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Focus on IBC
Inflammatory Breast Cancer Research Foundation Newsletter
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American Society of Clinical Oncology (ASCO) Annual Meeting
by Ginny Mason, R.N, B.S.N.,Executive Director Last month I reported some basics on the American Society of Clinical Oncology (ASCO) Annual Meeting that took place June 3-7, 2011, at McCormick Place in Chicago, IL. The ASCO Annual Meeting is an enormous gathering of oncology professionals and advocates and can be overwhelming even to the veteran attendees. Our thanks to the Conquer Cancer Foundation of ASCO whose scholarships to Board member Gayla Little and me, covered our costs to attend this year. Earlier I reported on some general aspects of the meeting but didn't highlight the posters or presentations specific to IBC. This was not a "big" year for IBC, however there are seven abstracts on IBC available (enter the first 10 words of the title as shown below in the search box). Search 2011 ASCO Abstracts. - Use of HER2 amplification in the primary tumor to predict presence of circulating tumor cells in inflammatory breast cancer.
- Primary efficacy analysis of a phase II study of neoadjuvant bevacizumab (BEV), chemotherapy (CT), and trastuzumab (H) in HER2-positive inflammatory breast cancer (IBC): BEVERLY2 study.
- Therapeutic response to induction chemotherapy and prognosis of patients with inflammatory breast cancer in respect to HER2 and hormonal status.
- Correlation between miRNA and gene expression profiles and response to neoadjuvant chemotherapy in patients with locally advanced and inflammatory breast cancer.
- Postoperative complications in neoadjuvant treatment including bevacizumab for HER2-positive inflammatory breast cancer (IBC): Results from a phase II prospective trial.
- Long-term survival after high-dose chemotherapy followed by peripheral stem cell rescue for high-risk locally advanced/inflammatory and metastatic breast cancer.
- Outcomes of inflammatory versus noninflammatory T4 breast cancers in the age of taxanes and trastuzumab.
I'll admit there may have been additional abstracts that I didn't locate amid the thousands and thousands of entries! When attending a meeting like ASCO that covers all types of cancers, it can be useful to attend at least one session on something other than breast cancer. Since one of ibcRF's Medical Advisory Board members specializes in melanoma, I opted to attend two sessions on melanoma. With some exciting new treatment options for melanoma taking the spotlight at ASCO, these sessions were heavily attended, and interesting! It's important for advocates to broaden their horizons and take in sessions in areas other than their cancer of interest. It was exciting to see more international advocates attending this year's meeting. The ASCO leadership arranged a special time for the international advocates to connect with those of us from the U.S. and share with one another. I had another international opportunity through Advocacy in Action a program produced by Vital Options. Specific members of the cancer advocacy community were invited to participate in a discussion about international cancer advocacy. Professor David Kerr, President of the European Society of Medical Oncology (ESMO) set the stage for the discussion by sharing challenges in the global cancer community. In his soft-spoken Irish brogue, Professor Kerr implored the advocates to join their voices and efforts together to assist with cancer advocacy efforts worldwide. It was an exciting opportunity to be a part of the discussion. Part 1 of the discussion video is online: Advocacy in Action: International Perspectives in Cancer Patient Advocacy. If reading scientific abstracts provides more detail than you're interested in, visit ASCO's patient information website where you can listen to audio podcasts, view videos, and find research summaries from the Annual Meeting. If you are interested they have an e-newsletter available as well. All this is free and geared to patients and their families. While IBC information was limited this year, there were plenty of posters (4000+), presentations, and sessions focusing on various aspects of breast cancer. Triple negative breast cancer (TNBC), which doesn't over express estrogen, progesterone or the Her2/neu oncogene, seemed to be the subgroup of interest. Abstracts specific to TNBC can be found by using the search 2011 Abstracts link and putting the words triple negative on the title line. Of particular interest to many of the advocates were the presentations on the use of Metformin, a drug used to control blood