/     /     /  

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

Reviewer: Neha Vapiwala, MD
Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 20 de octubre del 2003

Presenter: William F. Hartsell
Presenter's Affiliation: RTOG
Type of Session: Plenary

Background

Palliation of metastatic disease is a substantial component of radiation oncology, and an important aspect of cancer patient care in general. Severe pain and debilitation resulting from untreated metastases have a significant impact not only on the patient's quality of life, but on health care and economics as well. This trial was designed to evaluate whether 8 Gy in a single radiation fraction provides equivalent pain relief to 30 Gy in 10 fractions for patients with painful bony metastases from breast or prostate cancers. The historical basis for this trial was RTOG 7402, which demonstrated overall pain relief rates of ~85%, regardless of the length of radiation treatment regimen. However, criticisms of RTOG 7402, including the lack of patient-based assessment and failure to stratify for narcotic use have contributed to the lack of its adoption into common practice.

Materials and Methods

• 949 patients enrolled from 1998-2002
• 897 eligible and analyzable
• 445 men with prostate cancer, 452 women with breast cancer
• Median age = 67 yrs
• Patients stratified by: a) solitary vs. multiple sites of metastases b) bisphosphonate usage c) initial score on pain intensity scale = 5-6 vs. 7-10 d) weight-bearing vs. non- weight-bearing bony involvement with tumor
• Eligible patients must have >3 months life expectancy, no prior radiation, no recent change in systemic therapy, no fractures.
• Randomization to : 8 Gy x 1 or 30 Gy in 10 fractions
• Treatment could be delivered to as many as 3 painful sites

Results

8 Gy vs. 30 Gy
• Median survival = 9.1 months vs. 9.5 months
• One-year survival = 41% vs. 42%
• Pain relief evaluated at 3 months Entire group: overall response = 66%, complete response = 17%, partial response =49%
• No statistically significant differences found between the two arms, regardless of stratification factors, in all of the following : complete and partial response rates, decrease in pain intensity scale scores, pathologic fracture rates or late toxicity
• Statistically significant difference between arms only found for : rate of in-field retreatment (10% vs. 4% p=0.0004), grade 2-4 acute toxicity (10% vs. 17% p<0.0001)

Author's Conclusions

• There is no difference in pain relief or long-term toxicity achieved with a palliative radiation regimen of 8 Gy in 1 fraction as compared to a more standard 30 Gy in 10 fractions.
• Although acute toxicities were statistically significantly worse with the 30 Gy arm, these toxicities were generally mild and self-limiting.
• The need for retreatment at the same site of disease was greater in the 8 Gy arm, but the lowered cost and increased patient convenience with a single dose regimen of radiation still warrant its consideration as a plausible alternative to 30 Gy.

Clinical/Scientific Implications

External beam radiation for palliation of painful bony metastatic disease is an effective treatment and an important part of symptom management. Radiation contributes greatly to patient analgesia and may allow many patients to reduce or eliminate narcotic needs for pain control. In those who may have relatively longer life expectancies and better overall performance status, a longer course of 30 Gy may provide longer-lasting pain relief with lower rates of in-field retreatment. However, at 3-month analysis, pain relief and decrease in narcotic use appear to be equivalent between the standard 30 Gy and a single fraction of 8 Gy. Thus, this shorter regimen is an option, particularly in those patients with metastatic lesions in peripheral bones. Those patients with lesions adjacent to structures sensitive to high doses of radiation such as the spinal cord should receive the more protracted course of radiation therapy.

Oncolink's ASTRO Coverage made possible by an unrestricted Educational Grant from Siemens Medical Solutions.