1. A phase II study of induction therapy with carboplatin and gemcitabine among patients with locally advanced non-small cell lung cancer.
- Author
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Aerts JG, Surmont V, van Klaveren RJ, Tan KY, Senan S, van Wijhe G, Vernhout R, Verhoeven GT, Hoogsteden HC, and van Meerbeeck JP
- Subjects
- Adult, Aged, Carboplatin administration & dosage, Carcinoma, Non-Small-Cell Lung mortality, Carcinoma, Non-Small-Cell Lung pathology, Confidence Intervals, Denmark, Deoxycytidine administration & dosage, Deoxycytidine analogs & derivatives, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Lung Neoplasms mortality, Lung Neoplasms pathology, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Staging, Probability, Prognosis, Remission Induction, Survival Analysis, Treatment Outcome, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy, Neoplasm Invasiveness pathology
- Abstract
Introduction: The objectives of this trial were to evaluate the activity and safety of gemcitabine carboplatin as induction therapy in patients with locally advanced non-small cell lung cancer, Methods: Patients received two cycles of gemcitabine (1250 mg/m on day 1 and 8), plus carboplatin (area under the curve = 5 on day 1), after which response was established. Patients received a third course only in the case of an objective response (OR). Non-responding patients were directly irradiated. Toxicity was assessed according to the NCI-CTC version 2, radiation toxicity was assessed according to RTOG criteria. Response evaluation was performed according to RECIST criteria., Results: We identified 42 patients, of whom 37 were eligible. Of these, 51% (95% CI, 34%-68%) achieved an OR, all partial responses. No disease progression on therapy was established. Toxicity was mostly hematological: 35% trombocytopenia grade 3 and 4, and 40% neutropenia grade 3 and 4. No severe bleeding or hospitalization because of febrile neutropenia occurred., Conclusions: Gemcitabine and carboplatin administered according to a 3-week schedule is an active and safe induction regimen. Pending the results of a phase III study, we believe that it is a reasonable alternative among patients for whom cisplatin-based chemotherapy is contraindicated.
- Published
- 2006