glucose levels in diabetics. Metformin has been shown to be associated with a reduced incidence of breast cancer and enhanced response to neoadjuvant chemotherapy in epidemiological studies of diabetic women. Results were reported from a phase II trial testing the hypothesis that Metformin has anti-cancer effects in non-diabetic women with breast cancer. Antiproliferative (growth inhibiting) and anti-cancer effects were noted and there are trials testing the use of Metformin, a common and inexpensive drug, in the treatment of breast cancer. While this is still in clinical trials, this certainly bears watching. Dr. Bryan Schneider of Indiana University presented some exciting work on the final day of the meeting. His study focused on single nucleotide polymorphisms (SNPs) associated with the development of peripheral neuropathy (nerve damage to hands/feet) in patients taking paclitaxel. Again, this is early data but it is exciting to think patients could be screened for this potential side effect before exposing them to the drug. This is the same Dr. Schneider who received a research grant from the Inflammatory Breast Cancer Research Foundation last year to study triple negative IBC samples using Next Generation Sequencing in the hopes of identifying new targets for therapy. In the midst of posters, presentations, and meetings with researchers/clinicians we did fit in some "fun" things as well. Invitations for an IBC get-together went out via email discussion lists and two Chicago area IBCers RSVP'd to join those of us at the meeting for dinner. You'll see our time together documented in the photo that accompanies this article. Melody, Kelly, Ginny, Lezli, Valerie and Gayla (along with Gayla's husband, Michael) enjoyed some wonderful Italian food and shared IBC stories. It was a special evening and great to make some new friends. Clearly ASCO isn't for everyone. It is a huge meeting and can be completely overwhelming since it deals with all forms of cancer. However, it is an excellent place to connect with other advocates, learn about the newest clinical trial data, and gain a better understanding of what's happening in the broader field of oncology. I hope this article will encourage you to explore further and visit http://www.asco.org to learn more. |
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Lezli, Kelly, Ginny, Melody,Valerie, Gayla
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In Our Own Words
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This is a newly revised portion of the web site that consolidates access to our personal stories of Inflammatory Breast Cancer. Included are inspirational stories of hope, help, and memories; erroneous explanations of IBC symptoms given by doctors; and essays on topics such as "What You Can Do For Me," Friends, "Cancer and the Support Community," and "Post-Treatment Depression: What to Expect and What to Do."
Click the title of this article to go directly to that page. Or find it in the left side menu of all pages on the
IBC Research Foundation web site.
Take a look--you may find your story or that of a loved one previously submitted to the foundation. If your story is not there, and you would like to share it, send via email to Carol.ibcrf@gmail.com. Please include a written permission to post it, and how you would like your name to appear (first and last, first name and state, etc.). If you wish to update an existing story, just send the update and the name of the person whose story you are updating.
These are the stories that never, never die, that are carried like seed into a new country, are told to you and me and make in us new and lasting strengths."-- Meridel Le Sueur (1900-1996)
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Upcoming Events
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July 27 - National Cancer Institute (NCI) Town Hall Meeting; Warren Grant Magnuson Clinical Center @ NCI; 11 am. (meeting will be videocast live).
Videocast link.
Aug 2-5 - Era of Hope; Department of Defense (DOD) Breast Cancer Research Program Conference, Orlando, FL.
More information.
Aug 10-12 - The Science of Compassion: Future Directions in End-of-Life and Palliative Care; Bethesda, MD.
More information.
Aug 12-14 - Men Against Breast Cancer's National Male Caregivers' Conference; Atlanta, GA.
More information.
Sept 8-10 - Breast Cancer Symposium 2011; American Society of Clinical Oncology (ASCO), San Francisco, CA.
More information.
Sept 20 - Monitoring for Recurrence and Managing Fears; Teleconference.
More information.
Oct 1 - News You Can Use: Breast Cancer Updates for Living Well; LBBC's Annual Fall Conference.
More Information.
