Focus on Inflammatory Breast Cancer Newsletter

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Without going into gruesome detail, sometimes the browser one uses affects the content being viewed. For example, this newsletter!

Internet Explorer sometimes does not play nicely with web pages, or this newsletter. If you are seeing something that looks very odd, chances are excellent that your browser of choice is Internet Explorer.

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--Carol McWilliams

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REDESIGNING CLINICAL TRIALS TO TEST THERAPIES THAT COULD PREVENT METASTASIS
by Ginny Mason, RN, BSN

The June 12 issue of the NCI Cancer Bulletin (Volume 9/ Number 12) contained a fascinating and thought provoking article titled "A Conversation with Dr. Patricia Steeg on Redesigning Clinical Trials to Test Therapies that Could Prevent Cancer Metastasis."

Pat Steeg

Dr. Steeg heads the Women's Cancers Section in NCI's Laboratory of Molecular Pharmacology and also serves on the Medical Advisory Board for the Inflammatory Breast Cancer Research Foundation.

The NCI Bulletin piece follows an article "Perspective: the Right Trials" published May 30 in Nature where Dr. Steeg focused on the need for clinical trial redesign if we are to adequately test therapies for the prevention of metastasis. To date most research is aimed at stopping the growth of cancer and trials are developed to determine the efficacy and safety of compounds that stop or delay cancer growth. These clinical trials rely upon measurement, typically by imaging, of the tumor to document regression, stability, and progression. Therein lies the problem. When you're trying to prevent metastasis with a compound, what do you measure to prove it is working?

As Dr. Steeg says, "metastasis research is tough to do. There is no in vitro, or lab bench, model for metastasis, so you have to use animals and the experiments are long and complex." Even when this work is a success in animals, it hits a huge speed bump when trying to move it to human clinical trials.

To move this type of much needed research forward Dr. Steeg proposes "phase II randomized metastasis-prevention trials". Phase I trials evaluate safety and often point to some activity, then Phase II trials work to further study safety and determine the maximum tolerated dose (MTD). In Dr. Steeg's "phase II randomized metastasis-prevention trials" the compound would move from Phase I and combine it with standard of care with the goal of metastasis prevention. Patients enrolled would either be free of metastasis with high risk for developing metastasis or those with limited metastasis that have received standard therapy. Patients would be randomized to standard of care with the new agent or placebo.

This is a new way of thinking about drug development and validation and is likely to be criticized by some in the field. However, as a patient and someone who desperately wants to find answers that will eliminate metastatic disease, it not only demands my attention, it demands my support. Nearly 40,000 women will die again this year of breast cancer and that number has only changed minimally in the last 10 years. If metastasis could be prevented that number would change dramatically.

I encourage you to read both the NCI Bulletin interview with Dr. Steeg and then the article in Nature.

ASCO 2012: My Take-Home Message
by Ginny Mason RN, BSN

[This is Part 1 of 2]

For those who haven't had the experience of trekking through a huge convention center amid 30,000 or so people, each trying to get to their next session, you just don't know how to have fun! June 1-5, 2012, this was the scene at McCormick Place, Chicago, during the Annual Meeting of the American Society of Clinical Oncology (ASCO). "Collaborating to Conquer Cancer" was this year's theme so many presentations focused on the need and value of collaboration in the control of cancer.

Each year I weigh the pros and cons of attending this meeting and ultimately come to the decision that it is important that I attend and represent the Inflammatory Breast Cancer Research Foundation's voice. There was very little information specific to inflammatory breast cancer (IBC) this year. Of the over 4,500 abstracts, searchable on-line, I found eleven abstracts that mentioned IBC. Four of those were not included in the meeting proceedings and only available on-line as "e-abstracts". Of the remaining seven, three were not specific to IBC but did include IBC patients in the featured study. That leaves just four that were focused on IBC and two of those were negative study reports. One abstract looked at the value of surgery for stage IV IBC concluding that controlled clinical trials were needed to verify value.

In spite of the dearth of IBC information there were numerous interesting and informative sessions, many with implications for the IBC community. Two sessions on targeting of the PI3K pathway were fascinating. Data presented is moving quickly to the clinic in breast cancer (both Her2+ and ER+) and some other cancers. The highly anticipated EMILIA study results for T-DM1 will bring it closer to market but the modest 3+ month progression free survival (PFS) was disappointing.

Of interest to those struggling with chemotherapy induced, treatment resistant nausea and vomiting, a study reported improvement for patients using Zyprexa, an atypical antipsychotic medication. These results were from a Phase III trial. Another compound from the mental health medicine chest, Cymbalta, was found to help manage peripheral neuropathy from chemotherapy.

Unfortunately we also learned that too many physicians (most often primary care providers) are not familiar with the major long-term side effects of the four types of chemotherapy most often used to treat breast and colorectal cancers. Survivorship sessions highlighted the need for communication between healthcare providers and cancer survivors to make sure good follow-up care includes monitoring for long-term side effects.

For those who follow the changing landscape of clinical trials, a session on "Endpoints for Cancer Trials in 2012" was a must attend. Safe, effective anticancer agents need to be brought to the clinic more rapidly but what endpoints can provide clinically meaningful benefit to the patient? This session wrestled with the overall survival (OS) vs. progression free survival (PFS) debate, surrogate endpoints, and the difficulty in finding the necessary flexibility to develop safe and effective drugs for anxiously waiting patients. While no clear answers were given the presentations and discussions were thought provoking.

Part 2 will be published in the August 2012 issue of Focus on IBC.

IBC Research Foundation Highlighted on Blog

Last month Jean Campbell of the blog "No Boobs About It...." interviewed Ginny Mason, Executive Director of the Inflammatory Breast Cancer Research Foundation for a feature on the organization. Ms. Campbell is a "two-time breast cancer survivor and former director of the American Cancer Society's New York City Patient Navigator Program." Like many others, Ms. Campbell's diagnosis of breast cancer brought about some self-examination as she looked to the future. She was able to use her patient experience in a new way as she established and developed the patient navigator program in New York City through the American Cancer Society.

Prior to her breast cancer diagnosis' Ms. Campbell worked as an educator and administrator, admitting that she was a 'closet writer'. Since the cancer she's been able to write full time and has had varied experiences in journalism. Ms. Campbell says it best when she wrote on her website, "I doubt I would have given myself permission to live my dream if it had not been for getting cancer."

For those not familiar with the blog "No Boobs About It....", it is a "not for profit organization sharing information, resources and support on getting through treatment and on with life." There is a wealth of informative stories, links to cancer resources, and stories from others on a variety of topics.

The Inflammatory Breast Cancer Research Foundation is grateful to Ms. Campbell and "No Boobs About It...." for highlighting the work of the Inflammatory Breast Cancer Research Foundation and for including the organization in the resource list. Hopefully visitors to the website will find the information of interest and will visit the website.

Read the blog entry.