Roche announced new long-term follow up-data from two large pivotal studies evaluating adjuvant Herceptin 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 Herceptin 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 per cent of women receiving one year of Herceptin were alive free of the disease at five years follow-up.
“The course of this aggressive disease has been changed to the better, Herceptin is offering women with HER2-positive breast cancer greater chances of cure,” said William M Burns, CEO of Roche’s Pharmaceuticals Division. He continued, “The long-term follow-up results from pivotal studies solidly confirm that one year of Herceptin is the foundation of care.”
The trials confirmed Herceptin’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 Herceptin treatment.
N9831 is the only trial performed to study the impact of Herceptin administration either concurrently with or after chemotherapy. While the study clearly showed the long-term benefit of one year of Herceptin treatment with either regimen, there was a trend for the concurrent regimen being more beneficial to patients.
BCIRG006 evaluated Herceptin 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 Herceptin 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.”
N9831 is a US, phase-III, randomised, multicentre, open label trial of one year of adjuvant Herceptin.
BCIRG 006 is an independent, phase-III randomised study designed to evaluate the use of two chemotherapies (docetaxel and carboplatin) when combined with Herceptin following initial adjuvant treatment with doxorubicin and cyclophosphamide chemotherapy for early HER2-positive breast cancer.
Herceptin is a humanized antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential.