Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study.

BACKGROUND: There has been no phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy (HEC). PATIENTS AND METHODS: Patients with a malignant solid tumor who would receive HEC containing 50 mg/m(2) or more cisplatin were randomly assigned to either palonosetron (0.75 mg) arm (Arm P) or granisetron (1 mg) arm (Arm G), on day 1, both arms with dexamethasone (12 mg on day 1 and 8 mg on days 2-4) and aprepitant (125 mg on day 1 and 80 mg on days 2-3). The primary end point was complete response (CR; no vomiting/retching and no rescue medication) at the 0-120 h period and secondary end points included complete control (CC; no vomiting/retching, no rescue medication, and no more than mild nausea) and total control (TC; no vomiting/retching, no rescue medication, and no nausea). RESULTS: Between July 2011 and June 2012, 842 patients were enrolled. Of 827 evaluable, 272 of 414 patients (65.7%) in Arm P had a CR at the 0-120 h period when compared with 244 of 413 (59.1%) in Arm G (P = 0.0539). Both arms had the same CR rate of 91.8% at the acute (0-24 h) period, while at the delayed (24-120 h) period, Arm P had a significantly higher CR rate than Arm G (67.2% versus 59.1%; P = 0.0142). In secondary end points, Arm P had significantly higher rates than Arm G at the 0-120 h period (CC rate: 63.8% versus 55.9%, P = 0.0234; TC rate: 47.6% versus 40.7%, P = 0.0369) and delayed periods (CC rate: 65.2% versus 55.9%, P = 0.0053; TC rate: 48.6% versus 41.4%, P = 0.0369). CONCLUSION: The present study did not show the superiority of palonosetron when compared with granisetron in the triplet regimen regarding the primary end point. CLINICAL TRIAL REGISTRY IDENTIFIER: UMIN000004863.

[Experience of four cases of postoperative pulmonary embolism requiring surgical treatment].

Four patients underwent a pulmonary embolectomy using cardiopulmonary bypass for acute pulmonary embolism which had occurred after various operations. In two cases, dehydration due to either diabetes insipidus or ileus had existed. In two cases, pulmonary embolism suddenly occurred in our hospital. In the remainder, the disease occurred in the previous hospitals and its diagnosis was established on the 6th and 7th postoperative days, respectively. In massive pulmonary embolism, echocardiography and/or enhanced chest CT are useful for prompt and noninvasive diagnosis. Thrombolytic therapy was performed in only one case before surgical embolectomy, which was not effective. Three patients were discharged without any postoperative complications, but one requiring preoperative external cardiac massage died of multiple organ failure 9 days after operation. Acute pulmonary embolism is one of the fatal postoperative complications. Recognition of this entity, and prompt diagnosis and treatment are essential for managing the fatal disease. Even in the early postoperative period, embolectomy using cardiopulmonary bypass is a safe and effective treatment.

[Traumatic cardiac tamponade due to the nail stabbing].

A 45-year-old man was admitted to our hospital complaining of mild chest pain. The stab wound on the chest was very small and the nail had been completely buried under the skin. Emergency operation was mandatory for cardiac tamponade by the nail stabbing. Contused right ventricular wall was repaired using Teflon felt under cardiopulmonary bypass. It was important to have a suspicion as cardiac tamponade, when the patient showed uncertain hypotension.

[An operative case of spontaneous rupture of the esophagus 10 days after the onset].

This paper presents a rare case of spontaneous rupture of the esophagus operated on 10 days subsequent to its onset. A 69-year-old male, who was diagnosed as acute pancreatitis, came to this department after 10 days of conservative therapy. Emergency examination including computed tomography, esophagoscopy and esophagography indicated spontaneous rupture of the esophagus. At operation, despite severe inflammation of the pleural cavity, a 2 cm horizontal tear at the left wall of the lower esophagus could be directly closed, and reinforced with fibrin glue. Postoperative decompression therapy prevented the rupture of the closure. The early symptoms resemble other emergency diseases, thus making correct diagnosis difficult. Early management is required for lifesaving, and preoperative aggressive exploration must thus be conducted. Postoperative management including through decompression of the gastrointestinal tract is also essential, regardless of the mode of operation.