Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma

A. Broccoli, C. Pellegrini, A. Di Rocco, B. Puccini, C. Patti, G. Gini, D. Mannina, M. Tani, C. Rusconi, A. Romano, A. Vanazzi, B. Botto, C. Carlo-Stella, S. Hohaus, P. Musto, P. Mazza, S. Molica, P. Corradini, A. Fama, F. GaudioM. Merli, A. Gravetti, G. Gritti, A. Arcari, P. Tosi, A.M. Liberati, A. Pinto, V. Pavone, F. Gherlinzoni, V. Naso, S. Volpetti, L. Trentin, M.C. Goldaniga, M. Bonfichi, A. De Renzo, C. Schiavotto, M. Spina, S. Storti, A.M. Carella, V. Stefoni, L. Argnani, P.L. Zinzani

Research output: Contribution to journalArticlepeer-review

Abstract

Between November 2012 and July 2014, in accordance with national law 648/96, brentuximab vedotin was available in Italy for patients with relapsed systemic anaplastic large cell lymphoma outside a clinical trial context. A large Italian observational retrospective study was conducted on the use of brentuximab vedotin in everyday clinical practice to check whether clinical trial results are confirmed in a real-life context. The primary endpoint of this study was best response; secondary endpoints were the overall response rate at the end of the treatment, duration of response, survival and safety profile. A total of 40 heavily pretreated patients were enrolled. Best response was observed after a median of four cycles in 77.5%: globally, 47.5% patients obtained a complete response, 64.2% in the elderly subset. The overall response rate was 62.5%. At the latest follow up, 15/18 patients are still in complete remission (3 with consolidation). The progression-free survival rate at 24 months was 39.1% and the disease-free survival rate at the same time was 54% (median not reached). All the long-term responders were aged
Original languageEnglish
Pages (from-to)1931-1935
Number of pages5
JournalHaematologica
Volume102
Issue number11
DOIs
Publication statusPublished - 2017

Keywords

  • brentuximab vedotin
  • adolescent
  • adult
  • aged
  • allogeneic stem cell transplantation
  • anaplastic large cell lymphoma
  • Article
  • blood toxicity
  • cancer recurrence
  • cancer survival
  • clinical article
  • computer assisted tomography
  • disease free survival
  • drug dose reduction
  • drug efficacy
  • drug safety
  • drug tolerability
  • erythema
  • female
  • human
  • infusion
  • Italy
  • male
  • median survival time
  • multicenter study
  • multiple cycle treatment
  • nausea
  • neurotoxicity
  • neutropenia
  • observational study
  • overall survival
  • phase 2 clinical trial (topic)
  • positron emission tomography
  • progression free survival
  • retrospective study
  • survival rate
  • treatment response
  • weakness

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