Targeted Information for
Patients With
Non-Hodgkins Lymphoma
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Last evening, my wife, Louise, and I had dinner with a member of our extended lymphoma family.
A few months ago, I received a phone call from a personal friend who told me that he, in turn, had received a phone call about a man who was newly diagnosed with non-Hodgkin's lymphoma. The patient, then asymptomatic, had consulted with an oncologist who told him that he must, immediately, start a course of protracted chemotherapy. I was told that he was terribly frightened.
To make a long story short, I directly called the patient prior to his starting therapy. We met for lunch, as we both live near one another. I listend to him , then told "my story" and, finally, offered suggestions.
Now, he is not only feeling well (without chemotherapy), but more importantly, he is brimming with confidence and ease. As a result,, he is effusive in his praise of me for what I have done.
I am not worthy of such praise. Rather, it is my immense satisfaction to help, in any small way, a fellow patient.
Last night we had dinner with my friend and his lovely wife. Such a warm, wonderful meeting.
Mort
To clear up any confusion, RIT is approved for the following uses:
Both Zevalin and Bexxar are approved for patients with follicular lymphoma as a second line treatment. In other words, patients must have taken either chemo, Rituxan or a combination of the two before RIT can be used.
Interestingly, CVP is the only chemotherapy which has been approved to be used in combination with Rituxan for follicular lymphoma. CHOP is the only chemotherapy approved to be used in combination with Rituxan for diffuse large B-cell lymphoma. Almost everyone knows that CHOP plus Rituxan is commonly used in patients who have follicular lymphoma. The point is that Rituxan is commonly used "off label," that is, in ways that it has not been approved by the FDA. This is not uncommon in the practice of medicine, but the question must be asked why RIT is so rarely prescribed even for the use for which it was approved, especially when there is an impressive amount of data which substantiates the benefits.
There are 3 studies in particular which I cite:
1. From Christos Emmanoulides, et al, published in June 2005. The authors studied 4 clinical trials conducted at 30 centers. The patients had follicular lymphoma or transformed B-cell NHL. 30% of the patients were given Zevalin as their second treatment. The remaining 70% of the patients had previously had two or more treatments. The complete response was higher when Zevalin was used after the first relapse (49% versus 28% of the total population and 51% versus 28% for the follicular population). The authors concluded that Zevalin produced a consistently higher overall response rate and longer durable remission when used as the second treatment, rather than after two or more prior therapies. They also noted that "there were long-term durable remissions in 37% of the patients, some of them longer than 75 months." This study also noted that future treatments were possible if necessary.
2. From the ASCO 2006 Conference, DeMonaco, et al, reported use of R-CHOP followed by Zevalin in follicular lymphoma patients. The authors observed that the complete response rate jumped from 36% with R-CHOP alone to 89% when Zevalin followed R-CHOP.
3. From ASCO, 2005 Conference, Stephanie Gregory (Rush University) et al. The authors reviewed treatment responses in 1,177 patients in 10 clinical trials in which Bexxar was used as first, second, third, fourth or more treament. They found that "response rates, complete response rates, and associated durations of response to Bexxar all increased significantly as the number of prior therapies decreased." The results showed the following complete responses: 78% when used as first treatment; 46% when used as second treatment; 32% when used as third treatment; and 23% when used as the fourth or later treatment. The progression free survival also improved dramatically when Bexxar was used earlier in treatment rather than later.
These studies provide solid evidence that RIT has a better chance of working when it is used earlier. If anyone wants the links to these studies to show their own oncologists, please let me know. I will gladly provide them to you.
Betsy
I have just received a poignant email from a lymphoma patient who has been reading this blog.
She relates that she has learned that the pharmaceutical manufacturer of Zevalin has ceased marketing and promotion of this important radioimmunotherapy (RIT) medicine.
She wrote, "I just received my Zevalin. I may be the last person to receive this important drug".
The RIT medicines, Zevalin and Bexxar, are too valuable, indeed, life-saving, to be lost. We, the patients, are the only ones capable of saving these medicines. And how do we save them? By insisting on a consultation with a physician who is experienced and trained in administering RIT before deciding on a personal lymphoma treatment plan.
