新型药物在复发/难治性 B 细胞急性淋巴细胞白血病中的应用：blinatumomab 和 inotuzumab ozogamicin 作为一线或二线新型药物治疗复发/难治性急性淋巴细胞白血病的疗效可能相当。

Sequencing of novel agents in relapsed/refractory B-cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia.

机构信息

Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin.

Robert H. Lurie Comprehensive Cancer Center, Northwestern Hospital, Chicago, Illinois.

出版信息

Cancer. 2021 Apr 1;127(7):1039-1048. doi: 10.1002/cncr.33340. Epub 2020 Dec 1.

DOI:10.1002/cncr.33340

PMID:33259056

Abstract

BACKGROUND

The availability of novel agents (NAs), including blinatumomab and inotuzumab ozogamicin (InO), has improved the outcomes of patients with relapsed/refractory (RR) B-cell acute lymphoblastic leukemia (ALL). Because of the relative effectiveness, it is often a challenge for clinicians to determine how to best sequence these NAs with respect to efficacy and toxicity.

METHODS

In this multicenter, retrospective study of patients with RR ALL treated with blinatumomab, InO, or both, their efficacy as a first or second NA was compared.

RESULTS

Among 276 patients, 221 and 55 received blinatumomab and InO, respectively, as a first NA therapy. The complete remission (CR)/complete remission with incomplete count recovery (CRi) rate was 65% and 67% for the blinatumomab and InO groups, respectively (P = .73). The rate of treatment discontinuation due to adverse events was 4% and 7% in the blinatumomab and InO groups, respectively. Ninety-two patients (43%) in the blinatumomab group and 13 patients (29%) in the InO group proceeded with allogeneic hematopoietic stem cell transplantation. The median overall survival (OS) was 15 and 11.6 months in the blinatumomab and InO groups, respectively. A subset analysis was performed for 61 patients who received both NAs (blinatumomab and then InO [n = 40] or InO and then blinatumomab [n = 21]). The CR/CRi rate was 58% for patients who received InO as the second NA and 52% for patients who received blinatumomab as the second NA. The median OS was 10.5 for patients who received InO as the second NA and 5.9 months for patients who received blinatumomab as the second NA (P = .09).

CONCLUSIONS

Although the limited power of this study to detect a significant difference between subgroups is acknowledged, the data suggest that blinatumomab and InO may have comparable efficacy as a first or second NA therapy in RR ALL.

摘要

背景

新型药物（NAs）的出现，包括blinatumomab 和 inotuzumab ozogamicin（InO），改善了复发/难治性（RR）B 细胞急性淋巴细胞白血病（ALL）患者的预后。由于相对有效性，临床医生经常面临如何根据疗效和毒性来确定这些 NAs 的最佳顺序的挑战。

方法

在这项多中心、回顾性研究中，对接受blinatumomab、InO 或两者治疗的 RR ALL 患者进行了研究，比较了他们作为一线或二线 NA 的疗效。

结果

在 276 例患者中，221 例和 55 例分别接受了blinatumomab 和 InO 作为一线 NA 治疗。blinatumomab 和 InO 组的完全缓解（CR）/不完全计数恢复的完全缓解（CRi）率分别为 65%和 67%（P =.73）。blinatumomab 和 InO 组因不良反应而停止治疗的比例分别为 4%和 7%。blinatumomab 组 92 例（43%）和 InO 组 13 例（29%）患者接受了同种异体造血干细胞移植。blinatumomab 和 InO 组的中位总生存期（OS）分别为 15 个月和 11.6 个月。对接受两种 NAs 的 61 例患者进行了亚组分析（blinatumomab 后接受 InO [n = 40]或 InO 后接受 blinatumomab [n = 21]）。接受 InO 作为二线 NA 的患者的 CR/CRi 率为 58%，接受 blinatumomab 作为二线 NA 的患者为 52%。接受 InO 作为二线 NA 的患者的中位 OS 为 10.5 个月，接受 blinatumomab 作为二线 NA 的患者为 5.9 个月（P =.09）。