title: Lipoplatin monotherapy: A phase II trial of second-line treatment of metastatic non-small-cell lung cancer.
abstract: Lipoplatin is a liposome encapsulated form of cisplatin. phase i studies on lipoplatin have demonstrated that the compound has an excellent toxicity profile. therefore we performed a phase ii trial in heavily pre-treated patients with advanced non-small-cell lung cancer (NSClC), performance status 0-2 in which the primary endpoint was response rate and secondary endpoints were safety and overall survival.Nineteen patients, average age 64 years old, with stage iV NSClC, were treated with lipoplatin 100 mg/m(2) every two weeks, as second line chemotherapy.We observed 1 partial remission (5.2%) and 3 stable diseases (15.9%). Time to progression (ttp) was 16 weeks and median overall survival (OS) was 31 weeks (7.2 months). We observed G1-G2 toxicity during chemotherapy, mainly gastrointestinal with nausea and vomiting (4 patients), asthenia (3 patients), mucositis (2 patients) and anemia (4 patients).Our phase ii study does not support a more extensive use of lipoplatin in phase III studies. An increase of dosage and a better selection of patients are mandatory to understand the real therapeutic activity of lipoplatin.
authors.affiliation: Department of Oncology and Oncoematology, Infermi Hospital, Ramini, Italy. aravaiol@auslrn.net
authors.forename: A
authors.initials: A
authors.lastname: Ravaioli
authors.forename: M
authors.initials: M
authors.lastname: Papi
authors.forename: E
authors.initials: E
authors.lastname: Pasquini
authors.forename: M
authors.initials: M
authors.lastname: Marangolo
authors.forename: B
authors.initials: B
authors.lastname: Rudnas
authors.forename: M
authors.initials: M
authors.lastname: Fantini
authors.forename: S V L
authors.initials: SV
authors.lastname: Nicoletti
authors.forename: F
authors.initials: F
authors.lastname: Drudi
authors.forename: I
authors.initials: I
authors.lastname: Panzini
authors.forename: E
authors.initials: E
authors.lastname: Tamburini
authors.forename: L
authors.initials: L
authors.lastname: Gianni
authors.forename: G
authors.initials: G
authors.lastname: Pasini
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged
chemical_list: D000970:Antineoplastic Agents; C503131:lipoplatin; D002945:Cisplatin