Say it isn't so.
Mort
Radioimmunotherapy is often misunderstood and since several people are new to the blog, I'd like to simplify how it works.
RIT uses antibodies to attack malignant cells. Our bodies naturally produce antibodies which recognize and seek foreign substances that invade the body and they then call other components of the immune system into action. The concept of RIT dates back to 1908 when a German scientist, Paul Ehrlich, won a Nobel Prize for his studies of the immune system. Ehrlich believed that substances could be attached to antibodies to kill malignant cells. However, his theory required that scientists produce antibodies in the lab, and it wasn't until 1975 that two scientists produced man-made antibodies in a lab in Cambridge, England. When we hear the term "monoclonal antibodies," it means nothing more than antibodies that are man-made.
Scientists soon began to produce different monoclonal antibodies for different uses, but early trials fell short of expectations and interest in the monoclonals dwindled to a few small biotech companies and academics. One of those companies was Idec, which is now Biogen Idec. The company made history in 1997 when the FDA approved the first monoclonal antibody for the treatment of cancer, specifically for low-grade lymphoma. The drug, known as Rituxan, identifies, then attaches to lymphoma cells. Ideally, this action triggers the body's own immune system into attacking the diseased cells and causing them to self-destruct.
Several years earlier, in the late 1980's, two University of Michigan scientists, Drs. Mark Kaminski and Richard Wahl, believed that monoclonal antibodies would be more successful if, instead of relying on the body's own immune system, they could also carry radiation directly to the tumor cells. They began working with an antibody called B1, which recognizes and attaches to a specific protein, called CD20, which is located on the surface of B cells, from which virtually all lymphomas are derived. To that antibody, they attached minute quantities of a radioactive isotope known as I-131, which is a molecule that emits radiation. Effectively, this created a guided missile. The antibody seeks the target on the surface of the cells, latches on, and calls the body's own immune system into action. For an extra lethal effect, the I-131 emits a burst of radiation directly to the tumor. This dual-action drug became known as Bexxar.
In 1993, Idec began investigating its version of this treatment. To Rituxan, which was then still in the early stage of development, they added a different radioactive isotope called Yttrium-90. This combination became known as Zevalin.
Combining a monoclonal antibody with a radioactive isotope creates a radiolabeled antibody, and using radiolabeled antibodies for treatment is known as radioimmunotherapy. Unlike chemotherapy, which uses chemicals, requires months of treatment and often causes unpleasant, even life-threatening, side effects, RIT is given in two doses a week apart, and because it spares healthy cells, side effects are minimal. Better still, years of clinical trials show that RIT produces better results than either chemotherapy or Rituxan.
In my own case, two kinds of chemotherapy, one of which was combined with Rituxan, had to be suspended during treatment because it wasn't destroying the malignant cells. However, those treatments did deprive me of my hair and send me to the hospital with numerous side effects and complications. RIT became available in the nick of time and ultimately saved my life. I just had a checkup on Monday and remain free of lymphoma and full of energy. Today, that means that I have been disease free for 4 years, 4 months, and 14 days. As I told my doctor, I'm not counting the time, only my blessings.
Betsy
In her recent entry, Betsy wrote of second medical opinions when patients were dealing with difficult medical issues.
Indeed, the patient has the right to a second medical opinion; more importantly, the patient should feel entirely comfortable in saying to his or her oncologist that a second opinion is desired. Getting a second opinion not only means "good medicine". It may add a note of reassurance, a most powerful tonic.
If the two oncologists disagree, do not be distressed. That gives you time to think, to ask lots of questions and then, make the decision that is most comfortable for you. The second opinion may afford you options that you did not know to exist.
I have been in medicine for many years. In my experience, the most outstanding physicians were the ones who were entirely comfortable and cordial in helping the patient obtain a second opinion.
Mort
Each one of us is unique in every way, but I think most of us have one thing in common – we want the best "deal" when we make purchases. That doesn't necessarily mean the cheapest price. It means we want the best value for the money we spend.
Few of us buy the first car we look at and we certainly don't worry about offending the salesman by saying, "I'll think about it" before we walk out of the dealership. Even fewer of us marries the first person we date! Why, then, do most of us, myself included, accept the first treatment plan offered by the first doctor we see? We are, after all, purchasing medical services, even if our insurance companies are footing the bills - and what could be more important than purchasing the best treatment to save our own lives?
RIT may be your best treatment, but you'll never know until you find out from a doctor who is comfortable and familiar with RIT and who can make that determination. Unfortunately, RIT has been slow to gain widespread acceptance in the medical community for a variety of reasons. In 2005, only about 5% of the eligible lymphoma population got it. And in 2006, that percentage slipped to about 4%. In other words, there are somewhere between 36,000 and 38,000 patients per year who could potentially benefit from RIT but who aren't.
There are a variety of reasons that RIT has been so underutilized, but one of the major factors seems to be that oncologists used to giving chemotherapy and Rituxan have yet to incorporate it in the smorgasbord of treatment options, and patients aren't sure how to get it. Additionally, Mort and I have been dismayed to hear from many of you who have asked about RIT and been given inaccurate information.
Both Bexxar and Zevalin are approved for use in patients with low-grade follicular NHL or transformed B-cell NHL after one type of chemotherapy or chemotherapy plus Rituxan or plain Rituxan has failed. In other words, RIT is approved for use as the second option, and studies have shown that it is more effective when used earlier in treatment rather than after several types of chemo have failed.
So what do you do if you think you may be eligible for RIT? First, we need to change the way we think about our treatment. We're accustomed to going to an oncologist for cancer treatment. RIT requires that we see a nuclear medicine physician or a radiation oncologist, doctors whom very few of us would think to call. In fact, it wasn't until very recently that I learned that patients could, in fact, initiate their own appointment with a nuclear medicine physician or radiation oncologist - without a referral from an oncologist.
If you think you may be eligible for RIT, I would encourage you to contact the following:
For Bexxar Information: 1-887-4-BEXXAR (1-877-423-9927)
For Zevalin Information: 1-866-298-8433
Both of these are toll-free numbers, and you will talk with a live person who will help you find the treatment center nearest you. At that center, you'll talk with a coordinator who can answer your questions and guide you through the process.
You may or may not find that RIT is right for you, but at least you will have "shopped and compared," just as we do when we make any other purchase. And isn't our medical treatment the most important purchase we'll ever make?
Betsy
Yesterday, I spoke with a friend in Texas who, three weeks ago, received Zevalin radioimmunotherapy for his persistent non-Hodgkin's lymphoma. (About one year ago, we "met" on the telephone after he had obtained my name and number via an informal lymphoma network.)
In our conversation, he spoke of his attitude toward lymphoma treatment. He said, "I am a gradualist", meaning that he was most willing to go stepwise in therapy. Stepwise, meaning chemotherapy, more chemotherapy, waiting, and finally, radioimmunotherapy for the lymphoma that had never gone away.
In contrast, I am not a gradualist. I wanted to attack my lymphoma as early and as hard as I could. Therefore, I pursued a clinical trial and was lucky to receive Zevalin as "front-line" (or "first-line") treatment.
We all have different personalities and have varying comfort levels. When referring to personal differences, my dad used to say, "This is what makes horse races".
By the way, my Texas friend is ecstatic because he notes that the enlarged nodes in his neck have disappeared for the first time in four years.
Mort
During the past few months, I've read several studies and will share more about them in future entries, but today I want to focus on one which studied how patients would respond to Bexxar as the first and only treatment. The results were published in the New England Journal of Medicine in February 2005, and they showed that 59% of the patients remained disease free after a 5 year followup period. Further, it showed that Bexxar was more successful when used earlier in treatment rather than after several types of chemotherapy had failed.
I wondered if any of the patients in that study were still disease free, but I had no way of finding out because privacy laws prevent my getting information about other patients. But recently, a woman whose name is Teresa, contacted me. As she began to tell me about her treatment, I asked her if she was in that particular study and she said yes! Coincidentally, she lives across town, and over a lovely lunch last week, she told me the whole story with laughter and tears.
Teresa was a young mother when she was diagnosed in July 1996. Her doctors talked with her about a clinical trial using a type of treatment which targets cancerous cells. At the time, there was little information about it, but Teresa's husband is a scientist, and after discussing the mechanism of this drug with the doctors, he concluded that it made better scientific sense than standard chemotherapy.
In September 1996, two months after her diagnosis, Teresa took Bexxar and has lived a full, healthy cancer-free life ever since. To this day, she's so glad that her boys, ages 2 and 7 at the time, never had to watch her go through months of chemotherapy. Imagine - two months from diagnosis to the end of treatment - and more than ten years of health!
Meeting Teresa was so uplifting for me, and I was still dancing on air later that evening when I got yet another inspirational call from a man who was also in the study! Two in one day! Diagnosed in 1998, he lives in northern Michigan. At the time, his doctor had read about the study and suggested that he might be a candidate for it, which indeed he was. He laughed when he told me about taking the drug while watching the Redwings win the Stanley Cup that year. But then his voice broke when he told me that his son was only a year old when he was diagnosed, and he was so afraid that his son would never know him. He had to collect himself before cheerfully telling me that he now enjoys taking his son to hockey practice twice a week.
In the course of a single day, I had the privilege of listening to two people who have been healthy for 8-1/2 and 10 years because of RIT. They are examples of the tremendous healing potential of this treatment, a treatment that takes only one week to complete. They shine as such bright beacons of hope for all of us who have fought this disease, and both expressed their hope that RIT will soon become the standard of care for the type of lymphoma they had (follicular). In an email to me later, Teresa added, "RIT adheres to the physician's precept, 'First do no harm.' "
I couldn't agree more.
Betsy
As an educator, I always seek to condense and synthesize complex subjects into clearly understood principles. For example, there are many, many reasons why a person might faint. However, the "common denominator" in all wlho faint is a reduced blood flow to the brain.
In a real sense, Betsy and I are seeking to inform you, the lymphoma patient or caregiver, of another "common denominator".
There exist enormous complexities in lymphoma that relate to diagnosis, treatment options, cost and follow-up. Indeed, these are critically important. Yet, the most important factor---the "common denominator" is that the patient must come first. Not Medicare; not managed care plans; not reimbursement schedules for medical oncologists.
The principle of patient coming first should engender a second principle, namely, patient empowerment. The patient must control his destiny. The patient, not the physician, must be confident that all treatment options have been explored.
The patient must insist on the consultation with the physician who is experienced and has expertise in radioimmunotherapy.
Mort
From the time we’re little, we’re taught to respect authority – and that lesson almost always serves us well. To most of us, doctors are authority figures, and it is hard for many of us question them. That’s understandable, but sometimes we have to step over that comfortable, invisible line that separates us from finding all the answers to accepting what we’re told. It isn’t easy to question anyone whom we think has more knowledge than we do, no matter who they are, but it’s sometimes in our own best interest.
We simply must be our own best advocates by researching and asking hard questions, and in no way does that mean we should be disrespectful to anyone. I truly believe that doctors have their patients’ best interests at heart, but I question how it would be humanly possible for any general oncologist to know everything there is to know about each particular type of cancer. There is too much information coming out all the time for any single doctor to read everything and still have time to treat patients. There are only 24 hours in any given day!
Recently, the Associated Press had a great article about a study that was done on getting second opinions. Coincidentally, the study was done right here in my hometown of Ann Arbor, but I’d never heard about it until I read it on AP’s website. While it mostly talks about breast cancer, it does make a point that second opinions are worthwhile. Here’s the link for anyone who’s interested:
http://hosted.ap.org/dynamic/stories/H/HEALTHBEAT_SECOND_OPINIONS?SITE=NCWIN&SECTION=HOME&TEMPLATE=DEFAULT
In the case of NHL, you may have to cross that invisible comfort line in order to find a doctor who specializes in radioimmunotherapy, but that line is worth crossing. Mort and I are living proof – and I’ll share a couple more stories of others who are also living proof very soon!
