Herceptin(REG) Provides Proven Survival Benefit In Advanced Breast Cancer And The Best Chance Of A Cure In Early Breast Cancer
December 28, 2006 – 7:48 am | posted in Breast CancerCompelling new data confirming the survival benefits of Herceptin(REG) (trastuzumab) in early and advanced HER2-positive breast cancer were presented at the San Antonio Breast Cancer Symposium (SABCS).
Efficacy in Early Breast Cancer
BCIRG 006
Updated results of the BCIRG 006 study[i] showed that adding Herceptin to either of two adjuvant chemotherapy regimens reduced the risk of death by 34 to 41% compared with chemotherapy alone. Furthermore, the addition of Herceptin significantly reduced the risk of cancer coming back by 33-39%. These remarkable data confirm the survival benefit provided by Herceptin to women with HER2-positive early breast cancer, as previously seen in three other large adjuvant Herceptin studies[ii], [iii].
Efficacy in Advanced (Metastatic) Breast Cancer
Hermine
An observational cohort study investigated a large patient pool (623 patients) treated with Herceptin-based therapy under real-life conditions.[iv] Continuing Herceptin treatment after disease progression is associated with a marked survival advantage for patients with advanced stages of HER2-positive breast cancer:
- The median overall survival was 16.8 months for the group who did not continue Herceptin. For the group who received Herceptin after disease progression, the median overall survival had not yet been reached at 27.8 months
- Overall survival at 2 years was greater than 70% for those who continued Herceptin treatment after disease progression compared with less than 25% for those who did not
CHAT
The addition of Xeloda® (capecitabine) to Herceptin and Taxotere (docetaxel) as first-line therapy in patients with advanced HER2-positive disease increased the amount of time before their disease progressed[v]:
- Time to progression (the median amount of time from randomisation until tumour growth) increased significantly from 13.8 to 18.2 months
- Overall response rate (tumour shrinkage) was high in both arms, approximately 70%, without statistically significant difference
- At the time of the analysis, overall survival results were immature due to short follow-up. Follow-up of this study is ongoing and final data analysis is expected in 2007
TAnDEM
The addition of Herceptin to hormonal therapy, Arimidex (anastrozole), kept cancer under control for significantly longer than hormonal therapy alone in patients whose breast cancer is ‘co-positive’ for hormone receptor and HER2[vi]. The TAnDEM study is the first randomised trial in this population to show:
- Herceptin doubled the amount of time before patients’ disease progressed (4.8 months vs. 2.4 months; p = 0.0016)
- Patients in the combination arm responded significantly better to treatment (overall response rate was 20.3% versus 6.8%; p = 0.018)
- There was a positive trend in median overall survival (28.5 months versus 23.9 months) despite the fact that at least 70% of all patients randomized to receive anastrozole alone were treated with Herceptin later in the course of their disease.
M77001
Herceptin plus docetaxel given upfront provided a long term survival benefit in patients with HER2-positive metastatic breast cancer versus docetaxel alone[vii]:
- Long-term survival of more than 4 years which is uncommon in patients with HER2-positive advanced disease was twice as often in women receiving Herceptin plus docetaxel upfront (20 vs 10 patients)
- Patients treated with combination therapy survived, on average, at least 31.3 months compared with 22.7 months for patients on docetaxel alone
“These data confirm once again that Herceptin delivers compelling survival benefit in metastatic HER2-positive breast cancer and offers the best chance of a cure in early disease,†commented Dr Kapil Dhingra, Vice President, Medical Science, Oncology, Roche. “Herceptin is the only approved targeted tool we have to fight this aggressive type of breast cancer.â€
HER2 is a protein produced by a specific gene with cancer-causing potential. Approximately 20-30 percent[viii] of patients with breast cancer have tumours which strongly overexpress HER2. HER2-positive breast cancer is related to a poor overall prognosis with a faster time to relapse at all stages of the disease.
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