BY DEBU TRIPATHY | DECEMBER 12, 2013
We started off the San Antonio Breast Cancer Symposium this year with several discussions on new studies that analyze combined therapies in breast cancer.
Cancer cells are so complicated and have such a vast network that when you block one pathway with a targeted agent, the cells will try everything they can to get around it – or resist treatment. By combining targeted therapies, we hope to circumvent that. Herceptin has been used for years to treat HER2-positive breast cancer, but in metastatic breast cancer, the cancer cells eventually become resistant to the drug and begin to grow again.
In the Neo-ALTTO study, a combination of two HER2-targeted agents, Herceptin and Tykerb, were compared with Herceptin alone. These agents were given before surgery--the neoadjuvant setting. When you combine the two drugs compared to just one drug, the number of patients who had a complete pathological response--a complete disappearance of the cancer--is much higher. What's important about this is when you have a higher complete pathological response, overall survival is higher and the number of people who have a recurrence and die is lower.
It's important to see if the response rates can actually be linked to the long-term recurrence-free survival using this model of combination biological therapy before surgery--something the FDA is looking at to possibly approve future drugs for use in cancer treatment.
The results of the Neo-ALTTO study were presented earlier and it had been shown to improve pathological complete response. And with longer follow-up, fewer people had a recurrence. It's not quite statistically significant yet, but in hormone-negative patients, those patients did have a better recurrence rate if they had a complete pathological response. This is an important finding for us because it tells us we can study newer drugs in a much faster time frame.RELATED POSTS
BY KATHY LATOUR | DECEMBER 12, 2013
It isn't surprising that Cate Edwards would take up the breast cancer banner in memory of her mother. As the oldest child in a political family, Cate concedes that it is not in her nature to nod and move on.
She was in law school when her mother died, leaving Cate and her younger brother Jack, 10, and younger sister Emma, 12. Her brother Wade died in a car accident in 1997.
"My work is with Count Us, Know Us, Join Us," she says, referring to the online clearinghouse of support for women and their caregivers facing advanced breast cancer. Edwards is at the San Antonio Breast Cancer Symposium as the ambassador for the program, launched by Novartis last year.
"I want to bring awareness and support to women living with metastatic breast cancer, a group for whom there is no cure. Women with metastatic breast cancer are very isolated," she says, thus the website, which offers an online community connection through Inspire that allows women and men and caregivers to communicate with a similar community.
While awareness of metastatic disease is her primary goal, Cate says another important aspect of the campaign is to give caregivers tools for support and education.
Elizabeth Edwards was diagnosed with breast cancer in 2004 and her cancer recurred in 2007. She died in December 2010.
Cate Edwards addresses her mother's final weeks as an example. Edwards was moved to hospice care when the doctors where she was being treated said they had found tumors in her liver and gave her two weeks to two months to live.
"We had wonderful palliative care nurses," Cate says. "And my husband is a doctor who could translate what the medical information meant. She wanted to come home to die and we were able to do that. She died in only a few days after coming home."RELATED POSTS
BY KATHY LATOUR | DECEMBER 12, 2013
Terry Arnold sat toward the front of Tuesday's education session on inflammatory breast cancer at the San Antonio Breast Cancer Symposium.
She was watching slides intently, specifically those from Wendy Woodward, a radiation oncologist and section chief of the breast cancer radiation oncology program at MD Anderson Cancer Center in Houston.
Arnold is Woodward's patient and credits her with her six-year survival from inflammatory breast cancer. It is often called the most deadly form of breast cancer, in part because it doesn't act like normal breast cancer. There is no tumor.
Arnold was 49 and owner of a bookstore in Houston when she became concerned about the red, swollen appearance of her breast. It took her four months of doctors visits and trying one thing after the other before she was diagnosed. Since then she has been on a mission to educate women and the medical community about inflammatory, the breast cancer that has no tumor but presents as an infection--and kills the majority of women diagnosed.
Both she and Woodward were excited to see almost 500 in attendance at this pre-conference meeting. Attendees had asked for more on inflammatory, Woodward told the audience at the beginning.
