DOI: 10.1097/01.COT.0000326164.96851.64

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Issn Print: 0276-2234

Publication Date: 2008/06/25


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Two New Herceptin-Containing Regimens Approved

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The FDA has approved two new regimens containing trastuzumab (Herceptin) for the adjuvant treatment of HER2 node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer.
The first regimen, known as TCH (docetaxel [Taxotere], carboplatin, and trastuzumab), is in combination with docetaxel and carboplatin and does not contain an anthracycline component. When compared with the second regimen, AC-TH, which contains an anthracycline (doxorubicin), cyclophosphamide, and docetaxel, TCH is thought to provide a similarly effective treatment with less toxicity, which may allow more patients to benefit from and complete trastuzumab therapy.
The approval follows results from the BCIRG 006 study, which demonstrated increased disease-free survival with both trastuzumab-containing arms when compared with chemotherapy alone. The relative risk of recurrence was reduced by 33% and 40% with TCH and AC-TH, respectively, when compared with chemotherapy alone.
Congestive heart failure occurred in 0.4% of patients in the TCH arm and 2% of patients in the AC-TH arm, vs 0.3% of patients receiving chemotherapy alone. Grade 3–4 cardiac ischemia or infarction occurred in 0.3% of patients randomized to the AC-TH arm, 0.2% in the TCH arm, and no patients in the chemotherapy-alone arm.
No cardiac deaths were reported, and adverse events were similar to those observed in previous trastuzumab+chemotherapy trials, with the exception of a low incidence of congestive heart failure in patients randomized to TCH.
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