title: Results of a Phase II study of weekly docetaxel and carboplatin in Stage IIIB (with effusion) or Stage IV non-small cell lung cancer patients age<or=65 and performance status 2.
abstract: This study explores if advanced NSCLC patients with ECOG PS 2 and age<or=65 years can benefit from weekly docetaxel+carboplatin, with acceptable toxicities. Fifty-nine eligible patients with Stage IIIB (effusion) or Stage IV NSCLC were registered. Patients received docetaxel 35mg/m(2) and carboplatin AUC=2 on Days 1, 8, and 15 every 28-day cycle (maximum 8 cycles). Endpoints were 1-year survival, tumor response, PFS, and safety. Among the 59 eligible patients, the 1-year survival was 28% and median survival was 6 months (range: 1-24.3). The median duration of response for CR+PR was 5.4 months (range: 2.3-9.7), 1-year progression-free survival was 14% (median of 3.7 months, range<1-22.8). Patients received a median of 3 cycles (range: 1-9); 14 patients (24%) had toxicity-related reductions. Responses were: 1 CR (2%), 5 PR (10%), 22 SD (45%), and 21 PD (43%). Forty-nine patients were evaluable for response; 10 patients were non-evaluable due to: radiotherapy (1), withdrew consent (3), insurance issues (1), and early toxicity (1 each; dyspnea, weakness, and rash), and other illness (2). Fifty-eight patients were evaluable for safety. The primary Grade 3 or 4 toxicities were neutropenia and fatigue (10% each), nausea (9%), dehydration (7%), and vomiting (5%). A 12% response rate (plus 45% SD) confirms the relatively poor outcome of patients with advanced NSCLC who are PS 2. Toxicities of docetaxel+carboplatin are comparable to other regimens and this combination may provide an alternative for this group of patients. Further studies correlating patient characteristics with response are necessary.
authors.affiliation: US Oncology Research, Inc., 12941 North Freeway, Suite 700, Houston, TX 77060, USA. Charles.Weissman@usoncology.com
authors.forename: Charles H
authors.initials: CH
authors.lastname: Weissman
authors.forename: John
authors.initials: J
authors.lastname: Sandbach
authors.forename: Reginald
authors.initials: R
authors.lastname: Brooker
authors.forename: Mark
authors.initials: M
authors.lastname: Vellek
authors.forename: Deborah
authors.initials: D
authors.lastname: Lindquist
authors.forename: Paul
authors.initials: P
authors.lastname: Conkling
authors.forename: Des
authors.initials: D
authors.lastname: Ilegbodu
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
mesh_terms: D000328:Adult; D000368:Aged; 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 / Q000188:drug therapy* / Q000401:mortality; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin