1. ¹Christie Hospital NHS Trust, Manchester, UK
2. ²Weston Park Hospital, Sheffield, UK
3. ³Paterson Institute of Cancer Research, Manchester, UK
4. ⁴ALZA Pharmaceuticals, Mountain View, CA, USA

Correspondence: Dr SC White, Ludwig Department of Oncology, Austin Hospital, Studley Road, Heidelberg 3084, Australia. E-mail: shane.white@austin.org.au

Received 31 May 2006; Revised 9 August 2006; Accepted 9 August 2006; Published online 12 September 2006.

Abstract

To determine the efficacy and tolerability of SPI-77 (sterically stabilised liposomal cisplatin) at three dose levels in patients with advanced non-small-cell lung cancer (NSCLC). Patients had Stage IIIB or IV NSCLC and were chemo-naïve, and Eastern Oncology Cooperative Group 0–2. The first cohort received SPI-77 at 100 mg m^-2, the second 200 mg m^-2 and the final cohort 260 mg m^-2. Patients had also pharmacokinetics and analysis of leucocyte platinum (Pt)-DNA adducts performed. Twenty-six patients were treated, with 22 patients being evaluable for response. Only one response occurred at the 200 mg m^-2 dose level for an overall response rate of 4.5% (7.1% at 200 mg m^-2). No significant toxicity was noted including nephrotoxicity or ototoxicity aside from two patients with Grade 3 nausea. No routine antiemetics or hydration was used. The pharmacokinetic profile of SPI-77 was typical for a liposomally formulated drug, and the AUC appeared to be proportional to the dose of SPI-77. Plasma Pt levels and leucocyte DNA adduct levels did not appear to rise with successive doses. SPI-77 demonstrates only modest activity in patients with NSCLC.