Annals of Oncology 12:493-496, 2001
© 2001 European Society for Medical Oncology
research-article |
Phase I-II study of pegylated liposomal cisplatin (SPI-077 TM) in patients with inoperable head and neck cancer*
1ICRF Laboratory of Molecular Therapy, Imperial College of Science. Technology and Medicine, Hamersmith Hospital London, UK
2Molecular Medicine Program, Guggenheim 1836, Mayo Clinic, Rochester Minnesota, USA
3Department of Clinical Oncology, Charing Cross Hospital, Hammersmith Hospitals NHS Trust London, UK
4ALZA Corporation, Mountain View California, USA
5Department of Imaging, Imperial College of Science. Technology and Medicine. Hammersmith Hospital London, UK
Correspondence to: Dr K J Harrington, Molecular Medicine Program, Guggenheim 1836, Mayo Clinic, 200 1st Street SW, Rochester, MN 55902, USA, E-mail harrington.kevin{at}mayo.edu
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-naïve locally advanced, inoperable SCCHN. The first 10 patients received 2 cycles of 200 mg/m2, and the next 8 received 260 mg/m2, every 3 weeks before commencing radical radiotherapy (RT)
Results Only 2 of 18 (11%) patients had partial responses to SPI-077TM, 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
cisplatin, efficacy, head and neck cancer, pegylated liposome, toxicity
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