Papayannidis Cristina, Petracci Elisabetta, Zappasodi Patrizia, Fracchiolla Nicola, Ciceri Fabio, Sartor Chiara, Roncoroni Elisa, Di Raimondo Francesco, Mattei Daniele, Giannini Maria Benedetta, Lanza Francesco, Gottardi Michele, Del Principe Maria Ilaria, Borlenghi Erika, Fumagalli Monica, Vallisa Daniele, Sica Simona, Di Renzo Nicola, Fabbiano Francesco, Todisco Elisabetta, de Fabritiis Paolo, Luppi Mario, Passamonti Francesco, Corradini Paolo, Petruzziello Fara, Pane Fabrizio, Ferrara Felicetto, Mambelli Greta, Volpi Roberta, Frabetti Federica, Zingaretti Chiara, Marconi Giovanni, Martinelli Giovanni
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy.
Cancer. 2025 Apr 1;131(7):e35820. doi: 10.1002/cncr.35820.
Inotuzumab ozogamicin (IO) has helped to change the treatment paradigm in B-cell acute lymphoblastic leukemia (B-ALL) but real-world data are limited.
The INO-CD22 study is a multicenter retrospective cohort study of adult patients with relapsed/refractory B-ALL treated with IO in 24 Italian centers from 2014 to 2019, with the aim of assessing the response, survival, and toxicity of IO.
Data for 73 eligible patients were obtained: the median age at the start of IO treatment was 52.7 years (I-III quartiles, 51.9-53.5 years), the median number of previous lines was three (I-III quartiles, two to four), and prior exposure to induction standard chemotherapy and blinatumomab occurred in 85% and 57.5% of cases, respectively. IO was administered following the label schedule. A 74.0% overall response rate was achieved, with a 69.8% complete remission rate and a 4.1% complete remission with incomplete hematologic reconstitution rate. The median duration of response was 4.4 months (I-III quartiles, 2.3-11.2 months). With a median follow-up of 37.2 months, the median overall survival (OS) was 7.9 months (95% CI, 6.08-12.42 months) with a 3- and 5-year OS of 21.2% (95% CI, 11.9%-32.3%) and 5.3% (95% CI, 9.6%-29.8%), respectively. Overall, 37% of patients were able to proceed to allogeneic hematopoietic stem cell transplantation. Eight patients (11.0%) experienced veno-occlusive disease/sinusoidal obstruction syndrome; the most frequent grade ≥3 nonhematologic adverse events were liver toxicities and pneumonia (two grade 4 and one grade 5, respectively).
Despite the limitations of retrospective studies, the INO-CD22 study highlights the favorable safety profile and clinical activity of IO within a real-world context.
奥英妥珠单抗（IO）有助于改变B细胞急性淋巴细胞白血病（B-ALL）的治疗模式，但真实世界的数据有限。
INO-CD22研究是一项多中心回顾性队列研究，研究对象为2014年至2019年在意大利24个中心接受IO治疗的复发/难治性B-ALL成年患者，目的是评估IO的疗效、生存率和毒性。
获得了73例符合条件患者的数据：IO治疗开始时的中位年龄为52.7岁（第一至第三四分位数，51.9 - 53.5岁），既往治疗线数的中位数为3（第一至第三四分位数，2至4），分别有85%和57.5%的病例既往接受过诱导标准化疗和贝林妥欧单抗治疗。IO按照标签方案给药。总缓解率为74.0%，完全缓解率为69.8%，血液学未完全恢复的完全缓解率为4.1%。中位缓解持续时间为4.4个月（第一至第三四分位数，2.3 - 11.2个月）。中位随访37.2个月，中位总生存期（OS）为7.9个月（95%CI，6.08 - 12.42个月），3年和5年总生存率分别为21.2%（95%CI，11.9% - 32.3%）和5.3%（95%CI，9.6% - 29.8%）。总体而言，37%的患者能够进行异基因造血干细胞移植。8例患者（11.0%）发生了静脉闭塞性疾病/窦性阻塞综合征；最常见的≥3级非血液学不良事件是肝毒性和肺炎（分别有2例4级和1例5级）。
尽管回顾性研究存在局限性，但INO-CD22研究突出了IO在真实世界背景下良好的安全性和临床活性。
