Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI.
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Clin Lymphoma Myeloma Leuk. 2020 Aug;20(8):556-560.e2. doi: 10.1016/j.clml.2020.03.004. Epub 2020 Mar 19.
Inotuzumab ozogamicin (InO) is an anti-CD22 monoclonal antibody-drug (calicheamicin) conjugate that has shown superior efficacy compared to conventional chemotherapy in relapsed/refractory (RR) B-cell acute lymphocytic leukemia (ALL) patients. We sought to find the safety and efficacy of InO in a real-world setting.
A multicenter cohort analysis on 84 RR ALL patients who received InO outside of clinical trials was conducted to evaluate response and toxicity.
The median (range) age of patients at InO initiation was 50 (20-87) years. Forty patients (48%) had ≥ 3 therapies and 23 patients (27%) underwent allogeneic hematopoietic stem-cell transplantation (allo-HCT) before InO. The median (range) number of cycles of InO provided was 2 (1-6), and cumulative dose was 3.3 (1.8-9.3) mg/m. Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. Twenty-three patients (27%) with response received allo-HCT. The median duration of response was 11.5 months and when censored at allo-HCT was not reached (51% in remission at 2 years). The median overall survival after InO was 11.6 months and when censored at time of allo-HCT was 13.6 months. The most common grade 3 or higher adverse events observed were transaminitis (16%), hyperbilirubinemia (5%), bleeding (4%), veno-occlusive disease (2%), and hyperglycemia (2%). In multivariate analysis, allo-HCT after InO did not retain favorable significance for duration of response (hazard ratio = 1.27; 95% confidence interval, 0.89-1.61; P = .2) or overall survival (hazard ratio = 1.10; 95% confidence interval, 0.37-3.25; P = .85).
InO was well tolerated and had significant efficacy in RR B-cell ALL patients.
依妥珠单抗奥佐米星（InO）是一种抗 CD22 单克隆抗体-药物（加利车霉素）偶联物，与复发/难治性（RR）B 细胞急性淋巴细胞白血病（ALL）患者的常规化疗相比，具有更高的疗效。我们旨在寻找 InO 在真实环境中的安全性和疗效。
对 84 例在临床试验之外接受 InO 治疗的 RR ALL 患者进行了多中心队列分析，以评估其反应和毒性。
InO 起始时患者的中位（范围）年龄为 50（20-87）岁。40 例（48%）患者接受了≥3 种治疗，23 例（27%）患者在接受 InO 治疗前接受了同种异体造血干细胞移植（allo-HCT）。InO 提供的中位数（范围）周期数为 2（1-6），累积剂量为 3.3（1.8-9.3）mg/m。总缓解率（完全缓解/不完全计数恢复的完全缓解）为 63%；44%的患者达到完全缓解且微小残留病灶阴性。23 例有反应的患者接受了 allo-HCT。缓解的中位持续时间为 11.5 个月，在 allo-HCT 时未达到中位生存时间（2 年时缓解率为 51%）。InO 后中位总生存期为 11.6 个月，在 allo-HCT 时未达到中位总生存期（13.6 个月）。观察到的最常见的 3 级或更高级别的不良事件是肝转氨酶升高（16%）、高胆红素血症（5%）、出血（4%）、静脉闭塞性疾病（2%）和高血糖症（2%）。多变量分析显示，InO 后接受 allo-HCT 对缓解持续时间（风险比=1.27；95%置信区间，0.89-1.61；P=0.2）或总生存期（风险比=1.10；95%置信区间，0.37-3.25；P=0.85）均无有利意义。
InO 在 RR B 细胞 ALL 患者中耐受性良好，疗效显著。
