December 13 2011 - My 5 Year Cancerversary

Happy Holidays.

Each year on December 13th I write a blog entry that is a reflection of a nadir in my cancer journey that took place on that date, now 5 years ago today. This year I had the privilege of sharing my cancer anniversary story in the University of Texas M D Anderson Cancer Center blog, Cancerwise. As such, please click on the link below to read today's blog titled, "It's Holiday Time - The Gift of Life" appearing in Cancerwise:

http://www2.mdanderson.org/cancerwise/2011/12/its-holiday-time-the-gift-of-life.html#more

In addition, for ease of reference I am including a link to each prior year Cancerversary entry from my blog.

2010
http://hncancer.blogspot.com/2010/12/december-13-2010-cancerversary-3.html

2009
http://hncancer.blogspot.com/2009/12/december-13-2009.html

2008
http://hncancer.blogspot.com/2008/12/december-13-2008.html

2007
http://hncancer.blogspot.com/2007/12/december-13-2007.html

Lastly, for those who would rather read my entry here without going out to the Cancerwise blog, here it is. But, it looks much nicer on the M D Anderson site.

It's Holiday Time: The Gift of Life

                                  

By Cancerwise Blogger on December 13, 2011 8:00 AM | Comments (0)

By Ed Steger

Ed Steger was diagnosed with head and neck cancer in 2005. After 36 radiation treatments, 2 years in palliative care and 5 surgeries he is now in remission. He blogs about living with head and neck cancer at www.hncancer.blogspot.com.

In order to give back to the medical team that saved him, Ed is currently a SPORE Patient Research Advocate at MD Anderson.

Today, Dec. 13, 2011, is my five-year cancerversary. I was originally diagnosed in April, at age 53, with stage III/IV head and neck cancer at MD Anderson Cancer Center. Throughout my cancer journey, the largest setback came five years ago today. Here's my story.

Difficult journey
Between April 2005 and December 2006, I had 36 IMRT radiation treatments, Taxol chemotherapy and four surgeries. One surgery that I often refer to as the "salvage surgery" lasted 12 hours and was followed by two terrifying days in the ICU and a week longer stay in the hospital.

At the time, it was either this surgical procedure or getting my affairs in order. After careful deliberation, driven largely by wanting to see my 12-year-old daughter grow up along with strong encouragement and support from my family, I chose the salvage surgery that took place on July 12, 2006.

It was an incredibly difficult surgery involving the removal of my left side jaw bone, a large section on my upper esophagus, part of my soft palate and a piece of my tongue.

If that wasn't enough, my tibia bone was cut from my leg to replace the portion of my jaw that was removed, necessitating a skin graft on the tibia area.

I recovered from this ordeal relatively quickly. By October, through a lot of determined, physical effort, I had the tracheotomy apparatus and feeding tube removed. By December, my life was getting back to normal.

Just six months after this major surgery, I was actually feeling great. To test myself, I made a trip out West to visit friends and enjoyed a round of golf on the beautiful Monterrey, California peninsula.

There was life after surgery.

Visit with my surgeon changed everything
A CT scan followed by a clinic visit with my surgeon on Dec. 13, 2006, changed all that. The scan revealed five inoperable hot spots. Once again, I was faced with getting my affairs in order. With help from MD Anderson's Palliative Care Unit, I prepared to let go of life and begin the process of dying.

But, as one who believes in having a Plan B, I also visited my MD Anderson oncologist.

One week later, I began an intensive chemotherapy regimen. During the next eight months, I had the proverbial kitchen sink of chemotherapy agents thrown at me: Cetuximab, Docetaxel, Cisplatin, Avastin, Tarceva, more Taxol, Carboplatin and GEMZAR.

It may sound random, but it wasn't. My oncologist and surgeon were monitoring me carefully and modifying my treatment based on my responses. Ten months later and after setbacks that required two relatively minor surgeries, I was declared as having no evidence of disease (NED).

The five inoperable hot spots literally melted away. That was in October 2007, more than four years ago! Two years ago, I was reclassified as being in remission.

So, this holiday season, I have the gift of life.

I was able to see my daughter graduate from high school last May and begin the next stage of her life as a beautiful young woman and a college freshman.

It has been hard, but it's so worth it.

I intend to keep moving forward and giving back, in my own unique way, to the community who made it possible for me to be here today. I am so very grateful for the untiring efforts of my medical team at MD Anderson.

For all those who have participated with me in this journey, including physicians, researchers, support staff and my spouse, family and friends, I wish you a happy holiday season and thank you with all that I have for this generous and unbelievable gift.

"You have cancer." What now? My Top 12 List (updated).

Two and a half years ago on March 19 2009 I wrote a similar blog entry. A link to that entry is at the bottom of this post. There is a revolution (see number 7 of 12 below) taking place in the world of cancer prevention, detection, and treatment. If you or someone close to you was recently diagnosed with cancer or are currently undergoing treatment, this list is for you. I've written about all of these topics before, but so much research and translational science work is coalescing, it felt like time for an update.

