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Inotuzumab ozogamicin as chemotherapy-sparing salvage in a 67-year-old man with primary refractory B-cell acute lymphoblastic leukemia with high-risk genomic features.

ABSTRACT: Older adults with acute lymphoblastic leukemia (ALL) continue to have a poor prognosis, in part due to greater chemotherapy-related toxicities. We herein report a 67-year-old man with Philadelphia chromosome (Ph)-negative B-cell ALL, who exhibited refractoriness to 3 different regimens of induction chemotherapy and experienced multiple complications including intracranial bleeding and respiratory failure, who achieved minimal residual disease (MRD)-negative complete response (CR) after a single cycle of inotuzumab ozogamicin (IO). His ALL was characterized by several high-risk mutations, which may have contributed to chemotherapy-refractory disease. Our case supports incorporating IO into front-line induction regimens for older adults with high-risk B-cell ALL.

SUBMITTER: Yang X

PROVIDER: S-EPMC6904788 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Inotuzumab ozogamicin as chemotherapy-sparing salvage in a 67-year-old man with primary refractory B-cell acute lymphoblastic leukemia with high-risk genomic features.

Yang Xiaochuan X Sen Filiz F Geyer Mark B MB

Leukemia research reports 20191126

Older adults with acute lymphoblastic leukemia (ALL) continue to have a poor prognosis, in part due to greater chemotherapy-related toxicities. We herein report a 67-year-old man with Philadelphia chromosome (Ph)-negative B-cell ALL, who exhibited refractoriness to 3 different regimens of induction chemotherapy and experienced multiple complications including intracranial bleeding and respiratory failure, who achieved minimal residual disease (MRD)-negative complete response (CR) after a single ...[more]

PMID: 31867204

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Project description:IntroductionNo head-to-head studies have compared inotuzumab ozogamicin (InO) and blinatumomab (Blina) for the treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). Indirect treatment comparisons (ITCs), namely network meta-analysis (NMA), anchored matching-adjusted indirect comparison (MAIC), and simulated treatment comparison (STC), were conducted to compare the relative efficacy of these therapies.MethodsPatient-level data from a study that evaluated InO with standard of care (SoC) chemotherapy (INO-VATE-ALL) and published data from a study that evaluated Blina with SoC chemotherapy (TOWER) were used in the analyses. Endpoints evaluated included remission rate defined as complete remission or complete remission with incomplete hematologic recovery (CR/CRi), hematopoietic stem cell transplantation (HSCT), overall survival (OS), and event-free survival (EFS). For each outcome, treatment-effect modifiers were adjusted for in the anchored MAIC and STC analyses.ResultsAnalyses showed statistically significant higher rates of remission and HSCT with InO compared to Blina irrespective of the ITC method used or measure of the effect (i.e., odds ratio [OR] or rate difference). The treatment effects derived from the MAIC and STC analyses were consistent and stronger than those estimated from the NMA. A trend favoring InO was detected for EFS. The ITC results for OS suggest no difference between InO and Blina.ConclusionResults from these ITCs indicated a statistically significant advantage for InO over Blina for rates of remission and HSCT in adults with relapsed or refractory B cell precursor ALL. It was not possible to fully adjust for all treatment-effect modifiers, and the similarity in chemotherapy regimens used in the SoC comparator arms of the INO-VATE-ALL and TOWER studies is worthy of further exploration. Both studies, however, used chemotherapy regimens that have a low response rate; therefore, no significant differences in efficacy outcomes are expected between SoC arms.FundingPfizer Inc, New York, NY. Plain language summary available for this article.

Project description:BackgroundThe prognosis for adults with relapsed acute lymphoblastic leukemia is poor. We sought to determine whether inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, results in better outcomes in patients with relapsed or refractory acute lymphoblastic leukemia than does standard therapy.MethodsIn this phase 3 trial, we randomly assigned adults with relapsed or refractory acute lymphoblastic leukemia to receive either inotuzumab ozogamicin (inotuzumab ozogamicin group) or standard intensive chemotherapy (standard-therapy group). The primary end points were complete remission (including complete remission with incomplete hematologic recovery) and overall survival.ResultsOf the 326 patients who underwent randomization, the first 218 (109 in each group) were included in the primary intention-to-treat analysis of complete remission. The rate of complete remission was significantly higher in the inotuzumab ozogamicin group than in the standard-therapy group (80.7% [95% confidence interval {CI}, 72.1 to 87.7] vs. 29.4% [95% CI, 21.0 to 38.8], P<0.001). Among the patients who had complete remission, a higher percentage in the inotuzumab ozogamicin group had results below the threshold for minimal residual disease (0.01% marrow blasts) (78.4% vs. 28.1%, P<0.001); the duration of remission was longer in the inotuzumab ozogamicin group (median, 4.6 months [95% CI, 3.9 to 5.4] vs. 3.1 months [95% CI, 1.4 to 4.9]; hazard ratio, 0.55 [95% CI, 0.31 to 0.96]; P=0.03). In the survival analysis, which included all 326 patients, progression-free survival was significantly longer in the inotuzumab ozogamicin group (median, 5.0 months [95% CI, 3.7 to 5.6] vs. 1.8 months [95% CI, 1.5 to 2.2]; hazard ratio, 0.45 [97.5% CI, 0.34 to 0.61]; P<0.001); the median overall survival was 7.7 months (95% CI, 6.0 to 9.2) versus 6.7 months (95% CI, 4.9 to 8.3), and the hazard ratio was 0.77 (97.5% CI, 0.58 to 1.03) (P=0.04). In the safety population, the most frequent grade 3 or higher nonhematologic adverse events with inotuzumab ozogamicin were liver-related. Veno-occlusive liver disease of any grade occurred in 15 patients (11%) who received inotuzumab ozogamicin and in 1 patient (1%) who received standard therapy.ConclusionsThe rate of complete remission was higher with inotuzumab ozogamicin than with standard therapy, and a higher percentage of patients in the inotuzumab ozogamicin group had results below the threshold for minimal residual disease. Both progression-free and overall survival were longer with inotuzumab ozogamicin. Veno-occlusive liver disease was a major adverse event associated with inotuzumab ozogamicin. (Funded by Pfizer; INO-VATE ALL ClinicalTrials.gov number, NCT01564784.).

Dataset Information

Inotuzumab ozogamicin as chemotherapy-sparing salvage in a 67-year-old man with primary refractory B-cell acute lymphoblastic leukemia with high-risk genomic features.

Publications

Inotuzumab ozogamicin as chemotherapy-sparing salvage in a 67-year-old man with primary refractory B-cell acute lymphoblastic leukemia with high-risk genomic features.

Similar Datasets

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