Grigg Andrew, Dyer Martin J S, Díaz Marcos González, Dreyling Martin, Rule Simon, Lei Guiyuan, Knapp Andrea, Wassner-Fritsch Elisabeth, Marlton Paula
Department of Clinical Haematology, Austin Hospital, Heidelberg, Australia
Ernest and Helen Scott Haematological Research Institute, University of Leicester, UK.
Haematologica. 2017 Apr;102(4):765-772. doi: 10.3324/haematol.2016.152272. Epub 2016 Dec 23.
The GAUDI study assessed safety and preliminary efficacy of induction therapy with obinutuzumab plus chemotherapy, followed by maintenance therapy with obinutuzumab alone, in previously untreated patients with follicular lymphoma. Assignment to chemotherapy was decided on a per-center basis before the patients' enrollment. Patients (n=81) received four to six cycles of obinutuzumab plus bendamustine every 4 weeks or six to eight cycles of obinutuzumab plus CHOP every 3 weeks. Patients with an end-of-treatment response were eligible for obinutuzumab maintenance therapy every 3 months for 2 years or until disease progression. Induction treatment was completed by 90% of patients in the obinutuzumab plus bendamustine group and 95% in the obinutuzumab plus CHOP group, while maintenance was completed by 81% and 72% of patients, respectively. All patients experienced at least one adverse event during induction, most commonly infusion-related reactions (58%), the majority of which were grade 1/2. The most common hematologic adverse event was grade 3/4 neutropenia (36% during induction and 7% during maintenance). One treatment-related death occurred during the maintenance phase. At the end of induction, 94% of patients had achieved an overall response, with complete response based on computed tomography in 36%. The progression-free survival rate at 36 months was 90% in the obinutuzumab plus bendamustine group and 84% in the obinutuzumab plus CHOP group. These results demonstrate that induction therapy with obinutuzumab plus bendamustine or obinutuzumab plus CHOP, followed by obinutuzumab maintenance, is associated with tolerable safety and promising efficacy. This study is registered at ClinicalTrials.gov as NCT00825149.
GAUDI研究评估了在既往未接受治疗的滤泡性淋巴瘤患者中，使用奥妥珠单抗联合化疗进行诱导治疗，随后单独使用奥妥珠单抗进行维持治疗的安全性和初步疗效。化疗方案在患者入组前由各中心决定。81例患者每4周接受4至6个周期的奥妥珠单抗联合苯达莫司汀治疗，或每3周接受6至8个周期的奥妥珠单抗联合CHOP治疗。治疗结束时出现缓解的患者有资格每3个月接受奥妥珠单抗维持治疗，为期2年或直至疾病进展。奥妥珠单抗联合苯达莫司汀组90%的患者完成了诱导治疗，奥妥珠单抗联合CHOP组为95%；而维持治疗分别由81%和72%的患者完成。所有患者在诱导治疗期间均经历了至少一次不良事件，最常见的是输液相关反应（58%），其中大多数为1/2级。最常见的血液学不良事件是3/4级中性粒细胞减少（诱导治疗期间为36%，维持治疗期间为7%）。在维持治疗阶段发生了1例与治疗相关的死亡。诱导治疗结束时，94%的患者获得了总体缓解，其中基于计算机断层扫描的完全缓解率为36%。奥妥珠单抗联合苯达莫司汀组36个月时的无进展生存率为90%，奥妥珠单抗联合CHOP组为84%。这些结果表明，奥妥珠单抗联合苯达莫司汀或奥妥珠单抗联合CHOP进行诱导治疗，随后进行奥妥珠单抗维持治疗，具有可耐受的安全性和有前景的疗效。本研究已在ClinicalTrials.gov注册，注册号为NCT00825149。
