Quality of evidence about effectiveness of treatments for metastatic uveal melanoma.

PURPOSE To evaluate and comment on the published peer-reviewed literature for evidence of effectiveness of treatments for metastatic uveal melanoma. METHODS Literature search and analysis of satisfactory articles on treatment of metastatic uveal melanoma published between 1980 and 2007. RESULTS Of 71 identified articles, 10 (14.1%) were review articles without original case information, 2 (2.8%) were review articles combined with case reports, 17 (24.0%) were case reports, 15 (21.1%) were retrospective descriptive case series reports, 3 (4.2%) were pilot studies of a novel intervention, 2 (2.8%) were reports of a prospective nonrandomized phase I clinical trial, 7 (9.9%) were reports of a prospective nonrandomized phase I/II clinical trial, 14 (19.7%) were reports of a prospective nonrandomized phase II clinical trial, and 1 (1.4%) was a report of a prospective randomized phase II clinical trial. None of the articles was a report of a prospective randomized phase III clinical trial. None of the reports of a prospective study included a comparison group of similar but untreated patients. The largest reported unselected patient groups had a median survival time after detection of metastasis in the range of 3 to 4 months. In contrast, the largest selected patient groups tended to have substantially longer median survival times. CONCLUSIONS Although median survival time following diagnosis of metastatic uveal melanoma tends to be substantially longer in selected subgroups of patients subjected to aggressive invasive interventions than it is in unselected groups, and although this difference is frequently considered to be evidence of treatment-induced prolongation of patient survival, much if not most of this apparent difference in survival is likely to be attributable to selection bias, surveillance (lead time) bias, and publication bias rather than treatment-induced alteration of the expected outcome. Information about the impact of treatment of any type for patients with metastatic uveal melanoma that has been reported in the peer-reviewed literature is of extremely low quality and does not provide compelling evidence of a beneficial effect of such treatment on survival.