Efficacy and safety of vonoprazan-based regimen for Helicobacter pylori eradication therapy in Japanese adolescents: a prospective multicenter study.

BACKGROUND: Vonoprazan (VPZ)-based regimen for Helicobacter pylori (H. pylori) is safe and more efficacious than the proton pump inhibitor-based regimen mainly in adults. This study aimed to evaluate the efficacy and safety of a VPZ-based regimen for H. pylori eradication therapy in adolescents. METHODS: An H. pylori screening and treatment longitudinal project for third-year junior high school students in Saga Prefecture began in 2016. Students who tested positive for both urine and stool tests received a VPZ-based regimen. On the checklist, students were asked for diarrhea, fever, abdominal pain, nausea, vomiting, urticaria, dysgeusia, or bloody stool occurrence during the therapy. RESULTS: The longitudinal project for H. pylori screening and treatment among third-grade students in Saga Prefecture targeted 41,115 students from 2017 to 2021 and 836 as positive. Of the 645 students, 542 (84.0% in per protocol [PP] analysis and 73.6% in intention-to-treat [ITT] analysis) were successful in primary eradication therapy. The secondary eradication therapy was successful in 79 (96.3% in PP analysis and 76.7% in ITT analysis) of 82 students. In the primary eradication therapy, abdominal pain occurred in 164 (27.9%), diarrhea in 217 (36.9%), nausea or vomiting in 7 (1.2%), and urticaria in 13 (2.2%) students. In the secondary eradication therapy, abdominal pain occurred in 12 (19.4%) and diarrhea in 17 (27.4%) students. The eradication therapy of 5 students was interrupted due to adverse events only by primary eradication therapy. CONCLUSIONS: VPZ-based regimen for H. pylori was efficacious and safe for adolescents, as in adults, for both primary and secondary eradication therapies.

Gastrointestinal adverse reactions reduce the success rate of Helicobacter pylori eradication therapy: A multicenter prospective cohort study.

BACKGROUND: The screening and treatment of Helicobacter pylori infection for all junior high students in Saga Prefecture, Japan, were started in 2016. The present study aims to evaluate the influence of adverse reactions on the success of the eradication therapy. METHODS: From 2017 to 2019, 25,006 third-grade junior high school students were tested for urinary anti-H. pylori antibodies. Positive cases were confirmed by H. pylori stool antigen tests. Of the 531 students who were found to be H. pylori-positive, 390 (358 in first-line and 32 in second-line therapy) underwent eradication therapy, and 274 (242 in first-line and 32 in second-line) students actually completed a self-reported form to rate stool consistency (based on the Bristol Stool Scale), the maximum number of bowel movements, and abdominal symptoms during the 7 days of treatment. RESULTS: Among the 274 students, the total of primary and secondary eradication success rates was 87% (95% confidential interval: 82.9-90.1) in intention-to-treat analysis. On days 4, 5, and 6, stool consistency was looser in the primary eradication failure group than in the success group (p < .05). Looser stool consistencies were observed in male students with abdominal pain compared to those who did not experience pain (p < .05). Abdominal pain and diarrhea were detected in 28.5% and 42.7% of the subjects, respectively. The overall incidence of other adverse events was low (n = 8/274, 2.9%), and only two students discontinued treatment because of adverse events. CONCLUSIONS: Softening of the stool was related to the eradication failure in the junior high school students, especially in males with abdominal pain. Adverse effects did not induce discontinuation of the eradication treatment.

Clinical outcomes of EMR for gastric tumors: historical pilot evaluation between endoscopic submucosal dissection and conventional mucosal resection.

