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In a prospective, single-arm phase II trial, ultralow-dose radiation was followed by a pain response in 66% of evaluable patients at four weeks and 86% at six months. Researchers reported few treatment-related adverse events and no adverse effect on bone marrow status; 19% of patients received repeat radiation.
A prospective phase II trial found that ultralow-dose radiation was followed by meaningful pain relief for many patients with painful bone lesions from multiple myeloma, with researchers reporting few treatment-related side effects and no adverse effect on bone marrow status. Among patients who returned pain questionnaires, 66% had a complete or partial response at four weeks, rising to 86% at six months.
The trial enrolled 69 patients and compared a single 4-gray (Gy) treatment with two 2-Gy treatments. Both regimens delivered 4 Gy in total, substantially below the commonly used palliative schedule of 30 Gy over 10 treatments. Patients had painful bone lesions, defined by a Brief Pain Inventory score of at least 2, and were not eligible if they had prior radiation or surgery to the site, a long-bone fracture, spinal cord compression, or certain skull-base or orbital lesions.
The main outcome combined pain response with changes in daily oral morphine-equivalent medication use. A complete response meant no pain at the treated site and no increase in opioid dose; a partial response meant pain fell by at least two points or opioid use fell by at least 25%. Response rates were based on returned questionnaires: 66% at four weeks among 61 respondents, 64% at eight weeks among 47, and 86% at six months among 42. The changing respondent totals mean the later percentage does not represent the full enrolled group.
Rates were similar for the one- and two-treatment schedules at the measured time points, although the study presenter, Leslie Ballas of Cedars-Sinai Medical Center, said the median pain-score decrease at six months favored two fractions. Treatment-related adverse events were reported in five of 69 patients; none were grade 3 or higher or led to an interruption or change in treatment. Researchers reported that bone marrow status was not adversely affected. Twelve of 63 patients, or 19%, later received additional radiation, at a median of 61 days; the response rate after that treatment was 69%.
Preserving Marrow During Pain Relief
The results address a treatment trade-off in multiple myeloma: radiation can ease pain from bone disease, while exposure to bone marrow may affect blood counts and the ability to receive other therapies. Ballas said preserving marrow could leave room for ongoing chemotherapy and later options such as transplant or CAR T-cell therapy. The study did not establish that these options were improved by the radiation schedules, but the reported marrow findings are relevant to treatment planning for a disease in which patients may receive multiple lines of therapy.
The approach may also reduce the number of visits required for palliative treatment. A single treatment and a two-visit schedule are both shorter than 10 fractions, though the trial compared only those two low-dose regimens and was not a randomized comparison against the usual 30-Gy schedule. The findings may inform clinical decisions, but they do not show that low-dose radiation is suitable for every painful myeloma lesion or every patient.
ASTRO expert Chelsea Pinnix of MD Anderson Cancer Center said the results suggest many patients can have meaningful pain relief with a low initial dose and may prompt clinicians to consider radiation earlier for painful bone disease. That is an expert interpretation of the findings, not a separate trial result.
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How the Trial Fits Earlier Evidence
Earlier evidence for palliative radiation in myeloma was largely retrospective or observational, Ballas said. She described a prior randomized comparison of 30 Gy versus 8 Gy that measured pain and analgesic use; about 80% of patients had a complete or partial response. A more recent retrospective review included 11 patients with myeloma treated with low-dose radiation and reported a 95% pain-response rate, but its design and small myeloma subgroup limit direct comparison with the prospective trial.
The rationale for minimizing marrow exposure has grown as myeloma treatment has expanded and patients may live long enough to need successive therapies. Ballas cited a five-year overall survival rate of 64% and said the volume of bone marrow receiving at least 10 Gy has been associated with hematologic adverse events. The current trial tested whether a much smaller radiation dose could relieve pain while limiting that exposure.
The study was single-arm: it randomized participants between two low-dose schedules but did not include a standard-dose or no-radiation control group. Its results therefore describe outcomes among treated patients and cannot establish how much of the observed change was caused by radiation relative to other factors.
“Only 19% of patients needed a second course, but it is still available to them at any point during their lifetime.”
— Leslie Ballas, MD
Limits of the Six-Month Results
The response percentages came from patients who completed questionnaires, and the number of respondents fell from 61 at four weeks to 42 at six months. The six-month result may not reflect outcomes for all 69 enrolled patients. The source report does not provide further detail on why questionnaires were missing or whether those patients differed from respondents.
Because the trial had no standard-dose control group, it cannot determine whether the low-dose schedules provide pain relief equivalent to 30 Gy in 10 fractions. The study also does not establish how durable relief remains beyond six months, which patients are most likely to need repeat radiation, or whether reduced marrow exposure leads to better blood counts or greater ability to receive later therapies. Ballas said further trials probably are not needed and described the approach as ready for clinical practice with appropriate counseling; that is her assessment, not a finding established by a head-to-head trial.
Clinical Use and Longer Follow-Up
The report presents the schedules as options clinicians may discuss with patients who have painful myeloma bone lesions. Ballas said patients should be told that the approach is risk-adapted and that a small proportion may need repeat radiation. The trial data show that additional treatment was given to 19% of patients, with a median interval of 61 days, but do not define the best schedule for every case.
Further information on longer-term pain control, marrow outcomes and repeat-treatment patterns would help clarify how well the results hold up beyond the available six-month assessment. The source material does not specify a planned follow-up study or a next reporting date.
Key Questions
What radiation schedules did the trial test?
Patients received either one 4-Gy treatment or two treatments of 2 Gy each. The total dose was 4 Gy in both groups.
How many patients reported pain relief?
A complete or partial pain response was reported by 66% of 61 questionnaire respondents at four weeks and 86% of 42 respondents at six months. These percentages are based on returned questionnaires, not all 69 enrolled patients.
Did patients need repeat radiation?
Twelve of 63 patients, or 19%, received another course. The median time to repeat radiation was 61 days, and the reported pain response after re-irradiation was 69%.
Was the low-dose treatment compared with standard radiation?
No. The trial randomized patients between two low-dose schedules, but it did not include a standard-dose control group. Its results cannot establish equivalence to the commonly used 30-Gy schedule.
What side effects were reported?
Treatment-related adverse events occurred in five of 69 patients. None were grade 3 or higher or required treatment interruption or modification, according to the report.
Source: rss
