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Old 10-03-2014, 09:11 AM   #1
Hopeful
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Join Date: Aug 2006
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CLEOPATRA Trial Changes Standard Therapy for Metastatic HER2 Positive Breast Cancer

Successful targeting of the HER2 oncogene with trastuzumab plus chemotherapy converted HER2+ breast cancer from the worst prognosis to the best. Updated survival rests of CLEOPATRA, adding pertuzumab to docetaxel and trastuzumab, improved median OS by 16 months, more than the PFS was increased by dual anti- HER2 antibody therapy. This huge step forward confirms the power of dual blockade early in the treatment of HER2+ metastatic breast cancer.

Lugano/Madrid, 28 September 2014 -- Dual targeting with pertuzumab and trastuzumab plus chemotherapy has become the new standard therapy in metastatic HER2 positive breast cancer following the results of the CLEOPATRA trial, according to Dr Giuseppe Curigliano, Director of the Division of Experimental Therapeutics in Milan, Italy. Curigliano commented on treatment for metastatic HER2 positive breast cancer as the results of the landmark CLEOPATRA study were presented at the ESMO 2014 Congress in Madrid, Spain.

Curigliano said: “The CLEOPATRA trial changes clinical practice. We now have a new standard of care for patients with metastatic HER2 positive breast cancer. This is dual targeting with pertuzumab and trastuzumab plus chemotherapy, which was docetaxel in the trial. In the future, in any country of the world, when you have a patient with metastatic breast cancer that is HER2 positive, the proposal for treatment should include dual targeting with pertuzumab and trastuzumab plus chemotherapy.”

Highlighting the impact of this new treatment regimen on overall survival, Curigliano said: “The results of the study are really outstanding, because there is a 56.5 month median overall survival - that is unprecedented in first-line metastatic breast cancer. And the difference in overall survival between the previous standard of care (trastuzumab alone) and the new standard of care (dual targeting) is 15 months. This study provides sufficient evidence to demonstrate that dual targeting is better than mono-targeting in the metastatic setting.”

Similar efficacy results have been reported in the neoadjuvant setting. The NeoSphere trial found that dual targeting with pertuzumab and trastuzumab plus chemotherapy significantly improved the percentage of patients with early HER2 positive breast cancer who had a pathological complete response.

The potential of dual targeting in the adjuvant setting is being investigated in the ongoing APHINITY trial, which is comparing dual targeting with pertuzumab and trastuzumab versus trastuzumab alone. Curigliano said: “If data from the metastatic setting are confirmed in the adjuvant setting, we will also have a new standard of care in the adjuvant setting.”

Other trials are studying dual targeting with chemotherapeutic agents other than docetaxel. These include the PERUSE trial, a study of pertuzumab in combination with trastuzumab and a taxane in first-line treatment in patients with HER2 positive advanced breast cancer and the VELVET trial, which is testing a combination of pertuzumab, trastuzumab and vinorelbine for first-line treatment of patients with HER2 positive metastatic breast cancer.

Commenting on the safety profile in CLEOPATRA, Curigliano said: “The safety profile of pertuzumab and trastuzumab plus chemotherapy was consistent with the known safety profile of patients with long-term exposure to dual targeting. It means that we now have a treatment that improves overall survival and progression-free survival without affecting the quality of life of patients in terms of cardiac safety.”

He continued: “This is a very important point because we know that long-term exposure to trastuzumab may decrease left ventricular ejection fraction. CLEOPATRA did not find excessive toxicity in the dual targeting arm.”

Curigliano concluded: “The idea of using two monoclonal antibodies to target two different epitopes of an antigen can be exploited not only in breast cancer but in other solid tumours as well. The CLEOPATRA trial, together with trials in the neoadjuvant setting, is pioneering a new approach to treating breast cancer and other solid tumours.”

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