医学
伊布替尼
内科学
美罗华
胃肠病学
化学免疫疗法
临床研究阶段
中性粒细胞减少症
耐火材料(行星科学)
置信区间
肿瘤科
无进展生存期
随访中值
淋巴瘤
外科
临床试验
化疗
白血病
慢性淋巴细胞白血病
物理
天体生物学
作者
Ariela Noy,Sven de Vos,Morton Coleman,Peter Martin,Christopher R. Flowers,Catherine Thiéblemont,Franck Morschhauser,Graham P. Collins,Shuo Ma,Shachar Peles,Stephen D. Smith,Jacqueline C. Barrientos,Elizabeth Chong,Shiquan Wu,Leo W.K. Cheung,Kevin Kwei,Bernhard Hametner,Israel Arango-Hisijara,Robert Chen
出处
期刊:Blood Advances
[American Society of Hematology]
日期:2020-11-23
卷期号:4 (22): 5773-5784
被引量:67
标识
DOI:10.1182/bloodadvances.2020003121
摘要
Advanced marginal zone lymphoma (MZL) is an incurable B-cell malignancy dependent on B-cell receptor signaling. The phase 2 PCYC-1121 study demonstrated the safety and efficacy of single-agent ibrutinib 560 mg/d in 63 patients with relapsed/refractory MZL treated with prior rituximab (RTX) or rituximab-based chemoimmunotherapy (RTX-CIT). We report the final analysis of PCYC-1121 with median follow-up of 33.1 months (range: 1.4-44.6). Overall response rate (ORR) was 58%; median duration of response (DOR) was 27.6 months (95% confidence interval [CI]: 12.1 to not estimable [NE]); median progression-free survival (PFS) was 15.7 months (95% CI: 12.2-30.4); and median overall survival (OS) was not reached (95% CI: NE to NE). Patients with prior RTX treatment had better outcomes (ORR: 81%; median DOR: not reached [95% CI: 12.2 to NE]; median PFS: 30.4 months [95% CI: 22.1 to NE]; median OS: not reached [95% CI: 30.3 to NE]) vs those with prior RTX-CIT treatment (ORR: 51%; DOR: 12.4 months [95% CI: 2.8 to NE]; PFS: 13.8 months [95% CI: 8.3-22.5]; OS: not reached [95% CI: NE to NE]). ORRs were 63%, 47%, and 62% for extranodal, nodal, and splenic subtypes, respectively. With up to 45 months of ibrutinib treatment, the safety profile remained consistent with prior reports. The most common grade ≥3 event was anemia (16%). Exploratory biomarker analysis showed NF-κB pathway gene mutations correlated with outcomes. Final analysis of PCYC-1121 demonstrated long-term safety and efficacy of ibrutinib in patients with relapsed/refractory MZL, regardless of prior treatment or MZL subtype. This trial was registered at www.clinicaltrials.gov as #NCT01980628.
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