Preoperative cisplatin, fluorouracil, and docetaxel with or without radiotherapy after poor early response to cisplatin and fluorouracil for resectable oesophageal adenocarcinoma (AGITG DOCTOR): results from a multicentre, randomised controlled phase II trial

摘要: Background Patients with oesophageal/gastro-oesophageal junction adenocarcinoma (EAC) not showing early metabolic response (EMR) to chemotherapy have poorer survival and histological rates methods resectable EAC were enrolled randomised into two single-arm, multicentre phase II trials. After induction cisplatin 5-fluorouracil (CF), all assessed by day 15 positron emission tomography (PET). an EMR [maximum standardised uptake values (SUVmax) ≥35% reduction from baseline PET] received a second CF cycle then oesophagectomy. Non-responders 1 : cycles of docetaxel (DCF, n = 31) or DCF + 45 Gy radiotherapy (DCFRT, 35) The primary end point was major ( Results Of 124 patients recruited, achieved in 3/45 (7%) EMR, 6/30 (20%) DCF, 22/35 (63%) DCFRT patients. Grade 3/4 toxicities occurred 12/45 (27%) 13/31 (42%) 25/35 (71%) No treatment-related deaths occurred. LR 3 years seen 5/45 (11%) 10/31 (32%) 4/35 PFS [95% confidence interval (CI)] at 36 months 47% (31% 61%) for 29% (15% 45%) 46% (29% OS (95% CI) 60 53% (37% 67%) 31% (16% 48%) Conclusions is associated favourable OS, PFS, low LR. For non-responders, the addition augmented rates, but remained inferior compared responders. improved PFS/LR outcomes, matching group. Early PET/CT has potential tailor therapy chemotherapy. Trial registration ACTRN12609000665235.