TY - JOUR
T1 - Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi
AU - Merli, Francesco
AU - Cavallo, Federica
AU - Salvi, Flavia
AU - Tucci, Alessandra
AU - Musuraca, Gerardo
AU - Nassi, Luca
AU - Merli, Michele
AU - Tani, Monica
AU - Gini, G.
AU - Ferrari, Angela
AU - Molinari, Anna Lia
AU - Liberati, Anna Marina
AU - Conconi, Annarita
AU - Matteucci, P.
AU - Bari, Alessia
AU - Scalone, Renato
AU - Ferrero, Simone
AU - Zanni, Manuela
AU - Mammi, Caterina
AU - Luminari, Stefano
PY - 2019/7/8
Y1 - 2019/7/8
N2 - Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy. Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA). Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%). Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL.
AB - Objective: To evaluate activity and safety of obinutuzumab-miniCHOP (Ga101-miniCHOP) combination in older patients with Diffuse Large B-Cell Lymphoma (DLBCL) unfit to receive full dose immunochemotherapy. Materials and Methods: We conducted a Simon's two-stage phase II multicenter trial to investigate response rate (primary endpoint) and safety of six courses of Ga101-miniCHOP in older patients with DLBCL (≥65 years), prospectively defined as unfit according to a simplified Comprehensive Geriatric Assessment (sCGA). Results: Overall, 34 patients were enrolled (median age 82 years; range 68–89), with 27 out of the 33 eligible patients completing all six planned courses. Complete Remission (CR) rate was reported in fourteen patients (42%). After a median follow-up of sixteen months, the two-year Progression Free and Overall Survival (PFS and OS) were 49% (95% Confidence Interval (CI), 28 to 67) and 68% (95% CI, 49 to 81), respectively. The most frequent grade 3–4 adverse event was neutropenia in thirteen patients (26%). Conclusions: Based on the observed CR rate, study accrual was interrupted due to the very low probability of demonstrating the initial study hypothesis that Ga101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this group of patients. Nonetheless, results achieved with the 33 treated patients confirm activity and good tolerability of the Ga101-miniCHOP regimen for older unfit adult patients with DLBCL.
KW - Adapted immunochemotherapy
KW - Comprehensive geriatric assessment
KW - Diffuse large B-cell lymphoma
KW - Obinutuzumab-miniCHOP
KW - Older adult patients
KW - Unfit
UR - http://www.scopus.com/inward/record.url?scp=85068450728&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85068450728&partnerID=8YFLogxK
U2 - 10.1016/j.jgo.2019.06.020
DO - 10.1016/j.jgo.2019.06.020
M3 - Article
C2 - 31296461
AN - SCOPUS:85068450728
SN - 1879-4068
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
ER -