Abstract：
OBJECTIVE: The primary objective is to describe the real-life effectiveness and safety of nivolumab treatment in patients with relapsed or refractory classical Hodgkin\'s lymphoma. The secondary objective is to describe the therapeutic management after nivolumab monotherapy.
METHODS: Observational, retrospective, multidisciplinary study including all patients with relapsed or refractory classical Hodgkin\'s lymphoma treated with nivolumab monotherapy from November 2015 to March 2023. Patient and treatment-related variables were collected. Effectiveness was measured as overall response rate, progression-free survival and overall survival. Safety was measured as percentage of patients with adverse effects and severity.
RESULTS: Thirteen patients were included, median age 37.5 years (RIQ: 25.3-54.7), 84.6% male. The median number of previous lines of therapy was 3 (RIQ: 2.0-4.5), including autologous hematopoietic stem cell transplantation (84.6%) and brentuximab vedotin (100%). All received nivolumab 3 mg/kg/14 days, with a median of 11 cycles (RIQ: 6.5-20.5) per patient. Median time on treatment was 4.9 months (RIQ: 3.0-9.6) and median follow-up time was 9.2 months (RIQ: 5.6-32.3). Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%) and progression by 4 (30.8%). The objective response rate was 46.2%. Median progression-free survival was 23.9 months (95%CI: 0-49.1), median overall survival was not reached. At the study cutoff date, five patients had died (38.5%), four were in complete remission without active treatment (30.8%) and four were continuing treatment (30.8%). Adverse events occurred in 76.9% of patients, 44% of severity ≥3, the most frequent being hypothyroidism and hepatotoxicity. One patient discontinued treatment due to pneumonitis, two suffered treatment delays (thrombocytopenia and hypertransaminemia) and one changed the regimen to monthly (pulmonary toxicity).
CONCLUSIONS: Nivolumab in the treatment of relapsed or refractory classical Hodgkin\'s lymphoma has confirmed in the study sample favorable effectiveness data, expressed as objective response rate of 46.2% and clinical benefit of 69.2%. Safety was acceptable, manageable, and consistent with that described in the literature.
METHODS: Observational, retrospective, multidisciplinary study including all patients with relapsed or refractory classical Hodgkin\'s lymphoma treated with nivolumab monotherapy from November 2015 to March 2023. Patient and treatment-related variables were collected. Effectiveness was measured as overall response rate, progression-free survival and overall survival. Safety was measured as percentage of patients with adverse effects and severity.
RESULTS: Thirteen patients were included, median age 37.5 years (RIQ: 25.3-54.7), 84.6% male. The median number of previous lines of therapy was 3 (RIQ: 2.0-4.5), including autologous hematopoietic stem cell transplantation (84.6%) and brentuximab vedotin (100%). All received nivolumab 3 mg/kg/14 days, with a median of 11 cycles (RIQ: 6.5-20.5) per patient. Median time on treatment was 4.9 months (RIQ: 3.0-9.6) and median follow-up time was 9.2 months (RIQ: 5.6-32.3). Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%) and progression by 4 (30.8%). The objective response rate was 46.2%. Median progression-free survival was 23.9 months (95%CI: 0-49.1), median overall survival was not reached. At the study cutoff date, five patients had died (38.5%), four were in complete remission without active treatment (30.8%) and four were continuing treatment (30.8%). Adverse events occurred in 76.9% of patients, 44% of severity ≥3, the most frequent being hypothyroidism and hepatotoxicity. One patient discontinued treatment due to pneumonitis, two suffered treatment delays (thrombocytopenia and hypertransaminemia) and one changed the regimen to monthly (pulmonary toxicity).
CONCLUSIONS: Nivolumab in the treatment of relapsed or refractory classical Hodgkin\'s lymphoma has confirmed in the study sample favorable effectiveness data, expressed as objective response rate of 46.2% and clinical benefit of 69.2%. Safety was acceptable, manageable, and consistent with that described in the literature.
摘要：
目的：主要目的是描述纳武单抗治疗复发性或难治性经典霍奇金淋巴瘤患者的实际有效性和安全性。次要目标是描述纳武单抗单一疗法后的治疗管理。
方法：观察性，回顾性,多学科研究，包括2015年11月至2023年3月接受纳武单抗单药治疗的所有复发性或难治性经典霍奇金淋巴瘤患者。收集患者和治疗相关变量。以总体反应率衡量有效性，无进展生存期和总生存期。以具有不良反应和严重程度的患者的百分比来衡量安全性。
结果：纳入13例患者，平均年龄37.5岁（RIQ：25.3-54.7），男性占84.6%。先前治疗线的中位数为3（RIQ：2.0-4.5），包括自体造血干细胞移植（84.6%）和本妥昔单抗vedotin（100%）。所有接受纳武单抗3mg/kg/14天，每位患者的中位数为11个周期（RIQ：6.5-20.5）。中位治疗时间为4.9个月（RIQ：3.0-9.6），中位随访时间为9.2个月（RIQ：5.6-32.3）。3例患者达到完全缓解（23.1%），部分反应3（23.1％），疾病稳定3例(23.1%)，进展4例(30.8%)。客观有效率为46.2%。中位无进展生存期为23.9个月（95CI：0-49.1），未达到中位总生存期.在研究截止日期，5名患者死亡(38.5%)，4例完全缓解,未积极治疗(30.8%),4例继续治疗(30.8%).76.9%的患者发生不良事件，严重程度≥3的44％，最常见的是甲状腺功能减退和肝毒性。一名患者因肺炎停止治疗,其中2人出现治疗延迟(血小板减少和高转氨酶血症),1人将治疗方案改为每月一次(肺毒性).
结论：Nivolumab在治疗复发性或难治性经典霍奇金淋巴瘤的研究样本中证实了有利的有效性数据，客观缓解率为46.2%，临床获益为69.2%。安全性是可以接受的，可管理，与文献中描述的一致。
方法：观察性，回顾性,多学科研究，包括2015年11月至2023年3月接受纳武单抗单药治疗的所有复发性或难治性经典霍奇金淋巴瘤患者。收集患者和治疗相关变量。以总体反应率衡量有效性，无进展生存期和总生存期。以具有不良反应和严重程度的患者的百分比来衡量安全性。
结果：纳入13例患者，平均年龄37.5岁（RIQ：25.3-54.7），男性占84.6%。先前治疗线的中位数为3（RIQ：2.0-4.5），包括自体造血干细胞移植（84.6%）和本妥昔单抗vedotin（100%）。所有接受纳武单抗3mg/kg/14天，每位患者的中位数为11个周期（RIQ：6.5-20.5）。中位治疗时间为4.9个月（RIQ：3.0-9.6），中位随访时间为9.2个月（RIQ：5.6-32.3）。3例患者达到完全缓解（23.1%），部分反应3（23.1％），疾病稳定3例(23.1%)，进展4例(30.8%)。客观有效率为46.2%。中位无进展生存期为23.9个月（95CI：0-49.1），未达到中位总生存期.在研究截止日期，5名患者死亡(38.5%)，4例完全缓解,未积极治疗(30.8%),4例继续治疗(30.8%).76.9%的患者发生不良事件，严重程度≥3的44％，最常见的是甲状腺功能减退和肝毒性。一名患者因肺炎停止治疗,其中2人出现治疗延迟(血小板减少和高转氨酶血症),1人将治疗方案改为每月一次(肺毒性).
结论：Nivolumab在治疗复发性或难治性经典霍奇金淋巴瘤的研究样本中证实了有利的有效性数据，客观缓解率为46.2%，临床获益为69.2%。安全性是可以接受的，可管理，与文献中描述的一致。
