A Phase II trial of 8 weeks of degarelix for prostate volume reduction: Efficacy and hormonal recovery.

PURPOSE: The purpose of this study was to determine the efficacy of 8 weeks of degarelix for prostate downsizing before interstitial brachytherapy. We also report associated toxicity and the time course of endocrine recovery over the following 12 months. METHODS AND MATERIALS: Fifty patients were accrued to an open-label Phase II clinical trial (www.clinicaltrials.gov ID NCT01446991). Baseline prostate transrectal ultrasound (TRUS) was performed on all patients followed by degarelix administration and a repeat TRUS at Week 8. Brachytherapy was performed within 4 weeks of the 8-week TRUS for all patients who achieved suitable downsizing. RESULTS: The median prostate volume was reduced from 65.0 cc (interquartile range [IQR]: 55.2-80.0 cc) to 48.2 cc at 8 weeks (IQR: 41.2-59.3 cc), representing a median decrease of 26.2% (IQR: 21-31%). Functional recovery of testosterone within an age-adjusted normal range occurred at a median of 34.1 weeks (IQR: 28.2-44.5 weeks) from the date of the final injection. Despite this recovery, follicle-stimulating hormone and luteinizing hormone levels remained abnormally elevated throughout 12 months. Quality-of-life implications are discussed. CONCLUSIONS: Degarelix is effective for prostate downsizing before prostate brachytherapy with a median volume decrease of 26.2% by 8 weeks. Despite the short course of treatment and eventual testosterone recovery, follicle-stimulating hormone and luteinizing hormone remain elevated beyond 12 months. Further investigation with randomized comparisons to other hormonal agents is warranted.

The Effect of Waiting Times for Postoperative Radiotherapy on Outcomes for Women Receiving Partial Mastectomy for Breast Cancer: a Systematic Review and Meta-Analysis.

AIMS: To determine the effect of delay in postoperative radiotherapy on local recurrence and overall survival in women receiving partial mastectomy for breast cancer. MATERIALS AND METHODS: This was a systematic review and meta-analysis of published literature. Relevant reports were identified from MEDLINE, EMBASE and the Cochrane Register of Controlled Trials in all languages from 1975 to April 2015, in addition to the abstracts from the annual meetings of major radiotherapy conferences from 2000 to 2011. Reference lists were hand searched to find additional relevant reports and OvidSP's 'Find Citing' function was used to find studies citing papers identified in the primary search. Studies were included if they met the following criteria: (i) all patients received partial mastectomy and radiotherapy, (ii) a delay from surgery to radiotherapy was reported and (iii) one or more of local control/failure and/or survival were reported. Observational studies and randomised controlled trials were included. Studies including patients with in situ disease were excluded. Studies were classified as high quality if they adequately controlled for factors known to be associated with the outcomes of interest. Study quality was independently assessed by three authors. Initial disagreements about three studies were resolved by consensus. Only high-quality studies were included in the primary analysis. Delay was modelled as a continuous variable and the relative risk of local recurrence and the relative risk of death are reported per month of delay. The study results were combined using a fixed-effects model. RESULTS: Thirty-four relevant publications including 79 616 patients were identified in the systematic review. Ten high-quality publications reported on local recurrence (13 291 patients) and four high-quality studies reported on overall survival (2207 patients). The relative risk of local recurrence per month of delay was 1.08 (95% confidence interval 1.02-1.14). The relative risk of death per month of delay was 0.99 (95% confidence interval 0.94-1.05). CONCLUSIONS: Delays in post-lumpectomy radiotherapy are associated with a significant increase in the risk of local recurrence. We recommend that waiting times for radiotherapy should be kept as short as reasonably achievable.

Tryptic soy bile-kanamycin test for the indentification of Bacteroides fragilis.

A simple and practical test for the identification of Bacteroides fragilis is described. It utilizes two well-known properties of this species, i.e., stimulation of growth by bile and resistance to kanamycin. The test media are a tryptic-soy bile agar plate and a supplemented blood agar plate on which a kanamycin 1,000-mug/ml disk is placed. Incubation is for 24 h at 37 C in GasPak. The results of screening 190 strains, mostly clinical isolates, indicate that B. fragilis can be easily and reliably distinguished from other Bacteroides and from Fusobacterium species by its growth on tryptic-soy bile agar and resistance to kanamycin.