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You make a valid objection to the Times piece. As I was reading I found myself growing more and more confused about the various factors in play — but as your blog post shows, perhaps the confusion wasn’t my fault.

I am one of those “stern” looking patients in the NY Times article, and believe me, as a cancer survivor, I am thrilled to be alive and wear a smile most of the time.

The story of Bexxar and Zevalin is complex. The statement that they have not been clinically proven to prolong survival compared to other therapies is true. Indeed, they have not been clinically tested head-to-head against other treatments, but neither have many other drugs for many illnesses.

We must remember that doctors embraced Rituxan maintenance therapy well before it was FDA approved or compared to other treatments. In fact, the National Comprehensive Cancer Network’s most recent “Suggested Treatment Regimens” for follicular lymphoma, published in June 2007, remarks that in combination with chemotherapy, Rituxan has increased the duration of response but has not shown a benefit in overall survival. Yet Rituxan is the top selling cancer drug in the world, easily prescribed and administered by oncologists.

For patients to receive Bexxar or Zevalin, oncologists must refer them to nuclear medicine physicians or radiation oncologists for administration. Medicare and private insurers do not pay the oncologists since they they don’t administer the drugs. Perhaps this is why oncologists continue to use chemotherapy and Rituxan despite the fact that no study exists which shows even the same or better results than Bexxar and Zevalin.

As Dr. Connors says, “The doctors looking after people tend to turn to tools that they themselves know how to use and are familiar with.” But medicine would never advance if doctors continue that mindset. Dr. Oliver Press, in a recent Lymphoma Research Foundation newsletter, said, “Patients who receive RIT (Bexxar or Zevalin) are generally extremely happy with the convenience of the treatment because they come into a treatment center for a test dose one week and a treatment dose the next. However, physicians often don’t feel RIT is as convenient as patients do.”

Frankly, I doubt many patients are concerned about how inconvenient the coordination of a treatment may be for a doctor. We are there to get well. And many times these same doctors who are resisting Bexxar and Zevalin are coordinating transplants which are just as difficult, if not more so, to coordinate.

Several studies prove that Bexxar and Zevalin work better when used earlier in treatment rather than after multiple courses of other therapies. And a recent study of Bexxar as first line therapy showed that 64% of the patients were disease free after 8 years. I personally know several patients who took Bexxar 9, 10 and 11 years ago and are still disease free - which I realize is anecdotal but still compelling.

As for the costs, yes, these drugs are costly. In a period of twelve months (during 2002), my medical expenses totalled $199,339.22. My RIT treatment, including the drugs, all the scans, tests and doctors’ visits for it, totalled $36,929.50. The remaining $162,409.72 covered chemotherapy (my disease resisted the two types that were given to me and I could not complete the full regimen of either), hospitalizations, treatments for more side effects than I care to recall, frequent visits to the doctor, scans, tests and other procedures that I would prefer to forget. And never mind the loss of income or productivity during the months that I was too sick to work. I was unable to get RIT any earlier because both drugs were under FDA review, but I am lucky that they came along when they did and rescued me when all else failed.

As the author of a book about my experience with lymphoma, I have spoken with numerous patients around the country for the past couple of years. Few of them are ever offered Bexxar or Zevalin as an option. As I stated in the Times article, I am not saying that these drugs are right for everyone, but I deeply believe that patients with all types of illnesses should be told all their options, and I’m afraid that’s not going to happen until the economics of medicine makes all drugs equal.

Betsy

Betsy,

Wonderful to hear from you and glad you are smiling! No doubt the Times wanted the stern look to reinforce the spin of the article.

I applaud your activism. The point I take from it is that patients need to play a central and –if necessary– aggressive role in their care because their life may depend on it. That’s a tough thing to do, especially when you’re dying of cancer and sickened and exhausted by the treatments and stress. It can also feel impolite, which is a hard barrier to cross. That’s why it also makes sense to recruit a close family member –preferably a physician– as your advocate. Another avenue –appropriate for some but not all– is to head overseas for a better chance to be treated as a customer. (See www.medtripinfo.com for more on that.)

