Treating asymptomatic, high-risk bone metastases with radiation can reduce painful complications and hospital admissions and may prolong survival in people with metastatic cancer. location, a phase II clinical trial found. The results of the randomized, multicenter trial (NCT03523351) will be presented today at the American Society of Radiation Oncology (ASTRO) Annual Meeting.
Clinical trial findings show radiation oncologist may play a valuable role in the treatment of extensive bone metastases even in the absence of symptoms. Palliative radiotherapy has traditionally focused on reducing current pain and other symptoms when a patient’s cancer is no longer considered curable. The investigators hoped to be able to prevent painful complications by treating asymptomatic bone metastases with radiation and were surprised to find that the benefits could extend beyond comfort.
“It is stimulating to think that radiation prevents pain,” says Erin F. Gillespie, MD, lead author of the study and a radiation oncologist at Memorial Sloan Kettering Cancer Center in New York. can prolong life. “It shows that treatment to cure cancer isn’t the only thing that can help people live longer.”
Dr Gillespie said the study stemmed from the observation that many patients hospitalized for painful bone metastases had evidence of these lesions on CT scans several months earlier. Although external beam radiation therapy is the standard of care for painful lesions, it is not used for asymptomatic lesions outside of an oligometastatic basis; In general, patients remain on systemic therapy until the lesions become symptomatic. Dr Gillespie and her colleagues wanted to determine “if and when we can intervene .” before These symptoms occur to prevent hospitalizations and debilitation from cancer. “
For the study, the researchers identified 78 adults with metastatic melanoma and more than five metastatic lesions, including at least one asymptomatic high-risk bone lesion. Whether a lesion is high-risk is determined by its size (if it is 2 cm or more in diameter); its location in the articulating spine; whether it involves the hip joint or the sacrum; or if it is located in one of the long bones of the body, such as the bones in the arms and legs. Among all patients involved, there were 122 cumulative bone metastases.
Among study participants, the most common basic types cancer lung (27%), breast (24%) and prostate (22%). Participants are randomly assigned to receive standard treatment, which may include systemic therapy (such as chemotherapy or targeted agents) or observation, with or without radiation therapy for treatment. all of their high-risk bone metastases. The dose of radiation varies but is usually low (i.e. non-destructive). All patients were followed for at least 12 months or until they battled their disease.
The primary aim was to determine if treatment of asymptomatic lesions could prevent bone-related events (SREs) – a common and often painful and debilitating complication of skeletal metastasis. SREs include pain, fractures, and spinal cord compression requiring surgery or radiation. They may contribute to an increased risk of death and higher health care costs.
The researchers found that treating asymptomatic lesions with radiation reduced the number of hospitalizations associated with SRE and SRE and extended survival, compared with those who did not receive radiation therapy. At the end of one year, for patients receiving radiation therapy, SREs occurred in 1 of 62 lesions (1.6%), compared with 14 of 49 lesions (29%) in those receiving standard care. (p .)
After 2.4 years of median follow-up, overall survival was significantly longer for patients who received radiotherapy, compared with those who did not (hazard ratio 0.50, 95% confidence interval 0.28-0.91, p = 0.02). Median survival was 1.1 years for 11 patients who experienced SRE, compared with 1.5 years for 67 patients without SRE.
After the first trimester, patients in the radiotherapy group reported less pain than patients in the standard care group (p
Although it was not part of the original study design, Dr Gillespie said the team performed an unplanned analysis of which lesions were more likely to cause SRE. While they expected to find the long bones that could have caused more fractures and pain, they found that it was the metastases in the spine that were more likely to cause pain, cord compression, or pain. subsequent fracture. However, the number is small and will require further evaluation to confirm.
Dr Gillespie said treating those lesions with “even low doses of radiation is enough to stop the damage from progressing and causing problems”.
Dr Gillespie emphasized that because of the small size of the study, its findings, while hypothesis-generating, are uncertain and that a larger study is needed to replicate and extend these analyses. “Our trial results add to the growing area of research to test the potential of early supportive care, but they still need to be confirmed in a larger, early-stage trial,” she explains. III.
She also said future research should seek to answer questions such as: “Does this apply to people early in their metastatic disease stage, who may not have any symptomatic lesions?” How will they benefit from radiation intervention? There are many patients with multiple sites of metastasis, but how do we identify the lesions that are most likely to become a problem?”
“And, once we confirm this is the right thing to do,” she said, “how do we make sure patients who could benefit have access to this treatment?”
American Society of Radiation Oncology
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