Evaluation of Efficacy and Safety of Nivolumab in Treatment of Relapsed/Refractory Classical Hodgkin Lymphoma at King Abdulaziz Medical City-Jeddah/the Kingdom of Saudi Arabia Experience

Abstract

Introduction: Hodgkin's lymphoma (HL) is one of the most common lymphoid cancers. Preclinical studies suggest that Reed-Sternberg cells exploit the programmed death 1 (PD-1) pathway to evade immune detection. In classic Hodgkin's lymphoma, alterations in chromosome 9p24.1 increase the abundance of the PD-1 ligands, PD-L1 and PD-L2, and promote their induction through Janus kinase (JAK)-signal transducer and activator of transcription (STAT) signaling. Nivolumab, an immune checkpoint inhibitor, which has shown great efficacy in relapsed/refractory cHL (R/R cHL) in multiple clinical trials. The aim of this study is to evaluate the efficacy and safety of Nivolumab in R/R cHL patients treated at King Abdulaziz Medical City in Jeddah-Kingdome of Saudi Arabia Methods: We conducted a retrospective analysis on all patients received nivolumab for R/R cHL at King Abdulaziz Medical City, Jeddah, Saudi Arabia. From introduction of nivolumab in our center till the present time, it was used in a total of 21 patients, all of them were included in our analysis. Data of these patients were entered into an Excel sheet, and analyzed using SPSS software version 25.0. Statistical significance was determined as (P<0.05). Results: Total of 21 patient were included in this analysis. The average age of the participants was 26 years, almost equal gender distribution, 63% were advanced stage, 72% were nodular sclerosis subtype. Patients had received a median of 5 prior regimens (range 4-7). 12 patients received Nivolumab as post-ASCT salvage and 9 patients did not undergo ASCT prior Nivolumab treatment. The number of treatment cycles with Nivolumab ranged between 3 and 121, with an average of 31 cycles. Overall response rate (ORR) was 84.2% includes 52.6% of patients has achieved complete response (CR). In the patients who received the Nivolumab as post-ASCT salvage, 40% had CR, 20% had PR, 10% had stable disease and 30% had disease progression. ORR was 60% and 40% of those patients had disease progression later. 28.6% of the patients studied were still on Nivolumab, and the main reason for stopping the Nivolumab was the disease progression. Nine patients still required treatment after Nivolumab. Our study showed that neutropenia and hypothyroidism were the most common adverse effects of Nivolumab therapy, 33.3%, and 19.0%, respectively, whereas fatigue, tachycardia, fever, itching, pneumonitis and cough were less common, 4.8% for each. Conclusion: Nivolumab is a safe drug and could be given to patients with HL. However, neutropenia and hypothyroidism were the most common adverse effects; therefore, routine complete blood count and thyroid function tests should be obtained. Regarding the efficacy of Nivolumab, our results revealed relatively low survival and response rates.