Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0268596 (EMA)
 2,520 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Pertuzumab is a humanized monoclonal antibody targeting HER2 that is different from trastuzumab in that it binds to a different domain of HER2; hence, combining the two drugs leads to a more comprehensive blockade of the receptor. This is the first drug to receive fast-track approval from US FDA based on the pathologic complete response (as the primary end point) attained in patients treated with neoadjuvant chemotherapy for breast cancer. Pertuzumab is approved in first-line treatment in metastatic setting both by FDA and EMA in combination with trastuzumab and docetaxel. Combining two targeted therapies ('dual blockade') will certainly escalate treatment costs and it remains to be seen if this strategy will find its way in to the clinic for all patients.
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PMID:Pertuzumab: a new anti-HER2 drug in the management of women with breast cancer. 2576 Sep 74

In 2005, two adjuvant trials revolutionised breast cancer treatment demonstrating a 50% reduction in relapses when trastuzumab was added to adjuvant chemotherapy. In order to improve further on these results three large phase III trials were conducted. ALTTO trial evaluated lapatinib. This trial was negative and lapatinib was quite toxic. ExteNET trial evaluated neratinib in patients who already had completed adjuvant treatment with trastuzumab. Neratinib reduced the risk of relapse by 27% and the drug is FDA approved. However 40% of patients experienced grade 3 diarrhoea and this toxicity profile will be an issue in daily practice. APHINITY trial evaluated a combination of pertuzumab and trastuzumab. Pertuzumab reduced the risk of relapse by 19% with a good toxicity profile. However the absolute invasive disease-free survival (IDFS) benefit at 4 years was only 1.7%. Despite this modest absolute benefit we believe that pertuzumab should be added to trastuzumab at least in two indications: first, in patients with node positive breast cancer, in whom the absolute IDFS benefit is 3.2% and qualify for a high clinical benefit based on ESMO magnitude of clinical benefit scale; second, in patients suitable for neoadjuvant chemotherapy. In this group, the absolute IDFS benefit could be estimated as high as 7% (starting pertuzumab in the neoadjuvant setting and following it in the adjuvant setting up to a total of 18 injections). Our arguments are developed in this viewpoint. Pertuzumab is approved in these two indications by FDA and EMA.
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PMID:Category "viewpoints and debates" Is trastuzumab as a single agent obsolete in early breast cancer? Yes. 3073 44