Sequential Regimen for HER2+ Breast Cancer Non-Inferior to Concurrent Treatment


Sequential administration of HER2+ therapy and chemotherapy did not affect survival outcomes in patients with breast cancer.

For women with human epidermal growth factor receptor 2 positive (HER2+) breast cancer, no difference in survival outcomes was found between sequential or concurrent treatment regimens with anthracycline-based chemotherapy and trastuzumab (Herceptin), according to a new study in JAMA Oncology.

The phase 3 clinical trial included 280 women with operable HER2+ invasive breast cancer at 36 cancer centers across the United States from September 2007 to December 2011. Patients were assigned to neoadjuvant anthracycline-based chemotherapy and trastuzumab regimens, either given sequentially or concurrently, prior to surgery.

In the sequential arm, 138 patients received a 3-drug chemotherapy combination regimen known as FEC on day 1 of a 21-day cycle for 4 cycles, followed by paclitaxel plus trastuzumab weekly for 12 weeks.

The concurrently-treated group included 142 patients who received paclitaxel plus trastuzumab weekly for 12 weeks, followed by FEC on day 1 of a 21-day cycle and trastuzumab on days 1, 8, and 15 of the 21-day cycle for 4 cycles.

All enrolled patients received a total of 1 year of trastuzumab therapy. Women with hormone-receptor positive tumors received endocrine therapy and underwent radiation at their physician’s discretion.

According to the data, the researchers found no differences in pathologic complete response rate (pCR), disease-free survival, or overall survival rates with concurrent or sequential treatment, with a median follow-up time of 5 years. In the sequential treatment arm, 18 women recurred and 2 were diagnosed with secondary cancers compared with 22 recurrences and 3 secondary cancers in the concurrent treatment arm.

“Our findings from both studies allow for all women with this class of breast cancer to be spared of cardiotoxicities associated with anthracycline and trastuzumab given at the same time,” study author Kelly Hunt, MD, professor and chair, Breast Surgical Oncology, said in a press release. “The research also offers physicians definitive clinical guidance. Many have opted to treat with a more aggressive approach because the patient’s disease was a higher stage, or because of the woman’s young age. Our study confirms that for HER2+ breast cancer patients, less is more.”

These findings build on previous research that showed patients can achieve a high pCR when the same therapy regimen is given sequentially. The researchers noted that the results of this study could help patients avoid unnecessary costs and toxicities associated with concurrent treatment.

The phase 3 study was conducted through the American College of Surgeons Oncology Group, which is now called the Alliance for Clinical Trials in Oncology.


Buzdar AU, Suman VJ, Bernstam FM, et al. Disease-free and overall survival among patients with operable HER2-positive breast cancer treated with sequential vs concurrent chemotherapy. JAMA Oncology. 2018. Doi: 10.1001/jamaoncol.2018.3691

Study finds no difference in disease-free, overall survival for HER2+ breast cancer patients receiving treatment concurrently or sequentially. MD Anderson’s website. Accessed September 10, 2018.

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