BOLD- FIRST REPORT OF ACTIVE SYSTEMIC THERAPY(INTERFERON IN THE TREATMENT OF METASTATIC UVEAL MELANOMA )

We conducted a phase II trial of bleomycin + vincristine + lomustine dacarbazine (BOLD) with intercycle alpha interferon-2b in previously untreated patients with metastatic uveal melanoma, Objective tumor res ponse and toxicity were assessed. Twenty-three patients with histologi cally verified metastatic uveal melanoma were enrolled into this study between November 1992 and August 1995. Chemotherapy was administered in the following fashion: dacarbazine (DTIC), 200 mg/m(2) intravenousl y on days 1-5; vincristine, 1 mg/m(2) (not to exceed 2 mg) intravenous ly on days 1 and 4; bleomycin, 15 mg intravenously on days 2 and 5; lo mustine (CCNU), 80 mg orally on day 1; and alpha interferon-2b, 3 x 10 (6) IU subcutaneously on days 8, 10, 12, 15, 17, 19. A cycle was 28 da ys, and patients were reevaluated after every 2 cycles. Among twenty e valuable patients, four objective responses were observed (RR = 20%), Hematologic toxicity was modest by comparison to some other combinatio n chemotherapy regimens in common use. Neurotoxicity was frequently ob served, but it was seldom severe. An unexpected and unpredictable seve re pulmonary toxicity was observed in 3 patients, the etiology of whic h remains unclear. The regimen of BOLD + interferon is active in the t reatment of metastatic uveal melanoma. The precise role of the regimen has to be defined in light of its toxicity, particularly the unpredic table pulmonary toxicity. The pattern of occurrence of these pulmonary events is most consistent with either an acquired hypersensitivity re action or a cumulative toxic effect of 2 or more of the agents. Patien ts considered for treatment with this regimen must be judiciously sele cted. Those with no clear contraindications may benefit from a trial o f this regimen, but they must be monitored closely.