Some older women with early-stage breast cancer might be able to skip radiation therapy after breast-conservation surgery, according to a phase 3 randomized controlled trial.
The study, known as PRIME II, demonstrated a modest but statistically significant reduction in cancer recurrence in women who received radiotherapy, compared with those who did not. However, 5-year overall survival was similar in the two groups.
The results were published online January 28 in the Lancet Oncology.
"I think the PRIME II trial may be a practice-changing 'tipping point' in considering the omission of radiotherapy in selected older patients after breast-conserving surgery and adjuvant endocrine therapy. The omission of postoperative radiotherapy does not compromise survival," said first author Ian Kunkler, FRCR, from the Edinburgh Cancer Research Center, West General Hospital, Scotland, United Kingdom.
Currently, the standard of care for all breast cancer patients in the United Kingdom is breast-conservation surgery and adjuvant endocrine therapy followed by whole-breast radiation, according to Dr Kunkler.
"Candidate patients for omission of radiotherapy would be those with grade 1 or 2 hormone-receptor-positive tumors up to 3 cm, axillary node-negative after breast-conserving surgery with clear margins, and receiving adjuvant endocrine therapy," he added.
The possibility of radiation should not be excluded for all patients who meet these criteria, but skipping radiotherapy might be an option to discuss. "Some patients may still wish to have radiotherapy and accept the risks of toxicity, despite the modest reduction in risk of local recurrence from radiotherapy," he explained.
The study contained too few patients with grade 3 tumors to reach conclusions on the safety of skipping radiotherapy in this group.
"This subgroup should continue to receive radiotherapy as standard," Dr Kunkler stated. He added that there are plans for a 10-year follow-up.
In an accompanying comment, Kevin Hughes, MD, codirector of the Avon Comprehensive Breast Evaluation Center at Massachusetts General Hospital in Boston, and Lauren Schnaper, MD, from the Greater Baltimore Medical Center, take that a step further. They suggest skipping radiotherapy in all women who meet the eligibility requirements of this study.
Some older women with early-stage breast cancer might be able to skip radiation therapy after breast-conservation surgery, according to a phase 3 randomized controlled trial.
The study, known as PRIME II, demonstrated a modest but statistically significant reduction in cancer recurrence in women who received radiotherapy, compared with those who did not. However, 5-year overall survival was similar in the two groups.
The results were published online January 28 in the Lancet Oncology.
"I think the PRIME II trial may be a practice-changing 'tipping point' in considering the omission of radiotherapy in selected older patients after breast-conserving surgery and adjuvant endocrine therapy. The omission of postoperative radiotherapy does not compromise survival," said first author Ian Kunkler, FRCR, from the Edinburgh Cancer Research Center, West General Hospital, Scotland, United Kingdom.
Currently, the standard of care for all breast cancer patients in the United Kingdom is breast-conservation surgery and adjuvant endocrine therapy followed by whole-breast radiation, according to Dr Kunkler.
"Candidate patients for omission of radiotherapy would be those with grade 1 or 2 hormone-receptor-positive tumors up to 3 cm, axillary node-negative after breast-conserving surgery with clear margins, and receiving adjuvant endocrine therapy," he added.
The possibility of radiation should not be excluded for all patients who meet these criteria, but skipping radiotherapy might be an option to discuss. "Some patients may still wish to have radiotherapy and accept the risks of toxicity, despite the modest reduction in risk of local recurrence from radiotherapy," he explained.
The study contained too few patients with grade 3 tumors to reach conclusions on the safety of skipping radiotherapy in this group.
"This subgroup should continue to receive radiotherapy as standard," Dr Kunkler stated. He added that there are plans for a 10-year follow-up.
In an accompanying comment, Kevin Hughes, MD, codirector of the Avon Comprehensive Breast Evaluation Center at Massachusetts General Hospital in Boston, and Lauren Schnaper, MD, from the Greater Baltimore Medical Center, take that a step further. They suggest skipping radiotherapy in all women who meet the eligibility requirements of this study.
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