Phase II study of combination therapy with liposomal doxorubicin and carboplatin in patients with previously untreated small cell lung cancer.

Abstract

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.

Cite this paper

@article{Rapoport2004PhaseIS, title={Phase II study of combination therapy with liposomal doxorubicin and carboplatin in patients with previously untreated small cell lung cancer.}, author={Bernardo Rapoport and Conrad F Slabber and Daniel Alberto Vorobiof and Albert S. Alberts and Almari Uys}, journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, year={2004}, volume={22 14_suppl}, pages={7349} }