Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi

• Published in: Journal of geriatric oncology Vol. 11; no. 1; pp. 37 - 40
• Main Authors: Merli, Francesco, Cavallo, Federica, Salvi, Flavia, Tucci, Alessandra, Musuraca, Gerardo, Nassi, Luca, Merli, Michele, Tani, Monica, Gini, Guido, Ferrari, Angela, Molinari, Anna Lia, Liberati, Anna Marina, Conconi, Annarita, Matteucci, Paola, Bari, Alessia, Scalone, Renato, Ferrero, Simone, Zanni, Manuela, Mammi, Caterina, Luminari, Stefano
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.01.2020
• Subjects: Adapted immunochemotherapy; Comprehensive geriatric assessment; Diffuse large B-cell lymphoma; Obinutuzumab-miniCHOP; Older adult patients; Unfit; Comprehensive geriatric assessment; Unfit; Adapted immunochemotherapy; Older adult patients; Diffuse large B-cell lymphoma; Obinutuzumab-miniCHOP
• ISSN: 1879-4068; 1879-4076
• DOI: 10.1016/j.jgo.2019.06.020

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. 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). 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%). 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.