BACKGROUND: EMR is currently a standard treatment for mucosal gastric tumors. Endoscopic submucosal dissection (ESD) has been developed for en bloc resection. OBJECTIVE: We evaluated the clinical outcomes of ESD compared with conventional EMR. DESIGN: Not applicable. SETTING: A historical control study was performed between EMR and ESD. PATIENTS: EMR of 245 gastric tumors was performed in 229 patients. Lesions were divided into two groups. Conventional EMR was performed in group A from February 1999 to June 2001, and ESD was performed in group B from July 2001 to March 2004. Group B was divided into subgroups: subgroup B-1 underwent ESD from July 2001 to March 2003 and subgroup B-2 from April 2003 to March 2004. INTERVENTIONS: All lesions were resected with conventional EMR or with ESD. MAIN OUTCOME MEASUREMENTS: En bloc resection rate, rate in completeness of resection, required time, remnant ratio, and complications were evaluated. RESULTS: With regard to lesions >10 mm in size, the en bloc resection rate and the rate in completeness of resection of group B was significantly higher than that of group A (p < 0.01). Although the required time was longer in group B than A (p < 0.01), it was shorter in subgroup B-2 compared with B-1 (p < 0.05) with lesions < or =10 mm in size. The remnant ratio and perforation rate were not different between groups. LIMITATIONS: Not applicable. CONCLUSIONS: The en bloc resection rate was better with ESD than with conventional EMR. The required time was longer in ESD, but this disadvantage might be improved with experience.

Pepsinógenos séricos para detectar cáncer gástrico en Costa Rica / Serum pepsinogen in screening for gastric cancer in Costa Rica

Las concentraciones de pepsinógenos (PG) I y II en suero, reflejan el estado funcional y morfológico de la mucosa gástrica. En este estudio se determinaron los puntos de corte óptimos de los niveles séricos de PGI, PGII y de la razón PGI/PGII, para identificar a las personas con alto riesgo de cáncer gástrico en una población de alto riesgo en Costa Rica. La población en estudio estaba formada por 338 personas sin cáncer gástrico y por 20 pacientes con cáncer gástrico. Los niveles de PGI y el valor de PGI/PGII fueron significativamente más bajos en las personas con cáncer gástrico que en los controles. Los puntos de corte óptimos para la detección de cáncer gástrico fueron de PGI ¾ 2,5. Usando estos puntos de corte la sensibilidad y especificidad fueron de 90 y 64 por ciento. Las concentraciones bajas de PGI y valores bajos de PGI/PGII indican alto riesgo de presentar un cáncer gástrico. El tamizaje por medio de pepsinógenos es simple y relativamente barato, sin embargo el beneficio real de esta prueba debe determinarse en el impacto sobre las tasas de mortalidad por cáncer gástrico

Pepsinógenos séricos para detectar cáncer gástrico en Costa Rica / Serum pepsinogen in screening for gastric cancer in Costa Rica

Las concentraciones de pepsinógenos (PG) I y II en suero, reflejan el estado funcional y morfológico de la mucosa gástrica. En este estudio se determinaron los puntos de corte óptimos de los niveles séricos de PGI, PGII y de la razón PGI/PGII, para identificar a las personas con alto riesgo de cáncer gástrico en una población de alto riesgo en Costa Rica. La población en estudio estaba formada por 338 personas sin cáncer gástrico y por 20 pacientes con cáncer gástrico. Los niveles de PGI y el valor de PGI/PGII fueron significativamente más bajos en las personas con cáncer gástrico que en los controles. Los puntos de corte óptimos para la detección de cáncer gástrico fueron de PGI 2,5. Usando estos puntos de corte la sensibilidad y especificidad fueron de 90 y 64 por ciento. Las concentraciones bajas de PGI y valores bajos de PGI/PGII indican alto riesgo de presentar un cáncer gástrico. El tamizaje por medio de pepsinógenos es simple y relativamente barato, sin embargo el beneficio real de esta prueba debe determinarse en el impacto sobre las tasas de mortalidad por cáncer gástrico (AU)

A case of diabetic mastopathy with multiple lesions mimicking breast cancer.

