Radiation Oncology/RTOG Trials/9714

RTOG 97-14 (PROSTATE, BREAST, PALLIATION)

• Title: Randomized Trial of Palliative Radiation Therapy For Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
• Objectives:
  • (1) To determine whether 8 Gy in a single fraction provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients with painful bone metastases.
  • (2) To determine the frequency and duration of pain relief and narcotic relief for each of the two treatment arms.
  • (3) To determine the effect on quality of life measures for each of the two treatment arms.
  • (4) To determine the incidence of pathologic fracture within the treatment field for 8 Gy in a single fraction compared to 30 Gy in 10 fractions.
  • (5) To evaluate resource utilization and create a model to compare resources/costs for each of the two protocol treatment arms.
  • (6) To correlate survival time with physician prediction of survival, Karnofsky performance status, and FACT quality of life score to determine which gives the best estimation of actual survival time in this group of patients.
  • (7) To determine cost-effectiveness of therapies in terms of cost/quality adjusted life years.
• Protocol:
  • Arm (1): 3 Gy x 10 (30 Gy in 2 weeks)
  • Arm (2): 8 Gy x 1 (8 Gy single dose)
• Eligibility:
  • Breast or prostate malignancy
  • Radiographic evidence of bone mets, excluding skull, hands, and feet
• Enrollment Target: 898 patients
• Activated: February 1, 1998
• Closed: April 30, 2001
• Conclusion:
  • 2005 PMID 15928300 -- Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. (Hartsell WF, J Natl Cancer Inst. 2005 Jun 1;97(11):798-804.) Conclusion: Both regimens equivalent for pain control and narcotic relief at 3 months. 8/1 less acute toxicity but higher retreatment

• Publications:
  • PMID 19632065 -- Functional interference clusters in cancer patients with bone metastases: a secondary analysis of RTOG 9714. (Chow E, Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1507-11.) 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.
  • PMID 16814950 -- Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. (Konski A, Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):229-33). Conclusion: Patients receiving 8 Gy in a single fraction had significantly higher retreatment rates compared with patients receiving 30 Gy in 10 fractions.
  • ASCO Abstract -- Breast cancer patients have better outcomes than prostate cancer patients for palliation of painful bone metastases: Results of RTOG 97-14 (Hartsell WF, ASCO 2005). Conclusion: Women with bone metastases from breast cancer experience better outcomes in terms of pain control and survival compared to men with prostate cancer with bone mets treated with palliative radiotherapy. Further consideration should be given to tailoring treatment by gender.
  • ASTRO Abstract -- Can Physicians Accurately Predict Survival Time in Patients with Metastatic Cancer? Analysis of RTOG 9714 (Hartsell WF, ASTRO 2004). Conclusion: KPS, FACT scores, and physician predicted survival all are correlated with actual survival. Physicians on this study were able to predict which patients would have longer survival times, although the prediction of survival was optimistic compared to actual survival by an average of 3 months.
  • ASTRO Abstract -- Prospective Health-Related Quality of Life Valuations (Utilities) of 8 Gy in 1 Fraction vs 30 Gy in 10 Fractions for Palliation of Painful Bone Metastases: Preliminary Results of RTOG 97-14 (Bruner DW, ASTRO 2004). Conclusion: Based on this data, there is no difference in overall HUI-III-HRQL scores between the two treatment arms at baseline or at 3 mos. Utility scores increased significantly from baseline to 3 mos. for each of the treatment arms. The increased utility of changes in emotion on the 30Gy arm may indicate a benefit from increased social support gained with longer treatment time. Cognition decreases equally on both arms congruent with the literature on metastasis. Value added of utilities to standard quality of life and symptom assessment is a quantitative valuation of improvement.
  • ASTRO Abstract -- Phase III Randomized Trial of 8 Gy in 1 Fraction vs. 30 Gy in 10 Fractions for Palliation of Painful Bone Metastases: Preliminary Results of RTOG 97−14 (Hartsell, ASTRO #1 2003; Hartsell WF, Scott C, Bruner DW, et al.: Int J Radiat Oncol Biol Phys 57 (2 Suppl): S124, 2003). Conclusion: Palliative external beam radiation therapy is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients. Pain and narcotic relief is equivalent for both 30 Gy in 10 fractions and 8 Gy in a single fraction. At 3 months follow−up, there is no difference between the two treatment arms, regardless of stratification. Treatment was well tolerated with few adverse effects.
  • Video Presentation -- Phase III Randomized Trial of 8 Gy in Fraction vs. 30 Gy in 10 Fractions for Palliation of Painful Bone Metastases: Preliminary Results of RTOG 97 -14 (Hartsell WF, ASTRO 2003)