BACKGROUNDNo adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer. METHODSWe conducted CheckMate 577, a global, randomized, double-blind, placebo-controlled phase 3 trial to evaluate a checkpoint inhibitor as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer. Adults with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease were randomly assigned in a 2:1 ratio to receive nivolumab (at a dose of 240 mg every 2 weeks for 16 weeks, followed by nivolumab at a dose of 480 mg every 4 weeks) or matching placebo. The maximum duration of the trial intervention period was 1 year. The primary end point was disease-free survival. RESULTSThe median follow-up was 24.4 months. Among the 532 patients who received nivolumab, the median disease-free survival was 22.4 months (95% confidence interval [CI], 16.6 to 34.0), as compared with 11.0 months (95% CI, 8.3 to 14.3) among the 262 patients who received placebo (hazard ratio for disease recurrence or death, 0.69; 96.4% CI, 0.56 to 0.86; P<0.001). Disease-free survival favored nivolumab across multiple prespecified subgroups. Grade 3 or 4 adverse events that were considered by the investigators to be related to the active drug or placebo occurred in 71 of 532 patients (13%) in the nivolumab group and 15 of 260 patients (6%) in the placebo group. The trial regimen was discontinued because of adverse events related to the active drug or placebo in 9% of the patients in the nivolumab group and 3% of those in the placebo group. CONCLUSIONSAmong patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, disease-free survival was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 577 ClinicalTrials.gov number, NCT02743494.
Introduction Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) are the two most frequently performed bariatric operations. These two types of metabolic surgery alter the anatomy and function of digestive tract producing significant weight loss in morbidly obese patients but may lead to malnutrition. Aim Analysis of incidence and severity of malnutrition after bariatric surgery in patients submitted to RYGB or LSG during 12 months of follow-up. Material and Methods Retrospective study of 98 patients after RYGB (n = 47) or LSG (n = 51) assessed for nutritional deficiencies during 12 months after surgery was conducted. The differences in body mass index (BMI) and blood tests including erythrocytes, haemoglobin, total protein, albumin, iron, ferritin, transferrin, vitamin B12, folic acid, calcium and phosphorus concentrations were compared between groups before the operations and at 1 and 12 months. Results Nutritional deficiencies were common before surgery with prevalence up to 19.6% for albumin in the LSG group. Median preoperative BMI levels and albumin concentrations were higher in the RYGB group compared to the LSG group, but there was no difference in percent excess weight loss (%EWL) at 1 and 12 months between LSG and RYGB. One month after LSG erythrocyte count, haemoglobin, iron, ferritin and transferrin levels were significantly higher than in the RYGB group. These differences subsided at 12 months. At 12 months, only the prevalence of vitamin B 12 deficiency was significantly higher in the RYGB group. Conclusion Both RYGB and LSG lead to nutritional deficiencies despite different properties of operations and similar %EWL during follow-up.
Nonsuction drainage is more effective than suction drainage with regard to drainage volume, drainage duration, and incidence of persistent air leakage. However, it is associated with a higher incidence of asymptomatic residual air spaces.
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