Abstract
7536 Background: Elderly pts is an heterogeneous population in which anticancer therapeutic decision is often difficult. The objective of this study was to evaluate the feasibility and activity of weekly D/G followed by E after progression versus E following by D + G after progression in fit elderly advanced NSCLC patients selected on the basis of a CGA and Charlson score. Methods: This multicenter phase II study randomized chemonaive pts with stage IV and IIIB with pleural effusion received D 30 mg/m2 weekly for 6 consecutive weeks (wks) plus G 900 mg/m2 days 1, 8, 22, 29 followed by 2 wks off, for a maximum of 24 wks or until progression, followed by E until second progression (arm A) versus E in first line followed by D+G until second progression (arm B). Only fit pts (without dependence for ADL or IADL and geriatric syndrom) selected by CGA using a software (EGSK) included in a palm assistant with 10 items: socio-economic conditions, cognitive assessment,depression scale, nutritional risk, quality of life (QOL), ADL, IADL, incontinence, falls, pain. Major endpoint was time to second progression (TTP2), secondary endpoints were response, time to first progression (TTP1), safety, QOL. Results: 100 pts (99 available) were enrolled from July 2006 to November 2008. Patients: Male/Female 59/40, median age 75.9; PS 0/1/2:43/49/6, median comorbidity 0, 4 (0-4) median global geriatric index: 18.5/20. Respectively for arm A and B: partial response was 26.3% and 18.8%, stable disease 42.1% and 33.3%, progressive disease 31.6% and 47.9%,TTP1: 4.7 and 3.1 months, TTP2: 7.7 and 6.6 months, median survival 9.4 and 7.1 months. The main WHO grade 3/4 toxicity was neutropenia 29.2% and fatigue 10.4% in arm A and fatigue 11.8% and cutaneous 11.8% in B. Conclusions: Preliminary analysis suggests that either the combination of weekly D and G followed by E or E followed by D+G appears to be promising with a favourable toxicity profile in fit elderly NSCLC pts with mild comorbidity. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Boehringer Ingelheim, Lilly, Roche Amgen, Lilly, Roche Amgen, Lilly, Pfizer, Roche, sanofi-aventis
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