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Investigational New Drugs
Published in: Investigational New Drugs 3/2019

01-06-2019 | Lymphoma | PHASE II STUDIES

The metronomic all-oral DEVEC is an effective schedule in elderly patients with diffuse large b-cell lymphoma

Authors: M. Christina Cox, Sabrina Pelliccia, Luigi Marcheselli, Roberta Battistini, Annalisa Arcari, Paola Anticoli Borza, Caterina Patti, Ivana Casaroli, Francesca di Landro, Arianna Di Napoli, Francesca Fabbri, Matteo Caridi, Agostino Tafuri, Guido Bocci, Gerardo Musuraca

Published in: Investigational New Drugs | Issue 3/2019

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Summary

Metronomic-chemotherapy (M-CHT) has been rarely assessed in non-Hodgkin-lymphoma (NHL). Therefore, in 2011 we started experimenting a new all-oral M-CHT schedule termed DEVEC (Deltacortene®, etoposide, vinorelbine, cyclophosphamide, +/-Rituximab) in diffuse-large-B-cell lymphoma (DLBCL) patients. Methods Patients with stage Ib-IV were enrolled as follows: 1) treatment-naïve, frail ≥65y, or unfit ≥85y; and 2) relapsed/refractory (R/R) ≥55y. Data were prospectively collected from six Italian centres and compared for efficacy to two reference groups, treated with established iv Rituximab-CHT in 1st and 2nd line respectively. Results from April-2011 to March-2018, 17/51(33%) naïve, 21/51(41%) refractory and 13/51(25.5%) relapsed patients started DEVEC; 39/51(76.5%) were de-novo DLBCL; 10/51(19.6%) transformed-DLBCL and 2/51(3.9%) unclassifiable-DLBCL/classical-Hodgkin-lymphoma. The median age was 85y (range=77-93) and 78y (range=57-91) in naïve and R/R respectively and overall the DEVEC patients had very poor features compared to the reference. The rate of grade≥3 haematological-AEs was 43%(95CI=29-58%): G3-neutropenia was the most frequent; grade≥3 extra-haematological-AEs was 13.7% (95%CI=5.4-25.9%), the most frequent was infection. One-year OS and PFS were 67% and 61% for naive, 60% and 50% for reference-naïve respectively; Cox proportional hazard ratio (Cox-PH-ratio) for OS and PFS were 0.69 (95%CI=0.27-1.76;p=.441) and 0.68 (95%CI=0.28-1.62;p=.381) respectively. One-year OS and PFS were 48% and 39% in the R/R, 36% and 17% in the reference-R/R respectively; Cox-PH-ratio for OS and PFS, were 0.76 (95%CI=0.42-1.40; p=.386) and 0.48 (95%CI=0.28-0.82; p=.007) respectively. Conclusion The favourable activity of DEVEC compared to a real-life series and the convenience of an oral administration, may possibly lay the groundwork for a paradigm-shift in the treatment of elderly DLBCL.
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Metadata
Title
The metronomic all-oral DEVEC is an effective schedule in elderly patients with diffuse large b-cell lymphoma
Authors
M. Christina Cox
Sabrina Pelliccia
Luigi Marcheselli
Roberta Battistini
Annalisa Arcari
Paola Anticoli Borza
Caterina Patti
Ivana Casaroli
Francesca di Landro
Arianna Di Napoli
Francesca Fabbri
Matteo Caridi
Agostino Tafuri
Guido Bocci
Gerardo Musuraca
Publication date
01-06-2019
Publisher
Springer US
Published in
Investigational New Drugs / Issue 3/2019
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-019-00769-5

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