TY - JOUR
T1 - Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma
T2 - results of the GAUDI study (BO21000)
AU - Radford, John
AU - Davies, Andrew
AU - Cartron, Guillaume
AU - Morschhauser, Franck
AU - Salles, Gilles
AU - Marcus, Robert
AU - Wenger, Michael
AU - Lei, Guiyuan
AU - Wassner-Fritsch, Elisabeth
AU - Vitolo, Umberto
PY - 2013/8/15
Y1 - 2013/8/15
N2 - The safety and activity of obinutuzumab (GA101) plus chemotherapy in relapsed/ refractory follicular lymphoma was explored in 56 patients. Participants received obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (G-CHOP; every 3 weeks for 6 to 8 cycles) or obinutuzumab plus fludarabine and cyclophosphamide (G-FC; every 4 weeks for 4 to 6 cycles). Patients were randomly assigned to either obinutuzumab 1600mg on days 1 and 8 of cycle 1 followed by 800mg on day 1 of subsequent cycles or 400 mg for all doses. Treatment responders were eligible for obinutuzumab maintenance every 3 months for up to 2 years. Grade 1/2 infusion-related reactions (IRRs) were the most common treatment-related adverse event (AE) (all grades: G-CHOP, 68%; G-FC, 82%). Grade 3/4 IRRs were rare (7%) and restricted to the first infusion. All patients received the planned obinutuzumab dose. Neutropenia was the most common treatment-related hematologic AE for G-CHOP (43%) and G-FC (50%). At induction end, 96% (27/28) of patients receiving G-CHOP (complete response [CR], 39% [11/28]) and 93% (26/28) receiving G-FC (CR, 50% [14 of 28]) achieved responses. G-CHOP and G-FC had an acceptable safety profile with no new or unexpected AEs, but G-FC was associated with more AEs than G-CHOP. Obinutuzumab plus chemotherapy resulted in 93% to 96% response rates, supporting phase 3 investigation. This trial was registered at www.clinicaltrials.gov as # NCT00825149.
AB - The safety and activity of obinutuzumab (GA101) plus chemotherapy in relapsed/ refractory follicular lymphoma was explored in 56 patients. Participants received obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (G-CHOP; every 3 weeks for 6 to 8 cycles) or obinutuzumab plus fludarabine and cyclophosphamide (G-FC; every 4 weeks for 4 to 6 cycles). Patients were randomly assigned to either obinutuzumab 1600mg on days 1 and 8 of cycle 1 followed by 800mg on day 1 of subsequent cycles or 400 mg for all doses. Treatment responders were eligible for obinutuzumab maintenance every 3 months for up to 2 years. Grade 1/2 infusion-related reactions (IRRs) were the most common treatment-related adverse event (AE) (all grades: G-CHOP, 68%; G-FC, 82%). Grade 3/4 IRRs were rare (7%) and restricted to the first infusion. All patients received the planned obinutuzumab dose. Neutropenia was the most common treatment-related hematologic AE for G-CHOP (43%) and G-FC (50%). At induction end, 96% (27/28) of patients receiving G-CHOP (complete response [CR], 39% [11/28]) and 93% (26/28) receiving G-FC (CR, 50% [14 of 28]) achieved responses. G-CHOP and G-FC had an acceptable safety profile with no new or unexpected AEs, but G-FC was associated with more AEs than G-CHOP. Obinutuzumab plus chemotherapy resulted in 93% to 96% response rates, supporting phase 3 investigation. This trial was registered at www.clinicaltrials.gov as # NCT00825149.
KW - CHRONIC LYMPHOCYTIC-LEUKEMIA
KW - B-CELL LYMPHOMA
KW - ANTI-CD20 MONOCLONAL-ANTIBODY
KW - RANDOMIZED CONTROLLED-TRIAL
KW - PROGRESSION-FREE SURVIVAL
KW - RITUXIMAB MAINTENANCE
KW - 1ST-LINE TREATMENT
KW - INDOLENT LYMPHOMA
KW - PROLONGS SURVIVAL
KW - OPEN-LABEL
U2 - 10.1182/blood-2013-01-481341
DO - 10.1182/blood-2013-01-481341
M3 - Article
SN - 0006-4971
VL - 122
SP - 1137
EP - 1143
JO - Blood
JF - Blood
IS - 7
ER -