Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer.

BACKGROUND: Some trial havedemonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared to surgery alone. ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI (irinotecan plus 5-fluorouracil/folinic acid [5-FU/LV]) followed by docetaxel plus cisplatin improves disease free survival in comparison to 5-FU/LV in patients with radically resected gastric cancer. METHODS: Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m2 day one, LV 100 mg/m2 as two hour-infusion and 5-FU 400 mg/m2 as bolus, day one and day two followed by 600 mg/m2/day as 22-hour continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m2 day one, cisplatin 75 mg/m2 day one, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm). RESULTS: From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis: 562 in sequential and 538 in 5-FU/LV arm. With a median follow-up of 57.4 months, 581 patients recurred or died (297 sequential arm and 284 5FU/LV arm), and 483 died (243 and 240, respectively). No statistically significant difference was detected for both disease free (HR 1.00; 95%CI: 0.85-1.17; p=0.974) and overall survival (HR 0.98; 95%CI: 0.82-1.18; p=0.865). Five-year disease free and overall survival rates were 44.6% and 44.6%, 51.0% and 50.6% in sequential and 5FU/LV arm, respectively. CONCLUSIONS: A more intensive regimen failed to show any benefit in disease free and overall survival versus monotherapy [ClinicalTrials.gov Identifier: NCT01640782].