title: Interim results of a phase III trial. Paclitaxel/carboplatin vs paclitaxel/gemcitabine in advanced non-small-cell lung cancer.
abstract: The Hellenic Cooperative Oncology Group conducted a randomized phase III trial to compare paclitaxel (Taxol) 200 mg/m2 i.v. 3-hour infusion on day 1 plus carboplatin (Paraplatin) at an area under the curve (AUC) of 6 (group A) with paclitaxel at the same dose plus gemcitabine (Gemzar) 1,000 mg/m2 on days 1 and 8 (group B) every 3 weeks for a maximum of six cycles in patients with advanced non-small-cell lung cancer. To date, 127 eligible patients have been randomized, 63 to group A and 64 to group B, and median follow-up is 4.6 months. Preliminary results suggest that both combinations are well tolerated and can be administered at full doses. Grade 3-4 neutropenia was generally mild but more prominent in group A (10%) and thrombocytopenia was insignificant in both groups. Severe neurotoxicity, hepatotoxicity, or cardiac toxicity have not been recorded in the majority of patients in either group. There was a trend toward higher response rates in favor of group B (group B vs group A, 37.5% vs 21.8%, respectively), although time-to-disease progression did not differ significantly (group B vs group A, 7.25 vs 7.1 months, respectively). Further maturation of the study is needed before definitive conclusions can be drawn.
authors.affiliation: 2nd Medical Oncology Department, Hygeia Hospital, Athens, Greece. parkosmi@otenet.gr
authors.forename: P
authors.initials: P
authors.lastname: Kosmidis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage; D013921:Thrombocytopenia / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine