title: Phase II study of an alternate carboplatin and gemcitabine dosing schedule in advanced non-small-cell lung cancer.
abstract: We conducted a phase II single-institution trial in a homogenous patient population with advanced non-small-cell lung cancer to determine whether changing the carboplatin schedule in the carboplatin/gemcitabine doublet would enhance tolerability and/or results. Thirty patients with stage IIIB (with malignant effusion) or stage IV disease received gemcitabine 1100 mg/m2, days 1 and 8 plus carboplatin at an area under the curve of 5 on day 8. Cycles were repeated every 28 days, up to 6 cycles. A response rate of 10% was demonstrated (none complete), but an additional 45% of patients had stable disease. The median time to progression was 5.8 months and the median survival was 8.3 months. A 1-year survival rate of 27% and a 2-year survival rate of 16% were seen. The main nonhematologic toxicity was non-neutropenic infection. Thrombocytopenia occurred in 8 patients (27%; 7 grade 3, 1 grade 4). Carboplatin/gemcitabine with a day 8 administration of carboplatin is well tolerated with a similar survival to established platinum-based doublets.
authors.affiliation: Texas A & M University System Health Science Center College of Medicine, Temple 76508, USA. fmott@swmail.sw.org
authors.forename: Frank E
authors.initials: FE
authors.lastname: Mott
authors.forename: Christian T
authors.initials: CT
authors.lastname: Cable
authors.forename: Neeraj
authors.initials: N
authors.lastname: Sharma
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000628:therapy*; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine