Skip to main content
padlock icon - secure page this page is secure

Role of Anti-HER-2 Therapies in the Neo-Adjuvant Setting: Is Complete Pathological Response a Solid Surrogate?

Buy Article:

$68.00 + tax (Refund Policy)

Breast cancer continues to be a major health problem. Both patients and clinicians demand faster access to drugs that could result in better outcomes. In part motivated by this necessity, there has been a change in the dominant paradigm regarding how drugs become approved. Complete pathological response (pCR), understood as the absence of remanent and viable tumor after a neoadjuvant treatment, is now considered by a large proportion of the medical community as a valid surrogate. The presumption is that patients achieving pCR are less likely to develop tumor recurrence. Consequently, if a drug can improve the number of patients achieving pCR it could then obtain approval by the regulatory agencies. Pertuzumab, an anti-HER- 2 monoclonal antibody, was granted accelerated approval based on this principle. The unprecedented approval of this drug is now an example that can help us to understand the advantages but also the potential risks associated with this new approach. In this review, we will discuss the results of the two clinical trials leading to the FDA-approval of pertuzumab in the neo-adjuvant setting. We will also analyze the outcomes from long term follow up of two important neoadjuvant clinical trials, the NeoALTTO and the NOAH studies. These last ones had provided further insights regarding the magnitude, the quality as well as some limitations of the relationship between pCR and harder endpoints such as event-free or overall survival. It seems evident that the acknowledgement of pCR as a potential surrogate endpoint represents an important step in the right direction. However, it still remains controversial whether this is applicable to all subtypes of breast cancers. Additional investigations may be necessary to safely generalize this concept.
No References
No Citations
No Supplementary Data
No Article Media
No Metrics

Keywords: Breast Cancer; HER-2; NOAH NeoSphere; NeoALTTO; THYPHAENA; neoadjuvant; pertuzumab; trastuzumab

Document Type: Research Article

Publication date: June 1, 2015

More about this publication?
  • Reviews on Recent Clinical Trials publishes frontier reviews on recent clinical trials of major importance. The journal's aim is to publish the highest quality review articles in the field. Topics covered include: important Phase I - IV clinical trial studies, clinical investigations at all stages of development and therapeutics.

    The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials.
  • Editorial Board
  • Information for Authors
  • Subscribe to this Title
  • Ingenta Connect is not responsible for the content or availability of external websites
  • Access Key
  • Free content
  • Partial Free content
  • New content
  • Open access content
  • Partial Open access content
  • Subscribed content
  • Partial Subscribed content
  • Free trial content
Cookie Policy
Cookie Policy
Ingenta Connect website makes use of cookies so as to keep track of data that you have filled in. I am Happy with this Find out more