Aurer Igor, Jakšić Ozren, Bašić-Kinda Sandra, Mišura-Jakobac Karla, Sinčić-Petričević Jasminka, Novaković-Coha Sabina, Galušić Davor, Holik Hrvoje, Valković Toni, Županić-Krmek Dubravka, Hude-Dragičević Ida, Milunović Vibor, Pejša Vlatko
Division of Hematology, Department of Internal Medicine, University Hospital Centre Zagreb and Medical School, University of Zagreb, 10000 Zagreb, Croatia.
Division of Hematology, Department of Internal Medicine, University Hospital Dubrava and Medical School, University of Zagreb, 10000 Zagreb, Croatia.
Biomedicines. 2024 Dec 20;12(12):2902. doi: 10.3390/biomedicines12122902.
Obinutuzumab was approved for front-line treatment of chronic lymphocytic leukemia in combination with chlorambucil pulses administered every 2 wks. Alternative schedules of chlorambucil enable the administration of higher total chlorambucil doses, and have better antileukemia activity. So far, evidence on the feasibility of combining obinutuzumab with alternative chlorambucil schedules is lacking. We performed this retrospective analysis to analyze real life outcomes in chronic lymphocytic leukemia patients receiving a combination of obinutuzumab with different chlorambucil schedules. This was a retrospective survey performed in order to analyze the feasibility and efficacy of different obinutuzumab and chlorambucil combinations in a real-life setting. Patients receiving this combination as a front-line therapy for chronic lymphocytic leukemia in participating centers, outside of clinical trials, in 2017 and 2018 were included. Seventy-three patients fulfilling entry criteria were identified. Their median age was 76 years, and ranged from 58 to 90 years. The median follow up time was 59 months. The response rate was 89%, with a median progression-free survival time of 27 months, and an overall survival time of 49 months. Chlorambucil was administered as planned in 15 of the 22 (79%) patients treated with chlorambucil pulses every 2 weeks; in 15 of the 42 (34%) patients treated with 7-day courses of chlorambucil administered every 4 weeks; and in 0 of the 10 patients treated with a continuous high dose of chlorambucil ( = 0.002). Changes in treatment schedules were made due to side effects. The progression-free and overall survival rates were similar between the three groups. The combinations of obinutuzumab with more intensive chlorambucil schedules are less feasible, preventing the administration of the intended higher total dose of chlorambucil, and do not improve outcomes in comparison to chlorambucil pulses administered every 2 weeks.
奥妥珠单抗被批准用于与每2周给予一次苯丁酸氮芥脉冲疗法联合，一线治疗慢性淋巴细胞白血病。苯丁酸氮芥的替代给药方案能够给予更高的苯丁酸氮芥总剂量，并且具有更好的抗白血病活性。到目前为止，缺乏关于奥妥珠单抗与苯丁酸氮芥替代给药方案联合使用可行性的证据。我们进行了这项回顾性分析，以分析接受奥妥珠单抗与不同苯丁酸氮芥给药方案联合治疗的慢性淋巴细胞白血病患者的实际治疗结果。这是一项回顾性调查，旨在分析不同奥妥珠单抗和苯丁酸氮芥联合方案在实际临床环境中的可行性和疗效。纳入了在非临床试验的参与中心于2017年和2018年接受该联合方案作为慢性淋巴细胞白血病一线治疗的患者。确定了73名符合入选标准的患者。他们的中位年龄为76岁，年龄范围在58至90岁之间。中位随访时间为59个月。缓解率为89%，中位无进展生存期为27个月，总生存期为49个月。在每2周接受苯丁酸氮芥脉冲疗法治疗的22名患者中，有15名（79%）按计划给予了苯丁酸氮芥；在每4周接受7天疗程苯丁酸氮芥治疗的42名患者中，有15名（34%）按计划给药；而在10名接受持续高剂量苯丁酸氮芥治疗的患者中，有0名按计划给药（P = 0.002）。因副作用而更改了治疗方案。三组之间的无进展生存率和总生存率相似。奥妥珠单抗与更强化的苯丁酸氮芥给药方案联合使用的可行性较低，导致无法给予预期的更高苯丁酸氮芥总剂量，并且与每2周给予苯丁酸氮芥脉冲疗法相比，并未改善治疗结果。