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Quick Links
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1-877-STOP-IBC 1-877-786-7422
email: |
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What Next? The Avastin Saga
by Ginny Mason
In December 2007, the Oncologic Drug Advisory Committee (ODAC) of the Food & Drug Administration (FDA) met to provide guidance to the FDA regarding potential accelerated approval for Avastin (bevacizumab). As in most ODAC meetings, the FDA representative provided an opening statement that was followed by the sponsor (pharmaceutical company), in this case Genentech. Once the sponsor presented the compound basics along with clinical trial, safety and efficacy data the FDA took the podium and presented their interpretation of the same data covered by the sponsor. After both presentations the ODAC panel members asked questions of both the sponsor and FDA. It's important to remember that ODAC members are provided confidential material ahead of time so they can prepare for the meeting. Many come with a list of questions based on the pre-meeting information. All of this took place during an open meeting, although there was no input from the audience until a specified time.
Following the discussion period a public hearing took place for individuals to present their thoughts at the microphone. To speak during the public hearing, individuals must register in advance with the FDA. Speakers are encouraged to disclose any financial ties to the sponsor but are not required to do so. ODAC panel members go through a rigorous conflict of interest screening prior to each meeting and are disqualified if there is any potential bias noted.
At the close of the public hearing the meeting most often moves to the "question(s)" presented by FDA to the ODAC panel for a vote. Sometimes there are 'discussion only' questions that do not require a vote, but in the case of the Avastin meeting, there was a vote. After much discussion, the vote was taken and the result indicated a split (5 to 4) in the panel that favored not granting accelerated approval to Avastin. However in 2008, FDA granted accelerated approval to Avastin for first line treatment in metastatic breast cancer based on the progression free survival (PFS) improvement demonstrated in the E2100 clinical trial. No overall survival (OS) benefit was demonstrated by the trial. FDA made it clear that conversion of the accelerated approval to full approval would require confirmatory clinical benefit and no new safety signals in the post-marketing trials that were currently underway at the time of the meeting.
The 2008 decision allowed Genentech to market Avastin for metastatic breast cancer while additional trials were conducted and data collected, per the guidelines set forth in the accelerated approval program. Accelerated approval allows a promising new treatment to be used in the patient population while additional data is collected. Of course one hopes the additional trials will indeed confirm the benefit and show no new safety issues. The sponsor will be required to provide confirmatory data to the FDA in a timely fashion if full approval is sought.
Fast forward to July 2010 when ODAC convened to determine if the new data confirmed the clinical benefit of the magnitude seen in E2100, the pivotal trial for Avastin in breast cancer. In a scenario similar to that of the 2007 meeting both the sponsor and FDA presented the combined results of the completed trials. Disappointingly, none of the confirmatory trials provided increased OS and unfortunately did not back up the strong PFS signal noted in the E2100 trial. The true effect appeared to be much smaller than anticipated at the time of the accelerated approval decision. With these results the ODAC panel felt the risks outweighed any potential benefit for Avastin as a treatment for metastatic breast cancer. The panel was not specifically asked if the metastatic breast cancer indication should be withdrawn, instead the questions to ODAC had to do with demonstrated statistically significant PFS in the confirmatory trials.
Later, when the FDA announced their intent to remove metastatic breast cancer as an approved indication from Avastin, there was outrage from many in both the public and medical community. Petitions were circulated in an attempt to sway FDA into leaving the metastatic breast cancer indication and numerous articles appeared across the media. In the midst of all the media attention, Genentech appealed the
decision for withdrawal of approval and asked for a special hearing on the subject.
Scheduled for June 28-29, 2001, the 2-day hearing was a first of its kind for the FDA, and Genentech is the first company to challenge the withdrawal of a drug indication from the market. The format was not the typical ODAC meeting scenario but instead more of a courtroom atmosphere with the ODAC members forming something akin to a jury and lawyers representing both sides. There were presentations by the
sponsor and FDA as well as hours of patient testimony. Karen Midthun, director of the Center for Biologics Evaluation and Research (CBER) presided over the meeting and was charged with keeping participants on track.
