1141P - Percutaneous Hepatic Perfusion (CHEMOSAT® or CS-PHP) of Melphalan vs. Best Alternative Care (BAC) in Patients (PTS) with Hepatic Metastases from Melanoma: Update of a Randomized Phase 3 Study

Abstract

ABSTRACT Background CS-PHP (CHEMOSAT®; Delcath Systems Inc, New York, NY) is a regional therapy which isolates and perfuses the liver with high-dose chemotherapy. Unwanted systemic exposure is minimized by extracorporeal filtration of hepatic venous blood. Methods A prospective randomized multicenter phase 3 study compared CS-PHP of melphalan with BAC in pts with proven unresectable hepatic metastases from ocular or cutaneous melanoma. A survival update was performed on 31 March 2011. CS-PHP melphalan 3.0 mg/kg ideal body weight was infused into the hepatic artery over 30 min with concurrent extracorporeal filtration for 60 min. Up to 6 treatments were given every 4–8 wks. In the BAC group, crossover to CS-PHP melphalan was permitted after hepatic disease progression. The primary endpoint was investigator-assessed hepatic progression-free survival (hPFS). An exploratory post-hoc analysis of pts who crossed from BAC to CS-PHP vs. BAC-only pts was also performed. Results 93 pts were randomized to CS-PHP (n = 44) or BAC (n = 49). After hepatic disease progression, 28 pts crossed over to CS-PHP. Results are shown in the Table. The most common grade 3/4 toxicities in CS-PHP pts (n = 40) were hematological peri-procedural thrombocytopenia (73%) and anemia (55%) and post-procedural (beyond day 4 post-treatment) neutropenia (93%) or thrombocytopenia (83%). The safety profile in crossover pts was similar to that in pts randomized to CS-PHP melphalan. Conclusions CS-PHP melphalan significantly prolonged hPFS compared with BAC in pts with liver-dominant metastatic melanoma, thereby meeting the primary study objective. Efficacy was similar after hepatic disease progression in BAC-CS-PHP crossover pts as in those randomized initially to CS-PHP. Treatment group n Median hPFS, mo Hazard ratio (95% CI) Median OS, mo Hazard ratio (95% CI) CS-PHP 44 8.0 0.35 (0.23-0.54) 9.8 1.08 (0.69-1.68) BAC 49 1.6 P 9.9 NS BAC only 21 1.6 0.32 4.1 0.33 BAC → CS-PHP crossover 28 8.8 15.3 Disclosure All authors have declared no conflicts of interest.