Monday, August 29, 2011

Getting the right doctor can save your life

This proves what I have been saying for years. You need a CLL specialist heading up your team. Odds are you will live years longer.

This is probably less true in common diseases such as diabetes or breast cancer where most providers have many such patients.

But this is sure true for CLL/SLL.

Thank you ACS and thank you my friends at Mayo. The research may be seen by some as self serving, but it is hard to argue with the numbers.

Hematologist/oncologist disease‐specific expertise and survival: Lessons from chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)


Tait D. Shanafelt, Neil E. Kay, Kari G. Rabe, David J. Inwards, Clive S. Zent, Jose F. Leis, Susan M. Schwager, Carrie A. Thompson, Deborah A. Bowen, Thomas E. Witzig, Susan L. Slager, Timothy G. Call



The impact of physicians' disease‐specific expertise on patient outcome is unknown. Although previous studies suggest a survival advantage for cancer patients cared for at high‐volume centers, these observations may simply reflect referral bias or better access to advanced technologies, clinical trials, and multidisciplinary support at large centers.


We evaluated time to first treatment (TTFT) and overall survival (OS) of patients with newly diagnosed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) at a single academic center based on whether they were cared for by a hematologist/oncologist who subspecializes in CLL (CLL hematologist) or a hematologist/oncologist with expertise in other areas (non‐CLL hematologist).


Among 1309 newly diagnosed patients with CLL cared for between 1999 and 2009, 773(59%) were cared for by CLL hematologists and 536 were cared for by non‐CLL hematologists. Among early‐stage patients (Rai 0‐I), median TTFT (9.2 vs 6.1 years; P < .001) and OS (10.5 years vs 8.8 years; P < .001) were longer for patients cared for by CLL hematologists. For all patients, OS was superior for patients cared for by CLL hematologists (10.5 years vs 8.4 years;P = .001). Physician's disease‐specific expertise remained an independent predictor of OS after adjusting for age, sex, stage, and lymphocyte count at diagnosis. Patients seen by a CLL hematologist were also more likely to participate in clinical trials (48% vs 16%; P < .001).


Physician disease‐specific expertise appears to influence outcome in patients with CLL. To the greatest extent possible, patients should be cared for by a hematologist/oncologist expert in the care of their specific malignancy. When not possible, practice guidelines developed by disease‐specific experts should be followed. Cancer 2011. © 2011 American Cancer Society.


Friday, August 26, 2011

Better Access to Developmental Drugs. The Life you Save might be your Own.

Here is an email between a friend in the CLL community and the larger general cancer community, both fighting for the same goal, to allow earlier access to life saving drugs. We all owe a huge debt to these heros who are willing to see beyond themselves and fight the good and much bigger fight of changing the world through changing Washington. They need all our support. The life you save might be your own.

The HIV community won this fight for their cause, but it some ways ruined it for those who came after, as some procedures such as bone marrow transplants for breast cancer were legislated into place for emotional and feel good reasons and were subsequently found to be not only expensive, but useless and likely lead to much unneeded suffering. As a result, there is some hesitancy to rush down this path again. Scientific purists object for good reasons as this can screw up the critical studies needed to show that a therapy works or doesn't as happened with breast cancer and transplants, plus it is not in the interest of big PHARMA or in the legislatures or insurers that will need to pay for these expensive trials of one. (The Pulitzer prize winning, Emperor of All Maladies tells the whole story with clarity and wisdom. It is great read for this and a million other reasons. I highly recommend it.)

So we need to be astute and thoughtful on how we precede. After reading the following email if you want to help, please contact:

Give Patients a Fighting Chance


I want to ask Give Patients a Fighting Chance to join in on the early
stages of a very important effort.

