A large international study conducted over 10 years found that radiation therapy after mastectomy did not improve survival for women with early-stage breast cancer considered at ‘intermediate risk,’ calling into question a long-standing component of post-surgical treatment for many patients.
Researchers followed more than 1,600 women who had undergone mastectomy, lymph-node surgery, and systemic therapy, including chemotherapy, for a median of 9.6 years. Overall survival was nearly identical for those who received radiation to the chest wall and those who did not: 81.4 percent with radiation and 81.9 percent without.
Only 29 patients in the trial reported a recurrence, nine (1.1%) in the radiation group and 20 (2.5%) in the non-radiation group, and the difference did not translate into a survival benefit, the authors reported Wednesday in the New England Journal of Medicine.
Study mainly focused on women with stage II breast cancer
The study focused on patients classified by the investigators as “intermediate risk,” generally women with stage II disease who had one to three positive lymph nodes or those with aggressive tumor features but no lymph node involvement, and this is a group for which treatment recommendations have been unclear.
“This finding potentially allows patients to avoid unnecessary treatments, leading to more effective and efficient use of health and care resources,” said John Simpson, who leads a U.K. government group that evaluates clinical trials, in a statement accompanying the results.
The trial enrolled patients from the United Kingdom, seven countries in continental Europe, Israel, and Turkey. Radiation has been a standard element of breast cancer care since the early 20th century, but its use has been declining for lower-risk patients as systemic therapies and surgical techniques have improved. The authors noted that overall breast cancer mortality has fallen since the trial began and that advances in systemic treatment have contributed to higher survival rates.
Radiation therapy can have damaging effects on patients; avoiding it can help reduce treatment burden
Radiation therapy can cause short-term side effects such as hair loss, soreness, swelling, and skin irritation that can resemble sunburn. More serious, less common complications can include lung inflammation and nerve damage in the shoulder or arm, which may lead to numbness, tingling, pain, or weakness.
“Avoiding unnecessary irradiation will reduce both treatment burden and, for example, the detrimental effects on breast reconstruction for these mastectomy patients,” said Dr. Nicola Russell, a radiation oncologist at the Netherlands Cancer Institute and one of the study’s authors.
The investigators said the results support a continued shift away from routine use of radiotherapy in lower-risk settings and could help refine recommendations for women at intermediate risk after mastectomy. They also emphasized that individual treatment decisions should remain personalized, taking into account tumor characteristics, patient preferences, and other clinical factors.
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