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Radiotherapy may be unnecessary for older patients with breast cancer

Issue: December 25, 2013

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SAN ANTONIO — Radiotherapy may be unnecessary in a select group of older patients with hormone-receptor positive, axillary node-negative breast cancer, according to research presented at the San Antonio Breast Cancer Symposium.

The PRIME II study — an international, phase 3, randomized controlled trial — evaluated whole-breast radiotherapy in 1,326 patients aged 65 years or older.

All patients had hormone receptor-positive, low-grade breast cancer, with tumors smaller than 3 cm, no disease in axillary lymph nodes and no metastasis. All patients received hormone therapy, and they had clear excision margins (≥1 mm).

Patients were followed for an average of 5 years.

Researchers randomly assigned patients to whole breast radiotherapy (n=658) or no radiotherapy (n=668).

Ipsilateral breast tumor recurrence served as the primary endpoint.

 

Ian Kunkler

At 5 years, six patients (1.3%) who received radiation had ipsilateral breast tumor recurrence compared with 26 (4.1%) of those who did not receive radiotherapy (HR=4.34; P=.001).

Although the difference in recurrence rate was statistically significant, “the absolute benefit is very small … and excluding radiotherapy doesn’t compromise survival,” Ian Kunkler, FRCR, professor of clinical oncology at the Edinburgh Cancer Research Center in the University of Edinburgh, said during a press conference.

Researchers reported 5-year OS rates of 93.8% without radiation and 94.2% with radiation (P=.24). They observed no significant differences in rates of regional recurrence, contralateral breast cancer or distant metastases between arms.

“It’s a matter of discussion between the patient and the physician as to whether that very modest benefit is worth the potential risks and complications of the therapy and the burden of undergoing treatment,” Kunkler said. “Our results are likely to lead to the consideration of omission of postoperative radiotherapy in patients meeting eligibility criteria for the trial.”

For more information:
Kunkler I. Abstract #S2-01. Presented at: San Antonio Breast Cancer Symposium; Dec. 10-14, 2013; San Antonio.

Disclosure: This study was supported by the Chief Scientist’s Office for Scotland. Kunkler reports no conflicts of interest.