A phase II study of induction therapy with carboplatin and gemcitabine among patients with locally advanced non-small cell lung cancer
Journal of Thoracic Oncology , Volume 1 - Issue 6 p. 532- 536
INTRODUCTION: The objectives of this trial were to evaluate the activity and safety of gemcitabine carboplatin as induction therapy in patients with locally advanced non-small cell lung cancer METHODS: Patients received two cycles of gemcitabine (1250 mg/m on day 1 and 8), plus carboplatin (area under the curve = 5 on day 1), after which response was established. Patients received a third course only in the case of an objective response (OR). Non-responding patients were directly irradiated. Toxicity was assessed according to the NCI-CTC version 2, radiation toxicity was assessed according to RTOG criteria. Response evaluation was performed according to RECIST criteria. RESULTS: We identified 42 patients, of whom 37 were eligible. Of these, 51% (95% CI, 34%-68%) achieved an OR, all partial responses. No disease progression on therapy was established. Toxicity was mostly hematological: 35% trombocytopenia grade 3 and 4, and 40% neutropenia grade 3 and 4. No severe bleeding or hospitalization because of febrile neutropenia occurred. CONCLUSIONS: Gemcitabine and carboplatin administered according to a 3-week schedule is an active and safe induction regimen. Pending the results of a phase III study, we believe that it is a reasonable alternative among patients for whom cisplatin-based chemotherapy is contraindicated.
|, , ,|
|Journal of Thoracic Oncology|
|Organisation||Department of Pulmonology|
Aerts, J.G.J.V, van Meerbeeck, J.P, Surmont, V, van Klaveren, R.J, Tan, K.Y, Senan, S, … Hoogsteden, H.C. (2006). A phase II study of induction therapy with carboplatin and gemcitabine among patients with locally advanced non-small cell lung cancer. Journal of Thoracic Oncology, 1(6), 532–536. doi:10.1097/01243894-200607000-00006