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

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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)548-558
Number of pages11
JournalInvestigational New Drugs
Volume37
Issue number3
DOIs
Publication statusPublished - Jun 15 2019

    Fingerprint

Keywords

  • Bendamustine
  • CHOP
  • Comprehensive geriatric assessment, CGA
  • Diffuse large B-cell lymphoma
  • DLBCL
  • Elderly
  • Gemox
  • Low-dose
  • Metronomic chemotherapy
  • NHL

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Cox, M. C., Pelliccia, S., Marcheselli, L., Battistini, R., Arcari, A., Borza, P. A., Patti, C., Casaroli, I., di Landro, F., Di Napoli, A., Fabbri, F., Caridi, M., Tafuri, A., Bocci, G., & Musuraca, G. (2019). The metronomic all-oral DEVEC is an effective schedule in elderly patients with diffuse large b-cell lymphoma. Investigational New Drugs, 37(3), 548-558. https://doi.org/10.1007/s10637-019-00769-5