We report a case of diabetic mastopathy with multiple unilateral lesions in an insulin dependent patient. The patient was a 62-year-old woman with two hard tumors in the right breast, who had been treated with insulin for diabetes mellitus. Mammography revealed a highly dense tumor in the right breast, while ultrasonography showed two irregular hypoechoic lesions with marked posterior acoustical shadowing, suggesting scirrhous carcinoma. On magnetic resonance imaging the two lesions had slightly heterogeneous enhancement. Aspiration breast cytology showed insufficient cellular material for evaluation. Excisional biopsy was performed because the patient wanted confirmation and treatment. Fibrosis with dense lymphocytic infiltration around the lobules and ducts was diagnosed histopathologically. These findings were compatible with diabetic fibrous mastopathy. Although this disease is thought to be a diabetes-induced reaction of autoimmune origin, multiple lesions are rare. This is the first case of unilateral multiple lesions of diabetic mastopathy.

Adenocarcinoid of the appendix: report of two cases.

Adenocarcinoid of the appendix is a rare tumor with the histological features of both adenocarcinoma and carcinoid tumor. However, its biological behavior and malignant potential are still unclear. We treated two patients with this unusual tumor; a 60-year-old man and a 79-year-old woman. Both patients were initially diagnosed with acute appendicitis followed by an appendectomy. At surgery, the appendix was seen to be acutely inflamed without any macroscopic signs of tumor. Postoperative histological analysis revealed an adenocarcinoid tumor in the appendix, which had spread diffusely into its wall without forming a mass. Immunohistochemical staining with p53, MIB-1, bcl-2, and carcinoembryonic antigen suggested that neither of these tumors were particularly aggressive. Adenocarcinoid of the appendix is a rare tumor, which is very difficult to diagnose preoperatively and even macroscopically, making histological examination essential.

Pylorus-preserving pancreaticoduodenectomy without homologous blood transfusion in a Jehovah's witness with pancreatic cancer: report of a case.

A case of successfully treated pancreatic cancer without homologous blood transfusion in a Jehovah's witness is reported. The patient was a 60-year-old Japanese man and he was diagnosed with pancreatic cancer. Based on the patient's informed consent, human recombinant erythropoietin (12000 IU/day), saccharated ferric oxide (60 mg/day), and 25% human serum albumin (100 mL/day) were administrated for 7 consecutive days prior to the operation. As a result, the hemoglobin level increased by 1.6 g/dL during the week, pylorus-preserving pancreaticoduodenectomy was performed on June 5, 1998. We used a technique of transfusing diluted autologous blood, hypervolemic hemodilution, and a cell-saver device for autologous transfusion during the operation. The operation took 10 hours and 35 minutes, blood loss was 600 mL, and the hemoglobin level at the end of surgery was 12.0 g/dL. He had an uneventful postoperative course, and was discharged on the 31st postoperative day. Although there have been numerous reports on surgery without homologous blood transfusion in Jehovah's witnesses, many of the cases of major surgery have involved cardiovascular procedures. However, major digestive surgery may be feasible in more Jehovah's witnesses if adequate alternative treatments and strict nutritional management are carefully implemented, as in our case.

Experience of intravenous digital subtraction angiography (IV-DSA) in evaluation of neoadjuvant chemotherapy for advanced breast cancer.

Intravenous digital subtraction angiography (IV-DSA) was performed before and after neoadjuvant chemotherapy (NACT) in five patients with locally advanced breast cancer, and the efficacy of NACT was evaluated on the basis of the results of IV-DSA and histopathological examination. Following NACT, the maximum density of tumor enhancement (MAX) in the IV-DSA image decreased by 61.6% in case 1, 50% in case 2, 58.1% in case 3, 90.8% in case 4, and 97.2% in case 5. In all five patients, the efficacy of chemotherapy was rated as a partial response in terms of tumor size, while histological efficacy was rated as slightly effective in cases 1-4 and moderately effective in case 5. The pathological efficacy of NACT was highest in case 5, which showed the greatest decrease in MAX. These results indicate that variations in MAX reflect clinical efficacy, and, to some extent, also permit prediction of pathological efficacy.

[Early phase II dose-finding study of exemestane in postmenopausal patients with advanced/recurrent breast cancer].

