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

Sergio Storti, Michele Spina, Emanuela Anna Pesce, Flavia Salvi, Michele Merli, Alessia Ruffini, Giuseppina Cabras, Annalisa Chiappella, Emanuele Angelucci, Alberto Fabbri, Anna Marina Liberati, Monica Tani, Gerardo Musuraca, Annalia Molinari, Maria Pia Petrilli, Carmela Palladino, Rosanna Ciancia, Andrea Ferrario, Cristiana Gasbarrino, Federico Monaco & 4 others Vincenzo Fraticelli, Annalisa De Vellis, Francesco Merli, Stefano Luminari

Research output: Contribution to journalArticle

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/m2 days (d)1-2] and rituximab (375 mg/m2 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).

Original languageEnglish
Pages (from-to)1345-1350
Number of pages6
JournalHaematologica
Volume103
Issue number8
DOIs
Publication statusPublished - Aug 2018

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Frail Elderly
B-Cell Lymphoma
Non-Hodgkin's Lymphoma
Multicenter Studies
Geriatric Assessment
Lymphoma, Large B-Cell, Diffuse
Therapeutics
Bendamustine Hydrochloride
Rituximab
Neutropenia
Disease-Free Survival
Safety

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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; Spina, Michele; Pesce, Emanuela Anna; Salvi, Flavia; Merli, Michele; Ruffini, Alessia; Cabras, Giuseppina; Chiappella, Annalisa; Angelucci, Emanuele; Fabbri, Alberto; Liberati, Anna Marina; Tani, Monica; Musuraca, Gerardo; Molinari, Annalia; Petrilli, Maria Pia; Palladino, Carmela; Ciancia, Rosanna; Ferrario, Andrea; Gasbarrino, Cristiana; Monaco, Federico; Fraticelli, Vincenzo; De Vellis, Annalisa; Merli, Francesco; Luminari, Stefano.

In: Haematologica, Vol. 103, No. 8, 08.2018, p. 1345-1350.

Research output: Contribution to journalArticle

Storti, S, Spina, M, Pesce, EA, Salvi, F, Merli, M, Ruffini, A, Cabras, G, Chiappella, A, Angelucci, E, Fabbri, A, Liberati, AM, Tani, M, Musuraca, G, Molinari, A, Petrilli, MP, Palladino, C, Ciancia, R, Ferrario, A, Gasbarrino, C, Monaco, F, Fraticelli, V, De Vellis, A, Merli, F & Luminari, S 2018, '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, vol. 103, no. 8, pp. 1345-1350. https://doi.org/10.3324/haematol.2017.186569
Storti, Sergio ; Spina, Michele ; Pesce, Emanuela Anna ; Salvi, Flavia ; Merli, Michele ; Ruffini, Alessia ; Cabras, Giuseppina ; Chiappella, Annalisa ; Angelucci, Emanuele ; Fabbri, Alberto ; Liberati, Anna Marina ; Tani, Monica ; Musuraca, Gerardo ; Molinari, Annalia ; Petrilli, Maria Pia ; Palladino, Carmela ; Ciancia, Rosanna ; Ferrario, Andrea ; Gasbarrino, Cristiana ; Monaco, Federico ; Fraticelli, Vincenzo ; De Vellis, Annalisa ; Merli, Francesco ; Luminari, Stefano. / 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. In: Haematologica. 2018 ; Vol. 103, No. 8. pp. 1345-1350.
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T1 - Rituximab plus bendamustine as front-line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-Hodgkin lymphoma

T2 - a phase II multicenter study of the Fondazione Italiana Linfomi

AU - Storti, Sergio

AU - Spina, Michele

AU - Pesce, Emanuela Anna

AU - Salvi, Flavia

AU - Merli, Michele

AU - Ruffini, Alessia

AU - Cabras, Giuseppina

AU - Chiappella, Annalisa

AU - Angelucci, Emanuele

AU - Fabbri, Alberto

AU - Liberati, Anna Marina

AU - Tani, Monica

AU - Musuraca, Gerardo

AU - Molinari, Annalia

AU - Petrilli, Maria Pia

AU - Palladino, Carmela

AU - Ciancia, Rosanna

AU - Ferrario, Andrea

AU - Gasbarrino, Cristiana

AU - Monaco, Federico

AU - Fraticelli, Vincenzo

AU - De Vellis, Annalisa

AU - Merli, Francesco

AU - Luminari, Stefano

N1 - Copyright© 2018 Ferrata Storti Foundation.

PY - 2018/8

Y1 - 2018/8

N2 - 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/m2 days (d)1-2] and rituximab (375 mg/m2 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).

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U2 - 10.3324/haematol.2017.186569

DO - 10.3324/haematol.2017.186569

M3 - Article

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SP - 1345

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JO - Haematologica

JF - Haematologica

SN - 0390-6078

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