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

Alessandro Broccoli, Cinzia Pellegrini, Alice Di Rocco, Benedetta Puccini, Caterina Patti, Guido Gini, Donato Mannina, Monica Tani, Chiara Rusconi, Alessandra Romano, Anna Vanazzi, Barbara Botto, Carmelo Carlo-Stella, Stefan Hohaus, Pellegrino Musto, Patrizio Mazza, Stefano Molica, Paolo Corradini, Angelo Fama, Francesco GaudioMichele Merli, Angela Gravetti, Giuseppe Gritti, Annalisa Arcari, Patrizia Tosi, Anna Marina Liberati, Antonello Pinto, Vincenzo Pavone, Filippo Gherlinzoni, Virginia Naso, Stefano Volpetti, Livio Trentin, Maria Cecilia Goldaniga, Maurizio Bonfichi, Amalia De Renzo, Corrado Schiavotto, Michele Spina, Sergio Storti, Angelo Michele Carella, Vittorio Stefoni, Lisa Argnani, Pier Luigi Zinzani

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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 <30 years at first infusion. The treatment was well tolerated even in this real-life context and no deaths were linked to drug toxicity. Brentuximab vedotin induces clinical responses quite rapidly, i.e. within the first four cycles of treatment in most responders, thus enabling timely use of transplantation. For patients ineligible for transplant or for those in whom a transplant procedure failed, brentuximab vedotin may represent a feasible effective therapeutic option in everyday clinical practice.

Original languageEnglish
Pages (from-to)1931-1935
Number of pages5
JournalHaematologica
Volume102
Issue number11
DOIs
Publication statusPublished - Nov 2017

Keywords

  • Journal Article

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    Broccoli, A., Pellegrini, C., Di Rocco, A., Puccini, B., Patti, C., Gini, G., Mannina, D., Tani, M., Rusconi, C., Romano, A., Vanazzi, A., Botto, B., Carlo-Stella, C., Hohaus, S., Musto, P., Mazza, P., Molica, S., Corradini, P., Fama, A., ... Zinzani, P. L. (2017). Italian real-life experience with brentuximab vedotin: results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma. Haematologica, 102(11), 1931-1935. https://doi.org/10.3324/haematol.2017.171355