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

Francesco Merli, Federica Cavallo, Flavia Salvi, Alessandra Tucci, Gerardo Musuraca, Luca Nassi, Michele Merli, Monica Tani, G. Gini, Angela Ferrari, Anna Lia Molinari, Anna Marina Liberati, Annarita Conconi, P. Matteucci, Alessia Bari, Renato Scalone, Simone Ferrero, Manuela Zanni, Caterina Mammi, Stefano Luminari

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalJournal of Geriatric Oncology
DOIs
Publication statusPublished - Jan 1 2019

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Lymphoma, Large B-Cell, Diffuse
Confidence Intervals
Geriatric Assessment
Safety
obinutuzumab
Neutropenia
Multicenter Studies
Disease-Free Survival

Keywords

  • Adapted immunochemotherapy
  • Comprehensive geriatric assessment
  • Diffuse large B-cell lymphoma
  • Obinutuzumab-miniCHOP
  • Older adult patients
  • Unfit

ASJC Scopus subject areas

  • Oncology
  • Geriatrics and Gerontology

Cite this

Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi. / Merli, Francesco; Cavallo, Federica; Salvi, Flavia; Tucci, Alessandra; Musuraca, Gerardo; Nassi, Luca; Merli, Michele; Tani, Monica; Gini, G.; Ferrari, Angela; Molinari, Anna Lia; Liberati, Anna Marina; Conconi, Annarita; Matteucci, P.; Bari, Alessia; Scalone, Renato; Ferrero, Simone; Zanni, Manuela; Mammi, Caterina; Luminari, Stefano.

In: Journal of Geriatric Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Merli, Francesco ; Cavallo, Federica ; Salvi, Flavia ; Tucci, Alessandra ; Musuraca, Gerardo ; Nassi, Luca ; Merli, Michele ; Tani, Monica ; Gini, G. ; Ferrari, Angela ; Molinari, Anna Lia ; Liberati, Anna Marina ; Conconi, Annarita ; Matteucci, P. ; Bari, Alessia ; Scalone, Renato ; Ferrero, Simone ; Zanni, Manuela ; Mammi, Caterina ; Luminari, Stefano. / Obinutuzumab and miniCHOP for unfit patients with diffuse large B-cell lymphoma. A phase II study by Fondazione Italiana Linfomi. In: Journal of Geriatric Oncology. 2019.
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abstract = "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.",
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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 - 2019/1/1

Y1 - 2019/1/1

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

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