We aimed to assess the ability of (18)F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scan to predict pathologic complete response (CR) and survival in patients with oesophageal cancer ...treated with preoperative chemoradiotherapy (CRT). The study cohort consisted of 62 consecutive patients with operable oesophageal cancer who were treated with preoperative CRT followed by oesophagectomy. Endoscopy, computed tomography (CT) and PET were performed before and after CRT. Of the 62 patients, 56 (90%) patients responded to preoperative CRT. FDG-PET-determined complete metabolic response (CMR) was achieved by 33 patients (54.1%), whereas pathologic CR was achieved by 28 patients (45.2%). Compared with endoscopic biopsy or CT scan, CMR by FDG-PET showed the highest correlation with pathologic CR (concordance, 71%). At a median follow-up of 19.3 months (range, 3.9-57.1 months), median overall survival (OS) was not reached in patients with CMR compared to 22.4 months in patients who did not achieve CMR. Median disease free survival (DFS) was not reached in patients with CMR compared to 17.4 months in patients who did not achieve CMR. By multivariate analysis, CMR by FDG-PET was significantly associated with better DFS and OS (P=0.006, P=0.033, respectively). The variables associated with pre-CRT PET scan were not predictive of survival. In conclusion, CMR by FDG-PET has a significant correlation with pathologic CR and can predict the long-term outcome in oesophageal cancer patients undergoing CRT. Although surgery is standard treatment for respectable oesophageal cancer, currently even in patients with CMR, the addition of (18)F-FDG-PET could be used to select the patient subgroup not requiring surgery.
Background/Aims
S-isomer (S) pantoprazole is more bioavailable and less dependent on cytochrome 2C19 than is racemic pantoprazole. We aim to evaluate the efficacy and safety of 10 mg S-pantoprazole ...for treatment of non-erosive reflux disease (NERD).
Methods
In this phase 3, double-blind, randomized placebo controlled, multicenter study, 174 NERD patients were randomized to one of both treatment groups: 10 mg S-pantoprazole, or placebo once daily for 4 weeks. Symptoms and safety were assessed. The efficacy endpoints were complete relief of symptoms, > 50% improvement of all reflux symptoms and recurrence.
Results
Eighty-eight patients were assigned to the S-pantoprazole group (25 males, mean 43.7 years old) and 86 to the placebo group (32 males, mean 43.0 years old), and 163 patients were subjected to full Analysis Set. A higher proportion of patients in the S-pantoprazole group had complete symptom relief (42.0 % 34/81 vs 17.1% 14/82, P < 0.001) and > 50% symptom responses (66.0% vs 50.0%, P = 0.010 for heartburn; 64.2% vs 28.0%, P = 0.010 for acid regurgitation; and 51.9% vs 30.5%, P = 0.03 for epigastric discomfort) compared to the placebo group. The factors associated with poor responsiveness to PPI were older age, female, greater body mass index, and severe baseline symptoms.
Conclusions
Low dose of S-pantoprazole (10 mg) for 4 weeks was more efficacious than placebo in providing reflux symptom relief in patients with NERD, especially acid regurgitation. More doses or longer periods of treatment with S-pantoprazole would be needed to completely eliminate symptoms.
(J Neurogastroenterol Motil 2021;27:223-230)