Woodward also thinks inflammatory is much more prevalent than the 5,000 or so cases reported every year.
"Physicians don't recognize it," Woodward says. "And when you go through the SEER data, you can see many are not coded correctly--or the physician thought if you call it metastatic, what difference does it make to correctly identify it if it's inflammatory. That hurts us because they think it is so few people."
Woodward say 10 percent of those women who die each year of breast cancer had inflammatory.
One of the challenges with inflammatory is the way it moves in the breast, Woodward says.
"In usual breast cancer when one cell becomes malignant and begins to divide, it clumps together and forms a tumor in most cases. With inflammatory the cells immediately begin to travel. They travel like metastatic disease, and this makes it harder to treat, because it behaves in a different way."
Arnold likens it to dropping water on a hot griddle--it spatters all over. The tumor spatters all over instead of staying where it lands. Why the griddle is hot, Woodward says, is the question researchers are trying to answer.
The result is a breast cancer that can involve the whole breast very quickly. While most breast cancer doesn't even show on the surface of the breast, inflammatory breast cancer looks like what the imagination would conjure for breast cancer. A red and swollen breast, distorted into a frightening site that may have open, boil-looking patches. When it travels to the skin on the breast and trunk, there are large red patches that look like an angry rash.
This is what Arnold wants women to know. If it's inflammatory, the breast may be warm and look like an infection. And when they do a breast self exam, there is no lump.
Read on for more about treatment, Arnold and her one-woman campaign.RELATED POSTS
BY KATHY LATOUR | DECEMBER 11, 2013
Well, we are here again at the San Antonio Breast Cancer Symposium with some 7,500 breast cancer clinicians and advocates from more than 90 countries – and not one, not one oral presentation out of 43 has to do with survivorship. There is one presentation on exercise that is getting some play, but come on.
Nothing in 74 papers accepted for the ongoing clinical trial session relate to survivorship, and of the 1,091 posters (these are literally large posters with study information detailed), there are only a handful that address survivorship and/or quality of life.
The mission of the meeting, according to the home page, is to be "an international scientific symposium for interaction and exchange among basic scientists and clinicians in breast cancer." In another place it says the meeting is "to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease, to an international audience of academic and private physicians and researchers."
I guess that leaves survivorship out, but you would think someone would be asking what the outcomes are of the treatments down the road.
There is a full feature in The Wall Street Journal this week titled "The Next Front in Cancer Care" that explores the survivorship issues we all face. It's exciting to see this kind of headlines for those of us who focus our time and energy on life after treatment.
It is also exciting to once again see the full complement of advocates at this year's meeting. For the past 16 years the Alamo Breast Cancer Foundation, an all–volunteer advocacy organization in San Antonio, has brought women from all over the world to learn more about the disease. This year 23 advocates are on site, each one assigned a "hot topic" about which they will become an expert.
Each evening of the symposium the advocates attend a session with the lead researchers in attendance where the day's studies are discussed and synthesized for the lay audience.
I had lunch with four of the advocates today, and it reminded me how powerful advocacy can be, and how a diagnosis can mean a totally different life. Each of the four women had a career before breast cancer turned them into full-time advocates. You could say it was cancer as a career move.
Lori Baran was a medical technician before her diagnosis of DCIS in 2008. She decided she wanted a bilateral mastectomy, which was her only treatment. In 2010 she felt a lump under her arm in her remaining lymph nodes. It was malignant, as were all the remaining lymph nodes, 38, on the right side. They were removed, but scans showed spots on her liver too. Chemotherapy took care of the liver spot, and she was declared NED – until 2011 when it was a repeat performance on her left side. She was given two years to live even if she chose the drastic treatment offered her. Instead she found an integrative oncologist who combined a number of components including changing her diet – she is now in remission. "Women have to advocate for themselves first," she says.
