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A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer: First results from the CRITICS study.
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2016
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Surgical OncologyGastrointestinal OncologyMedicineCancer ManagementPhase Iii TrialGastroenterologyCritics StudyCurative TreatmentGastric Cancer ResectionNeo-adjuvant ChemotherapySurgeryGastric CancerUpper Gastrointestinal SurgeryCancer TreatmentOncologyRadiation OncologyCancer Research
4000 Background: The mainstay of potentially curative treatment of gastric cancer is radical surgical resection. Because most patients in the Western world present with advanced stages long-term survival remains poor at about 25%, with local recurrences as part of treatment failure in up to 80% of cases. Postoperative chemoradiotherapy (CRT) and perioperative chemotherapy (CT) have demonstrated a survival benefit over surgery alone. The current randomized phase III CRITICS-study (NCT00407186) investigated whether chemoradiotherapy after neo-adjuvant chemotherapy and adequate (D2) surgery leads to improved overall survival (OS) in comparison with postoperative chemotherapy. Furthermore, toxicity of both treatment regimens was explored. Methods: Patients with stage Ib-IVa resectable gastric cancer were randomized after diagnosis. Neo-adjuvant CT was prescribed in both arms and consisted of 3 courses of epirubicin, cisplatin/oxaliplatin and capecitabine (ECC/EOC). After gastric cancer resection, patients received another 3 courses of ECC/EOC or CRT (45 Gy in 25 fractions combined with weekly cisplatin and daily capecitabine). Primary endpoint is OS; secondary endpoints are: disease free survival, toxicity profile and quality of life. Results: Between January 2007 and April 2015, 788 patients from The Netherlands, Sweden and Denmark were randomized (393 CT; 395 CRT). Baseline characteristics were well balanced with 70% males and a median age of 61 years. 84% completed 3 cycles before surgery. In the CT arm 46% and in the CRT arm 55% completed treatment according to protocol. After a median follow-up of 50 months, 405 patients have died. The 5-year survival is 41.3% for CT and 40.9% for CRT (p=0.99). Toxicity was mainly hematological (grade III or higher: 44% vs 34%; p=0.01) and gastrointestinal (grade III or higher: 37% vs 42%; p=0.14) for CT and CRT, respectively. Conclusion: No significant difference in overall survival was found between postoperative chemotherapy and chemoradiotherapy. Clinical trial information: NCT00407186.