Impact of a comprehensive geriatric assessment to manage elderly patients with locally advanced non-small–cell lung cancers: An open phase II study using concurrent cisplatin–oral vinorelbine and radiotherapy (GFPC 08-06). (July 2018) - Locher, Chrystèle
Highlights: CGA select elderly locally advanced NSCLC eligible for standard therapy. 77.5% Of these selected patients received full concurrent therapy. 22.5% Experienced toxicity grade >2 (including three treatment-related deaths). Median PFS was 15 (95%CI: 8, 7–35, 2) months, OS 21.8 (95%CI: 16–NR) months. One-, 2- and 4-year survival rates were 77.5%, 45% and 34.8%. Abstract: Introduction: Few data have been published on the optimal management of elderly patients with locally advanced non-small–cell lung cancers (La-NSCLC). This prospective, multicenter, phase II study was undertaken to evaluate the ability of a comprehensive geriatric assessment (CGA) to select the elderly La-NSCLC patients who potentially may benefit from concurrent radio-chemotherapy. Methods: The main inclusion criteria were: La-NSCLC, >70 years old, at least one measurable target, ECOG performance status (PS) 0/1 and normal CGA. Weekly cisplatin (30 mg/m 2 ) and oral vinorelbine (30 mg/m 2 ) were combined with standard thoracic radiotherapy (66 Gy, 33 fractions) for 6.5 weeks. The primary evaluation criterion was <15% clinically relevant grade >2 toxicity. Secondary criteria were response rates, overall survival (OS) and progression-free survival (PFS). Results: Among the 49 patients screened, 40 were included: 87.5% men, median age: 75.1 (70–84) years, 67.5% with PS 0, 52.5% squamous cell carcinomas. The full concurrent regimen was administrated in 77.5% of the cases (chemotherapy: 85%, radiotherapy: 90%); 22.5% of the patients experienced toxicity grade >2 (with three treatment-imputed deaths), 15% when restricted to clinically relevant >2 grade toxicities. One (2.6%) patient achieved a complete response, 53.8% had partial responses and 35.9% stable disease. Median PFS was 15 (95%CI: 8, 7–35, 2) months, OS 21.8 (95%CI: 16–NR) months and 1-, 2- and 4-year survival rates were 77.5%, 45% and 34.8%. Conclusion: CGA was able to select fit elderly patients with La-NSCLCs eligible for concurrent chemoradiotherapy with a satisfactory risk/benefit ratio.