A weekly regimen of cisplatin, paclitaxel and topotecan with granulocyte-colony stimulating factor support for patients with extensive disease small cell lung cancer: a phase II study

The present study was aimed at defining the antitumour activity of the cisp latin-paclitaxel-topotecan (CPT) weekly administration with G-CSF support i n chemo-naive SCLC patients with extensive disease (ED-SCLC). Chemonaive ED -SCLC patients received cisplatin 40 mg/m(2), paclitaxel 85 mg/m(2), and to potecan 2.25 mg/m(2) weekly, with G-CSF (5 mug/kg days 3-5) support. for a maximum of 12 weeks. 37 patients were treated, for a total of 348 cycles de livered. 8 complete responses (22%) and 22 partial responses (59%) were rec orded, giving an 81% [95% CI = 65-92%] ORR. At a 13-month (range, 4-26) med ian follow-up, median progression-free and overall survival were 8 months a nd 12.5 months, with 1-year and 2-year projected survivals of 55% and 21%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocyto penia occurred in 6 and 3 patients, respectively. Only one case of neutrope nic sepsis was recorded, while haemorrhagic thrombocytopenia was never obse rved. Diarrhoea, paraesthesias and fatigue were the main nonhaematologic to xicities being severe in 6, 2 and 10 patients, respectively. The weekly CPT combination with G-CSF support represents a well tolerated therapeutic app roach in chemo-naive ED-SCLC patients. The activity rate seems at least sim ilar to that achievable with the standard front-line approaches. (C) 2001 C ancer Research Campaign.