1. Know your cancer. The American Cancer Society (ACS) published a 68 page PDF containing a wealth of cancer information covering the year 2010. They estimated that there will be over 1.5 million new cancer cases diagnosed and almost 600,000 deaths (1,500 per day) in 2010. There is a marked increase in the 5 year survival rate when comparing a period in the mid 1970s (50%) to a period in early 2000 (68%). The document highlights 15 different types of cancers (many with multiple sub-types) listed along with cancers stratified along geographic, demographic, race, and ethic backgrounds. The document then delves into specific cancers. The more you know about your cancer, the better off you are in working with your medical team and making decisions about how to proceed. This document published by the ACS is a great starting point.

2. Use the Internet. This is such a powerful tool to research your specific cancer and discover the resources available. My focus is on head and neck cancer. So, by way of example, I've found the following web resources. 1) SOPHNC - Support for People with Head and Neck Cancer (www.sophnc.org). They have 108 support chapters throughout the US, many of which meet at least once a month. They also have the National Survivor Volunteer Network (NSVN) which matches patients and caregivers going through treatment with people who have already gone through similar ordeals. 2) The Oral Cancer Foundation (www.oralcancerfoundation.org). This is a non-profit entity designed to reduce suffering and save lives through prevention, education, research, advocacy, and patient support activities. 3) The Head and Neck Cancer Alliance (www.headandneck.org). This was formerly known as the Yul Brenner Head and Neck Cancer Foundation. Much of their effort goes into prevention and fund raising.

Most of these sites have Newsletters on up to date treatment breakthroughs, patient and caregiver forums, activities on how to become involved, and fund raising. For head and neck cancer, this list just touches the surface; there are dozens of other reputable sites (e.g., www.CancerCompass.com, www.redtoenail.org, www.beingcancer.net). Although I haven't focused my attention on other cancer types, I suspect that more pervasive cancers have an even greater treasure trove of support and information resources available.

3. Find the right cancer clinic. Cancer will kill over 600,000 people in the US this year. That is more than one death per minute, 24 hours per day, 365 days per year. Cancer doesn't take off for weekends or holidays. Finding the right clinic can help save your life. In my journey I've met enough people who either said, if I hadn't come here (referring to their current cancer center), I'd be dead now. On the other hand, I’ve known people who have passed away, in some cases unnecessarily, because they waited too long to find the right cancer treatment clinic. You want a cancer clinic that specializes in your type of cancer. Many clinics are fully prepared and qualified for plan A, but if plan A doesn't work, they are not going to be able to perform plan B. Plan B for them is referring you to a larger, better equipped center. For me, I’d rather start off with a clinic that can perform plan A, B, C, and D.

4. Find the right doctor(s) within the cancer clinic. I switched one of my doctors within my cancer clinic after the first year. I lost faith in my original doctor, so I asked to switch doctors. This is your life, and you should feel confident in the treatment prescribed. There are many options, and being an informed patient will help in choosing a path that is right for you.

5. Treat your core set of doctors as a team. Cancer is so complicated, one doctor is not enough. To be great, doctors specialize. In my case, the core team included an oncologist, surgeon, radiologist, and their physician assistants. They have been supplemented at times with other doctors who specialized in pain management, psychology, and other areas. You should understand how your doctors collaborate. For me, I liked knowing that each week my doctors gathered to talk about each patient, their treatments, progress, and next steps.

6. Understand your treatment and options. This means their probable success, timing, and life altering outcomes. Cancer is treated in slang terms as slash (surgery), burn (radiation), and poison (chemotherapy). These terms were not arrived at lightly. Many cancer treatments are as much art as science. Even the best doctors don’t have all the answers and field is constantly changing. They use their best judgment and if you are confident in your doctor, then you will have an easier time choosing the right paths.

7. Consider genetic testing. This is where the revolution is taking place and it may save your life. If your cancer center doesn't offer a genetic testing service consider a different cancer center or an independent testing laboratory. There are now many therapies which target specific genetic mutations. A great example of this is the EML4-ALK mutation in lung cancer. I've written about this before and you can search my blog or the Internet for more information on this specific mutation. The discovery of this mutation and the drug, Crizotinib, which has thrown a life line to about 7,000 lung cancer patients per year in the US is a remarkable success story for select patients, researchers, physicians, and pharmaceutical companies. In addition, Vanderbilt-Ingram Cancer Center has created a public database named My Cancer Genome at www.mycancergenome.org which currently lists six cancers including breast, lung, prostate, and melanoma where genetic mutations have been identified and based on a specific mutation, therapies have been shown to be effective in treating that mutation for that cancer. This whole field is causing an explosion of paradigm shifts within cancer centers, pharmaceutical companies, and even in the basic building blocks for how cancer is viewed. I'll touch on each of these areas briefly.

Cancer centers - MD Anderson Cancer Center recently announced the establishment of the Center for Targeted Therapies (CTT). See reference. The CTT's mission begins with hypothesis-driven research that identifies and validates targets; continues with the discovery, development and design of biological therapies and drug agents; and is followed by pre-clinical and clinical trials – with each step working toward the goal of personalized medicine. In an ASCO presentation last June, MD Anderson announced a goal of genetically testing each of their 30,000 patients annually within 5 years. In another example, the University of Pittsburgh Medical Center (UPMC ) recently announced that it will invest nearly $300 million to create the Center for Innovative Science, a research facility that aims to revolutionize the way treatments are designed for individual patients.