The Abigail Alliance with our friends and allies is at the beginning
of launching a very significant and strong effort to bring attention
to and legislation for change at the FDA to save and extend many more
lives of patients fighting for their lives. This effort will be
launched with the premier, hopefully at the January 2012 Sundance Film
Festival, of a documentary that features the Abigail Alliance and the
issues we have been and continue to bring to the fore. The film is
being produced and directed by two time Oscar winner Barbara Kopple of
Cabin Creek Films.

In January of this year we learned that California billionaire
entrepreneur Alfred Mann ( )and the new organization
Break Through Cancer Coalition (See attachment.) are the financial
backers of the film. Alfred Woods daughter Carla Mann Woods
( ) heads the new group
Break Through Cancer Coalition and is married to actor and producer
Eric Woods ( ).

Break Through Cancer Coalition is raising money to promote the
documentary, to bring national attention to problems that are blocking
better access to promising new therapies, and to promote legislation.
Carla is also working on getting friends in Hollywood CA to help bring
visibility to the effort.

The Abigail Alliance and Break Through Cancer Coalition would like you
to join in on the early organizing of this lifesaving and life
extending effort. Our first goal is to get as many patient advocates
as possible on board and on the same page.

Thinking of you and your good work,

Abigail Alliance for Better Access to Developmental Drugs
8881 White Orchid Place
Lorton, VA 22079

COMPASSIONATE ACCESS ACT: The Abigail Alliance along with others is in
the process of very significantly reinvigorating the Compassionate
Access Act in the U.S. Congress.

DOCUMENTARY: Sometime mid to late this year a documentary featuring
the Abigail Alliance will be coming out!

ALSO, the Abigail Alliance has a VERY tight budget, so your help


Wednesday, August 24, 2011

To J Dean and TomD on AIHA, FCR, PCR, and flu shots

Friends, please please please, ask me medical questions only using email, not in the comments as I can not respond to your questions without your email address that I don't have. It is frustrating for all of us

My email is listed on my blog: for that purpose.

Remember I can not give medical advice and all my suggestions are only fodder for discussion with your doctors who know you best and must be discussed with them.

J Dean- I see very little advantage in PCR over FCR in terms of AIHA risk. Both P and F are purine analogues with similar toxicities. Both can cause auto-immune problems. P may be a touch safer in terms of auto-immunity but it can and does cause big problems similar to F in terms of wiping out red cells and platelets.

Instead talk to your doctor about HDMP +R (high dose methylprednisilone and rituximab. Or Dr. Rai's protocol of RCD (see study below) or a trial or single agent ofatuzamab.

I don't know enough about the circumstances to give strong advice, but I personally would never ever do PCR after getting bad AIHA from FRC. Never. And I think most CLL experts would agree. Not all, but most. Get a second opinion!

Here is a recent article on RCD

Rituximab, cyclophosphamide and dexamethasone (RCD) effectively target lymphocytes and inhibit autoimmune processes.

Auto-immunehemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP) are known complications of CLL.

Dr Rai and his colleges used the follow formulation to treat AIHA in CLL patients.

Rituximab 375 mg/m(2) i.v. infusion given on day 1,

cyclophosphamide 750-1000 mg/m(2) i.v. on day 2 and

dexamethasone 12 mg day 1-7 given every 3 weeks. Response to

treatment was seen in all 20 patients with CLL with AIHA. Median

hemoglobin pre-treatment was 8 g/dL. The median change in

hemoglobin was 5.2 g/dL and the median post-treatment

hemoglobin level was noted to be 13.1 g/dL. Median duration of

response was 22 months.

Fifty percent of evaluable patients converted to Coombs negative with

median duration of response of 41 months vs. 10 months for those

who did not convert.

Steroid-refractory immune thrombocytopenia was present in three

patients and all responded to RCD. There were no hospitalisations or

infections directly related to RCD. RCD is a safe and effective regimen

in the treatment of immune cytopenias associated with CLL.

