Published risk stratified adjuvant therapy trials for uveal melanoma using molecular techniques
| Study | Design | Inclusion criteria | Enrolment (N) | Median follow-up | Outcomes |
| Adjuvant dendritic cell vaccination in high-risk uveal melanoma (Bol et al 2016) | Non-randomised phase II clinical trial | High-risk chromosome status (monosomy 3) | 23 patients completed at least one cycle, 18 patients completed all three vaccination cycles | Not reported | Median DFS 34.5 months (95% CI: 27.2 to 41.8) Median OS 51.8 months (95% CI :42.1 to 62.7) |
| Adjuvant sunitinib in high-risk patients with uveal melanoma (Valsecchi et al 2018) | Retrospective cohort study | 1) High-risk chromosome status (monosomy 3 and 8q amplification) or GEP class two or (2) high-risk chromosome status (monosomy 3) and large tumour size (T3-4 AJCC) | 128 (54 treated patients) | Median 52.7 months (range: 0.26–108 months) | Median PFS-treated patients 58.6 months (95% CI: 33.1 to 84.1) 5-year OS probability Sunitinib 0.75 (95% CI: 0.59 to 0.85) No sunitinib 0.55 (95% CI 0.43 to 0.66) |
| A prospective trial of adjuvant therapy for high-risk uveal melanoma: assessing 5-year survival outcomes (present study) | Non-randomised prospective clinical trial | High-risk chromosome status (monosomy 3) | 150 (33 treated patients) | Median (for metastasis-free patients still being followed) 63.9 months (range: 1.0–97.5) | 5-year MFS enrolled 64%±9%, not enrolled 33%±10% 5-year OS 66%±9% enrolled, 37%±10% not enrolled |
AJCC, American Joint Committee on Cancer; DFS, disease-free survival; GEP, gene expression profiling; MFS, metastasis-free survival; OS, overall survival; PFS, progression-free survival.