Interim Safety Analysis From A Randomized, Open-Label, Multicenter, Phase Iii Trial Of Capecitabine Plus Oxaliplatin (Xelox) Versus Capecitabine (X) As First-Line Chemotherapy In Elderly Patients With Advanced Gastric Cancer (Agc).

158 Background: While combination chemotherapy involving fluoropyrimidines and platinum is currently considered a standard regimen in AGC, there has been a price to pay in terms of toxicity. Since the main goal of treatment in AGC remains palliation, the current multi-center phase III trial compares efficacy and safety of XELOX combination with those of X monotherapy in elderly patients with AGC. Methods: AGC Patients aged 70 years or older were randomized 1:1 to receive X (capecitabine 1000 mg/m2 bid po on D1-D14) or XELOX (capecitabine 1000 mg/m2 bid po on D1-D14 plus oxaliplatin 110 mg/m2 iv on D1). Treatment was repeated every 21 days until disease progression, unacceptable toxicity, or patient’s refusal. Primary endpoint was overall survival, and the target sample size was 200 eligible patients. This interim safety analysis contains toxicity data from the first 27 randomized patients. Results: Among the 27 patients (X: 13, XELOX 14), median age was 77 (range, 70-84) years and 24 patients had symptomatic (ECOG PS 1-2) disease. The arms of the study were balanced with respect to baseline characteristics. No treatment-related serious adverse events (SAEs) or unexpected toxicities were observed. The most frequent toxicities were anorexia, fatigue, anemia, and hand-foot skin reactions. Fatigue and sensory neuropathy were more common in XELOX than X patients. QOL data showed no significant differences between the two arms. Conclusions: Our data indicate that the addition of oxaliplatin does not add to the toxicity of single agent capecitabine as first-line chemotherapy in elderly (age ≥70 years) AGC patients. The accrual is currently ongoing (ClinicalTrials.gov, NCT01470742). Clinical trial information: NCT01470742.