More than twice as many patients treated with 24 Gy in two stereotactic body-radiation therapy (SBRT) fractions reported lasting and complete pain relief compared to those treated with 20 Gy in five conventional radiation (CRT) fractions.
The findings were presented during a press briefing October 26 at the American Society for Radiation Oncology (ASTRO) virtual annual meeting.
"This is the first phase III randomized trial that has shown an improvement with dose escalation for painful spinal lesions," lead author Dr. Arjun Sahgal, deputy chief of radiation oncology at the Sunnybrook Health Sciences Centre of the University of Toronto, said in a statement.
"Pain deteriorates a patient's quality of life and nobody with advanced cancer should have to endure this kind of pain. Patients with painful spinal metastases who meet the eligibility criteria should be offered this treatment," he added.
The study enrolled 229 patients whose primary tumors (mainly in the breast, urinary tract or lung) had spread to painful spinal lesions. All patients had initial pain scores of greater than 2 on a scale of 1 to 10 (with a median score of 5) on the brief pain inventory. One hundred fourteen patients were treated with the shorter/higher-dose SBRT regimen and 115 with CRT.
The complete response rate at three months (the primary endpoint) was 35% in the SBRT group versus 14% in the CRT group (P<0.001), Dr. Sahgal reported. At six months, freedom from pain was sustained for 32% of those who had SBRT versus 16% of those who had CRT (P=0.004).
In multivariable analysis, SBRT was independently associated with greater likelihood of complete response at three and six months, with odds ratios of 3.47 and 2.45, respectively.
There were no significant between-group differences in radiation site-specific progression-free survival or overall survival. At three months, 92% of patients in the SBRT group and 86% in the CRT group had no cancer at the treated site. The rates at six months were 75% and 69%.
Both radiation approaches were safe with respect to fractures and there was no radiation damage to the spinal cord observed in either cohort. Overall, patients in both groups had low rates of serious adverse events and there were no fatal events.
Of note, said Dr. Sahgal, patients were more satisfied with SBRT in terms of quality-of-life measures related to financial considerations, although other quality of life measures did not differ between the two groups.
"Patients felt they were in a financially better position coming to the hospital and getting two treatments, rather than five. Even though the complexity of the treatment was greater, it was better for the patient," he said in the news release.
Commenting on the study, briefing moderator Dr. Sue Yom of the University of California, San Francisco, said, "I consider this a practice-changing study."
"The increased dose that was given in this study to the metastatic site over only two fractions of SBRT produced results that allowed significantly more patients to achieve complete pain relief than the patients who got a conventional treatment with five fractures for that site," she noted.
"Also, the rate of complete resolution of the spine tumors at six months was superior, so actual oncologic benefits in patients receiving SBRT," said Dr. Yom.
But what's "really fascinating about this study," she said, "is that the financial perception of those receiving SBRT was superior. So being able to have fewer treatments is significant to patients and that is an additional buttress to this study's importance," she concluded.
By Megan Brooks
SOURCE: https://bit.ly/2HFaJzE ASTRO 2020 Annual Meeting, presented October 26, 2020.
Posted on
site created by:
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy