Page 109 - Haematologica August 2018

Non-Hodgkin Lymphoma
Rituximab plus bendamustine as front-line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-Hodgkin lymphoma: a phase II multicenter study
of the Fondazione Italiana Linfomi
Ferrata Storti Foundation
Sergio Storti,1 Michele Spina,2 Emanuela Anna Pesce,3 Flavia Salvi,4
Michele Merli,5 Alessia Ruffini,6 Giuseppina Cabras,7 Annalisa Chiappella,8 Emanuele Angelucci,9 Alberto Fabbri,10 Anna Marina Liberati,11 Monica Tani,12 Gerardo Musuraca,13 Annalia Molinari,14 Maria Pia Petrilli,1 Carmela Palladino,4 Rosanna Ciancia,2 Andrea Ferrario,5 Cristiana Gasbarrino,1 Federico Monaco,4 Vincenzo Fraticelli,1 Annalisa De Vellis,1 Francesco Merli15 and Stefano Luminari15,16
Haematologica 2018 Volume 103(8):1345-1350
1Department of Hematology, Universita' Cattolica Sacro Cuore Campobasso; 2Division of Oncology A, National Cancer Institute Aviano; 3Fondazione Italiana Linfomi Onlus; 4Hematology Unit, Antonio e Biagio e Cesare Arrigo Hospital, Alessandria; 5Department of Hematology, Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi, Varese; 6GRADE - Gruppo Amici Dell’Ematologia; 7Unit of Hematology Ospedale Businco, Cagliari; 8Department of Hematology, Città della Salute Hospital and University, Torino; 9Ospedale Policlinico San Martino, Genova; 10Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia, Siena; 11Università degli Studi di Perugia, A.O.S. Maria, Terni; 12Department of Hematology, S. Maria delle Croci Hospital, Ravenna; 13Department of Hematology, IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola; 14Department of Hematology, Infermi Hospital, Rimini; 15Department of Hematology, Azienda Unità Sanitaria Locale IRCCS di Reggio Emilia and 16Department of Clinical Diagnostic and Public Health Medicine, Università degli Studi di Modena e Reggio Emilia, Modena, Italy
ABSTRACT
We conducted a phase II study to assess activity and safety profile of bendamustine and rituximab in elderly patients with untreated diffuse large B-cell lymphoma (DLBCL) who were prospectively defined as frail using a simplified version of the Comprehensive Geriatric Assessment (CGA). Patients had to be over 70 years of age, with histologically confirmed DLBCL. Frail patients were those younger than 80 years with a frail profile at CGA or older than 80 years with an unfit profile. Treatment consisted of 4-6 courses of ben- damustine [90 mg/m2 days (d)1-2] and rituximab (375 mg/m2 d1) admin- istered every 28 days. Other main study end points were complete remis- sion rate and the rate of extra-hematologic adverse events. Forty-nine patients were enrolled of whom 45 were confirmed eligible. Overall, 24 patients achieved a complete remission (53%; 95%CI: 38-68%) and the overall response rate was 62% (95%CI: 47-76%). The most frequent grade 3-4 adverse event was neutropenia (37.8%). Grade 3-4 extra-hema- tologic adverse events were observed in 7 patients (15.6%; 95%CI: 6.5- 29.5%); the most frequent was grade 3 infection in 2 patients. With a median follow up of 33 months (range 1-52), the median progression-free survival was ten months (95%CI: 7-25). The study shows promising activity and manageable toxicity profile of BR combination as first-line therapy for patients with DLBCL who are prospectively defined as frail according to a simplified CGA, as adopted in this trial (clinicaltrials.gov identifier: 01990144).
Correspondence:
stefano.luminari@ausl.re.it
Received: December 20, 2017. Accepted: May 3, 2018. Pre-published: May 10, 2018.
doi:10.3324/haematol.2017.186569
Check the online version for the most updated information on this article, online supplements, and information on authorship & disclosures: www.haematologica.org/content/103/8/1345
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