TY - JOUR
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).
AB - 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).
U2 - 10.3324/haematol.2017.186569
DO - 10.3324/haematol.2017.186569
M3 - Article
C2 - 29748444
VL - 103
SP - 1345
EP - 1350
JO - Haematologica
JF - Haematologica
SN - 0390-6078
IS - 8
ER -