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Early-Stage, HER2-Positive Breast Cancer Patients at Increased Risk of Recurrence

HOUSTON, Tex -- November 2, 2009 -- Patients with early-stage breast cancer and with HER2 positive tumours <= 1 cm are at significant risk of recurrence of their disease, compared with those with early-stage disease who do not express the aggressive protein, according to a study published today online in the Journal of Clinical Oncology.

The findings of the study suggest that women with early-stage HER2 positive breast cancer should be assessed for risk of recurrence and considered for additional treatment.

"Our findings show that women with early stage HER2 positive breast cancer have a 23% chance of recurrence. In contrast, the 5-year survival rate of all women with such early-stage breast cancer is more than 90%," said Ana M. Gonzalez-Angulo, MD, Department of Breast Medical Oncology and Systems Biology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.

"The findings indicate that physicians need to consider offering these women Herceptin-based therapy in the post-operative, or adjuvant setting," Dr. Gonzalez-Angulo continued.

Current guidelines call for no additional therapy after surgery and radiation if tumours are < 5 millimeters and Herceptin-based adjuvant therapy should be discussed with patients if the tumours are from 6 to 10 millimeters, Dr. Gonzalez-Angulo explained.

She said the number of patients with HER2 positive tumours <1 cm continues to increase as breast cancer surveillance and early detection become increasingly sophisticated.

"Before now, there's been no data regarding how to treat these women because they were excluded from all the definitive trials confirming Herceptin's benefit," she said. "This data strongly suggests that we need to rethink how we treat early-stage breast cancer patients with HER2 positive tumours and likely offer anti-HER2 therapy in the adjuvant setting."

For the retrospective study, researchers used M. D. Anderson's Breast Cancer Research Database to analyse 965 patients treated between 1990 and 2002. All of the patients' tumours were < 1 cm. Patients whose receptor status could not be analysed and/or had received adjuvant chemotherapy or Herceptin at any time were excluded. To validate the findings, a second cohort of 350 patients from European institutions was also analysed.

Of the M. D. Anderson patient population, more than 10% (98 patients) had HER2 positive tumours. In addition, 77% were hormone-receptor positive and 13% were triple receptor-negative.

In those analyzed with HER2 positive tumours, the 5-year, recurrence-free survival was 77.1%; in contrast, HER2 negative patients' recurrence-free survival was 93.7%. Five-year distant recurrence-free survival was 86.4% in women with HER2 positive tumours compared with 97.2% in women with HER2-negative tumours. Patients with HER2-positive tumours had 2.68 times higher risk of recurrence and 5.3 times higher risk of distant recurrence than those with HER2-negative tumours.

In addition, women with HER2-positive tumors had 5.09 times the risk of recurrence and 7.81 times risk of distant recurrence than women with hormone receptor-positive tumours.

The European subset confirmed the M. D. Anderson findings and showed reproducibility, said Gonzalez-Angulo.

SOURCE: University of Texas M. D. Anderson Cancer Center

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