Acute mesenteric ischemia is a rare but serious complication of open heart surgery. Between January 2009 and January 2012, 1360 adult patients underwent open heart surgery with cardiopulmonary bypass at our institution; 29 patients presented gastrointestinal complications. Eight patients developed acute mesenteric ischemia and all of them died. Significant predictors of the complication were New York Heart Association functional class III/IV, history of extensive atherosclerosis and chronic renal failure, acute renal failure following surgery, low cardiac output, use of 2 or more vasoconstrictor drugs, prolonged mechanical ventilation, and multiorgan failure. Atherosclerosis is a multisystemic disease that affects several organs. Radiologic evaluation of mesenteric arterial system should be performed in high-risk patient populations. Perioperative percutaneous and open vascular procedures will reduce the risk of acute mesenteric ischemia that may develop after cardiac surgery and consequent morbidity and mortality rates.
Open surgery in acute type B dissections yielded excellent immediate and long-term durability in our series with no false lumen patency or aortic expansion. However, incorporation of both false and true lumina into distal anastomosis in patients with chronic dissection resulted in false lumen patency with aortic expansion.
TPS182 Background: Trastuzumab in combination with chemotherapy has been shown to prolong survival of HER2+ esophago-gastric cancer patients. The primary aim of our study was to evaluate safety and tolerability of trastuzumab (T) in combination with oxaliplatine (O), capecitabine (C) and radiation (R) therapy in the adjuvant setting in curatively resected esophago-gastric cancer patients. Methods: Forty patients with IB or higher stages was planned to be recruited and here we report the interim analyses on 22. We would consider the study positive if at least 64.4% of patients could tolerate the therapy. Eligible patients received T 8 mg/kg intravenously (iv) on Day 1 of cycle 1 and 6 mg/kg iv on day 1 of every following 3-weekly cycle for 1 year as 17 cycles, with O 100 mg/m2 iv on Day 1 of cycles 1-3 and C 850 mg/m2 orally twice daily on days 1-14 of cycles 1-3 and on 5 days per week during chemo-radiotherapy. R was given at a total dose of 45 Gy divided into 25 doses on 5 treatment days per week for 5 weeks starting from the 1st day of cycle 4. Results The median age was 57.5 years (Min-Max: 35-74). Of 22 patients; 15 were male (68.2%), 21 (95.5%) had an ECOG PS score ≤ 1, 21 (95.5%) had D2 lymph node resection. There were 11 serious adverse events. Two patients died on therapy; 1 secondary to pulmonary thrombo-emboli, and the other had to cerebral ischemia (thought to be due to Behçet’s disease), and 7 died of progression. There were 6 dose reductions (1 for T, 2 for O and 3 for C), T was stopped in 1 patient, C was interrupted 8 times (mostly during radiotherapy). Patients who have completed 3 cycles of O, C, T and 4th and 5th cycles of chemo-radiation therapy with C and T were defined as tolerable. Out of 22 patients, 19 (86.4%) were tolerable (Chi Square test: p = 0.0623). Median survival time for interim analysis patients (n = 22) was 22 months (95% CI: 11-23 months). Conclusion T in combination with O, C and chemo-radiation with C and T was tolerable with the tolerability rate of 86.4%, in curatively resected HER2 + esophago-gastric cancer adjuvant treatment. Clinical trial information: NCT01748773.
This study showed that in general there is sufficiently good agreement between the reference laboratory and the participating centers for immunohistochemical HER2 assessment.
26 Background: We evaluated the safety and tolerability of trastuzumab (T) in combination with oxaliplatin (O), capecitabine (C) and chemo-radiotherapy in the adjuvant setting in operated, HER-2 positive gastric or gastroesophageal junction adenocarcinoma patients. Methods: We have screened 212 and enrolled 34 patients who were curatively resected (R0, R1 with partial or total gastrectomy, with D2 lymph node dissection) and were HER2-positive (IHC 2+/FISH+ or IHC 3+). The primary objectives were safety and tolerability of the treatment combination and secondary objectives were disease-free and overall survival rates. Patients received T 8 mg/kg intravenously (iv) on Day 1 of cycle 1 and 6 mg/kg iv on day 1 of every following 3-weekly cycle for 1 year as 17 cycles, O 100 mg/m2 iv on Day 1 of cycles 1-3 and C 850 mg/m2 orally twice daily on days 1-14 of cycles 1-3 and 5 days per week during chemo-radiotherapy. Radiotherapy was given at a total dose of 45 Gy divided into 25 doses 5 treatment days per week for 5 weeks starting from the 1st day of cycle 4. Results: The median age was 57 years and 73.5% were male, 97.0% had an ECOG PS score ≤ 1,33, 97.0% had D2 lymph node resection. Staging was 3A or higher at the time of diagnosis in 76.4% of patients. Patients had high rate of tolerability to the combination regimen (90.3%) and successfully completed 3 cycles of O+C+T plus chemoradiotherapy followed by continuation with T, achieving the primary goal of the study by showing a better tolerability rate as compared to tolerability reported for INT0116 study (p = 0.0068). After 25 months of follow-up confirmed through a telephone visit, 59.8% patients were still alive and median overall survival was not yet reached. Twelve patients died secondary to disease progression. There were no deaths due to toxicity and 6 dose reductions overall (1 for T, 2 for O and 3 for C). T was stopped in one patient; C was temporarily interrupted 11 times (mostly during radiotherapy) and stopped in 1 patient. Conclusions: T in combination with C, O and radiotherapy in the adjuvant setting for gastric or gastroesophageal junction adenocarcinoma seems safe and tolerable. Clinical trial information: NCT01748773.
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