Betsy
I have read a blog reader's comment that was so upsetting to me. A physician apparently told a non-hodgkin's lymphoma patient that there was "no hope for other treatment" when the patient never was considered for radioimmunotherapy (RIT).
This is not an isolated example; indeed, I have heard many similar stories. I cannot fathom why medical oncologists, seemingly, do not advise lymphoma patients of this therapy.
Betsy and I had advanced non-Hodgkin's lymphoma. My cancer cells were lodged in my bone and were swimming in my blood stream. Now, 4 1/2 years after RIT, the most sophisticated tests do not show a hint of lymphoma.
And yet, patients with non-Hodgkin's lymphoma are told of "no hope for other treatment".
We, the patients, must lift our voices and cry out, for it is our lives that are at stake.
Dear fellow patients---insist upon a consultation with a radiation oncologist or nuclear medicine physician.
Mort
Mort's last entry speaks of why RIT has been so underutilized. I'm going to expound on this with the hope that it will help each and every one you to make a more informed decision.
Few of us understand the way Medicare and insurance pay for our treatments. I certainly didn't, and it is only recently that I have come to understand this - with the help of doctors and reimbursement specialists.
Medicare determines the amount physicians should be paid based on the value of their services. Most private insurers base their reimbursements on Medicare's fee schedule.
Up until the late 1980's, most chemotherapy required hospital stays. As new drugs were developed to offset side effects, chemo could be administered in doctor's offices. This was actually better for patients who no longer had to stay in the hospital for treatment, and Medicare designed a program to allow oncologists to administer chemotherapy drugs in their offices. While this reduced the cost of cancer care, it also basically turned oncologists into retail pharmacists because it allowed them to profit from the drugs they prescribe. They are not required to disclose this fact to patients.
In the case of RIT, oncologists must refer patients to nuclear medicine physicians or radiation oncologists who administer the treatment. Thus oncologists lose the income that is generated by drugs they can prescribe - namely, chemotherapy and Rituxan.
Lest oncologists come under fire for this, we must remember that they work within a system which they did not create and that reimbursements for drugs help to cover a host of services that are not billable. I've talked with many doctors who as frustrated with the system as I am. It has not kept pace with the development of new drugs such as RIT which requires a team effort by both an oncologist and a nuclear medicine physician or radiation oncologist.
This places the burden squarely on the shoulders of the people who turn to the medical community when they need help most - patients. The system forces us to understand its financial implications before deciding on a treatment plan. At the same time, we must establish a trusting relationship with our doctors. Perhaps this lousy system merits a conversation with your oncologist - or as Mort has suggested - a consultation with a nuclear medicine physician or radiation oncologist. You do not need your oncologist's permission to do so.
Betsy
Five years ago yesterday, I was driving on the interstate when my cell phone rang. Cancer was calling. As I heard the doctor tell me that he suspected lymphoma, I remember wondering if I was hearing words or if the semi traveling next to me had just crashed into my car. We all remember where we were when we heard the words, "You have cancer," and I'll never pass that exact spot again without thinking about that call.
It sent me on a path I never wanted to travel. No one does. At first, I experienced the usual anger and denial, and I really wondered how a big chicken like me would ever find the strength to fight such a formidable foe. Clearly, my survival instincts had never been put to the test, but they soon kicked in and gave me strength I never knew I had. Survival is in all our genes and you, too, will find strength you never knew you had.
In the months that followed my diagnosis, there were setbacks and relapses. There were times that I was really scared and times that I sobbed. But somehow I always found a way to laugh, and it was laughter that kept me from wallowing in permanent despair.
Sometimes we think there is no laughter left, but there is. There are times you just have to look a little harder for it. Just keep looking, even if you have rent funny old movies. I actually did!
