Metastatic melanoma from in intraocular primary tumors - Southwest Oncology Group experience in phase II advanced melanoma clinical trials

Ocular melanoma is an uncommon malignancy that, in the presence of metastat ic disease, has a poor prognosis for response to treatment and survival. Pa tients with ocular melanoma are often excluded from clinical trials because of the Impression that these patients have a poorer response rate to treat ment with anticancer agents and poorer survival, possibly related to the pr edominance of the Liver as a site of metastasis. Sixty-four eligible patien ts with advanced melanoma arising from ocular primary tumors were entered i nto seven phase II clinical trials of anticancer therapy activated by the S outhwest Oncology Group (SWOG) during the 1980s. Eligible patients with non ocular primaries entered into these trials (420 patients) served as a compa rison group for survival, pretreacment characteristics, and response rates. Multivariate Cox model analysis of survival data (with survival from the t ime of study registration as the primary endpoint) was conducted. Among the 484 patients observed, patients with ocular melanoma were older than those with nonocular primary tumors and were more likely to have visceral metast asis, metastasis to the liver, and only one metastatic site at registration , primarily to viscera and liver. The median overall survival after registr ation to study for both groups was 5 months. There was no significant diffe rence in overall survival between patients with ocular melanoma and these w ith nonocular melanoma after adjusting for a number of prognostic factor (p = 0.43). Furthermore, the overall objective response rate of patients with ocular melanoma in these studies was not significantly different from that achieved in the nonocular group (9% vs. 11%; p = 1.00). Patients with adva nced ocular or nonocular melanoma have similar response rates and survival in this series of cooperative group phase II trials. Patients with ocular p rimaries should not be excluded from investigational studies in advanced me lanoma.