Donna Kaufman was an Army officer serving in Israel for a number of years and says she was part of a large cancer cluster in that country, which has a high rate of breast cancer. She had returned to the U.S. with her husband and two children just before finding out she had breast cancer. Her diagnosis and treatment left her feeling like her old job in public relations and marketing was not what she wanted. "It's hard to get excited about selling cereal when you've been through breast cancer." In response she turned her attention to lobbying for the state of Virginia and at the federal level where she has worked on projects such as the bill in Virginia for parity for oral chemotherapy drugs. It's in that work that Donna feels she is now contributing.
Meredith Parks says that as a criminal defense attorney she used to dread hearing that DNA was involved because it usually meant her client was guilty. "Now I know that DNA has a much greater impact." Diagnosed age 47 only two years ago with triple negative breast cancer, Meredith, the mother of four, volunteers one-on-one with patients at Johns Hopkins, which is near her Maryland home as well as advocating for research dollars. She has found a new passion with advocacy, serving on a number of panels for Susan G. Komen, AACR and NBCC, she says.
Deborah Evans, a Michigan resident until a recent move to California, is four and a half years out from her diagnosis of triple negative breast cancer at age 47. Educated in biological sciences in England before moving to the U.S. she loved teaching 7th grade science before her diagnosis turned her into a full time advocate.
She would like to see support for women in their 40s who fall between the young survivor and the older population, but her goal is simple. "I want a cure," she says.
By the time they leave San Antonio, these women will be armed with additional information to take to their communities to pass on to newly diagnosed women. With this year's advocates, The Alamo Breast Cancer Foundation has trained more than 500 women, who return home armed with new information and new passion to help other women face the disease.RELATED POSTS
BY KATHY LATOUR | DECEMBER 9, 2013
OK, we have all done it. Forgotten something and then laughingly blamed it on chemobrain, that cotton candy brain that came to stay to a greater or lesser degree with chemotherapy.
I even make a joke about it in my one-woman show when I say I tell those women in chemotherapy for breast cancer that they know they have chemobrain when they are having an intense discussion with someone and they cannot remember his name – and they are married to him.
It's funny but it's not funny.
I can remember in my support group back in 1989 when friends would talk about losing their minds. Their cancer was no longer a problem, but they could not go back to work because they couldn't remember how to do whatever it was they did.
Our oncologists swore it was the lack of estrogen – or at least that's what mine said. He said it was normal with the loss of estrogen when the chemo shut down my body. Whew eeee. That don't cut it anymore because we know now it's not just women, and it is many different kinds of cancer – and, finally, because of our complaints, the condition has been studied and they have found it is real.
I didn't have chemobrain during treatment – well, I don't think I did. Maybe I am really a rocket scientist or maybe I would have been compelled to get a PhD if it hadn't been for chemotherapy.
But now that I am having the age-related issues where I can't remember where I put something or someone's name, I can tell you that my frustration level has given me new insights into what those women went through.
Chemobrain is, if not the first, one of the first side effects of treatment that was studied as a result of patient input - that's the nice way of saying we were really upset and they finally heard us. I guess the oncologists heard the word frustrated enough to get their attention that something was going on here. I can remember talking to a friend who was an attorney who loved arguing cases in court. She was really fast on her feet and loved the back and forth quick witted banter.
She could really think on her feet. But after chemotherapy, she had to find another way to express herself. That is a huge loss of self esteem and all that makes us who we are. One of the reasons I wanted to write the story on rehabilitation for chemobrain in the current issue was to give some options of what people can do about it. It's one thing to say, "we know it's real and it's not in our head" and another all together to talk about ways to improve it.
I hope the story gives you some options to try. Let me know. And if you have discovered your own solution tell us in the comments section.RELATED POSTS
BY ELIZABETH WHITTINGTON | DECEMBER 6, 2013
Pancreatic cancer, while hard to treat, is gaining awareness, research dollars and inspirational advocates. Learn more about how we're gaining on this aggressive cancer in the Winter issue of CURE.
BY GUEST BLOGGER | DECEMBER 3, 2013
November was an exciting month for nurses conducting research in the area of cognitive changes related to cancer and cancer treatment.
