title: Phase I-II study of gemcitabine and paclitaxel in pretreated patients with stage IIIB-IV non-small cell lung cancer.
abstract: Gemcitabine and paclitaxel are among the most active new agents in non-small cell lung cancer (NSCLC) and are worth considering for second-line chemotherapy. In this phase I-II study, we combined gemcitabine and paclitaxel for second-line treatment of advanced NSCLC. Gemcitabine doses were kept fixed at 1000 mg/m2 on day 1 and 8, and paclitaxel doses were escalated from 90 mg/m2 on day 1 of the 21-day cycle. Thirty-seven patients were treated at six different dose levels. Grade 4 neutropenia was dose-limiting toxicity (DLT), since it occurred in two out of six patients treated at paclitaxel 240 mg/m2; the paclitaxel dose level just below (210 mg/m2) was selected for phase Il evaluation. Non-hematologic toxicity was mild. One complete response (CR) (3%) and 13 partial responses (PR) (36%) were observed in 36 evaluable patients for an overall response rate of 39% (95% C.I., 23-57%). Median duration of response was 35 weeks (range, 8-102). All of the observed objective responses occurred in the 19 patients who had previously responded to the first-line therapy. Median survival was 40 weeks (range, 8-108 weeks). The combination of gemcitabine and paclitaxel is a feasible, well-tolerated, and active scheme for second-line treatment of advanced NSCLC; further evaluation, at least in selected patients, such as those previously responding to first-line chemotherapy, is definitely warranted.
authors.affiliation: Università di Cagliari, Cattedra di Oncologia Medica, Italy.
authors.forename: R V
authors.initials: RV
authors.lastname: Iaffaioli
authors.forename: A
authors.initials: A
authors.lastname: Tortoriello
authors.forename: A
authors.initials: A
authors.lastname: Gravina
authors.forename: G
authors.initials: G
authors.lastname: Facchini
authors.forename: G
authors.initials: G
authors.lastname: Turitto
authors.forename: S
authors.initials: S
authors.lastname: Elia
authors.forename: S
authors.initials: S
authors.lastname: Griffo
authors.forename: M
authors.initials: M
authors.lastname: Gentile
authors.forename: G
authors.initials: G
authors.lastname: Fraioli
authors.forename: A
authors.initials: A
authors.lastname: Frattolillo
authors.forename: P
authors.initials: P
authors.lastname: Muto
authors.forename: M
authors.initials: M
authors.lastname: Libutti
authors.forename: V
authors.initials: V
authors.lastname: De Marino
authors.forename: A
authors.initials: A
authors.lastname: Illiano
authors.forename: A
authors.initials: A
authors.lastname: Barbarisi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D005260:Female; 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; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine