This trial was unable to adequately test the ability of beta-hydroxy beta-methylbutyrate, glutamine, and arginine to reverse or prevent lean body mass wasting among cancer patients. Possible contributing factors beyond the efficacy of the intervention were the inability of patients to complete an 8-week course of treatment and return in a timely fashion for follow-up assessment, and because the patients may have only had weight loss possible not related to cachexia, but other causes of weight loss, such as decreased appetite. However, there was a strong trend towards an increased body mass among patients taking the Juven compound using the secondary endpoint of AUC.

Background RTOG 97-14 revealed no difference between radiation delivered for painful bone metastases at 8Gy/1 fraction (SFRT) and 30Gy/10 fractions (MFRT) in pain relief or narcotic use 3 months post randomization. SFRT for painful vertebral bone metastases (PVBM) has not been well accepted, possibly due to concerns about efficacy and toxicity. The present study evaluates the subset of patients treated specifically for PVBM. Methods PVBM includes cervical, thoracic, and/or lumbar spine regions. Among PVBM, differences in re-treatment rates and in pain relief, narcotic use, and toxicity 3 months post randomization were evaluated. Results Of 909 eligible patients, 235 (26%) had PVBM. PVBM and non-PVBM patients differed in percentage of males [55% vs. 47%, p=0.03] and patients with multiple painful sites [57% vs. 38%, p<0.01]. Amongst PVBM, more MFRT patients had multiple sites treated [65% vs. 49%, p=0.02]. There were no statistically significant treatment differences in pain relief [62% vs. 70%, p=0.59] or freedom from narcotic use [24% vs. 27%, p=0.76] at 3 months. Significant differences in acute grade 2-4 toxicity [20% vs. 10%, p=0.01] and acute grade 2-4 GI toxicity [14% vs. 6%, p=0.01] were seen at 3 months, with lower toxicities seen with SFRT. Late toxicity was rare. No myelopathy was recorded. SFRT showed higher 3-year re-treatment rates [5% vs. 15%, p=0.01]. Conclusion Results for the PVBM subset are comparable to those of the entire population. SFRT had less acute toxicity, and a higher rate of re-treatment than MFRT. SFRT and MFRT resulted in comparable pain relief and narcotic use at 3 months.

Purpose-The phase II component of RTOG 0631 assessed the feasibility and safety of spine radiosurgery (SRS) for localized spine metastases in a cooperative group setting.Materials and Methods-Patients with 1-3 spine metastasis with a Numerical Rating Pain Scale (NRPS) score ≥ 5 received 16 Gy single fraction SRS. The primary endpoint was SRS feasibility: image-guidance RT (IGRT) targeting accuracy ≤ 2mm, target volume coverage > 90% of prescription dose, maintaining spinal cord dose constraints (10 Gy to ≤ 10% of the cord volume from 5-6mm above to 5-6mm below the target or absolute spinal cord volume < 0.35cc) and other normal tissue dose constraints. A feasibility success rate < 70% was considered unacceptable for continuation of the phase III component. Based on the one-sample exact binomial test with α=0.10 Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. (1-sided), 41 patients were required. Acute toxicity was assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0. NIH Public AccessResults-Sixty-five institutions were credentialed with spine phantom dosimetry and IGRT compliance. Forty-six patients were accrued, and 44 were eligible. There were 4 cervical, 21 thoracic and 19 lumbar sites. Median NRPS was 7 at presentation. Final pre-treatment rapid review was approved in 100%. Accuracy of image-guided SRS targeting was in compliance with the protocol in 95%. The target coverage and spinal cord dose constraint were in accordance with the protocol requirements in 100% and 97%. Overall compliance for other normal tissue constraints was per protocol in 74%. There were no cases of grade 4-5 acute treatment-related toxicity. Conclusion-The phase II results demonstrate the feasibility and accurate use of SRS to treat spinal metastases, with rigorous quality control, in a cooperative group setting. The planned RTOG 0631 phase III component will proceed to compare pain relief and quality of life between SRS and external beam radiotherapy.

Introduction Erectile dysfunction (ED) may be the most commonly observed adverse event (AE) associated with the combination of radiation therapy (RT) and androgen deprivation therapy (ADT). A significant number of men are trying phosphodiesterase type 5 inhibitors (PDE5s) such as sildenafil to treat ED, yet sildenafil studies to date shed little light on the response to ED after ADT. Aim The purpose of this trial was to evaluate sildenafil in the treatment of ED in prostate cancer patients previously treated with external beam RT and neoadjuvant and concurrent ADT. Methods In this randomized, double-blinded crossover trial, eligible patients received RT/ADT for intermediate risk prostate cancer and currently had ED as defined by the International Index of Erectile Function (IIEF). Patients were randomized to 12 weeks of sildenafil or placebo followed by 1 week of no treatment then 12 weeks of the alternative. Treatment differences were evaluated using a marginal model for binary crossover data. Main Outcome Measures The primary end point was improved erectile function, as measured by the IIEF. Results The study accrued 115 patients and 61 (55%) completed all three IIEF assessments. Sildenafil effect was significant (P = 0.009) with a difference in probabilities of erectile response of 0.17 (95% confidence interval: 0.06, 0.29), and 0.21 (0.06, 0.38) for patients receiving ≤120 days of ADT. However, as few as 21% of patients had a treatment-specific response, only improving during sildenafil but not during the placebo phase. Conclusions This is the first controlled trial to suggest a positive sildenafil response for ED treatment in patients previously treated with RT/ADT, however, only a minority of patients responded to treatment. ADT duration may be associated with response and requires further study. The overall low response rate suggests the need for study of additional or preventative strategies for ED after RT/ADT for prostate cancer.

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