Pharmaceutical companies - Using Pfizer as an example, they created the drug Crizotinib for the treatment of the EML4-ALK mutation. Although this only addresses a small subset (4%) of people with non-small cell lung cancer, they made the investment and were successful in gaining fast track FDA approval for this drug on August 26 2011. In addition, Abbott Labs won speedy FDA approval for a test for this mutation. What is remarkable about this is the pharmaceutical company's recognition of the importance of how genetic findings will drive treatment approaches in the future. When one compares this to a drug like Lipitor, a cholesterol lowering medication and another Pfizer product having over five billion dollars in sales in 2010, it is this paradigm shift which is pushing even the largest drug companies to pursue drugs with relative small target populations. As a side note, a number of pharmaceutical companies offer assistance to those who can not afford an expensive chemotherapy agent. Talk to your cancer clinics business or clinical trial area for more information on this topic.

Basic building blocks for how cancer is viewed - Today, when one talks about cancer, they talk about lung cancer or breast cancer or prostate cancer, etc. The paradigm shift taking place in this area is talk about genetic mutations transcending specific cancer types. The American Society of Clinical Oncologists (ASCO) published a document last month which gives weight to this shift in thinking. I wrote about ASCO's document in my last blog entry and as such will not repeat myself here, but I predict that this shift is coming and there are cancer centers like MD Anderson, UPMC and Vanderbilt-Ingram which are embracing this shift. Then, there are the others. What is your cancer center doing in this field?

8. Understand clinical trials. Clinical trials are typically categorized as I, II, III, or IV. In a Phase I trial, the researchers are generally looking at the toxicity impacts on the human body. These trials are generally small with 10 or less humans. Phase II begins to assess drug efficacy. There may be varying dosages within a Phase II trial looking for the magic bullet and right balance between dosage and efficacy. Phase II trials are still primarily experimental and will be limited to a few hundred people. Phase III trials are where it goes mainstream. The research has proven that the drug can be tolerated (Phase I) and it has shown some promise (Phase II). A drug in a Phase III trial could include 1,000s of people across many different medical institutions and countries. They can take years to complete. One drug I’ve been interested in -- Crizotinib -- has been under study for about 4 years. There are currently 21 trials listed for this drug with a status of active, recruiting, terminated, or completed. Clinical trials have very specific inclusion and exclusion criteria. The http://www.clinicaltrials.gov/ website allows you to search among its 116,000+ trials taking place in 178 countries. This is a great resource. There may be a clinical trial out there for you.

9. Learn to live with uncertainty. As mentioned, for many cancers, treatment is as much art as science. It can take months for chemotherapy drugs to work or not work. It can be months between major tests. Some surgeries will require the surgeon to keep cutting until they find clean margins. They may not be able to tell you beforehand how much permanent damage there will be, how long the recovery time may take, or even if the surgery will be successful. I remember waking up after a major surgery. In the recovery room, the doctor was talking to the patient in the bed next to mine. He said, “I’m sorry, but the cancer has fully taken over several vertebrae and we were not able to remove it.” I could tell it had been a long, complicated surgery. I couldn’t see the patient as there was a curtain between us, but I could tell that the prognosis was bleak.

10. Understand your health insurance in depth. Read your health insurance document. Not just the guide, but the entire plan document. There are a lot of areas that become gray to one’s insurance company when the bills start coming in. What looked like a no brainer suddenly becomes a major issue. My insurance company has been reasonable, but not without a few major fights. Know your rights, stick up for them, and use the appeal process if you feel your rights have been violated. For those who have been paying insurance premiums for many years, it is an obligation (contract) for the insurance company to support your needs should they arise.

11. Take charge of the cancer. To the extent possible, don’t let the cancer control your life. There are drugs and therapies that can help you manage chronic, acute, and psychological pain and issues. Take advantage of these resources and make the most out of your current situation.

12. Understand the impact of your cancer on family and friends. Cancer can create stress in relationships. It can also create bonds. Sometimes cancer impacts close family and friends more so than the cancer patient. It has certainly impacted some of my relationships -- some for the better, and some for the worse. This impact can be more powerful than the cancer itself.

I hope sharing this information is helpful. If you would like to comment or add to the discussion, please post a comment. If you have ideas for other discussions or topics, please let me know.

References

"You have cancer." What now? My top 10 list (from March 19 2009)
http://hncancer.blogspot.com/2009/03/you-have-cancer-now-what-my-top-10-list.html

ACS 2010 Statistics
http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-026238.pdf

MD Anderson Center for Targeted Therapies
http://www.mdanderson.org/education-and-research/research-at-md-anderson/early-detection-and-treatment/centers/center-for-targeted-therapy/index.html

UPMC Announcement
https://www.dtmi.duke.edu/news-publications/research-news/upmc-to-build-300-million-center-for-innovative-science

FDA Crizotinib Approval
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm269856.htm

Abbott Labs ALK mutation test
http://www.genomeweb.com/blog/abbotts-alk-mutation-companion-dx-finds-home-ahead-schedule

Lipitor sales information
https://www.google.com/search?sourceid=navclient&ie=UTF-8&rlz=1T4DKUS_enUS214US215&q=lipitor
.

