Population-based study of biochemical and survival outcomes after permanent 125I brachytherapy for low- and intermediate-risk prostate cancer.

OBJECTIVES: To analyze the biochemical and survival outcomes after permanent low-dose-rate prostate brachytherapy in a large, consecutive, population-based cohort of patients. METHODS: A total of 1006 consecutive implants were performed from July 20, 1998 to October 23, 2003 for men with low-risk and "low-tier" intermediate-risk prostate cancer. The prescribed minimal peripheral dose was 144 Gy, using 0.33 mCi (125)I sources and a preplan technique with a strong posterior-peripheral dose bias. Most patients (65%) had received 6 months of androgen deprivation therapy. Supplemental external beam radiotherapy was not used. The prognostic features, dose metrics, and follow-up data were prospectively collected. Kaplan-Meier and Cox regression analyses were used to assess the factors associated with freedom from biochemical recurrence and survival. RESULTS: The median patient age at treatment was 66 years. The median follow-up was 54 months for biochemical outcomes and 66 months for survival. The actuarial freedom from biochemical recurrence rate was 95.6% +/- 1.6% at 5 years and 94.0% +/- 2.2% at 7 years. On multivariate analysis, the pretreatment prostate-specific antigen level (P = .03) and androgen deprivation therapy use (P = .04) were predictive of the freedom from biochemical recurrence. The actuarial rates of distant metastasis and disease-specific death at 5 years were both <1%. The overall survival rate at 5 years was 95.2% +/- 1.4% and was 93.4% +/- 1.8% at 7 years. On multivariate analysis, only age was predictive of overall survival (P = .011). CONCLUSIONS: When consistently planned and delivered, low-dose-rate brachytherapy, without supplemental external beam radiotherapy or intraoperative planning, can produce cancer-specific outcomes for men with low- and "low-tier" intermediate-risk prostate cancer at least equal to that produced by dose-escalated external beam radiotherapy or surgical prostatectomy.

Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system.

PURPOSE: Mucositis occurs in almost all patients treated with radiotherapy for head and neck cancer. The aim of this multicenter, double-blind, prospective, randomized trial was to evaluate the clinical efficacy of an economically viable antimicrobial lozenge (bacitracin, clotrimazole, and gentamicin [BcoG]) in the alleviation of radiation-induced mucositis in patients with head and neck cancer. PATIENTS AND METHODS: One hundred thirty-seven eligible patients were randomized to treatment with either antimicrobial lozenge (69 patients) or placebo lozenge (68 patients). The primary end point of the study was the time to development of severe mucositis from the start of radiotherapy. Secondary end points included severity and duration of mucositis, pain measurement, radiation therapy interruption, and quality of life. Mucositis was scored using a validated mucositis scoring system. RESULTS: Toxicity profiles were similar between the two arms of the study. The median time to development of severe mucositis from the start of radiotherapy was 3.61 weeks on BCoG and 3.96 weeks on placebo (P =.61). There were no statistically significant differences between the arms in the extent of severe mucositis as measured by physician, in oral toxicities as recorded by patients, or in radiotherapy delays. CONCLUSION: This study was conducted on the basis of a pilot study that demonstrated the BCoG lozenge to be tolerable and microbiologically efficacious. A validated mucositis scoring system was used. However, in this group of patients treated with conventional radiotherapy, the lozenge did not impact significantly on the severity of mucositis. Whether such a lozenge would be beneficial in treatment situations where rate of severe mucositis is higher (ie, in patients treated with unconventional fractionation or with concomitant chemotherapy) is unknown.