CEBU, Philippines - Roche announced recently its new long-term follow up-data from two large pivotal studies evaluating adjuvant trastuzumab in HER2-positive early- stage breast cancer presented at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). Both studies, N9831 conducted by the North Central Cancer Treatment Group (NCCTG) and BCIRG006 performed by the Breast Cancer International Research Group consistently showed that trastuzumab reduced the risk of the cancer returning by about one third in women with HER2-positive early breast cancer compared to patients receiving chemotherapy alone. In both studies, at least 80% of women receiving one year of trastuzumab were alive free of the disease at 5 years follow-up.
“The course of this aggressive disease has been changed to the better, trastuzumab is offering women with HER2-positive breast cancer greater chances of cure,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division. He continued by saying: “The long-term follow-up results from pivotal studies solidly confirm that one year of trastuzumab is the foundation of care.”
The trials confirmed trastuzumab’s favourable cardiac safety profile at long-term follow-up. In addition, both studies were seeking to answer questions the medical community has been contemplating regarding the best way of giving their patients trastuzumab treatment.
N9831 is the only trial performed to study the impact of trastuzumab administration either concurrently with or after chemotherapy. While the study clearly showed the long-term benefit of one year of trastuzumab treatment with either regimen, there was a trend for the concurrent regimen being more beneficial to patients.
BCIRG006 evaluated trastuzumab in combination with anthracycline-based chemotherapy versus an anthracycline free regimen. The study showed that both approaches extended survival without the cancer returning as well as overall survival compared to chemotherapy alone.
Dr. Dennis Slamon, director of clinical/translational research at UCLA’s Jonsson Comprehensive Cancer Center, highlighted “It is very rewarding to see that trastuzumab provides survival benefits when given in combination with anthracycline-free chemotherapy, thereby offering a better cardiac safety profile compared to the combination with anthracycline containing therapy.”