In the latter case, only 10% of the patients survive longer than 2 years. Systemic chemotherapy is recommended for patients with stage II or III disease as neoadjuvant or perioperative treatment and for patients with stage IV as a single-modality treatment. Gastric cancer is often diagnosed in locally advanced or metastatic stage and, therefore, has a poor prognosis.
Trial Registration identifier: NCT00849615 The AIO-FLOT3 trial provides a rationale for further randomized clinical trials. The median overall survival was 31.3 months (95% CI, 18.9-upper level not achieved) for patients who proceeded to surgery and 15.9 months (95% CI, 7.1-22.9) for the other patients.Ĭonclusions and Relevance Patients with limited metastatic disease who received neoadjuvant chemotherapy and proceeded to surgery showed a favorable survival. In arm B, 36 of 60 patients (60%) proceeded to surgery. The response rate for arm B was 60% (complete, 10% partial, 50%), which is higher than the 43.3% for arm C. Patients in arm B (n = 60) had only retroperitoneal lymph node involvement (27 patients ), liver involvement (11 ), lung involvement (10 ), localized peritoneal involvement (4 ), or other (8 ) incurable sites. Results In total, 238 of 252 patients (94.4%) were eligible to participate. Main Outcomes and Measures The primary end point was overall survival. Patients received a median (range) of 8 (1-15) cycles of FLOT.
Patients in arm C were offered FLOT chemotherapy and surgery only if required for palliation. Patients in arm B received at least 4 cycles of neoadjuvant FLOT and proceeded to surgical resection if restaging (using computed tomography and magnetic resonance imaging) showed a chance of margin-free (R0) resection of the primary tumor and at least a macroscopic complete resection of the metastatic lesions. Interventions Patients in arm A received 4 preoperative cycles of fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) followed by surgery and 4 postoperative cycles. Data cutoff was January 2012, and the analysis was performed in March 2013. Patients were enrolled from 52 cancer care centers in Germany between February 1, 2009, and January 31, 2010, and stratified to 1 of 3 groups: resectable (arm A), limited metastatic (arm B), or extensive metastatic (arm C). Objective To evaluate outcome in patients with limited metastatic disease who receive chemotherapy first and proceed to surgical resection.ĭesign, Setting, and Participants The AIO-FLOT3 (Arbeitsgemeinschaft Internistische Onkologie–fluorouracil, leucovorin, oxaliplatin, and docetaxel) trial is a prospective, phase 2 trial of 252 patients with resectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Importance Surgical resection has a potential benefit for patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.
Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.