Many of us were fortunate to attend the Oncology Nursing Society Connections conference in Dallas, where we had the opportunity to share research results and discuss future research projects dedicated to learning more about the cognitive changes that some cancer survivors experience. Additionally, the November issue of the Seminars in Oncology Nursing journal was devoted to "Cognitive Changes Associated with Cancer and Cancer Treatment."
"Chemobrain" and cognitive changes due to cancer and other related treatments pose a challenge to many survivors of cancer. Incidence estimates for cancer-related cognitive changes range from 75 to 90 percent of survivors at some point prior to, during or following treatment.
Around 25 percent of survivors struggle with long-term cognitive effects. Survivors describe the experience of these cognitive changes to include issues such as difficulty with word finding, misplacing things such as keys and cell phones, forgetting why they walked into a room, missing appointments and trouble multitasking. Results from neuro-psychologic tests have shown decreases in processing speed, memory and executive function (the ability to plan out and complete the steps necessary to accomplish a goal). All of these issues cause frustration and can decrease survivors' quality of life.
A great deal of research is being conducted to better understand the causes of these cognitive changes so that preventive strategies and interventions can be developed. Many different theories are being explored such as injury to neural progenitor cells (stem cells that give rise to mature brain cells), changes to DNA-repair genes, accelerated aging of the brain, and genetic pre-disposal to central nervous system injury. Results of studies that include the use of functional magnetic resonance imaging (MRI) and memory testing are demonstrating changes in brain volume and activation.
Additionally, exciting research is being conducted to explore interventions to reduce cognitive injury and/or improve cognitive function. Some interesting results are being seen in the areas of cognitive behavioral training and exercise.
Cognitive Behavioral Training includes exercises to assist with memory and processing speed as well as recommendations for strategies to accommodate for changes in cognitive function. Exercise studies to date have included yoga, Tai Chi, Qigong, aerobic exercise and resistance training. More research needs to be conducted to support the widespread use of these interventions, but these early results are encouraging. Additional results will be presented at the upcoming 2014 International Cancer and Cognition Task Force (ICCTF) Cancer and Cognition Conference to be held in Seattle next February. The Task Force is comprised of oncologists, radiologists, nurses, basic scientists and other disciplines all dedicated to finding solutions to the problem of cancer-related cognitive changes.
One study is currently being conducted to learn more about factors that may predict many of the symptoms associated with breast cancer prior to, during and following chemotherapy (including cognitive changes). Women with breast cancer are being asked to complete a confidential online questionnaire. If you or someone you know are newly diagnosed and have not yet received chemotherapy, or if chemotherapy was completed two or more years ago, please consider helping us learn more about predictive factors by completing the study questionnaire.
Jamie Myers, PhD, RN, AOCNS, is adjunct assistant professor at the University of Kansas School of Nursing and nurse researcher consultant for Carondelet Health in Kansas City. She also is the coordinator-elect for the Oncology Nursing Society Survivorship, Quality of Life, and Rehabilitation Special Interest Group.
To participate in the clinical study mentioned above, go to https://survey.kumc.edu/se.ashx?s=5A1E27D26B60E80F. Participants will be offered the opportunity to receive the study results. If you have questions about the study or would prefer to receive a hard copy questionnaire you can contact Jamie at firstname.lastname@example.org or 913-449-5996.RELATED POSTS
BY SUZANNE LINDLEY | NOVEMBER 27, 2013
"Life is a series of disastrous moments, painful moments, unexpected moments, and things that will break your heart. In between those moments: that is when you savor, savor, savor." ~Sandra Bullock
As Thanksgiving approaches, I am pulling from the thoughts of Sandra Bullock because life this year has been a series of all these challenges and more. Yet, it has given way to much celebration. There has been disaster in ways that are hard to describe, the pain of my mom's cancer diagnosis and the fear that ensued, the unexpected blessing of stable scans for myself, and heartbreaking loss of friends that were dear.
Life can, and has, thrown some difficult hurdles in my direction. However, there has been a cadence to the way life works and it has been in the breathtaking moments when the world should stand still, with little or no control, that I have felt unknown strength and abundant blessings.
