title: Phase II trial of alternating intravenous and oral vinorelbine in combination with cisplatin in advanced non-small cell lung cancer.
abstract: Cisplatin-based chemotherapy is the standard treatment for advanced non-small cell lung cancer (NSCLC). Several platinum-based doublets have been tested in phase II/III trials with equivalent results in terms of tumour response and survival. Our study was designed to evaluate activity, tolerability and convenience of alternating intravenous (i.v.) and oral vinorelbine in combination with cisplatin in advanced NSCLC. Forty chemo-naive patients with stage IV or relapsed unresectable disease and good performance status were enrolled to receive i.v. cisplatin 40 mg/m(2) on days 1 and 2 plus i.v. vinorelbine 25 mg/m(2) on day 1, every 3 weeks. Oral vinorelbine 60 mg/m(2) was given at home on day 5, without checking of blood cell count. A total of 175 treatment cycles were delivered. The overall response rate was 30% (one complete, 11 partial responses). Median time to progression and overall survival were 5 and 10 months, respectively. The main toxicity was haematological, with grade 3-4 neutropenia observed in 75% of patients, without febrile neutropenia. Non-haematological toxicity was mild. This schedule of cisplatin and vinorelbine treatment showed a good toxicity profile and an efficacy similar to other standard regimens. Oral vinorelbine could be administered safely at home on day 5.
authors.affiliation: Dipartimento di Oncologia Medica e Ematologia, Istituto Clinico Humanitas IRCCS, Via Manzoni 56, 20089, Rozzano, MI, Italy. elisabetta.campagnoli@humanitas.it
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Campagnoli
authors.forename: Isabella
authors.initials: I
authors.lastname: Garassino
authors.forename: Armando
authors.initials: A
authors.lastname: Santoro
authors.forename: Fabio
authors.initials: F
authors.lastname: De Vincenzo
authors.forename: Paolo Andrea
authors.initials: PA
authors.lastname: Zucali
authors.forename: Giovanni Luca
authors.initials: GL
authors.lastname: Ceresoli
authors.forename: Fabio Romano
authors.initials: FR
authors.lastname: Lutman
authors.forename: Marco
authors.initials: M
authors.lastname: Alloisio
authors.forename: Hector Josè
authors.initials: HJ
authors.lastname: Soto Parra
authors.forename: Raffaele
authors.initials: R
authors.lastname: Cavina
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine