1. Phase II trial of single-agent oral vinorelbine in elderly (or =70 years) patients with advanced non-small-cell lung cancer and poor performance status
- Author
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P. Puccinelli, C. Valsuani, M. Rondini, Domenico Amoroso, Andrea Camerini, Cheti Puccetti, G. Tartarelli, O. Siclari, F. Di Costanzo, S. Donati, and Francesca Mazzoni
- Subjects
Male ,medicine.medical_specialty ,Palliative care ,Lung Neoplasms ,Nausea ,Health Status ,Phases of clinical research ,Administration, Oral ,Neutropenia ,Vinorelbine ,Vinblastine ,Internal medicine ,Carcinoma, Non-Small-Cell Lung ,Activities of Daily Living ,Task Performance and Analysis ,Medicine ,Humans ,Lung cancer ,Survival analysis ,Aged ,Aged, 80 and over ,Leukopenia ,business.industry ,Palliative Care ,Hematology ,medicine.disease ,Antineoplastic Agents, Phytogenic ,Survival Analysis ,Surgery ,Oncology ,Disease Progression ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
Background Elderly patients with advanced non-small-cell lung cancer (NSCLC) with poor performance status (PS) are a special population requiring particular attention. Single-agent oral vinorelbine could be an attractive option. Patients and methods A total of 43 patients with stage IIIB–IV NSCLC and Eastern Cooperative Oncology Group (ECOG) PS of two or more with good functional status were prospectively recruited. Oral vinorelbine was administered at the dose of 60 mg/m2 on days 1–8 every 3 weeks. Primary end points were response rate and safety. Results Overall response rate was 18.6% with 8 partial responses; 18 of 43 (41.8%) experienced stable disease lasting >12 weeks and 17 of 43 (39.6%) disease progression for an overall clinical benefit of 60.4%. Median time to progression was 4.0 (range 2–22) months and median overall survival 8.0 (range 3–35) months. Treatment was well tolerated. Of 187 cycles, we did not observe any grade 3/4 toxicity with the exception of a single not-febrile G3 neutropenia. Regardless of severity, main toxic effects observed were nausea in 48.1% and vomiting in 22.9% of patients, anemia in 43.2%, fatigue in 32.6% and leukopenia in 23.2%. Conclusion Single-agent oral vinorelbine is extremely safe in elderly patients with advanced NSCLC and ECOG PS of two or more and may represent a valid option in this very special population.
- Published
- 2009