Panomics

Panomics is a word I've been hearing in oncology lectures and reading about in oncology-related materials, but when Googling it, it had no clear definition. This week I received an email from the American Society of Clinical Oncologists (ASCO) with a link to a document titled, "Accelerating Progress Against Cancer - ASCO's Blueprint for Transforming Clinical and Translational Research." A link to the document is at the bottom of this blog entry. Within this document, the word PANOMICS is used to refer to, "the combination of genes, proteins, molecular pathways, and unique patient characteristics which together drive the disease [cancer]." This document far exceeded my expectations as to deep thinking and actually does provide a roadmap for winning the war on cancer. It should be a must read for everyone in the cancer field - clinicians, researchers, and administrators. It's easy to read and short, but puts forth three simple guiding strategies.

It starts off compellingly by asking the reader to envisioning what the "patient" experience will look like in the future by tying together their genetic profile, all known medical information about that individuals at the touch of a button, and faster and smarter clinical trials. All this points clinicians to targeted therapies which have been shown to work in patients with a similar profile and steers them away from those therapies which have shown no benefit. The document talks about the importance of biomarkers and the leveraging of patient health information systems. It also lists three strategies to reach the goal of curing cancer. I won't articulated them here, but for those who are interested, please click on the link below and begin reading about wining the war on cancer.

Take care,
Ed

ASCO Article:

http://www.asco.org/ASCOv2/Department%20Content/Cancer%20Policy%20and%20Clinical%20Affairs/Downloads/Blueprint.pdf

Timeline of Cancer Progress - Explore 40 years of advancement in cancer treatment, detection, and prevention (a very cool interactive website referenced in the above document):

http://www.cancerprogress.net/
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Meltdown

I was at my cancer center today for two reasons. First, to have my obturator adjusted. Wearing it created enough pain that I stopped using it at the expense of loss in the quality of my speech. Some adjustments were made and I have a follow up appointment next week to assess whether or not a new device is required. Second, I began a volunteer role as a patient research advocate a few months ago. My primary responsibility to date has been to attend a one hour meeting each month.

While at the cancer center, a man of about 50 years old was pushed by me in a wheel chair. He was having a complete meltdown. It's not often that one sees a grown man cry. Cancer is a terrible disease. It's been 4 plus years, but I've been there on at least four occasions. I remember each one vividly. I'll share one here briefly. It was on September twelth four (or five) years ago today. I was in the chemotherapy unit scheduled to receive some very toxic substances. A nurse was making attempt number four at getting an IV line going. First one arm then the other, then the back of my hand when the other usual suspect areas didn't work. It was also the anniversary of my mom's death. She died at age 72 after a 6 month battle with lung cancer. The world felt pretty crummy right about then between the poking, the anticipation of toxic substances, and my mom's death from lung cancer. I lost it and had a good hard cry. I don't know anything about the man in the wheel chair today, but I know that cancer can have that affect of you.

Mom - rest in peace, thinking of you today.

Love,
Ed

Today's FDA Avastin Decision

There's a lot of news out there about the FDA's 6 to 0 vote today recommending that Avastin not gain full approval for treating women with metastatic breast cancer. This case has been watched closely by both drug companies and cancer patient advocate groups. The final decision for withdrawing full approval rests with the FDA Commissioner, Margaret Hamberg. According to one news source, that decision will be rendered later this summer.

I've followed this issue closely. I'm not going to comment on the accelerated approval process granted by the FDA which allowed on label use of this drug sooner than later. With some fear of upsetting people who sided against the FDA, based on what I've read and after careful consideration, the FDA panel is making a sound recommendation.

I base this on the assumption, which I believe to be true, that the NCCN (National Comprehensive Cancer Network) Compendium will continue to list Avastin as a treatment option for breast cancer. This compendium is used by many insurance companies and Medicare to determine which treatments will be reimbursed. The panel's recommendation and ultimate decision to remove the breast cancer approval will not prevent doctors from prescribing Avastin to their breast cancer patients. In addition, Avastin is a serious drug with potentially deadly side-effects (internal bleeding). Unfortunately for patients, Genentech, and our hope for a cure, Avastin showed only marginal benefit in two recent studies. There are many, myself included, that for some people Avastin is the answer and our medical community is hard at work to find the bio-markers which show which patients have the greatest chance of success without endangering women who will not benefit.

Today's recommendation is a win for patients, doctors, and the FDA. Patients will continue to have access to this treatment regimen, insurance companies will continue to pay for the treatment, doctors will still be able to prescribe it to patients who they believe it will benefits, and the FDA is protecting the American people against unnecessary risks.

