Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report.

BACKGROUND: Adding ovarian function suppression (OFS) after chemotherapy improves survival in young women with moderate- and high-risk breast cancer. Assessment of ovarian function restoration after chemotherapy becomes critical for subsequent endocrine treatment and addressing fertility issues. PATIENTS AND METHODS: In the adding OFS after chemotherapy trial, patients who resumed ovarian function up to 2 years after chemotherapy were randomised to receive either 5 years of tamoxifen or adding 2 years of OFS with tamoxifen. Ovarian function was evaluated from enrolment to randomisation, and patients who did not randomise because of amenorrhoea for 2 years received tamoxifen and were followed up for 5 years. Prospectively collected consecutive hormone levels (proportion of patients with premenopausal follicle-stimulating hormone [FSH] levels <30 mIU/mL and oestradiol [E2] levels ≥40 pg/mL) and history of menstruation were available for 1067 patients with breast cancer. RESULTS: Over 5 years of tamoxifen treatment, 69% of patients resumed menstruation and 98% and 74% of patients satisfied predefined ovarian function restoration as per serum FSH and E2 levels, respectively. Menstruation was restored in 91% of patients younger than 35 years at baseline, but in only 33% of 45-year-old patients over 5 years. Among these patients, 41% experienced menstruation restoration within 2 years after chemotherapy and 28% slowly restored menstruation after 2-5 years. Younger age (<35 years) at baseline, anthracycline without taxanes and ≤90 days of chemotherapy were predictors of menstruation restoration. CONCLUSIONS: During 5 years of tamoxifen treatment after chemotherapy, two-thirds of the patients experienced menstruation restoration, especially patients younger than 35 years. Young age, Adriamycin without taxanes and short duration of chemotherapy appeared to have a positive effect on ovarian reserves in the long term. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00912548.

Short-term clinical outcomes for 100 consecutive cases of laparoscopic pylorus-preserving pancreatoduodenectomy: improvement with surgical experience.

BACKGROUND: Few reports describe the use of laparoscopic pylorus-preserving pancreaticoduodenectomy (LPPPD) in centers with experience using this technique. In addition, the clinical outcomes of this procedure remain undetermined. METHODS: In the current study, 100 patients with benign or malignant lesions in the pancreatic head underwent LPPPD between May 2007 and December 2011. The overall clinical outcomes and changes in these outcomes during the surgeon learning period were analyzed to assess the feasibility and safety of this procedure. RESULTS: Pathologic examination of the pancreas confirmed intraductal papillary mucinous neoplasms in 37 patients, solid pseudopapillary tumors in 17 patients, neuroendocrine tumors in 15 patients, serous cystic neoplasms in seven patients, pancreatic ductal adenocarcinomas in seven patients, ampulla of Vater tumors and duodenal gastrointestinal stromal tumors in five patients, and other disease in seven patients. The median operative time was 7.9 h, which decreased with accumulating experience of the surgeon using this procedure, from 9.8 h for the first 33 cases to 6.6 h for the last 34 cases. Complications developed in 25% of the patients, including six cases (6%) with significant pancreatic fistula [International Study Group on Pancreatic Fistula (ISGPF) grade B]. The complication rate decreased from 33.3% for the first 33 cases to 17.6% for the last 34 cases. The mean hospital stay was 14 days, which also decreased from 20.4 days for the first 33 cases to 11.5 days for the last 34 cases. For the 12 patients in the study cohort with invasive malignant disease, the median tumor size was 2.8 cm, and the median number of lymph nodes harvested was 13. All the patients had margin-negative R0 resections. CONCLUSION: The LPPPD procedure is technically safe and feasible, with an acceptable rate of morbidity and other clinical outcomes for benign and malignant diseases. Clinical outcomes can be improved once a learning curve has been overcome.

Effects of nitrate or nitro supplementation, with or without added chlorate, on Salmonella enterica serovar Typhimurium and Escherichia coli in swine feces.

The effects of coincubating the active agent of an experimental chlorate product with nitrate or select nitro compounds, possible inducers and competing substrates for the targeted respiratory nitrate reductase, on concentrations of experimentally inoculated Salmonella enterica serovar Typhimurium and indigenous Escherichia coli were determined. Studies were completed in swine fecal suspensions as a prelude to the administration of these inhibitors to pigs. Results confirmed the bactericidal effect of chlorate (5 to 10 mM) against these fecal enterobacteria, reducing (P < 0.05) concentrations by > 2 log CFU ml(-1) after 3 to 6 h of incubation. An effect (P < 0.05) of pH was observed, with considerable regrowth of Salmonella and E. coli occurring after 24 h of incubation in suspensions buffered to pH 7.1 but not in suspensions buffered to pH 6.5 or 5.6. A 24-h coincubation of fecal suspensions with 5 to 10 mM chlorate and as little as 2.5 mM nitrate or 10 to 20 mM 2-nitro-1-propanol, 2-nitroethanol, and, sometimes, nitroethane decreased (P < 0.05) Salmonella but not necessarily E. coli concentrations. 2-Nitro-1-propanol and 2-nitroethanol exhibited inhibitory activity against Salmonella and E. coli by an undetermined mechanism, even in the absence of added chlorate.