The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+)

摘要: Abstract Background We evaluated the feasibility and tolerability of triple- versus double-drug chemotherapy in elderly patients with oesophagogastric cancer. Methods Patients aged 65years or older locally advanced metastatic cancer were stratified randomised to infusional 5-FU, leucovorin oxaliplatin without (FLO) docetaxel 50mg/m 2 (FLOT) every 2weeks. The study is registered at ClinicalTrials.gov, identifier NCT00737373. Findings One hundred forty three (FLO, 71; FLOT, 72) a median age 70years enrolled. triple combination was associated more treatment-related National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3/4 adverse events (FLOT, 81.9%; FLO, 38.6%; P p =.011). alopecia ( =.006) nausea =.029).). No differences observed treatment duration discontinuation due toxicity, cumulative doses toxic deaths between arms. improved response rates progression-free survival subgroup 65 but not group older. Interpretation triple-drug feasible However, toxicity significantly increased QoL deteriorated relevant proportion patients. Funding partially funded by Sanofi-Aventis.