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Results Indicate Improved Long-term Survival with Addition of Herceptin® to Taxotere® in Metastatic Breast Cancer
According to results recently presented at the 2005 annual meeting of the American Society of Clinical Oncology (ASCO), long-term results indicate that the addition of Herceptin (trastuzumab) to Taxotere (docetaxel) improves long-term survival in patients with HER2-positive metastatic breast cancer.
Herceptin is FDA approved as single-agent therapy in the treatment of HER2-positive patients with metastatic breast cancer that has recurred, or in addition to Taxol® (paclitaxel) as initial therapy in the treatment of HER2-positive metastastic breast cancer. The addition of Herceptin to taxane therapy has demonstrated significant activity, including prolonged survival. The M77001 multi-center trial included HER2-positive breast cancer patients with metastatic disease who were randomized to Herceptin (4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression) plus Taxotere (100 mg/m2 q3 weeks x 6 cycles) versus Taxotere alone as initial therapy. Patients randomized to Taxotere were allowed to cross over to the Herceptin arm upon progression.
The results presented at this year’s ASCO meeting included data at a follow-up of 24 months after the last patient entered the M77001 trial. At the 24-month cut-off, significant improvements were sustained in the Herceptin arm, including long-term survival. Patients randomized to the Herceptin arm (n=92) had an overall response rate of 61%, and those randomized to the Taxotere-only arm had a response rate of 34% (p=0.0002). Overall survival was 31.2 months for patients randomized to Herceptin, compared with 22.7 months for patients randomized to Taxotere-only (p=0.0325). The incidence of febrile neutropenia was greater in the Herceptin arm (23% vs 17%), and congestive heart failure occurred in 2% of patients treated with Herceptin, compared to 0% of patients treated with Taxotere only. However, the researchers reported that Herceptin added little toxicity when combined with Taxotere.
The researchers concluded that long-term results demonstrate an improvement in long-term survival in patients treated with Herceptin in addition to Taxotere, compared to Taxotere alone in the treatment of HER2-positive, metastatic breast cancer, with low toxicity.
Reference: Extra J, Cognetti F, Maraninchi D, et al. Long-term survival demonstrated with trastuzumab plus docetaxel: 24-month data from a randomized trial (M77001) in HER2-positive metastatic breast cancer. Proceedings from the annual meeting of the American Society of Clinical Oncology. Orlando FL. 2005; Abstract #555t.
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