title: 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 microg/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.
authors.affiliation: Southern Italy Cooperative Oncology Group (SICOG)-c/o National Tumor Institute of Naples via M. Semmola 80131, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Frasci
authors.forename: G
authors.initials: G
authors.lastname: Nicolella
authors.forename: P
authors.initials: P
authors.lastname: Comella
authors.forename: I
authors.initials: I
authors.lastname: Carreca
authors.forename: G
authors.initials: G
authors.lastname: DeCataldis
authors.forename: D
authors.initials: D
authors.lastname: Muci
authors.forename: C
authors.initials: C
authors.lastname: Brunetti
authors.forename: M
authors.initials: M
authors.lastname: Natale
authors.forename: F
authors.initials: F
authors.lastname: Piantedosi
authors.forename: A
authors.initials: A
authors.lastname: Russo
authors.forename: S
authors.initials: S
authors.lastname: Palmeri
authors.forename: G
authors.initials: G
authors.lastname: Comella
authors.forename: N
authors.initials: N
authors.lastname: Panza
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage; D043823:Taxoids; D013921:Thrombocytopenia / Q000139:chemically induced; D019772:Topotecan / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D019772:Topotecan; D017239:Paclitaxel; D002945:Cisplatin