Reach Us +44-1647-403003
Neoadjuvant Therapy For Early Stage Breast Cancer: A New Pathway To Registration? | 33667
ISSN: 1948-5956

Journal of Cancer Science & Therapy
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Neoadjuvant therapy for early stage breast cancer: A new pathway to registration?

World Congress on Breast Cancer

Graham Ross

Roche Products Limited, UK

ScientificTracks Abstracts: J Cancer Sci Ther

DOI: 10.4172/1948-5956.S1.041

One of the paradoxes in oncology research is that the more successful we are, the longer it takes to prove the clinical value of new treatments. Breast cancer is a very good example: from the time docetaxel was registered as a treatment for metastatic breast cancer, it took five years to define its role in the adjuvant treatment of early stage breast cancer; from the time trastuzumab was registered as a treatment for metastatic HER2 positive breast cancer it took eight years to establish its role in adjuvant therapy. It is imperative that we come up with strategies to accelerate the development process and to make new active therapies available to patients, especially in the era of molecular sub-typing and targeted therapies. Both the FDA and the EMA issued draft guidelines in 2014 on the potential for accelerated approval or approval with agreed conditions, respectively, based on the use of pathological Complete Response (pCR) following neoadjuvant therapy, provided that there certain criteria are met (for example the population treated needs to be at high risk of relapse, there has to be a convincing increase in the rate of pCR preferably by “adding on” to standard therapy in randomized studies, the mode of action has to be well characterized, the additional toxicity must be “minor” and a suitable confirmatory study needs to well underway). HER2 positive breast cancer is a good model for testing this potential new pathway, and the positive lessons as well as caveats and disappointments will be discussed.

Graham Ross was trained in Durban, South Africa in the Department of Radiotherapy and Oncology. For 20 years he has worked in medicines development in the pharmaceutical industry, the last nine years as the Global Clinical Science Leader for the development of pertuzumab. He has worked on the development of several compounds in various indications including small cell lung cancer, ovarian cancer, breast cancer and the management of emesis. He is a Fellow of the Faculty of Pharmaceutical Medicine.

Relevant Topics