Most of these blessings that I so gratefully enjoy include the muchness of family, special milestones and everyday magic. These days are relished because of the treatments and medical team that have worked so hard to keep me here...and this year to even give me a new smile. I cherish my friendships, too, for it has often been the simple touch, cyber hug or powerful thought that has given me the courage and hope to move forward. So, as I savor the "cancer calm" in the storm of stable tumors, these are some of the lessons for which I am forever grateful.
1. "Love is the answer." Jane and AJ Ali
2. "You are where you want to be." Loretta Baker
3. "Life is a treasure chest. What is your treasure today?" Leon Davis
4. "The bumble bee isn't supposed to be able to fly, and you aren't supposed to survive. But the bumble bee flies and you WILL survive." Jean DiCarlo Wagner
5. "Take a deep breath." Jean DiCarlo Wagner
6. "Hope is dope!" Snoop Dog
7. "Instead of thinking "it could be worse," remember "it can get better!" Desiree Gray
8. "Everyone is terminal; no one more and no one less." Gordon Gwosdow
9. "The footprints of friends will carry you and you have one very special angel watching over you." Russ Howard
10. "Oh Happy Day!" Bonita Jones
11. "Cherish the golden gossamer threads of life." Shirley Laverne
12. "We can make it to the top. We are angels!" Kevin Lebret-White
13. "We are here for each other through good and bad." Vicki Lehman
14. "No one can take away your ability to have hope." Keith Lyons
15. "Life doesn't happen around you, it happens between your own two ears." Keith Lyons
16. "Life is the most precious thing we have." Dalia MacPhee
17. "Hold fast and shine brightly." Brian McLeod
18. "Life is fabulous!" Erica Paul
19. "Talk doesn't cook rice." An old Chinese proverb I first heard from Nancy Roach
20. "If you go outside the box and open up yourself to new experiences, joy is there for the taking." Pam Schmid
21. "We have been blessed to know things others don't yet understand, and our challenge is a great one: We understand our mortality, and we revel in the blessing of every breath we draw and every day we see. Our job is to bring a little heaven to earth, in the form of faith and love." Tony Snow
22. "It's all about hope." Tami Thennis
23. "Find some hope." Shelly Weiler
24. Last but not least, Ronnie Lindley: "It will be OK!"
I am humbled by the rhythm of life; how it ebbs and flows. I am thankful for ALL of you that walk with me through the tragedies and triumphs of each day. You are treasured souls who have shown me that beauty often lies in the midst of struggle. You have helped me to strengthen my resolve. So as you enjoy the days and weeks to come with family and friends, however and wherever that may be; know that I am grateful for you. Happy Thanksgiving from our home to yours.
And with the words of Sandra Bullock, "Savor, savor, savor!"RELATED POSTS
BY ELIZABETH WHITTINGTON | NOVEMBER 26, 2013
Xalkori (crizotinib), a lung cancer drug that was approved in 2011 under the Food and Drug Administration's accelerated approval, has passed the last hurdle to regular approval. On Nov. 20, the FDA gave the ruling after a phase 3 clinical study confirmed that the drug works in patients who have metastatic cancer with a particular genetic mutation called ALK and who had progressed on platinum-based chemotherapy. Specifically, Xalkori works in lung cancers that are driven by a mutation in the anaplastic lymphoma kinase (ALK) gene, which occurs in about 5 percent of non-small cell lung cancers.
Accelerated approval is a conditional approval the FDA grants for drugs that show a significant improvement before a trial is completed. It can be based on survival, delayed disease progression or another endpoint that was pre-determined before the trial began. Efficacy of the drug must be verified in a later study, either a phase 3 or 4 trial before it can be given a regular approval.
Previous results, which led to the accelerated approval, were based on two single-arm studies, meaning all patients in the study received the investigational drug rather than being randomly assigned to receive the investigational drug or a standard of care. These studies showed Xalkori improved objective response rates, meaning the tumors shrunk with Xalkori in 50 percent and 61 percent of the time in the two studies, respectively.