In closing, I credit my medical team who had the foresight to treat me with Avastin (in off-label use for head & neck cancer) with significantly prolonging my life although I can't prove that it was the Avastin that did the trick. I wish the two recent Avastin breast cancer studies on which the FDA panel based their recommendation had shown great benefit for breast cancer patients, but they didn't.

Lastly, I apologize to anyone I may offend for having sided with the FDA on this one. It is not about the money, it is not about death panels, it is not about Obama care; it is about the science.

Take care.

What a H&N Cancer Patient doesn't want to have...

A sore throat. For most people, me included, a sore throat was (past tense) just that and nothing more. We all get them. That was then; now it dredges up a lot of bad memories and negative possibilities. I've been feeling a bit under the weather for about two weeks with frequent migraines, more than the usual fatigue and loss of appetite, and a SORE THROAT. I went to the doctors today for my annual physical (it's actually been a few years). They swabbed my throat and it came back positive for type A strep. I began a 10 day regimen of an antibiotic. In researching this on the Internet, it appears that this is a pretty common illness and that whatever contagion I may have will be gone within 24 hours of beginning my medication. For now, the best cure is a little extra rest.

I can't not wonder how I got this. I realize this is a stretch with possibly scant medical backing. For me, I believe it to be a somewhat compromised immune system from my cancer and all my cancer treatments and a potential side effect of the stress and close people contact associated with traveling (that trip to ASCO 2011 in Chicago two weeks ago). I've mentioned in the past that travelling is a challenge for me, this is one of a number of those challenges... real or imagined.

Take care everyone.

Ed

Targeted Cancer Therapies - A Peek Behind the Curtain

Lions, and Tigers and Bears! Oh my! It took Dorothy courage to look behind the curtain in the city of Oz. She found the Wizard.

I recently took a peek behind the curtain. For me, more so than courage, it was curiosity and a desire to make a personal contribution which prompted me to attend the June 2011 American Society of Clinical Oncology (ASCO) conference, Patients Pathways Progress. This is the premier annual oncology conference in the world. It attracted 30,000 oncology professionals. There were hundreds of sessions ranging from the kickoff of a large keynote address to meetings with individual researchers who were peer-selected to display their ground breaking research.

I expected to find a few presentations on the biology of cancer and how our growing knowledge of genetic science would lead to targeted cancer therapies. As with Dorothy in The Wizard of Oz, what I found behind the curtain surprised me. Unlike Dorothy, I found a set of true wizards comprised of oncologists, molecular biologists, epidemiologists, and statisticians who were willing to share their latest breakthroughs in the hopes of collectively and collaboratively finding cures to cancers.

Out of the dozens of presentations in which I participated, my personal favorite was the one delivered by Apostolia M. Tsimberidou, MD, PhD, titled Personalized Medicine in a Phase I Clinical Trials Program: The M. D. Anderson Cancer Center Initiative. The hypothesis of her study is, “Genetics and molecular analyses of patients’ cancers will identify biomarkers for targeted therapies that will improve clinical outcomes.” A phase I non-randomized trial within M. D. Anderson’s Investigational Cancer Therapeutics department was begun in 2007. The trial used tissue from patients referred for treatment to this trial to identify genetic mutations. If a genetic mutation was found and a drug regimen was available that targeted that specific mutation, the patient was enrolled in this phase I trial. Of the 1,144 patients whose tissue sample was analyzed for molecular aberrations, 40.2% were identified with one or more cancer-suspected genetic defects. This patient set was then placed on either a “Matched Therapy” or a “Therapy without Matching” regimen. Here’s the bottom line. The “matched therapy” group showed a 27% positive response rate whereas the “therapy without matching” group showed a 5% positive response rate. The conclusion, based on rigorous statistical methods, was that the matched therapy group faired far better than the non-matched group. By my way of thinking, more than 5 times better. The studies long term goals were twofold. First, over the next five year they hope to develop the capability to test all of M. D. Anderson’s 30,000 new patients a year for any genetic/molecular aberration in order to assign targeted therapy. Second, to perform research that proves efficacy so that the tests are reimbursed and become the standard of care.

This one presentation was one of hundreds during this five day conference focused on genetics and targeted therapies. This is what elevates my hope for a cure. Although targeted therapies are a relatively nascent science, the acceleration of discovery is shifting into high gear. As Dorothy said to Toto upon her arrival in Oz, “We’re not in Kansas anymore.”

"Major Shift in War on Cancer"

This is the headline of an article in today's (June 6 2011) Wall Street Journal regarding the 2011 ASCO (American Society of Clinical Oncologist) conference currently being held in Chicago at the McCormick Place conference center. There are about 25,000 attendees. Although traveling is a challenge for me, I am here as a patient research advocate volunteer and am honored and somewhat humbled to be one of those in attendance.

The WSJ article goes on to say, and I quote...

"New research is signaling a major shift in how cancer drugs are developed and patients are treated—offering the promise of personalized therapies that reach patients faster and are more effective than other medicines.

At the heart of the change: an emerging ability for researchers to use genetic information to match drugs to the biological drivers of tumors in individuals."

