Five-Year Follow-Up of Patients With Relapsed and Refractory Classic Hodgkin Lymphoma Treated With Low-Dose Nivolumab (40 mg): A Matched Cohort Study With Standard-Dose Therapy.
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The use of low-dose PD-1 inhibitors may offer a promising treatment strategy for patients with refractory Hodgkin lymphoma. This approach has the potential to mitigate the financial toxicity commonly associated with immune checkpoint inhibitors while also reducing the likelihood of severe adverse events. The aim of this study was to further investigate the efficacy and safety of nivolumab (nivo) at a 40 mg dose (LD group) within NCT03343665 clinical trial framework and to compare these results to the standard-dose therapy (SD group) using a propensity score matching approach. This study included 62 patients in each group. Median follow up was 63 (11-87) and 73 months (20-107) in the LD and SD group, respectively. The overall response rate and complete response was 68% and 39% versus. 70% and 39%, respectively. Five-year PFS was 26.8% (95% CI 17.8-40.7) and 22.1% (95% CI 12-40.6), p = 0.77, and 5-year OS 95.7% (95% CI: 90-100) and 93.3% (95% CI: 87-99), p = 0.33. The PFS was not statistically different regarding the prior treatment and key clinical factors. In the LD group the median dose of nivo was 0.58 mg/kg (0.35-0.91). There was no statistically significant difference based on dose per body weight in terms of survival. No differences were observed in the incidence of any AEs (69% vs. 77%) and 3-4 AEs (6% vs. 13%). Nivolumab therapy at a dose of 40 mg demonstrates comparable efficacy and safety to the standard dose of 3 mg/kg in patients with r/r cHL.