Breast Cancer Coverage from Every Angle

EBCC 12: Long-Term Survival Outcomes From Phase III Trial in HER2-Positive Breast Cancer

By: Jocelyn Solis-Moreira, MS
Posted: Monday, October 12, 2020

A 9-year follow-up analysis of the NEOALTTO Big-06 trial suggested pathologic complete response (pCR) may be an indicator of long-term survival in patients with HER2-positive breast cancer. Paolo Nuciforo, MD, PhD, of Vall d’Hebron Institute of Oncology, Barcelona, and colleagues found that patients given both lapatinib plus trastuzumab before surgery had higher pCR rates, which resulted in a lower recurrence rate and a nonsignificant association with survival. The results were presented at the 12th European Breast Cancer Conference (EBCC; Abstract 23).

“If we could predict, for example with pCR, which patients are at high risk of their cancer recurring in 3, 5, or 10 years, we could give more aggressive adjuvant therapies only to these women and not to those women who have achieved pCR and are at low risk of recurrence,” commented Dr. Nuciforo in a press release.

The multicenter, open-label, phase III clinical trial recruited 455 patients with HER2-positive early breast cancer. Patients were randomly assigned to oral lapatinib, intravenous trastuzumab, or a combination of lapatinib and trastuzumab for 6 weeks. This was followed by the patient’s assigned anti-HER2 treatment with paclitaxel for 12 weeks. After surgery, patients were given three cycles of fluorouracil, epirubicin, and cyclophosphamide followed by 34 weeks of neoadjuvant anti-HER2 therapy.

The average follow-up was 9.7 years. There were no statistically significant differences in event-free survival and overall survival between the treatment groups. In terms of pCR, patients with no signs of residual disease before surgery had a higher event-free survival (77% vs. 61%; P = .0008) and overall survival (88% vs. 72%, P = .0004) than those who did not. Event-free survival and overall survival were also higher in patients with pCR who had hormone receptor–negative disease (P = .002; P = .002) or who received the combination treatment (P = .004; P = .002).

Disclosure: For full disclosures of the study authors visit

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