Here are some of the highlights from my perspective based on people I met, presentations attended, and the overall conference materials:

• About 30% of the several hundred large presentations are on a deeper understanding of the genetics within many different cancers... head & neck, lung, ovarian, breast, melanoma, etc. In sessions I attended there is a focus on finding combinations of mutant genes which lead to cancer (or a prediction of cancer) versus a prior focus of finding one single gene mutation. Finding these gene combinations is akin to finding a needle in a haystack, but large teams of medical doctors, molecular biologists, and other researchers across cancer institutions and international boundaries are attacking focused research and making progress.  
• I spent an afternoon meeting with drug company representatives. The larger companies like GSK, Abbot Laboratories, Genentech, Pfizer, etc have 1,000 square foot plus exhibition spaces. Most of them have a subset space for discussions on current research staffed by highly knowledgeable researchers and molecular biologists. This resource allocation confirmed for me the conference’s focus on finding cures through deeper genetic understanding.
• About 20% of the exhibition space was dedicated to companies specializing is what appeared to be the most current technologies and biology's available for genetic mutation detection. The cost of testing is falling rapidly. There are three primary testing techniques. Single gene testing costs begin at about one hundred dollars while testing an individual’s entire genome is about ten thousand dollars. Elapse time for gene testing from patient consent to results has been shortened, but is still a 3 to 4 week process.
• Researchers are beginning to test genetic defects across cancer types. This is the paradigm shift I wrote about in my prior blog entry. It is too early to know what fruit this will bear.
• Multi drug cocktails are resulting in evidence-based patient benefits.
• Genetic testing is still part art and part science. Testing methods and processes are being refined and as these refinements are put into practice better data will lead to quicker and more accurate results.
• Genetic mutations are complex. There are missing gene pieces and gene mismatches. Some gene mutations promote tumor grow while other gene mutations affect genes which, when working properly, inhibit tumor growth. The downstream effect of promotion and inhibiting have very different biological effects that can affect many (up to about 100) cell processes. This is one of the factors that make finding a cure, even after finding a mutation, so complex.

It is hard to summarize this annual gathering of the world’s leading oncologists. My takeaway is a true sense of breakthroughs, progress, and an excitement from the participants about winning the war on cancer. For some patients it will come too late; for others it will mean the difference between life and death.

Take care everyone.

A Paradigm Shift in How Cancer is Evaluated and Treated

We all know there are many different cancers (lung, breast, ovarian, etc.). We have also heard that within similar cancers there are cancer subtypes. If one goes to a cancer website (e.g., the American Cancer Society at http://www.cancer.org/), it is generally organized by cancer type. Same with medical institutions... lymphomas, lung, bone, breast, etc.

There is a lot of buzz right now for a recent Pfizer drug, Crizotinib, in the fight against lung cancer. Pfizer has isolated a genetic mutation in a human gene known as ALK. It is estimated that 3 to 5% of those with lung cancer have this genetic mutation. Although that's not a large percentage, it's estimated to be 7,000 to 10,000 new cases of lung cancer (out of 220,000) in the U.S. per year. Crizotinib targets this genetic mutation leaving healthy cells alone. In an early trial with 82 patients there was measurable tumor shrinkage in 90% of patients after two months. This compares to an expected response rate closer to 10%. This genetic mutation was identified in 2007. Pfizer is requesting an accelerated approval from the FDA and expects it to be granted this year. The drug, if successful, could be FDA approved by as early as 2012. This would reduce the time of drug development from 8 to 10 years to five years. My hat is off to Pfizer and all those who participated in this discovery and development.

Now for the paradigm shift. What other cancers have this ALK mutation? Head and Neck cancer, Breast cancer, Liver cancer, Ovarian cancer, and the list goes on. An assay for the detection of this ALK mutation is a few hundred dollars. As an early step in a patient's cancer assessment process, would it not make sense to test for an ALK mutation?  And, in cases where there is an ALK mutation, would it not make sense to give the patient a choice as to joining a clinical trial for the use of Crizotinib? This would mean crossing organizational boundaries within established medical institutions. Within the best medical institutions, this will not be a roadblock.

For more information, Google Crizotinib. It has been written up in the Wall Street Journal, USA Today, various oncology-oriented publications and by Pfizer. This is truly an exciting development in the war on cancer.

Take car everyone.

Genetically Informed Medicine

I wish I was smart, astute, or quick enough to have developed the above phase, "genetically informed medicine." It captures part of the essence of my current medically-oriented research obsession. The article in which I read this was titled, The "Me Decade" of Cancer (see Reference #1). It's a play on the baby boomer "me" generation and covers the topics of personalized medicine and genetics. The phase used in the article was by Harold Varmus, Director of the National Cancer Institute (NCI).

There is a quiet revolution taking place in the world of genetically focused cancer treatment.

• For those with Ovarian cancer, a non-profit, The Clearity Foundation, will help women create a molecular model of their tumor and based on the specific genetics of that tumor, they will recommend treatment options (see reference #2).
• For those with Melanoma, another group, CancerCommons, has created a molecular model of melanoma and is offering treatment guidance based on one's genetic code (see reference #3).
• There is even a molecular model for head and neck cancer (see reference #4). This too offers insight into potential genetic-driven treatment options.

