Background
Adjuvant anti-PD1 immunotherapy for resected stage IIIB-IV melanoma significantly improves progression free survival (‘PFS’) and has been available in Australia in routine clinical practice since 2018.1,2 Yet, no overall survival (‘OS’) benefit has been demonstrated and it can result in long term toxicity, hospitalisation and prolonged steroid use.
We aimed to assess real world efficacy, toxicity, hospitalisation rates and steroid use in melanoma patients treated with adjuvant immunotherapy.
Methods
This is a retrospective audit of patients treated with adjuvant immunotherapy for resected stage IIIB-IV melanoma between May 2018 and 2023 at Eastern Health, Melbourne. Patient demographics, disease characteristics, treatment details, toxicity outcomes (including hospitalisation and steroid use) recurrence and survival outcomes were recorded.
Results
28 patients were identified; mean age was 64 years; 61% were male. 79% of patients had resected stage III melanoma. 32% of patients had a BRAF mutation. 89% of patients received Nivolumab.
14% of patients ceased treatment due to toxicity; 18% due to recurrence. 57% experienced at least 1 immune-related adverse event (irAE). The most common were: dermatitis (50%), arthritis (44%) and thyroiditis (38%). Four patients experienced a grade three irAE; no patients had a grade 4 or 5 irAE; only 2 patients required hospitalisation due to an irAE. 29% of patients required systemic steroids for an irAE; 18% required systemic steroids for > 12 weeks. Except for endocrinopathies all irAEs resolved. Of the 10 patients with disease recurrence, 5 occurred during adjuvant treatment. Median PFS and OS were not reached.
Conclusion
Real world efficacy and toxicity of adjuvant immunotherapy was similar to clinical trial data. Hospitalisation was rare and all irAEs resolved however a significant proportion of patient required systemic steroids.
Is this 18% correct - if so then more than 1 patient recurred during adjuvant treatment (below you say only 1 patient recurred on treatment). - can you make consistent etc.