纳武利尤单抗治疗复发或难治性经典型霍奇金淋巴瘤日本患者的 II 期研究的最终结果。
Final results of a phase II study of nivolumab in Japanese patients with relapsed or refractory classical Hodgkin lymphoma.
机构信息
Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Department of Hematology and Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan.
出版信息
Jpn J Clin Oncol. 2020 Oct 22;50(11):1265-1273. doi: 10.1093/jjco/hyaa117.
BACKGROUND
Many patients with classical Hodgkin lymphoma show increased programmed death-1 ligand expression in Reed-Sternberg cells. We report the final results of a phase II study of nivolumab, an anti-programmed death-1 monoclonal antibody, in Japanese patients with relapsed or refractory classical Hodgkin lymphoma.
METHODS
Japanese patients with previously treated classical Hodgkin lymphoma (aged ≥ 20 years) were administered nivolumab (3 mg/kg on Day 1 of 14-day cycles) until progressive disease, an unacceptable adverse event, or another clinically relevant reason. Treatment could continue beyond progressive disease at the investigator's discretion in selected patients.
RESULTS
Seventeen patients (median age: 63.0 years) were enrolled. The median follow-up was 38.8 months. One patient with non-Hodgkin lymphoma was excluded from efficacy analyses. The centrally assessed overall response rate in 16 classical Hodgkin lymphoma patients was 87.5% (95% confidence interval = 61.7-98.4%) and the disease control rate was 93.8% (95% confidence interval = 69.8-99.8%). The median (95% confidence interval) duration of response and progression-free survival were 8.5 (2.4-12.6) and 11.7 (1.8-42.3) months, respectively. The 3-year overall survival rate was 80.4% (95% confidence interval = 50.6-93.2%). Nivolumab was continued beyond progressive disease in seven patients; six were alive at the data cut-off. Adverse drug reactions occurred in all 17 patients with grades 3-4 adverse drug reactions in eight patients and no grade 5 adverse drug reactions. Pulmonary toxicities occurred in five patients; four of these occurred ≥17 months after starting nivolumab.
CONCLUSION
Nivolumab is effective and tolerable in Japanese relapsed or refractory classical Hodgkin lymphoma patients. Continued monitoring may be necessary to detect late-onset pulmonary toxicities.
CLINICAL TRIAL REGISTRATION
JapicCTI-142755 (Japan Pharmaceutical Information Center).
背景
许多经典霍奇金淋巴瘤患者的 Reed-Sternberg 细胞中程序性死亡配体 1 的表达增加。我们报告了纳武单抗（一种抗程序性死亡配体 1 的单克隆抗体）在日本复发或难治性经典霍奇金淋巴瘤患者中的 II 期研究的最终结果。
方法
先前接受过经典霍奇金淋巴瘤治疗的日本患者（年龄≥20 岁）接受纳武单抗（14 天周期的第 1 天 3mg/kg）治疗，直至疾病进展、不可接受的不良事件或其他具有临床意义的原因。在选定的患者中，在疾病进展后可以根据研究者的判断继续治疗。
结果
17 名患者（中位年龄：63.0 岁）入组。中位随访时间为 38.8 个月。1 名非霍奇金淋巴瘤患者被排除在疗效分析之外。16 例经典霍奇金淋巴瘤患者的中心评估总缓解率为 87.5%（95%置信区间=61.7-98.4%），疾病控制率为 93.8%（95%置信区间=69.8-99.8%）。中位（95%置信区间）缓解持续时间和无进展生存期分别为 8.5（2.4-12.6）和 11.7（1.8-42.3）个月，3 年总生存率为 80.4%（95%置信区间=50.6-93.2%）。7 名患者在疾病进展后继续使用纳武单抗治疗；数据截止时，6 名患者仍存活。17 名患者均发生药物不良反应，8 名患者发生 3-4 级药物不良反应，无 5 级药物不良反应。5 名患者发生肺部毒性；其中 4 例发生在开始使用纳武单抗后≥17 个月。
结论
纳武单抗在日本复发或难治性经典霍奇金淋巴瘤患者中有效且耐受良好。可能需要持续监测以检测迟发性肺部毒性。
临床试验注册
JapicCTI-142755（日本药品信息中心）。
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