I am not sure where all this will lead, but the future of individualize medicine is gaining momentum and appears bright.

Take care everyone.

References
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Ref #1 - The "Me Decade" of Cancer
http://www.the-scientist.com/article/display/58059/

Ref #2 - The Clearity Foundation
http://www.clearityfoundation.org/clearity-overview.aspx

Ref #3 - Cancer Commons
http://www.cancercommons.org/

Ref #4 - The Molecular Biology of Head & Neck Cancer
http://www.medscape.com/viewarticle/735920


Once again, I'd like to encourage a dialogue with those that find this information useful. It is easy to post a comment. Below is an image of a world map with pin points of recent blog visitors. Although many readers live in the US, this blog has gained a truly global following... India, Australia, Singapore, Egypt, Greece, Switzerland, Nigeria, and many other foreign lands.

You can double click on the map image to enlarge it.
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An “Ah-Ha” Moment for the Oncology Community

This is my third attempt at writing this complex blog entry. The first two attempts were too cumbersome and convoluted; they did however help me crystallize my viewpoint.

Here’s the hypothesis…

Given relatively recent advances in genetic testing, the human genome project, the cancer genome project, and human cell molecular modeling, individual results from clinical cancer trials are being sorely underutilized.

Personally, I’m closest to head and neck cancer as I follow news stories on it daily. However, my hypothesis applies to all clinical cancer trials. I will use a head and neck clinical cancer trial as an example in support of this hypothesis.

There are a set of head and neck oncologists who believe that patients with recurrent head and neck squamous cell carcinoma who do not respond to platinum-based chemotherapy have run out of treatment options and in turn have a very poor prognosis. See link in Reference #1 at the bottom of this blog entry. The article is about a paper presented at the 2010 ASCO (American Society of Clinical Oncologists) meeting and it backs up this assertion of a poor patient prognosis.

There have been early phase clinical head and neck cancer trials which on the surface have shown promising, but inconclusive results. See link in Reference #2 at the bottom of this blog entry to clinical trial NCT00442507 at www.clinicaltrials.gov. This was a phase II trial using a combination of Tarceva and Avastin that included 48 patients beginning in March 2007 and ending in January 2009. The results of that trial were printed in an article on www.cancerconnect.com (see Reference #3). On the surface the results of the clinical trial are positive, but lukewarm… Article headline, “Combination of Avastin® and Tarceva® Shows Promise in Head and Neck Cancer.” If you read the article it goes on to say, “Seven patients experienced a complete or partial disappearance of detectable cancer.”

Here’s the quandary. A group of oncologists at last year’s preeminent oncology event, ASCO, reported that the prognosis for recurrent head and neck cancer patients who failed platinum-based chemotherapy was poor. Yet, we have a study which completed in January 2009 where seven patients which fit the profile of this poor prognosis group experienced a complete or partial disappearance of detectable cancer. To my eyes, this is a major disconnect in viewpoints.

If, and this is a big “if,” one was able to use recently developed genetic testing to have pre-picked just those seven patients for this trial, the article headline would have read, “HEAD & NECK CANCER CURED IN SOME PATIENTS,” it would not be “Shows Promising Results.”

If I were part of the oncology community, this would be an “Ah-Ha” moment for me. What can we learn from those seven patients that will allow us to effectively use these targeted chemotherapies to save lives efficiently? I don’t know if the oncologists running this clinical trial have thought about exploring this path of reasoning. If my hypothesis is correct, they haven’t. In this example, I hope I'm wrong.

To test this hypothesis, I’m going to try and contact the oncologists for this clinical trial to understand where the results from this trial have led. Please remember, this is just one example. In a more strategic sense, what can we learn from all the other individual successes in all the other clinical cancer trials that have been recently completed or are in progress? My hypothesis says that the individual successes are being underutilized. More on this story as further facts are known.

Take care everyone.

References
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Ref #1 – 2010 ASCO Presentation article
http://www.medpagetoday.com/HematologyOncology/OtherCancers/25227

Ref #2 – Clinical Trial
http://clinicaltrials.gov/ct2/show/NCT00442507?term=head+neck+tarceva+avastin&rank=7

Ref #3 – Clinical Trial results article
http://news.cancerconnect.com/combination-of-avastin-and-tarceva-shows-promise-in-head-and-neck-cancer/

Post Script
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I struggled with this blog entry. Another appropriate title would be, "Reverse engineering a cure for cancer."
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Genetics and Cancer Treatment

This blog entry is not about my cancer. It’s focused on how genetic research and findings are transforming the field of cancer treatment. The first part of this blog will provide a foundation by way of definitions and a few basic premises. The second part will cite an article in today’s WSJ about how genetic testing could improve the prognosis and ultimately the treatment of prostate cancer.

Definitions, Foundation, and Hypothesis
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Cancer cells: Uncontrolled growth of aberant cells in the body. Cancer cells can grow, divide, and invade normal tissue in the body.

