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

Abstract

The present study was aimed at defining the antitumour activity of the cisplatin-paclitaxel-topotecan (CPT) weekly administration with G-CSF support in 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 topotecan 2.25 mg/m 2 weekly, with G-CSF (5 μg/kg days 3–5) support, for a maximum of 12 weeks. 37 patients were treated, for a total of 348 cycles delivered. 8 complete responses (22%) and 22 partial responses (59%) were recorded, giving an 81% [95% CI = 65–92%] ORR. At a 13-month (range, 4–26) median follow-up, median progression-free and overall survival were 8 months and 12.5 months, with 1-year and 2-year projected survivals of 55% and 21%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 6 and 3 patients, respectively. Only one case of neutropenic sepsis was recorded, while haemorrhagic thrombocytopenia was never observed. Diarrhoea, paraesthesias and fatigue were the main nonhaematologic toxicities being severe in 6, 2 and 10 patients, respectively. The weekly CPT combination with G-CSF support represents a well tolerated therapeutic approach in chemo-naive ED-SCLC patients. The activity rate seems at least similar to that achievable with the standard front-line approaches. © 2001 Cancer Research Campaign http://www.bjcancer.com

A review of topoisomerase inhibition in lung cancer

“…Frasci et al 45 reported a phase II trial of weekly IV topotecan plus cisplatin, paclitaxel and G-CSF in previously untreated SCLC with a median overall survival of 12.5 months and 1-and 2-year projected survival rates of 55% and 21% respectively. It is possible that addition of weekly topotecan to combination chemotherapy will allow for better symptom palliation and may improve response rates.…”

Emerging Role of Weekly Topotecan in Recurrent Small Cell Lung Cancer

“…The hematologic toxicity profile of weekly topotecan is favorable compared with the 5-day regimen, and nonhematologic toxicities are generally mild and manageable. Furthermore, weekly topotecan has been successfully included in combination chemotherapy trials, including a combination regimen of topotecan, paclitaxel, and cisplatin that has shown promising safety and activity in the SCLC setting [34,37].…”

“…In the nine patients with SCLC who had not received chemotherapy before study entry, seven (78%) responded, and in patients with relapsed SCLC, four (25%) responded. Based on the MTD determined in the phase I trial, Frasci et al [37] , and G-CSF support, in previously untreated patients with extensive SCLC. Grade 4 neutropenia occurred in six (16%) patients, and grade 4 thrombocytopenia occurred in three (8%).…”

Topotecan in the First-Line Treatment of Small Cell Lung Cancer

“…Frasci et al [37] investigated the safety and efficacy of a 12-week regimen that combined weekly treatment with cisplatin (40 mg/m ) with G-CSF support. That regimen produced a 22% CR and a 59% partial response (PR) rate in patients with extensive SCLC.…”