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 bendamustine [90 mg/m 2 days (d)1-2] and rituximab (375 mg/m 2 d1) administered every 28 days. Other main study end points were complete remission 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-hematologic 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).

Storti, S., Spina, M., Pesce, E. A., Salvi, F., Merli, M. C., Ruffini, A., Cabras, G., Chiappella, A., Angelucci, E., Fabbri, A., Liberati, A. M., Tani, M., Musuraca, G., Molinari, A., Petrilli, M. P., Palladino, C., Ciancia, R., Ferrario, A. A., Gasbarrino, C., Monaco, F., Fraticelli, V., De Vellis, A., Merli, F., Luminari, S., 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, <<HAEMATOLOGICA>>, 2018; 103 (8): 1345-1350. [doi:10.3324/haematol.2017.186569] [http://hdl.handle.net/10807/170026]

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

Storti, Sergio;Merli, Maria Clara;Petrilli, Maria Pia;Ferrario, Alberto Alfredo;
2018

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 bendamustine [90 mg/m 2 days (d)1-2] and rituximab (375 mg/m 2 d1) administered every 28 days. Other main study end points were complete remission 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-hematologic 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).
2018
Inglese
Storti, S., Spina, M., Pesce, E. A., Salvi, F., Merli, M. C., Ruffini, A., Cabras, G., Chiappella, A., Angelucci, E., Fabbri, A., Liberati, A. M., Tani, M., Musuraca, G., Molinari, A., Petrilli, M. P., Palladino, C., Ciancia, R., Ferrario, A. A., Gasbarrino, C., Monaco, F., Fraticelli, V., De Vellis, A., Merli, F., Luminari, S., 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, <<HAEMATOLOGICA>>, 2018; 103 (8): 1345-1350. [doi:10.3324/haematol.2017.186569] [http://hdl.handle.net/10807/170026]
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