Phase I-II study of pegylated liposomal cisplatin (SPI-077 (TM)) in patients with inoperable head and neck cancer

Background: Concomitant chemoradiotherapy (CCRT) for squamous cancers of th e head and neck (SCCHN) improves survival but increases toxicity. Pegylated liposomes localise to solid cancers and may deliver radiosensitizing agent s preferentially to tumour tissue, potentially improving the therapeutic ra tio of CCRT. Patients and methods: A phase I-II trial of pegylated liposome encapsulated cisplatin (SPI-077(TM)) was conducted in 18 patients with treatment-naive locally advanced, inoperable SCCHN. The first 10 patients received 2 cycles of 200 mg/m(2), and the next 8 received 260 mg/m(2), every 3 weeks before commencing radical radiotherapy (RT). Results: Only 2 of 18 (11%) patients had partial responses to SPI-077(TM), with 2 responses in 29 (6.9%) evaluable sites. SPI-077(TM) was tolerated we ll with no haematological, renal, hepatic or neurological toxicities. Nause a and vomiting were minimal. There were no drug-related delays in the deliv ery of RT. RT-induced mucosal and cutaneous toxicity were not significantly increased. Conclusions: SPI-077(TM) is essentially inactive against SCCHN and, in its present formulation, does not merit further evaluation as induction chemoth erapy or as part of a CCRT approach.