Gene: The basic unit of heredity in a living organism. All living things depend on genes. Genes hold the information to build and maintain an organism's cells and pass genetic traits to offspring. There are approximately three billion genes in humans.

DNA (deoxyribonucleic acid): A long linear polymer found in the nucleus of a cell and formed from nucleotides and shaped like a double helix; associated with the transmission of genetic information

Chromosome: An organized structure of DNA and protein that is found in cells. It is a single piece of coiled DNA containing many genes, regulatory elements and other nucleotide sequences. Chromosomes also contain DNA-bound proteins, which serve to package the DNA and control its functions. Humans have 22 chromosome pairs plus two sex chromosomes.

Genome: An understanding of the complete set of a living organism’s DNA.

Human Genome Project (HGP): An international scientific research project with a primary goal to determine the sequence of chemical base pairs which make up DNA and to identify and map the approximately 20,000–25,000 genes of the human genome from both a physical and functional standpoint.

Cancer Genome Project: Building off of the HGP and using high throughput mutation detection techniques, its goal is to identify somatically (i.e., cells in the human body) acquired sequence variants/mutations and hence identify genes critical in the development of human cancers.

Proteins serve many different functions within the chromosome and there are many different types of proteins. As such, I’m not going to define “protein” see (Wikipedia for a definition if interested). One function of a type of protein is cell division, either to encourage or discourage a cell from dividing. Proteins are complex and some proteins which regulate the growth of cancer cells have unique pathways. Admittedly, my knowledge here is weak and therefore should be treated as such. With this caveat, I’ll try to provide an example. In Head and Neck cancer, which for the most part is Squamous Cell Carcinoma, there is a protein called p53. This protein is also known as a tumor suppressor. There are other proteins which inactivate protein p53. Plus, to add to the complexity, the p53 protein may become compromised. So, in theory, if one could either 1) destroy the mutant p53 protein or 2) inactivate the proteins which inactivate the protein properly functioning p53 (yes, a double negative), then p53 could do its job in blocking the unregulated growth of cancer cells. From here, I’m on even thinner ice as I’m not sure about the relationship between p53 and my next statement (yet). Tarceva, a drug I have been on for 38 months is an EGFR (Epidural Growth Factor Receptor) inhibitor. It has special properties which in some way target a pathway into a protein which plays a significant role in solid cancer tumor growth. This is all very complex, so let me get to the hypothesis of this paragraph.

Hypothesis: If, through individualized genetic testing, one could find patients with an over-expression of the protein (or pathway) which Tarceva attacks, Tarceva (which is very expensive) could be targeted to those individuals for whom there is evidence of benefit (i.e., evidence based treatment). This in turn should increase the overall effectiveness of Tarceva on the population which is genetically receptive to this treatment regimen. It would in turn reduce unnecessary Tarceva treatment and reduce healthcare costs without impacting heath care effectiveness.

Today’s WSJ Article on Genetic Profiling and Cancer Treatment
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You may have thought I forgot about part two of this blog entry. I found today’s (2/3/2011) news story in the WSJ titled, “New Clues to Treat Prostate Cancer,” fascinating. It is about how four genes play an intricate and interrelated role is predicting which individuals with prostate cancers have an aggressive cancer where treatment (e.g., radiation, surgery) is recommended versus one in which it should be watched without treatment.

Here are the article highlights. The findings so far is in mice, not man. Human testing is a few years off. One study cited in the article said that 48 men were treated with radiation or surgery to save one life. (Note, although this was not in the article, side effects from prostate treatment can include erectile dysfunction, incontinence, and surgical complications.) The article went on to say that if this genetic test could increase the odds of determining who should have treatment from our current standard of care test (an individual’s PSA level and biopsy) which predicts at a 60 – 70% to a 90% level that many men with a "favorable profile" might want to monitor the progress of their cancer for a while before deciding to undergo aggressive treatment.

To me, this is a game changer and yet another example of how our genetic understanding will impact medical practice over the coming years.

For those with access to the online version of the Wall Street Journal, here’s a link to the article…

http://online.wsj.com/article/SB10001424052748703960804576120194229203936.html?mod=djkeyword

Take care everyone.

Ed

Happy New Year... And, a Brief Health Update

Hi,

I had a Head & Neck CT scan and a follow up visit with my oncologist on January 5th. The radiology report was finalized today and all systems are clear. No new evidence of disease and my anatomy, when compared to my last CT scan in June, appears stable. So, all good news.

On the subject of improving my speech and swallowing functions (see background from December 2 2010 blog entry), the news is disappointing. I visited with my reconstructive surgeon and his physician assistant on January 3rd. It had been over three years since I had last seen him. We spent a very high quality hour together going over my options. I won't get into the detail here, they are just not that interesting to anyone but me. The bottom line was... make the best of what I have; surgical treatment is not a viable option due to the treatment risk of performing surgery in an irradiated area. In early December I was in touch with the UC Davis physician who did the implant on the head and neck cancer patient in Uruguay to help with his swallowing function. I may still schedule a consultation with him, but I have to be cautious. For me, even a minor surgery in an irradiated area may lead to long term disastrous complications.

Happy 2011. Stay healthy.

Ed