Jennifer L. James

Economic analysis of radiation therapy oncology group 97-14: multiple versus single fraction radiation treatment of patients with bone metastases.

Introduction:Radiation Therapy Oncology Group 97-14 concluded that a single fraction of radiation was as effective in relieving pain as multiple fractions in the treatment of patients with bone metastases. A statistically significant higher retreatment rate, however, was noted in patients undergoing a single fraction treatment. The purpose of the analysis was to determine whether multiple fraction treatment is cost-effective in treating patients with bone metastasis, by preventing further retreatment. Methods and Material:A Markov model was used to evaluate the cost-effectiveness of 30 Gy in 10 fractions in comparison with 8 Gy in 1 fraction. Transition probabilities, cost, and utilities were obtained from the clinical trial. Costs and outcomes were not discounted because of the short time line for the study. Results:The expected mean cost and quality-adjusted survival in months for patients receiving 8 Gy in 1 fraction and 30 Gy in 10 fractions was

Single-fraction radiotherapy versus multifraction radiotherapy for palliation of painful vertebral bone metastases-equivalent efficacy, less toxicity, more convenient: a subset analysis of Radiation Therapy Oncology Group trial 97-14.

998 and 7.26 months and

Randomized, Double‐Blinded, Placebo‐Controlled Crossover Trial of Treating Erectile Dysfunction with Sildenafil After Radiotherapy and Short‐Term Androgen Deprivation Therapy: Results of RTOG 0215

2316 and 9.53 months, respectively. The incremental cost-effectiveness ratio was

Octreotide Acetate in Prevention of Chemoradiation-Induced Diarrhea in Anorectal Cancer: Randomized RTOG Trial 0315

6973/quality-adjusted life year. The results were sensitive to the utility of the posttreatment state for both single and multiple fraction treatments. Conclusion:Single fraction treatment was the less expensive treatment in the treatment of patients with bone metastasis treated on Radiation Therapy Oncology Group 97-14.

Phase 2 results from Radiation Therapy Oncology Group Study 0537: a phase 2/3 study comparing acupuncture-like transcutaneous electrical nerve stimulation versus pilocarpine in treating early radiation-induced xerostomia.

The Radiation Therapy Oncology Group (RTOG) trial 97‐14 revealed no difference between radiation delivered for painful bone metastases at a dose of 8 gray (Gy) in 1 fraction (single‐fraction radiotherapy [SFRT]) and 30 Gy in 10 fractions (multifraction radiotherapy [MFRT]) in pain relief or narcotic use 3 months after randomization. SFRT for painful vertebral bone metastases (PVBM) has not been well accepted, possibly because of concerns about efficacy and toxicity. In the current study, the authors evaluated the subset of patients that was treated specifically for patients with PVBM.

Phase 2 results from Radiation Therapy Oncology Group Study 0537

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.

Functional interference clusters in cancer patients with bone metastases: a secondary analysis of RTOG 9714.

BACKGROUND In anorectal cancer patients, an acute side effect of chemoradiotherapy is gastrointestinal toxicity, which often impedes treatment delivery. Based on previous trials, octreotide acetate is widely recommended for the control of chemotherapy-induced diarrhea. However, the effectiveness of octreotide in preventing or controlling radiation- and chemoradiation-induced diarrhea is not known. METHODS A randomized, double-blinded, placebo-controlled trial was designed to determine the efficacy of long-acting octreotide acetate (LAO) in preventing the onset of acute diarrhea in patients undergoing chemoradiation therapy for rectal or anal cancer. Between 4 and 7 days before the start of radiation therapy, patients received a 30-mg dose of LAO (109 patients) or placebo (106 patients) via intramuscular injection. A second dose was given on day 22 (+/-3 days) of radiation treatment. A total of 215 patients were included in the final analysis. The primary endpoint was the incidence of grade 2-4 acute diarrhea; secondary endpoints included treatment compliance, medical resource utilization, patient-reported bowel function, and quality of life (QoL). Statistical tests were one- or two-sided, as specified. RESULTS After a median follow-up time of 9.64 months, incidence rates of grades 2-4 acute diarrhea were similar in both groups (49% placebo vs 44% LAO; P = .21). No statistically significant treatment differences in chemotherapy or radiation delivery, medical resource utilization, patient-reported bowel function, or QoL were observed. CONCLUSION In this study, the prophylactic use of LAO did not prevent the incidence or reduce the severity of diarrhea and had no notable impact on patient-reported bowel function or QoL.

Utility of the Ace Inhibitor Captopril in Mitigating Radiation-associated Pulmonary Toxicity in Lung Cancer: Results From Nrg Oncology Rtog 0123

In this phase 2 component of a multi‐institutional, phase 2/3, randomized trial, the authors assessed the feasibility and preliminary efficacy of acupuncture‐like transcutaneous electrical nerve stimulation (ALTENS) in reducing radiation‐induced xerostomia.

Screening for depression in cancer patients receiving radiotherapy: Feasibility and identification of effective tools in the NRG Oncology RTOG 0841 trial

In this phase 2 component of a multi‐institutional, phase 2/3, randomized trial, the authors assessed the feasibility and preliminary efficacy of acupuncture‐like transcutaneous electrical nerve stimulation (ALTENS) in reducing radiation‐induced xerostomia.

Impact of sildenafil on marital and sexual adjustment in patients and their wives after radiotherapy and short-term androgen suppression for prostate cancer: analysis of RTOG 0215.

PURPOSE To explore the relationships (clusters) among the functional interference items in the Brief Pain Inventory (BPI) in patients with bone metastases. METHODS Patients enrolled in the Radiation Therapy Oncology Group (RTOG) 9714 bone metastases study were eligible. Patients were assessed at baseline and 4, 8, and 12 weeks after randomization for the palliative radiotherapy with the BPI, which consists of seven functional items: general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Principal component analysis with varimax rotation was used to determine the clusters between the functional items at baseline and the follow-up. Cronbachs alpha was used to determine the consistency and reliability of each cluster at baseline and follow-up. RESULTS There were 448 male and 461 female patients, with a median age of 67 years. There were two functional interference clusters at baseline, which accounted for 71% of the total variance. The first cluster (physical interference) included normal work and walking ability, which accounted for 58% of the total variance. The second cluster (psychosocial interference) included relations with others and sleep, which accounted for 13% of the total variance. The Cronbachs alpha statistics were 0.83 and 0.80, respectively. The functional clusters changed at week 12 in responders but persisted through week 12 in nonresponders. CONCLUSION Palliative radiotherapy is effective in reducing bone pain. Functional interference component clusters exist in patients treated for bone metastases. These clusters changed over time in this study, possibly attributable to treatment. Further research is needed to examine these effects.