Five years ago, I never thought I could love or appreciate life more than I already did, but at the risk of sounding trite, cancer gave me an even greater appreciation. Now, nothing is taken for granted -- neither the little things nor the big things. Even life's challenges and disappointments are opportunities to find solutions -- opportunities I wouldn't have if I were not still alive.
I know how difficult this journey can be, but we must all hold on to the hope and belief that the disease is beatable. Mort and I are living proof, but we are only a small part of a much larger community of long term survivors who are enjoying healthy, normal lives, and in our upcoming entries, we plan to share stories of hope as well as real ideas that can help you join our growing, long-term survivor community.
Betsy
We have heard from several patients who have been told that re-treatment is not possible after RIT. Much has been written about this to show that re-treatment is indeed possible with either additional radioimmunotherapy, chemotherapy, Rituxan, or stem cell transplants or even bone marrow transplants.
I know a woman who went through chemotherapy about the same time that I did and responded to it as badly as I did. She took Zevalin 3 weeks after me (in 2002). A year later, she needed Bexxar. In December of 2005 she finally had to have a bone marrow transplant and at last is doing fine. Needless to say, her disease was quite stubborn.
Following are two links to articles about retreatment. The first is a summary about retreatment after Zevalin. The second is an article about using Bexxar following a Bexxar treatment.
http://www.electronicipc.com/journalez/detail.cfm?code=39560020050311&cfid=&cftoken
http://patient.cancerconsultants.com/news.aspx?id=35127
There are more articles about re-treatment than these. The important thing to know is that taking RIT does not necessarily close the door to future treatment if that becomes necessary.
Betsy
I have just learned, to my intense dismay, of an apparently widespread, yet incorrect, belief of many lymphoma patients.
Iit is true that most lymphoma patients are under the care of a medical oncologist. However, the lymphoma patient who wishes to have a consultation with a physician experienced in radioimmunotherapy does NOT NEED TO GET PERMISSION FROM THE MEDICAL ONCOLOGIST for such consultatlion. I have learned that many lymphoma patients have not had the benefit of such consultation (and treatment with RIT) because they have not obtained "permission" from the medical oncologist.
I do, however, understand that an individual patient may have specific requirements or restrictions related to his/her medical insurence. These generally relate to the primary care physician, not the medical oncologist, giving approval for the RIT consultatlion.
Mort
T.S. Eliot wrote, "What we call the beginning is often the end. And to make an end is to make a beginning. The end is where we start from." Each new year is in many ways about endings and beginnings. Children understand this concept perhaps better than adults. Toddlers begin exploring on all fours, and then one day they amaze their proud moms and dads when they stand erect and take their first steps. Soon, they begin running. With each experience they complete, they naturally begin the next.
As adults, we often want to hang on to what we know. We've become comfortable with the way things are. But each ending gives us an opportunity to separate from our past and open a larger future.
A friend of mine, whose name is Thom, opened a larger future for himself because he refused to believe in the end. His story begins in Pennsylvania in October 1989. That's when Thom was diagnosed with NHL. He subsequently underwent 6 different types of treatments, between which the length of his remission periods decreased.
Around Thanksgiving in 1998, he was not responding to the current treatment. His doctor suspended it, saying there was nothing more that could be done. Thom refused to believe in that end. He went home, did some research, found a clinical trial at the University of Nebraska and was soon on a plane to Lincoln.
On New Year's Eve 1998, Thom was in the hospital taking Bexxar, certainly a unique way to spend New Year's Eve. But what Thom did that night gave him a new beginning and 8 more years that he wouldn't have had otherwise.
Thom's had no further treatment, and today, he's healthy and enjoying life to the fullest.
A growing community of people like Thom and Mort and me are here today, looking forward to this new year, because we were the beneficiaries of great science which gave us new beginnings. People like us are living proof that this treatment works well for so many people for long periods of time, and I hope that we shine as bright beacons of hope to all of you.
To say that I wish you a happy new year is simply too trite. What I wish for each of you is courage and comfort as you face each new day, and most especially, I hope with all my heart, that many more of you will benefit from the same treatment that gave Mort and me our new beginning.
Betsy
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