Investigators at Dana-Farber Cancer Institute (MA, USA) and other institutions have reported that women with small (stage I) HER2+ breast tumors receiving a combination of lower-intensity chemotherapy (paclitaxel) and a targeted drug (trastuzumab) following surgery were very unlikely to experience recurrence within 3 years of treatment. The findings of this Phase II clinical trial, published recently in the New England Journal of Medicine, may help establish the therapy as the first standard treatment approach for this group of patients.
Owing to the relatively low risk of disease recurrence among women with small (<2cm in diameter) HER2+ breast tumors that have not spread to nearby lymph nodes, many prior studies excluded this group of women from clinical trials of trastuzumab, as it was not considered advisable to expose them to an investigational drug. Thus treatment approaches for these women have varied widely due to the lack of a single, standard treatment.
“Women with small, HER-2+, node-negative breast tumors have a low, but still significant, risk of recurrence of their disease,” commented Eric Winer (Dana-Farber Cancer Institute), the study’s senior author. “This study demonstrates that a combination of lower-intensity chemotherapy and trastuzumab – which is associated with fewer side effects than traditional chemotherapy regimens – is an appealing standard of care for this group of patients.”
The trial included 406 patients with HER2+, node-negative breast tumors
A total of 3 years after therapy completion, 98.7% of the participants were alive and free of invasive breast cancer. Furthermore, the side-effect profile was milder than that associated with traditional chemotherapy regimens.
“We’re committed to identifying treatment regimens that are geared not only to the specific biological features of a woman’s cancer, but also to the stage of the cancer – the size of the tumor and how far it has advanced,” commented Sara Tolaney (Dana-Farber Cancer Institute), the study’s lead author. “This study is a prime example of the value of that approach.”