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BCIRG 006: Trastuzumab outperforms anthracycline-based therapy in HER2-positive tumors
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San Antonio Breast Cancer Symposium
Results from the third analysis of BCIRG 006 showed that patients with HER2-positive breasts tumors assigned trastuzumab had a disease-free survival as good as, or better than, that of patients assigned to anthracycline-based chemotherapy.
When presenting the results during the San Antonio Breast Cancer Symposium, Dennis J. Slamon, MD, PhD, said the new findings again showed that trastuzumab (Herceptin, Genentech) is as efficacious as anthracycline-based chemotherapy without similar toxicity.
“Trastuzumab provides a similar and significant advantage for both DFS and OS when used with either anthracycline-based or non-anthracycline chemotherapy,” said Slamon, director of clinical/translational research and director of the Revlon/UCLA Women’s cancer research program at Jonsson Comprehensive Cancer Center. “This advantage is seen in both low- and high-risk patients.”
In the three-arm trial, researchers assigned patients with axillary lymph node-positive or high-risk negative tumors to either standard doxorubicin and cyclophosphamide followed by docetaxel (ACT) or either doxorubicin/cyclophosphamide/docetaxel with trastuzumab for one year (AC-TH) or docetaxel and carboplatin with trastuzumab (TCH) for one year. Patients were prospectively stratified by number of positive nodes (zero, one to three vs. four or more) and hormone receptor status.
There were 214 DFS events in the TCH group (HR=0.75; 95% CI, 0.63-0.90) vs. 257 in the ACT group and 185 in the AC-TH group (HR=0.64; 95% CI, 0.58-0.78). There were 113 deaths in the TCH group (HR=0.77; 95% CI, 0.60-0.99) vs. 141 in the ACT group and 94 in the AC-TH group (HR=0.63; 95% CI, 0.48-0.81).
Slamon said there was no statistical advantage for DFS in the AC-TH arm compared with TCH, although there were 29 fewer events. However, he noted 21 congestive heart failures in the AC-TH group compared with four in the TCH group.
These new findings, he said, support the long-standing position that anthracyclines are unnecessary and often harmful for some patients.
“BCIRG-006 demonstrates that the incremental benefit conferred by anthracyclines that is known for HER2-positive patients, which is well known in the literature, is restricted to TOP2A co-amplified malignancies which constitute a subset of these cancers,” he said. “This same incremental benefit can also be achieved by trastuzumab used in a non-anthracycline regimen, avoiding the long-term and life-altering toxicities, congestive heart failure and acute leukemia, seen with the anthracycline-based regimens.” – by Jason Harris
For more information:
- Slamon D. #62. Presented at: the 32nd Annual CTCR-AACR San Antonio Breast Cancer Symposium; Dec. 9-11, 2009; San Antonio, Texas.
Dr. Slamon has a persuasive argument; however, the DFS is not 100% and there still are likely to remain subsets of patients who benefit from AC-TH more than TCH. It is interesting that the AC-TH arm is trending toward slightly better benefit, but that is not statistically significant. Moreover, these data are still unpublished, so I do not think it is safe to say that AC-TH is obsolete. Longer follow-up could help clarify this issue. One could also argue that it is unnecessary to administer trastuzumab when Topo IIa is co-amplified with HER2. TCH is a good regimen for women with concerns about cardiac function, which is a consistent finding through all of the analyses presented so far.
– Douglas Yee, MD
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