PD-1抑制剂治疗复发或难治性经典型霍奇金淋巴瘤的疗效和安全性分析

OBJECTIVE: This retrospective, single-center study aimed to evaluate the efficacy and safety of programmed death-1（PD-1）inhibitors, either as monotherapy or in combination with chemotherapy, in the management of relapse/refractory classical Hodgkin's lymphoma（R/R cHL）. METHODS: A total of 35 patients with R/R cHL who received treatment at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College from September 2016 to December 2020 were enrolled in this study. Among them, 17 patients received PD-1 inhibitor monotherapy（PD-1 inhibitor group）, while 18 patients received a combination of PD-1 inhibitor and chemotherapy（PD-1 inhibitor + chemotherapy group）. Clinical data and follow-up information were retrospectively analyzed, and survival analysis was conducted using the Kaplan-Meier method and Cox proportional hazards model. RESULTS: The median age of the 35 patients with R/R cHL was 29 years（range: 11–61 years）, with 54.3％ being male. According to the Ann Arbor staging system, 62.9％ of patients presented with advanced（stage Ⅲ/Ⅳ）disease, and 48.6％ had extranodal involvement. Before PD-1 inhibitor therapy, the median number of prior lines of therapy was 2（range: 1–3）. Objective responses were observed in 28 patients, including 22 complete response（CR）cases, resulting in an overall response rate（ORR）of 80.0％ and a CR rate of 62.9％. Specifically, the ORR and CR rates were 64.7％ and 58.8％, respectively, in the PD-1 inhibitor group and 94.4％ and 66.7％, respectively, in the PD-1 inhibitor + chemotherapy group. Among the 18 patients who underwent sequential autologous hematopoietic stem cell transplantation（auto-HSCT）［13 CR and five partial response（PR）cases］, eight patients received PD-1 inhibitor therapy after auto-HSCT as consolidation therapy. All patients maintained a CR status after transplantation, and they exhibited significantly improved progression-free survival（PFS）rates compared with those who did not undergo sequential auto-HSCT（4-year PFS rates: 100％ vs 53.5％; P＝0.041）. The incidence of immune-related adverse events was 29％, with only one patient experiencing grade≥3 adverse reactions, which indicated a favorable safety profile for the treatment approach. CONCLUSION: PD-1 inhibitor monotherapy demonstrates notable efficacy and sustained response in patients with R/R cHL. PD-1 inhibitors combined with chemotherapy significantly improve response rates. Additionally, for salvage therapy-sensitive patients, consolidation treatment with PD-1 inhibitors after auto-HSCT exhibits the potential for prolonging PFS.