Phase III trial of doxorubicin plus cyclophosphamide (AC), docetaxel, and alternating AC and docetaxel as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802).

BACKGROUND: This randomized, multicenter, phase III trial compared doxorubicin plus cyclophosphamide (AC), single-agent docetaxel (D), and an alternating regimen of AC and docetaxel (AC-D) as first-line chemotherapy in metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients with MBC resistant to endocrine therapy were entered in a randomized study to receive either six cycles of AC (doxorubicin 40 mg/m2 plus cyclophosphamide 500 mg/m2), D (60 mg/m2), or alternating treatment with AC-D (i.e. three cycles of AC and three cycles of D). Treatment was administered every 3 weeks. RESULTS: A total of 441 patients were entered in a randomized study. Response rates were 30% for AC, 41% for D, and 35% for AC-D. The median times to treatment failure (TTFs) were 6.4, 6.4, and 6.7 months (one-sided log-rank test, P = 0.13 for AC versus D, P = 0.14 for AC versus AC-D) and median overall survival (OS) was 22.6, 25.7, and 25.0 months (P = 0.09 for AC versus D, P = 0.13 for AC versus AC-D) in the AC, D, and AC-D, respectively. CONCLUSION: There was no difference in the TTF among the three arms. However, there was a trend toward a better response and better OS in the D than in the AC.

Palliative effect of lafutidine on oral burning sensation.

UNLABELLED: Lafutidine is a unique histamine H(2)-receptor antagonist (H2RA) that has a sensitizing effect on capsaicin-sensitive afferent neurons (CSAN). This effect may make lafutidine useful for the treatment of burning mouth syndrome (BMS). METHODS: To evaluate the efficacy and safety of lafutidine in patients with oral burning sensation, a randomized controlled trial was performed. Patients who had been receiving other H2RAs with no sensitizing effect on CSAN were randomly assigned to receive lafutidine 10 mg twice daily for 12 weeks, instead of the previous H2RAs, plus gargling with azulene sulfonate sodium (ASS) (lafutidine group, n = 36) or to continue to receive the previous H2RAs plus ASS gargling (control group, n = 35). The intensity of burning sensation was scored by means of a visual analog scale (VAS). RESULTS: Thirty-four patients in the lafutidine group and 30 in the control group completed the study. In the lafutidine group, the rate of improvement in the VAS score as compared with the baseline value was significant after 4, 8, and 12 weeks of treatment (P < 0.05). The improvement rate was consistently higher in the lafutidine group than in the control group; the differences between the groups were significant (P < 0.05) after 4, 8, and 12 weeks of treatment. Only two mild abdominal adverse events occurred in the lafutidine group, but neither required the termination of treatment. CONCLUSION: Oral lafutidine is very safe and effective for reducing the intensity of oral burning sensation and may therefore be a viable option for the treatment of BMS.

Atlas hypoplasia as a cause of high cervical myelopathy. Case report.

A high cervical myelopathy due to atlas hypoplasia is described in a 56-year-old man; the condition caused marked segmental compression of the spinal cord. A remarkable neurological recovery followed decompressive laminectomy of the atlas and adjacent regions. The authors discuss the embryology and etiology of this anomaly.

Early and long-term results of coronary artery bypass grafting in dialysis patients.

OBJECTIVE: We evaluated the surgical outcome of coronary artery bypass grafting in dialysis patients. METHODS: We retrospectively analyzed 25 consecutive dialysis patients requiring isolated coronary artery bypass grafting. Their mean age was 61.6 years and average dialysis duration 80.4 months. RESULTS: Eight patients (32%) had emergency or urgent surgery. The mean number of bypassed vessels was 3.3 +/- 1.2. Internal thoracic artery grafts were used in 19 patients and gastroepiploic artery grafts in 5. Two (8%) died during hospitalization and complications occurred in 11 (44%). No cerebral complications were observed. All survivors showed ameliorated symptoms and improved overall function. Of 14 late deaths, 5 were cardiac-related, with 2 involving obvious myocardial ischemic events. Actuarial survival, including hospital deaths, at 1 year was 70.9%, at 3 years was 43.5%, and at 5 years was 34.8%. Cardiac-death-free survival was 70.2% at 3 years and 70.2% at 5 years. CONCLUSION: Coronary artery bypass grafting in dialysis patients is associated with a higher incidence of complications but has acceptable surgical mortality and effectively relieves angina symptoms.

[Proximal ligation of the vertebral artery for treatment of vertebral aneurysms].

Vertebral aneurysms are not necessarily rare. In general neck clipping of vertebral aneurysms is the surest method for treatment of aneurysms, but as for vertebral aneurysms, it is often difficult to clip the neck without danger, because they cross over lower cranial nerves and are often fusiform. The indication of proximal ligation of the vertebral artery for treatment of vertebral aneurysms has not yet established. This procedure in 28 cases in the literature and our 3 cases treated successfully was discussed and following results were obtained. 1) Proximal ligation of the vertebral artery was useful for prevention of a rupture of vertebral aneurysms. 2) Intracranial ligation of the vertebral artery was better than the ligation in the cervical region. 3) It was necessary for the diameter of the contralateral vertebral artery to be, at least, approximately same. 4) In order the diameter of the vertebral artery to enlarge to 1.2 times as wide as that of a preoperative state, and the blood flow in the basilar artery to be enough, it was necessary for the contralateral vertebral artery not to be sclerotic.

[Operative results of composite aortic root replacement by a Svensson's method].