Exemestane was administered orally to postmenopausal women with advanced/recurrent breast cancer at a dose of 10 mg/day or 25 mg/day once daily for more than 8 weeks in order to evaluate the drug's anti-tumor effects and safety in a dose-finding study. The response rate (CR + PR) in the 10 mg and 25 mg group was 25.0% (8/32) and 31.4% (11/35), respectively, demonstrating no significant differences between the two groups, yet a higher efficacy rate was observed in 25 mg group. The efficacy rate in hormone-treatment-resistant patients within the 10 mg and 25 mg groups was 14.3% (3/21) and 26.1% (6/23), respectively, demonstrating more than a 20% response rate in 25 mg group. Incidences of the adverse events of which relevance to the drug could not be excluded were 30.6% (11/36) in the 10 mg group. 13.9% (5/36) in the 25 mg group and 22.2% (16/72) in the total group. The major adverse events were, hot flashes, numbness of the limbs, nausea, headache etc. Abnormal findings in clinical laboratory tests were as follows: ALP increase; GOT increase; GPT increase; gamma-GTP increase; total cholesterol increase; urinary sediment present. Abnormal findings in endocrine function were as follows: aldosterone decrease; testosterone.cortisol.DHEA-S decrease. But discontinuation due to abnormal laboratory findings was not found. No abnormal findings in physical tests were observed. A significant decrease in plasma estrogen concentration at week 4 was observed in both the 10 mg and 25 mg groups compared with baseline. These low levels were maintained throughout the study period. On the basis of these results, the efficacy of exemestane 25 mg/day was verified to be slightly higher than 10 mg/day. In addition the safety profile had no major adverse events to notice. In these patients with advanced/recurrent breast cancer, 25 mg/day was recommended as the most appropriate dose to be used clinically.

Monotherapy with paclitaxel as third-line chemotherapy against anthracycline-pretreated and docetaxel-refractory metastatic breast cancer.

We describe a patient with anthracycline-pretreated and docetaxel-refractory metastatic breast cancer who achieved a complete response after third-line chemotherapy with paclitaxel. A 59-year-old woman underwent modified radical mastectomy for advanced cancer in her left breast after local arterial neoadjuvant chemotherapy with anthracycline. Postoperatively anthracycline-containing adjuvant therapy was administered. Pulmonary metastases occurred 15 months after surgery, which did not respond to 4 cycles of second-line chemotherapy with docetaxel, given at 60 mg/m(2) every 3 weeks. Therefore 210 mg/m(2) of paclitaxel was given every 3 weeks as third-line monotherapy and induced a complete response with grade 3 neutropenia and hair loss as the major adverse effects. We suggest that paclitaxel is potentially effective as third-line monotherapy for anthracycline-resistant and docetaxel-refractory metastatic breast cancer.

Prevalence of Helicobacter pylori in the residual stomach after gastrectomy for gastric cancer.

BACKGROUND/AIMS: In recent years, the role of Helicobacter pylori in gastritis of the residual stomach has attracted much attention. We investigated the prevalence of Helicobacter pylori in the residual stomach after distal gastrectomy for gastric cancer, as well as the correlations between Helicobacter pylori positivity and clinical characteristics or the severity of gastritis in the residual stomach. METHODOLOGY: The subjects were 66 patients with gastric cancer who underwent distal gastrectomy with Billroth I reconstruction at our department. Helicobacter pylori was detected by the 13C-urea breath test, and patients were considered to be Helicobacter pylori-positive if the delta 13C value was > 2.5@1000. RESULTS: The overall Helicobacter pylori positivity rate of the gastrectomy patients was a high 80.3%, with the rate being especially high in patients under 60 years of age and in those tested less than 5 years after surgery. There was a close relationship between Helicobacter pylori positivity and the severity of gastritis. CONCLUSIONS: Helicobacter pylori infection appears to cause the development of gastritis. Helicobacter pylori eradication needs to be taken into consideration in the management of Helicobacter pylori-positive patients after gastrectomy.