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- W4240772657 abstract "7120 Background:Single agent IV NVB has proven its effectiveness in elderly NSCLC pts with reduced toxicity. IV and oral NVB formulation have proven comparable bioavailability. This phase II was conducted with oral NVB to evaluate efficacy/tolerability. Methods:Pts to be recruited were ≥70y with unresectable localised or metastatic NSCLC. Oral NVB was given weekly 60mg/m2x3 weeks/1 cy and then escalated to 80mg/m2 if no G4 or no more than 2 G3 neutropenia during 1stcy. At 80mg/m2, if 1 G4 or 2 consecutive G3 neutropenia occurred, dose was reduced to 60mg/m2.Treatment given up to progression. Primary endpoint was response rate (OR) with secondary endpoints being time dependant parameters and clinical benefit evaluation taking into account 6 lung cancer symptoms evaluation by visual analogic scales, weight and PS changes. Results:56 pts were recruited in 11 European centres. Median age was 74y (70–82), 75% were male with a KPS of 80 in 48%, others being 90/100. 43 pts (76.8%) were metastatic at inclusion. Co-morbidities were present in 87.5% of pts with 18% having ≥3. Median dose intensity (DI) was 46.5mg/m2/w with RDI of 65%. 66.7% pts receiving 2d cy were escalated to 80mg/m2. In ITT/evaluable pts, 6 PR (10.7/12.8%) and 25 SD (disease control=55.4/66%) were reported. Response duration was 5.2m, PFS 3.7m and MS 8.2m. 92 doses (73%) were skipped due to haematological toxicity, mostly G3/4 neutropenia in 61cy (30.8%) and leucopenia in 43cy (21.5%); 2 febrile neutropenia were recorded in 1 patient. G3 non-haematological toxicities were fatigue (4%cy), nausea (2.5%cy), diarrhea (1.5%cy). 1 pt had a G4 thrombosis (0.5%). Regarding clinical benefit, improvement was clear for chest pain, cough and dyspnea. Fatigue, appetite and hemoptysis remained stable or slightly decreased. Weight remained stable. On 32 evaluable pts, the clinical benefit response rate was 31.25%. Conclusions:Oral NVB given as a weekly monotherapy was easy to administer and well tolerated, offering an optimal disease control in this elderly NSCLC population leading to a favorable activity /toxicity ratio associated with a clinical benefit. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Institut de Recherche Pierre Fabre Glaxo Institut de Recherche Pierre Fabre" @default.
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- W4240772657 date "2004-07-15" @default.
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- W4240772657 title "Single agent oral vinorelbine (NVB) in advanced non-small cell lung cancer (NSCLC) in the elderly: Patient benefit improvement by weekly schedule" @default.
- W4240772657 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.7120" @default.
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