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

Background: Concomitant chemoradiotherapy (CCRT) for squamous cancers of the head and neck (SCCHN) improves survival but increases toxicity. Pegylated liposomes localise to solid cancers and may deliver radiosensitizing agents preferentially to tumour tissue, potentially improving the therapeutic ratio 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 well with no haematological, renal, hepatic or neurological toxicities. Nausea and vomiting were minimal. There were no drug-related delays in the delivery 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 chemotherapy or as part of a CCRT approach.