studies are registered at ClinicalTrials.gov: identification numbers NCT01063179 and NCT00551928.

Keywords: Complete response (CR); Maintenance therapy; Multiple myeloma (MM); Newly diagnosed; Prognosis.

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Conflict of interest statement

FDR has received honoraria from Celgene, BMS, and Janssen; FP has received honoraria from Celgene, Janssen, BMS; CN has served on the Advisory Board for Celgene; TC has received consultancy fees from Takeda and served on the advisory board for Jannsen, Celgene, BMS, Amgen; PM has received Honoraria from Janssen-Cilag and Celgene; PC has received honoraria from Celgene; MO has received honoraria from Celgene; AP is currently a Takeda employee; MTP has received honoraria from Celgene, Janssen-Cilag, BMS, Amgen, Takeda; MB has received research funding from Amgen, BMS, Celgene, Janssen, Mundipharma, Novartis, Sanofi; and honoraria from AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Sanofi. FG has served on the advisory board for Takeda, Seattle Genetics, Roche, Mundipharma, Janssen; and received honoraria from Takeda, Amgen, Celgene, Janssen, BMS. All the other authors have no potential conflicts of interest.

Figures

Fig. 1
Fig. 1
Progression-free survival 1 according to maintenance/ no maintenance in CR patients: a analysis in all patients; b subgroup analysis
Fig. 2
Fig. 2
Progression-free survival 2 according to maintenance/ no maintenance in CR patients: a analysis in all patients; b subgroup analysis
Fig. 3
Fig. 3
Overall survival according to maintenance/ no maintenance in CR patients: a analysis in all patients; b subgroup analysis
Fig. 4
Fig. 4
Survival curves according to best response achieved and maintenance/no maintenance therapy: a progression-free survival 1; b progression-free survival 2; c overall survival
See this image and copyright information in PMC

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