A phase II multi-center trial of maintenance biotherapy (MBT) after induction concurrent biochemotherapy (BCT) for patients (Pts) with metastatic melanoma (MM).

7503 Background: BCT improves responses in MM but survival benefit remains disappointing. We developed a novel MBT regimen following induction BCT to improve survival. (CCR 8(9):2775, 2002) Methods: In this multi-center trial, MBT was given to non-progressing pts following induction BCT with decrescendo IL-2 (JCO 17(9):2752, 1999). The 12 mo. MBT (28 d cycle) regimen consisted of low dose IL-2 (2 MIU sq d1-5, 8-12, 15-19, 22-26) and GM-CSF (250 mcg sq d1-14) combined with pulses of high dose decrescendo IL-2 (18 MIU/m2 IV over first 6 hrs, 18 MIU/m2 IV over next 12 hrs and 18 MIU/m2 IV over final 24 hrs) mos 1-6, 8, 10, 12. OS and TTP were primary and secondary endpoints respectively.,133 pts were evaluable. 12% of pts were M1a, 20% M1b, and 68% M1c. ECOG 0, 1 were 71% and 24%. 35% failed high dose adjuvant interferon. The median number of BCT cycles and MBT cycles were 4 and 5. Response to BCT was 8% CR, 36% PR, 29% SD and 27% PD. 4 pts had response to MBT (3 PR to CR, 1 SD to PR). 5 pts (3 PR and 2 SD) underwent complete resection of residual disease. The median TTP and OS were 9 (7.8-12.0) and 14 mos (11.5-15.4) respectively. The 12 and 24 mo. survivals were 57% and 23%. 20% of pts remain alive and 12% are NED with median follow-up 30 mos. 52 pts (39%) developed CNS progression. 21 of these (40%), CNS was the only site or first site of progression. The median CNS TTP and subsequent survival was 8 and 5 mos.,MBT post induction BCT appears to prolong TTP and improve OS compared to multi-center trials of BCT or chemotherapy. CNS progression remains a formidable challenge. A new trial incorporating CNS consolidation into this BCT, MBT sequential regimen is ongoing. [Table: see text].