Early results from a large European post-treatment breast cancer trial support using Genomic Health’s OncotypeDX test to single out higher-risk patients with estrogen-receptor-positive disease who would benefit from adding chemotherapy to standard hormonal therapy, the company said Wednesday. 

The determining factor — a number on the cancer Recurrence Score — allowed patients with a low number to be spared chemotherapy without compromising outcome, said lead investigator Ulrike Nitz, with Bethesda Hospital in Moenchengladbach, Germany.

The 3,198-patient trial was undertaken by the Women’s Healthcare Study Group to assess the efficacy of an anthracyline-free adjuvant chemotherapy regimen, using the Oncotype DX to identify higher-risk patients who would benefit from the regimen. Most patients qualified for chemo under traditional parameters, Genomic said.

Patients with a Recurrence Score of 12 or higher received chemotherapy, while those with scores of 11 or less received only hormonal therapy. After three years of follow-up, those with scores of 11 and below had a 98.3 percent survival rate without recurrence, despite having node-positive disease or high-risk node-negative disease by traditional parameters, the company said.

Genomic Health said it will continue to track the patients and report results on drug treatment and longer-term outcomes. — Kellen Owings

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