7349 Background: A recent phase I study of the combination of CBDCA and Caelyx conducted at The Medical Oncology Centre of Rosebank, Johannesburg has shown that CBDCA at area under the curve (AUC) 5 and Caelyx 50mg/m2 given every 4 weeks, could be combined with acceptable toxicity. METHODS The objective of this phase II study is to determine efficacy and toxicity of Caelyx at a dose of 50mg/m2 in combination with CBDCA (AUC = 5), in patients with chemo-naïve small cell lung cancer. Cycles are repeated every 28 days. RESULTS Twenty-three patients have been entered to date. There are 17 males and 6 females. The median age is 63 years (range 42-73). The majority of patients (77%) presented with an ECOG PS of 0 - 1, despite the fact that more than 80% of patients had extensive disease at onset of treatment. A total of 86 cycles have been administered, with a median of 4 cycles (range 1-6). At this stage 17of the 23 patients are evaluable for response. One patient withdrew consent, one patient died of pneumonia after 1 cycle and 4 patients are too early for evaluation. Documented responses include 3 complete and 6 partial responses. Five patients have stable disease and 3 patients progressed. Haematological toxicity includes anaemia (grade I-II: 8 patients; grade III: 5 patients), neutropenia (grade I-II: 8 patients; grade III-IV: 4 patients) and thrombocytopenia (grade -II: 5 patients; grade III-IV: 3 patients). One patient developed febrile neutropenia. Non haematological toxicity includes PPE (grade I-II: 11 patients), nausea and vomiting (grade I - II in 4 patients), stomatitis (grade I-II: 6 patients; grade III-IV: 1 patient) and aesthenia (grade I-III: 10 patients). No renal toxicity has been observed. CONCLUSIONS The combination of Caelyx at a dose of 50mg/m2 with CBDCA at AUC = 5 appears to be a safe and active first line chemotherapy regime for extensive disease small cell lung cancer. Treatment is well tolerated. The study is ongoing. No significant financial relationships to disclose.