This new approval is based on results that showed the drug delayed disease progression for 7.7 months compared to chemotherapy, which only kept the cancer from growing for 3 months. Side effects included vomiting, diarrhea, constipation, fatigue and vision impairments.
Many accelerated approvals later receive regular approval. A paper examining accelerated approvals and post-marketing studies found that from Dec. 11, 1992 to July 1, 2010, the FDA granted 35 oncology products accelerated approval, which accounted for 47 new indications. Clinical benefit was later confirmed in subsequent studies for 26 of the 47 new indications. The average time between accelerated approval and regular approval was more than four years, but ranged anywhere from less than a year to more than 12 years. During that time, three indications were revoked or had a restricted distribution due to follow-up studies.
To better understand this newest approval for Xalkori, we asked the FDA a few questions:
1. What is the significance of the regular approval for Xalkori?
• Xalkori received a broad indication for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) in 2011 because this magnitude of high response rates had not been observed with standard approved treatments for lung cancer. Because of this, we didn't want to require patients to progress on chemotherapy before enabling access to a drug that appeared to provide a significant benefit over the standard of care. Xalkori's accelerated approval in 2011 was based on response rates in single-arm trials, and its regular approval is based on a post-marketing trial that provides confirmation of the clinical benefit based on a randomized study against chemotherapy.
2. What does it mean to patients?
• Xalkori's regular approval highlights an evolving paradigm of very rapid drug development, where we are able to get drugs to the patients who need them most at an accelerated pace. Practically speaking for NSCLC patients, Xalkori's regular approval gives access to a therapy that demonstrates superior progression-free survival by about five months and a reduction in the relative risk of progression by about 50 percent. The post-marketing trial provided supporting evidence of higher response rates – 65 percent of tumors shrunk versus 20 percent in those receiving chemotherapy. The randomized trial also provided additional safety data, which helped the FDA determine that its risk-benefit was acceptable.
You can read more about the regular approval at fda.gov.
You can also read more about accelerated approval and other routes to FDA approval in CURE's article "A Primer on How Faster Approval Works."
We'll be featuring advancements in lung cancer in an upcoming issue of CURE, so stay tuned for more updates.RELATED POSTS
BY SUZANNE LINDLEY | NOVEMBER 20, 2013
I've mentioned the Synergy 2013 meeting in a couple of my blogs now. It was great to see so many brilliant physicians, nurses, treatments and thoughts coming together. It was a learning experience for me, a time to see some old friends, and to also meet some new ones.
On my last day in Florida, Dr. Andrew Kennedy brought Dr. Jim Caridi over to the YES booth and introduced us. It was the most profound moment of the entire meeting for me. Dr. Caridi is a very gifted interventional radiologist of whom I've often heard reference. What I didn't know is the story that follows, taken with permission from his website (OneIAMClub.com).
"As a physician, his efforts were to allay the fears of the patient and make them more comfortable in their situation. He has an uncanny ability to put himself in others shoes and would attempt to lessen the discomfort of the situation. Jim would enter the hospital every day and passing patients, would think to himself "as long as I am on the other side of the glass, I am OK."
On August 10th, 2011, the glass shattered and he entered the other side. Our world stopped when we received the deafening news--Jim had bone cancer. A year has passed and we have been through the emotional roller coaster that all cancer patients and their significant others endure. Though we have not achieved remission, Jim has fought this battle with the same passion and finesse that made him successful in his career and life in general."
Here is a link to his speech at Synergy presented to his peers...from his perspective as a patient.
His talk ends with a quote from Jimmy V, "A good day is when you laugh, you think, and you cry." Jim says he gets two or three of these most of the time and eloquently added two additional thoughts to Jimmy V's quote. You need to dream and be passionate about your dream and you need to pay it forward.
You might ask what do you mean: "pay it forward?" All of you in this room have the ability to pay it forward...I can name 30 people in this room who have emailed me, called me, given me this opportunity. It's simple to do and can make such a difference in people's lives."
I hope you enjoy the video. I hope you are inspired. AND I hope you "Pay it Forward." Truly, it's quite simple! What will you do?RELATED POSTS