Various reports of the meeting speak to the sensitivity and emotions associated with the topic. Security at the FDA campus was heightened, protestors were visible on the highway at the entrance to the compound, and ODAC members were quietly brought into the building through a back entrance. Not all sitting members of the ODAC panel were able to attend and participate in the hearing. Some suggested this was a deliberate attempt to "stack the deck" by the FDA to obtain a desired outcome. The atmosphere was tense as the data were presented, once again, and testimony heard. After two days, a series of questions were presented to ODAC and as they had before, the panel concluded that the data presented did not present an adequate risk benefit profile to continue marketing of Avastin for metastatic breast cancer. However, FDA did encourage the sponsor to continue with trials and research that might characterize any further benefit and stressed they would be willing to work with the sponsor on such plans.
The hearing is over now and FDA Commissioner Margaret Hamburg will be the one to decide if the indication remains or is removed. The docket in the case remains open through July 28 but there is no deadline for Ms. Hamburg to make her decision. In the meantime, some third-party payers have agreed to continue to reimburse for Avastin in breast cancer treatment.
The above is an abbreviated overview of the Avastin story in breast cancer, from my perspective. For a more detailed report of the saga, I would suggest you read the special issues of The Cancer Letter devoted to the subject. Editor Paul Goldberg provides a detailed look into the process and players involved. In the July 1, 2011 Special Issue article you'll find links to the previous issues focusing on the Avastin issue. The Cancer Letter is a subscription only publication but Mr. Goldberg is making these special issues available free of charge in an effort to add to the transparency of the FDA process and public understanding.
For The Cancer Letter Special Issue for July 1, 2011
to download the free PDF:
http://www.cancerletter.com/articles/20110701
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Musings from the Executive Director
by Ginny Mason
For the past few months I've been wading through a fascinating book The Emperor of All Maladies by Siddhartha Mukherjee, a cancer physician and researcher. I say "wading" because this is not a book that can be skimmed or considered a 'quick read', at least not in my opinion. The hard-bound copy has 472 pages, not including the notes, glossary, and index! Initially I checked the book out of the library, since I still prefer to hold a paper copy in my hands but I'm too cheap to pay $30.00 for a copy! I'd only gotten to page 63 when my two weeks were up and the book had to go back. This meant another wait since the book was in hot demand. Fortunately a friend shared that she had gotten the book for Christmas and didn't expect to have time to read it for quite a while and would be willing to share her copy with me. I was excited and accepted her offer to borrow the book and returned to my reading on page 63. As usual, life gets in the way of my plans and far too many days went by without reading more than a few pages. What I read was very interesting and I was learning so much about the history of cancer....but I just couldn't find blocks of time for reading. Not wanting to risk damage to the book, I lost important reading time during three flights and the associated wait times. Yes, I know that if I had an electronic reader I wouldn't have had to worry about carrying a heavy book or damaging the cover but I don't have one of those devices and as I said earlier, I still like holding a book in my hands. Through the pages of this book I've learned about the history of the National Institutes of Health, National Cancer Institute, and the development of cancer chemotherapy. Some might question why I'd want to read about such subjects, but I like having a better understanding of how things have developed and how we arrived where we are today in our treatment and understanding of cancer. In the midst of reading this book, I took a moment to read Dr. George Sledge's recent ASCO blog entry, A Foreign Country, and realized how it fit with what I was reading in The Emperor of All Maladies. As Dr. Sledge says, "we tend to date cancer research from Richard Nixon's 'War on Cancer' declaration and are now some 40 years from the time when fighting cancer finally became identified as a great national priority." Then he reminds us that the National Cancer Institute (NCI) was created by an act of Congress in 1937. If you don't have time to devote to The Emperor of All Maladies right now, or even if you do, I'd encourage you to read Dr. Sledge's blog entry for a mini-course on cancer history. It might whet your appetite to tackle those 472 pages! http://connection.asco.org/commentary/article/id/2989/a-foreign-country.aspx or use this short link: http://tinyurl.com/3d76m5y |
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