TYKERB (lapatinib ditosylate) - Updated Information on Efficacy (Health Canada)

HER-2 Breast Cancer http://goo.gl/LwBZB (Photo credit: TipsTimes)

TYKERB (lapatinib ditosylate) - Updated Information on Efficacy - For Health Professionals - Recalls & alerts - Healthy Canadians Website: 

Note that this was previously highlighted in June of 2012 at ASCO in Chicago:

"In his discussion, Gunter von Minckwitz, MD, PhD, of the German Breast Group and the University of Frankfurt, Germany, said there is increasing evidence that lapatinib is not as active as trastuzumab in a number of breast cancer therapy settings, perhaps because of the rapid development of secondary resistance and because dual blockade appears to be the most promising approach for the future."

It often takes time, but Health Canada has now made notice of updated prescribing information.

Excerpt from Health Canada update via GlaxoSmithKline Inc:

"Subject: Updated Information on Efficacy - TYKERB® (lapatinib ditosylate)-based regimens are less effective than HERCEPTIN®(trastuzumab)-based regimens in certain settings:

Based on the results of preplanned interim analyses of two studies, GlaxoSmithKline would like to advise you of the following:

• In patients with HER2+ metastatic breast cancer who have not received prior trastuzumab, comparative data have shown that lapatinib-based regimens are less effective than trastuzumab based treatment regimens.

• Prescribers are reminded that TYKERB^® should not be prescribed in combination with capecitabine unless patients have progressed on prior trastuzumab therapy in the metastatic setting.

• GlaxoSmithKline has updated the TYKERB^® Product Monograph to include a statement that lapatinib-based regimens are less effective than trastuzumab-based regimens in certain settings.

CEREBEL(EGF111438) (N=540) is a randomised Phase III study comparing the effect of  lapatinib in combination with capecitabine relative to trastuzumab in combination with capecitabine on the incidence of CNS as site of first relapse in women with HER2 positive metastatic breast cancer. Patients were stratified based on prior trastuzumab treatment (yes versus no) and number of prior treatments for metastatic disease (0 versus ≥1 line). The study was stopped early due to results of a pre-planned interim analysis (N=475). There was superior efficacy with the trastuzumab plus capecitabine combination in terms of progression-free survival (PFS) and overall survival (OS) compared to the lapatinib plus capecitabine combination. Median PFS was 6.60 months in the lapatinib-containing arm compared with 8.05 months in the trastuzumab-containing arm (HR=1.30; 95%CI 1.04 to 1.64).  The median OS was 22.7 months in the lapatinib-containing arm compared with 27.3 months in the trastuzumab-containing arm (HR=1.34 (95%CI 0.95 to 1.90).

COMPLETE is a randomised Phase III study (EGF108919) (N=636) comparing the activity of lapatinib plus taxane followed by lapatinib alone versus trastuzumab plus taxane followed by trastuzumab alone as first line therapy for women with HER2 positive metastatic breast cancer. The study was stopped early due to superior efficacy of the trastuzumab plus taxane combination in terms of progression-free survival.  Results from a pre-planned interim analysis showed that  the PFS in the lapatinib-containing arm was lower than in the trastuzumab-containing arm (median PFS was 8.8 months in the lapatinib-containing arm compared with 11.4 months in the trastuzumab-containing arm; HR=1.33; 95% CI 1.06 to 1.67, p=0.01).  The hazard ratio for OS was 1.1 (95% CI 0.75 to 1.61; p=0.62), based on 18% (n=115) deaths."

The revised Product Monograph for TYKERB^® may be accessed on the Health Canada Website or on the Canadian Website of GlaxoSmithKline.

*Click here for link to full Health Canada release information.

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The Rare Disease Search Engine That Outperforms Google | MIT Technology Review

Logo of Office of Rare Diseases, part of United States National Institutes of Health. (Photo credit: Wikipedia)

The Rare Disease Search Engine That Outperforms Google | MIT Technology Review: 


Exerpt:

"The problem (using google to search for rare diseases), of course, is that  common-or-garden search engines are not optimised for this process. Google, for example, considers pages important if they are linked to by other important pages, the basis of its famous PageRank algorithm. However, rare diseases by definition are unlikely to have a high profile on the web. What’s more, searches are likely to be plagued with returns from all sorts of irrelevant sources.

Although still a research project, Dragusin and co have made their rare disease search engine publicly available at www.findzebra.com. This could clearly become a valuable tool for the medical community.

What is less clear, however, is how this tool will be used by the general public. The site comes with the forlorn message: “Warning! FindZebra is a research project and it is to be used only by medical professionals” ."

Read the full article here.

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Cancer Rates in Canada: National Post Infographic

Cancer rates in Canada: Graphic | Graphics | News | National Post:

"Cancer killed 74,529 Canadians in 2009, making it the country’s top cause of death. With this in mind, the National Post’s Richard Johnson breaks down which cancers are killing us."

Click here to see NP's infographic regarding cancer numbers in Canada.

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Expert Explains How DNA Testing is Revolutionizing the Search for Family Roots, Ethnic Ancestry, and Genetic Health Information

Animation of the structure of a section of DNA. The bases lie horizontally between the two spiraling strands. (Photo credit: Wikipedia)

Your genetic health may be vitally important as you can inherit and develop hereditary illnesses. If you get married, there is also a genetic risk that you may pass certain health problems on to your children.

You may want to know more about your ethnic background and your ancestors. Would you be surprised to find out the real mix of European, Asian, and African ancestry? Would you want to know if there was a Native American or Ashkenazi Jewish ancestor in your bloodline?

Richard Hill author of the book Finding Family: My Search for Roots and the Secrets in My DNA, explains what the newest breakthroughs in DNA testing mean to people who want to gain from the knowledge of their family origins.

DNA Testing Breakthroughs Offer New Insights and Answers

The technology breakthroughs over past few years have resulted in DNA tests that are now readily available to answer all these questions and more.

A new science called genetic genealogy uses a variety of DNA tests to expand our knowledge of family trees. Instead of stopping when the paper trail runs out, genealogists and others are using individual test results and the vast and ever expanding databases of DNA results and online family trees to uncover previously unknown cousins and identify and confirm our common ancestors.

Adopted at birth, Mr. Hill was one of the first adoptees to use these tests to learn the truth about his own beginnings and reunite with his first family. However, there’s a revolution going on as countless people analyze their ancestral composition.

Direct-to-consumer tests are now quite inexpensive (currently $99 to $289) and allow you to collect your DNA sample in the privacy of your home.  The sampling process itself is painless – you either brush the inside your cheek or spit some saliva into a tube.

23andMe  www.23andme.com offers just one test, which includes a matching feature called Relative Finder. This test also includes a report on your genetic health traits.

DNA Test Comparisons Open Up the Door to Understanding

While many basic questions are answered by testing the DNA of just one person, the best results are often revealed by comparing the test results that that of another person and to the genetic data and information being compiled and stored in various databases.

• Finding biological relatives is achieved by comparing your DNA to all the individuals who took the same type of test.

• Information about your ethnicity comes from comparing your DNA to dozens of scientifically accepted population studies.

• Genetic health issues are ascertained by comparing your DNA against the findings of medical research. You can see how your risk for a particular condition compares to the average person of your age and background, the carrier status for diseases that could impact your descendants, and even your likely response to certain drugs.

Finding Family: My Search for Roots and the Secrets in My DNA

Richard Hill

List $15.00

Trade paperback 260 pages Also available in Kindle edition

ISBN-10: 1475190832  ISBN-13: 978-1475190830

Available in bookstores nationwide and online.

For more information visit www.DNA-Testing-Adviser.com

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