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Targeted and Biological Therapies |
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Welcome to the Targeted and Biological Therapies SIG website. A few things to help you:
1) Bookmark this address for easy access to the site: biotherapy.vc.ons.org
2) This site is intended to be an index of resources for our Sig members interested in targeted therapies. It's still a work in progress and we're very eager to hear your comments and wishlists.
3) 01/12/2012 Highlights thus far:
- Check out the Congress highlights section to find out about Congress events
- We've uploaded three important files as resources: Index table with links for the monoclonal antibodies, Index table with links for the small molecule inhibitors, and an animated power point presentation of the targeted therapies basic mechanisms.
Thanks for visiting our site and we very much look forward to hearing from you!
Kristine Abueg, RN, MSN, OCN, CBCN
kdeano@hotmail.com
SIG Coordinator
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Congress 2012 is quickly approaching!!
Highlights and suggested sessions for SIG members
Unique Dermatology and Quality of Life Needs in Targeted Therapy & Special Attention to Elderly
Christine Boers-Doets, CNS, researcher
The dermatologic side effects of targeted therapy can be especially challenging for older adults. In addition to the cosmetic issues, patients are troubled by the associated symptoms of irritation, pain, stinging and itching as well as existing comorbid conditions. Also, some complications (e.g., mucositis, loss of appetite, dehydration, dry skin, forgetfulness, fatigue, decreased renal function, peripheral neuropathy, cardiomyopathy) are more common in this population and can interfere with therapy. Effective collaboration between the nurse and dermatologist is crucial to a patient's diagnosis and treatment. This session will specifically focus on dAE's as the impact the older population. Additionally, a second major focus will be the assessmen of dermatologic adverse events (dAE) on the Health Related Quality of Life using, the FACT-EGFRI-18, an 18-item symptom specific, patient reported outcome (PRO) measurement.
PARP is a Perp: Biology of Cancer Update
Julie Eggert, PhD, RN, GNP, AOCN
Emerging knowledge about the biology of cancer is leading basic science researchers to target and develop new treatments for cancer. An understanding of the biology of cancer is important for nurses as they care for and educate their patients while communicating effectively with their professional colleagues. A new and unique treatment approach is the Poly(ADP-Ribose) Polymerase (PARP) enzyme inhibitors. The objectives of this interactive, instructional session are to describe the action of new therapies based on the PARP enzyme in relation to cancer biology; identify the role of the nurse in patient education and symptom management during PARP inhibitor therapy; and, apply principles presented in the session to a clinical scenario. Some therapies in clinical trials will be identified and discussed as examples. This is the first time PARP inhibitor information has been included in the Congress schedule. An innovative game of DNA Repair Jeopardy to highlight and re-enforce pearls of new knowledge from the session content and participation in a clinical scenario will engage participants and assist in the delivery of content. Participants will walk away from the session with new knowledge about advances in cancer therapy, patient education and symptom management for the PARP inhibitors.
What's New in HER2: Advances in Anti-HER2 Therapeutics
Kristine Abueg, RN, MSN, OCN, CBCN
HER2 positive breast cancer is a notably aggressive form of the disease associated with high rates of metastases, recurrence, and mortality. Since their advent anti-HER2 agents have had significant impact on survival rates. This session will begin with a review of the biology of HER2 targeting using animation to illustrate mechanisms. Clinical applications (risks and benefits) of currently approved agents will be reviewed next. The major foci of this session are two key areas of research and controversy: a) refinement of testing techniques and b) emerging anti-HER2 agents. This session will utilize patient case studies of both adjuvant and metastatic cases. The interactive participant responder system will be used to facilitate audience participation and to gauge audience familiarity with both current NCCN guidelines and as well institution-specific practices.
Personalized Healthcare: Interpreting What it Means for the Practitioner and the Patient
Karen Roesser,RN,MSN,AOCN
Mary Thomas , RN MS AOCN
Personalized medicine/healthcare is discussed everyday as the “latest” way to practice and the direction we are going in with all of our care of patients with cancer. This session will begin with an overview of what personalized healthcare means and will then utilize case scenarios to describe patients with two different diseases: colon cancer and multiple myeloma. Personalized care will be addressed from diagnosis, to tumor pathology, to further testing, and treatment. Throughout this, the use of biomarkers and the utilization of targeted therapies to assist in the decision-making process and work-up of a patient will be discussed. The clinician will be directed toward the individual features associated with this patient’s cancer and how care was aimed toward this.
We hope to see you there!
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Targeted Therapy News - Bevacizumab 1/12/2012 |
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By now you may have heard in the news about changes in bevacizumab indication by the FDA. Bevacizumab will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme); however, as described below breast cancer will be removed as an indication. The text below is from the NCI website (http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab) accessed 01/12/2012:
On November 18, 2011, Food and Drug Administration Commissioner Margaret Hamburg revoked the agency’s accelerated approval of the breast cancer indication for bevacizumab (Avastin®, made by Genentech). Bevacizumab used for metastatic breast cancer has not been shown to provide a benefit, in terms of delay in the growth of tumors, that would justify its serious and potentially life-threatening risks. Nor is there evidence that use of bevacizumab will either help women with breast cancer live longer or improve their quality of life.
This decision involves bevacizumab used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from bevacizumab's product labeling.
Bevacizumab was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.
After the accelerated approval of bevacizumab for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.
FDA's Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication. Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That hearing took place June 28-29, 2011.
Dr. Hamburg has now made her decision based on a review of the arguments and evidence presented at the hearing, briefs filed by both CDER and Genentech before and after the hearing, public comments and data from multiple clinical trials.
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Targeted and Biological Therapies SIG's Favorites |
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