Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin.
Robert H. Lurie Comprehensive Cancer Center, Northwestern Hospital, Chicago, Illinois.
Cancer. 2021 Apr 1;127(7):1039-1048. doi: 10.1002/cncr.33340. Epub 2020 Dec 1.
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.
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.
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).
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.
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。
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。
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）。
尽管本研究的效力有限，无法检测到亚组之间的显著差异，但数据表明，blinatumomab 和 InO 作为 RR ALL 的一线或二线 NA 治疗可能具有相当的疗效。
