Study ESOGIA-GFPC 08-02: Phase III, randomized, multicenter trial involving subjects over age 70 with stage IV non-small cell lung cancer and comparing a “classical” strategy of treatment allocation (dual-agent therapy based on carboplatin or monotherapy with docetaxel alone), based on performance status and age, with an “optimized” strategy allocating the same treatments according to a simplified geriatric screening scale, plus

Abstract

TPS219 Background: Oncogeriatry has grown fast, it’s recommended to use comprehensive geriatric assessment (CGA) to predict the patient’s vulnerability, treatment tolerance.The integration of CGA’s results in treatment decision making and in the choice of type of treatment does not remain clearly defined. Methods: We compare a treatment algorithm based on PS and age in arm A with an optimized algorithm based on an abbreviated GA(aGA) plus or more a CGA in arm B. In arm B, if the aGA results are normal, the patient is treated with 4 cycles of dual-agent therapy (carboplatin AUC 5 D1 + pemetrexed 500 mg/m2 D1 q21D if non epidermoid histology, carboplatin AUC5 D1 + gemcitabin 1000 mg/m2 D1-D8 q21D if epidermoid histology), with no further GA. When the aGA reveals abnormalities, a CGA is used to define two subpopulations on Balducci’s fragility scale, who will receive either monotherapy (docetaxel 38 mg/m2, D1-D8 q21D) or best supportive care. In arm A, the same dual agent therapy or monotherapy will be allocated but according only to PS and age. For the aGA, we’re using: charlson’s score, PS, ADL, IADL, the mini-MMSE, GDS 5, we’re searching repeated falls, fecal or urinary incontinence. For the CGA, we are evalating also: mini-MMS of Folstein, nutritional status, IRIS QoL pain, motor status. Objectives: primary endpoint: Time to treatment failure TTF(progression, unacceptable toxicity), secondary endpoints: QoL (LCSS, EuroQol), ORR, OS, toxicities. Statistics: For an improvement of TTF of 30% in arm B compare to arm A, hazards ratio of 1.30, a 5% risk (bilateral), an 80% power, 5% of lost patients, the total number of subjects to enroll is 490 (245 patients by arm). Calendar: Number of patients to include: 490 from January 2010 to December 2012. As of 31/01/2011, 149 patients are enrolled in this study.