The results of reconstruction of the aortic root performed on 9 patients by Svensson's method were examined. Nine subjects comprised 6 men and 3 women aged 23-69 years. In the preoperative diagnosis, annulo-aortic ectasia (AAE) was found in 7 cases, acute Type A aortic dissection in 1 case and AAE accompanied by chronic dissection after AVR in 1 case. Every patient underwent reconstruction by direct implantation of the right coronary artery button and interposition grafting for the left coronary artery, using a composite valve graft made of SJM valve and collagen coating artificial graft. Although one patient was lost due to multiple cerebral infarction, no marked changes were observed in other 8 patients. Angiography at short-term after operation showed no problems in the composite valve graft, and revealed good coronary arterial flow. Now, 2-62 months after operation (41 months on average), no late death occurred. On angiography of 2 cases performed after a long-term period, patency of the interposition graft was excellent. The early and late results of aortic root reconstruction by Svensson's method appeared favorable.

[A case of tricuspid infective endocarditis in a drug addict].

This report describes a successful operative case of tricuspid infective endocarditis in a drug addict. A 24-year-old man with a history of drug addiction (6 months) complained of general fatigue and high fever. Echocardiography showed a large vegetation attached to the tricuspid valve and severe tricuspid regurgitation. Blood cultures revealed septicemia due to methicillin sensitive Staphylococcus aureus. He was treated for about 1 week with intravenous antibiotics. However, subsequent severe heart failure necessitated emergency operation. The tricuspid valve was replaced with Carpentier-Edwards bioprosthesis because of severe destruction of the tricuspid valve. The postoperative course was uneventful and he has remained free from endocarditis for 15 months after surgery.

[Three cases of hyperkalemia after reperfusion associated with revascularization for massive acute arterial occlusions].

We encountered three cases of hyperkalemia after the reperfusion of ischemic limbs associated with revascularization surgery for acute arterial occlusions. Two patients died because of uncontrollable hyperkalemia in spite of intravenous insulin and forced diuresis. Careful attention should be paid to hyperkalemia and metabolic acidosis for several hours after the reperfusion in cases of ischemia and/or extensive ischemia of long duration. The aggressive prophylaxis and treatment for MNMS are vital to the anesthetic management of revascularization for acute arterial occlusions.

[Preventive effects of intra-arterial infusion chemotherapy of liver metastasis in non-resectable pancreatic cancer].

This is a study which evaluates intra-arterial chemotherapy for non-resectable carcinoma of the pancreas without liver metastasis (locally advanced). Twenty-one patients received ia-chemotherapy (MA-CP: Methotrexate + Angiotensin II----Citrovorum factor + Prostaglandin E1). They showed a 39% 1-year survival rate and 92% of 1-year cumulative rate of survival without liver metastasis. These incidences were significantly higher than those of (13%, 50%) 52 patients who underwent systemic chemotherapy (control). As the reason for such significant differences, we suspected that a high dose of chemotherapeutic view after MTX had been infused into the pancreatic-supplying arteries. This speculation was confirmed by the serial determination of the MTX concentration in the portal blood.

Comparative study of protected environment for children with malignant disease.

Thirty-three children with malignancy were investigated to evaluate the effect of reverse isolation with or without decontamination on prevention of infection. They were allocated to three groups: Group A, isolation in a laminar air flow room plus oral nonabsorbable antibiotics and sterile food; group B, isolation in a vertical air flow room without decontamination; group C, isolation in a conventional private room. Infectious episodes were the fewest and the rate of response to cancer chemotherapy was the highest in group A. Pyrexial days (greater than 38 degrees C) and days on systemic antibiotics were significantly fewer in groups A and B. Episodes of infection were also significantly fewer in group A but not in group B, as compared with group C. The usefulness and the necessity of a laminar air flow room as well as a vertical air flow room for management of childhood cancer were demonstrated.

Aortocoronary saphenous vein graft aneurysm in redo coronary artery bypass grafting: report of a case.

We report herein the case of an 80-year-old woman who underwent successful redo coronary artery bypass grafting (CABG) for a saphenous vein graft aneurysm found 10 years after her initial operation. On presentation, coronary angiography (CAG) revealed aneurysmal dilatation of the saphenous vein graft and severe stenosis of the left main trunk (LMT). A percutaneous transluminal coronary angioplasty (PTCA) of the LMT lesion was performed; however, a CAG after the PTCA revealed restenosis and the patient developed anginal chest pain at rest. Thus, repeat CABG was urgently carried out, which was followed by a good outcome. Histological examination of the aneurysmal dilatation showed a true aneurysm. Only 15 other cases of redo CABG for this indication have been reported, the features of which are also discussed.

Clinical features of vesicoureteral reflux in infants and outcome of conservative therapeutic approach.

OBJECTIVES: We evaluated the clinical features of vesicoureteral reflux (VUR) detected in infants and the outcome of a conservative therapeutic approach. METHODS: Consecutively 67 infants with VUR (55 boys and 12 girls) were enrolled in this study. Of the 67 patients, 34 had primary and 33 had secondary VUR. Underlying abnormalities in secondary VUR were: posterior urethral valve (PUV) in 7; bulbar urethral stenosis (Cobb's collar) in 16; neurovesical dysfunction (NVD) in 8, and others in 2. Transurethral incision was performed in patients with PUV or Cobb's collar. NVD was managed with intermittent catheterization. All patients were followed with antibiotic prophylaxis. RESULTS: No significant difference was found in VUR grades between primary and secondary VUR. Spontaneous resolution of VUR was noted in 31% of primary and 54% of secondary VUR (p<0.02). VUR downgrading including VUR resolution was also noted more often in secondary than in primary VUR (80 vs. 48%; p<0.01). CONCLUSIONS: The distribution of primary and secondary VUR in infants was almost equal in our study. Resolution of reflux is seen more often in secondary than in primary cases. Thus, early detection and proper management of underlying lower urinary tract abnormalities, either structural or functional, are crucial in the treatment of VUR in infants.