Source: Leuk Lymphoma. 2009 Apr 23; 1-8

If your doctor is not familiar with these protocols, absolutely you must get a second opinion. In fact you should get a second opinion any way. Sorry to be so emphatic, but in case tou didn't notice, I am worried that PCR may not be the best therapy for your man.

TomD- It seems a bit early for flu shots. I have not been following the CDC weekly reports to see if they are predicting an early flu season, but I worry that a shot in August won't do you much good in February at what might be the height of flu activity.

Two shots, one how and one in six to twelve weeks, is always a possibility as is the experimental use of ranitidine to boost response.

I would go for the higher dose myself, but it is just a best guess. It is supposed to help the elderly with their reduced response to vaccines, so it makes sense it would help us too, but there is no proof.

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Monday, August 15, 2011

What do Designer T cells mean to you and me?

The breakthrough in genetic engineering that lead to two of three patients with bad CLL getting a clean bill of health has generated world wide excitement, with good reason.

It's dramatic, it's a first, it's not chemo, it's mostly drug and big pharma money free , it's a doable technology for CLL that has possible applications for any cancer that can be recognized by its protein markers that protrude from their cell wall (in this case CD19), and it's still working a year later.

My bet is there will be a lot of money to move beyond this proof of concept to phase 1 trials, both at U Penn and other eager centers that can make the requisite designer genes.

That is mostly companies like Amgen and Genentech and a million start-ups, and universities, and big cancer centers such as MDACC, UCSD, Stanford, Dana-Faber, and others.

My bet is that these trials will not be hitting the local oncologists office anytime soon.

My bet is that the demand for this will outstrip the number of openings. It is a very personalized, hands on, and expensive therapy. My T cells won't work for you and vice versa.

My bet is that dosing will be critical as always in Phase 1 trials, but even more so here, where we know we have a very big bomb that can have quite a long fuse. Remember that the onset of the tumor lysis syndrome (TLS), the state where there is a very rapid and dangerous amount of cancer killed in a short time exceeding the kidneys' ability to handle all the debris, was quite delayed in the U Penn trial. Too high a cell dose, and the unpredictable TLS can kill you, too little, and the response is too feeble and the cancer continues to grow.

My bet is that choosing the right target is also critical. CD19, the target in the U Penn trial, is found on all B cells and its precursors, so this therapy wipes out nearly the entire immune army that produces antibodies. Does that mean you are cured of cancer, but may be at risk of dying from measles or chickenpox as the oldest soldiers (the memory cells) die off? We don't know, yet.

Are other targets better and more selective? Will they work as well without the immune risks? Again, that's what trials are all about- to answer these questions.

So what does this all mean to those of us with CLL?

Here's my best case scenario.

It means nothing today.

But I bet (when you have cancer you are always making bets with less than perfect knowledge), that in less than a year we will have limited opportunities to enter phase 1 trials on new iterations of the designer T cell therapies. This is too good a result and way too much fun for the MD/PHDs not to tinker with creating new cells to not work its way through the IRB committees quickly. Most trials will they likely be small and be restricted at first to those at the end of the present therapeutic rope, but as experience and safety data grows, in three years or so, bigger phase 1/11 trials now with pharma money may open for those looking at earlier or even front line therapy.

If all goes great, and and this is a big if, they can find a way to pay for this, we could have a new revolutionary treatment option in less than ten years. Maybe even seven or if a prominent senator is diagnosed with aggressive CLL, five.

That's the Cinderella story. The perfect fitting glass slipper and the lucky girl living happily thereafter.

But it won't be easy choosing what size or design is best, which virus is the safest to do the heavy lifting (the U Penn people used an HIV like virus with its reproduction genes disabled), what cancer center is best ready to handle possible TLS weeks out, what dose of T cells, what chemo if any is needed to clear the table before the gene therapy can begin, and a thousand other unknown unknowns.

