April 17, 2014
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Trastuzumab associated with durable EFS in HER-2–positive breast cancer

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Patients with locally advanced or inflammatory HER-2–positive breast cancer who underwent neoadjuvant chemotherapy plus trastuzumab followed by adjuvant trastuzumab demonstrated durable EFS, according to updated phase 3 study results.

The analysis included 235 patients with HER-2–positive breast cancer. Of these patients, 118 received chemotherapy alone, and 117 received chemotherapy plus trastuzumab (Herceptin, Genentech) for 1 year before and after surgery. Ninety-nine patients with HER-2–negative disease who were included in a parallel cohort received neoadjuvant chemotherapy alone.

Researchers conducted additional long-term analyses after a median follow-up of 5.4 years (Interquartile range, 3.1-6.8).

A higher percentage of patients assigned chemotherapy plus trastuzumab achieved 5-year EFS (58% vs. 43%; HR=0.64; 95% CI, 0.44-0.93).

Sixty-eight patients achieved pathologic complete response (trastuzumab, n=45; chemotherapy alone, n=23). Researchers identified a strong association between pathologic complete response and EFS in patients assigned trastuzumab (HR=0.29; 95% CI, 0.11-0.78).

Researchers noted one case each of grade 2 lymphostasis and grade 2 lymphoedema in the trastuzumab arm, and one case each of grade 2 thrombosis and grade 2 deep vein thrombosis in the chemotherapy arm.

“These results show a sustained benefit in EFS from trastuzumab-containing neoadjuvant therapy followed by adjuvant trastuzumab in patients with locally advanced or inflammatory breast cancer, and provide new insight into the association between pathological complete remission and long-term outcomes in HER-2–positive disease,” the researchers wrote.

Disclosure: The study was funded by F. Hoffmann-La Roche.