So again for us patients, the trick is to stay alive, try to keep our powder dry by avoiding therapies that damage the marrow or immune system as long as possible, keep our ears to the ground for new research, assess whether we really need to do anything so don't get caught up in the hype and pressure and worry that we might miss the boat if we don't jump at this, and if we do need therapy, is what is available in a gene trial therapy the best choice?

The good news is that when we do need therapy, the choices are getting both better and tougher.

The devil we know such a FCR or Revlimid or Bendamustine or HSCT, or the devil that we are just getting to know such as the new small molecules such as CAL101, PCI 32765, ABT99 and more and more sharply focused cancer pathway blockades, or the completely unknown devil with his great promise, the new very sexy new kid in town - designer T cell therapy?

An exciting time for sure. I love these possibilities, but that is what they are possibilities. But so was Gleevec at one time.

For me, I am nervous about jumping too fast until I see more data, especially long term safety data. I am frightened that I will be, as Leonard Cohen said, "torn by what I have done and can't undo." Still the appeal is undeniable- the benefits of an allogenic transplant with much of the downside taken out of the equation.

So I plan to stay alive and follow my own advice given above.

But first I am going fishing in Missouri. And I don't even eat fish.

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Saturday, August 13, 2011

A major breakthrough in CLL therapy. There's a new serial killer in town.

They did it, they got the benefits of an allogenic transplant, namely a new population of T cells that alert the immune system in an ongoing way to search and destroy the cancerous B cells. A transplant sans transplant. The benefits without many of the most horrific risks.

Here's a link to a VIDEO that tells the story.

These T cells have been changed with the insertion of new genetic information by infection outside the body with an HIV type retrovirus that, when they are put back into the same patient, gives them the ability to recognize and attach to the CLL cells, to arouse a very robust inflammatory response (read that they initiate a killing frenzy of both cancerous and good B cells and its precursors), and most importantly to proliferate and stay around for at least a year.

Am I encouraged? You bet.

This has the potential to change everything. This has the real potential to cure CLL.

But at this point it all still potential and conjecture, and all therapies look great when they are brand new. There are may unknowns and concerns. Still, it is an exciting time to be a CLL patient.

More soon on what I think this means for anyone with CLL in general and for me in particular.

In the meantime, I am rooting for these new cops, this new "007" secret agents with their license to kill.

And all this was done with no pharma money!

Anyway you look at it, this is very good news.

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Friday, August 12, 2011

Rift on "How ya doing?"

Gregg writes a great blog detailing with humor and true colors the cold realities of the trials of a post transplant journey.

In response to his response to the question"How are you doing?", which is almost always followed by: "You look so good." I wrote the following comment.


I too hate when people tell me how well I look. And ask with genuine concern about how I am doing. The truth is way too complicated and depressing. I may look good but I've got scary huge nodes hiding out in my guts, my bone marrow has aged 10 years in the last 3 years from the hit it took in the failed transplant, I take enough medicine twice a day to choke a T-REX to keep me "looking good", I have fatigue that you could cut with a knife, and my CLL is getting less and less responsive to my latest moves and I better think carefully of my next therapy cuz my options are limited.

But instead I say: "Thanks for asking. I am happy to be here and looking good". Which is also true.

And is also a very good place to be with still a few good cards to play and a lot of game left in me.

Stay strong bro

We are all in this together.



Thursday, August 4, 2011

Dying, Awake

More that I did not write.

This is one I hope I don't need to write for, say another 30 years or so.

But I do hope I am as well prepared for that message.

But for now, I have no intention of dying, awake or otherwise.

Thank you Sarah for finding this.

The ENJOY EVERY SANDWICH is the wisdom of rock icon, Warren Zevon when he learned he had a fatal lung cancer.

Dying Awake

"The cancer is back."

On the other end of the line, there was a moment of silence and a deep sigh as my wife registered my news.

"Are you sure?" she asked, then quickly shifted into physician mode. "What's the cell type? Is it herceptin sensitive?"

"I don't know yet. This sucks," was all I could say in response.

We hung up the phone, and I found myself standing just a few blocks from my friend Donald's office. In addition to being a close friend, Donald is an oncologist, so I decided to stop by and talk to him. Being a physician has its perks: quick answers, even if they're not the answers I want to hear.

"It's been a miracle that you've been alive for these past two years," Donald told me. "At this point, it's about controlling symptoms only. There is no cure." Though Donald's words were professional, his eyes were wet. We are not just colleagues, but friends. The news was hard for both of us.

Two years earlier, I 'd been diagnosed with metastatic adenocarcinoma of my esophagus. I had endured eight months of chemotherapy and radiation, and for the past year, I have been cancer free. Despite a 90 percent mortality rate, I felt hopeful. I was planning my career moving forward and preparing for my book tour -- blocking out dates, scheduling talks and travel -- for Enjoy Every Sandwich; Living Each Day as if it Were Your Last, which is being published in November.

Now, two days before a family vacation, all had come to a halt with the news that I have eight, maybe 12, months left to live. There are lots of stories of miraculous cures out there, lots of programs to beat cancer, but none with consistency or solid evidence. Outside of a miracle, it seems that I am toast.

On our family vacation the next week, we laughed and had a great time. At night, Kathy would hold me and say, "Don't leave me." What could I do? Whether I died or not was not my choice. I could seek out other therapies (and I did, consulting friends in the alternative medicine world about what was available for me now that the allopathic world was only talking about pain control), but I had no control over the final outcome. All I could do was to hold my wife of 28 years, while she suffered with the thought of losing me.

I have spent the past weeks telling people about my prognosis, watching them get sad, angry or depressed. I am powerless in my dying, aware that those whom I love are hurt by the news. I have also spent the last few weeks in pain from my cancer's spread, sitting up and meditating to distance myself from the mental agitation of suffering. On most nights this works well, as I remind myself that, though I am in pain, this will pass or I will pass, but it will not be forever.

A sense of peace prevails. I am still alive.

It may seem peculiar that I am calm while others in my life are suffering. I can assure you their suffering makes me sad; I wish this weren't happening. Yet after almost 30 years of meditating, I have learned to embrace optimism, gratitude and the knowledge that I am not in control over my life or death. Instead of being mad at the hand of fate, I am focused on what is going on -- mentally, physically, and emotionally -- with myself and those that I love. In spiritual language, I am awake.

I have no bucket list of things to do. I have been living my bucket list for some time now, and when I was first diagnosed, it came to me that the real list in my life was not the places I wanted to see, but the list of friends in my life with whom I want to spend my time.

I am focusing on the playful parts of life: Buying concert tickets, traveling while I still can, enjoying nature while the weather is still good. This jump to acceptance is a little premature for Kathy. She is still holding out for miracles, while my view is that a miracle would be great, but I'm not going to wait around for it, so why not play. Just enjoy life, stay awake and see what happens.

If I have eight months to live, there is a lot of fun to be had. Once I am too sick or tired, I can watch movies, read books and have friends over. When I become too weak for that, I can enjoy the peace of our sweet home and the hugs of my wife. Not a bad way to spend the rest of my life.

My mantra of "it is what it is" means more to me now than ever. Regretting anything left undone would be a waste of time and energy. I will enjoy what is left.

My meditation practice has eliminated my fear of dying, opening me up to what might come after death (I know I can't possibly know until it happens) and allowing me to just be there for the ride. I am at peace: awake and aware. So, here I am, dying awake.

LEE LIPSENTHAL, M.D., ABIHM, is an internist, trained in the prevention of heart disease and in integrative medicine. A popular and respected speaker and author, he was the medical director of Dean Ornish's Preventive Medicine Research Institute for a decade and has also served as president of the American Board of Integrative Holistic Medicine. He is the author of the soon to be released ENJOY EVERY SANDWICH (Crown Archetype)