I don’t agree that making “all drugs equal” is the right answer, however, especially in this case. Conscientious physicians and pushy patients seem like a more realistic answer to me. Pharmaceutical company marketing to physicians and patients might also help.

David Williams

It’s a complex issue as you and Betsy have illuminated.

* Dr. Bruce Cheson - a nationally recognized expert on Lymphomas – telling remarks are as follows: “RIT is the most effective, least used treatment in oncology.” Companies are both losing money. Done once, it’s over. 70-80% CR; up to half the patients depending on the context. It’s easily tolerated, but you can’t sell it. ….

Reasons you can’t do it? ” Complicated, but mainly: “Requires the oncologist to send the patient somewhere else to get treatment, falling under the category of Duh. Source: Presentime.com

* Regarding: The drugs have not been clinically proven to prolong survival, compared with other therapies…

As you know, because of the long survival of patients with indolent lymphomas, it’s difficult to prove a survival benefit for one protocol over another (cross over , etc.). But there’s a strong historical correlation between duration of response and improved survival, and on that account RIT has a clear advantage over Rituxan and an apparent advantage even over combination chemotherapy. A potential long term risk of RIT however is the risk of Myelodysplasia (MDS) - a secondary cancer. This risk seems to be low, however, and also associated with chemotherapy. First line use of bexxar in 75 patients reported no incidence of MDS at a median of 5 years.

* Regarding: Doctors agree that Rituxan is an excellent drug with only minor side effects for most patients…

Rituxan is a management approach to treating lymphomas, which has about a 50% response rate in patients who have never received it before (lower for second use); only a small fraction of patients achieve a CR, and the duration of the response is rarely more than 12 months.

Compare with RIT, which not uncommonly produces durable remission measured in years … 6 years and longer in some patients. Duration of response have been so long in some patients to suggest the possibility of cure, even in the relapse setting. This information needs to be shared with patients to satisfy the principle of informed consent.

~ Karl Schwartz
Patients Against Lymphoma

Tositumomab (Zevalin) and iodine-131 tositumomab (Bexxar) produces durable complete remissions in a subset of heavily pretreated patients with low-grade and transformed non-Hodgkin’s lymphomas.
J Clin Oncol. 2005 Oct 20;23(30):7565-73. Epub 2005 Sep 26. PMID: 16186600

Response rates in the five trials ranged from 47% to 68%; CR rates ranged from 20% to 38%.

With a median follow-up of 5.3 years, the 5-year progression-free survival was 17%. Eighty-one (32%) of 250 patients had a time to progression of > or = 1 year (termed durable response population). For the durable response population, 44% had not progressed at > or = 2.5 to > or = 9.5 years and had a median duration of response of 45.8 months.

The median duration of complete response was not reached. The durable response population had many poor prognostic characteristics, including bone marrow involvement (41%), bulky disease > or = 5 cm (49%), and transformed histology (23%). Forty-three percent of the patients had been treated with more than four prior therapies and 36% had not responded to their most recent therapy.

David
I find that your approach seemed rather caustic, as well as very inside the box.

My Mother who has Stage IV Mantle Cell, NHL, was given 6-12 mos, and “let me cut through the chase” attitude of several Dr’s… all who wanted her to try rigorous chemo cocktail blends over a series of 6-18 rounds over the period of 1-2 years, which MAYBE could extend her life.

She had decided against rounds of chemo which were not having any success for a woman age of 73.

This is about choices, and having the opportunity to being informed by your Dr’s that there are other choices - other than chemo/radiation.

I grew up in Los Alamos, around nuclear everything including the cancer beam research which was developed there. I think that Zevalin and Bexxar, and someof the new ideas coming out of Europe are worth exploring as well as being made READILY available to patients.

I blogged just after Christmas and found result from the World Hematology conference from mid December 2006. And thank heavens for the internet - otherwise we would have to be in this foggy 2007 sensibilities that resemble the Dark Ages.

[…] used as pawns by big pharma? (If you think patient activists are sheep, check the responses to my post on Bexxar and Zevalin.)  So I asked an MD friend who has done research on the pharmacokinetics of epilepsy drugs (not […]

[…] used as pawns by big pharma? (If you think patient activists are sheep, check the responses to my post on Bexxar and Zevalin.) So I asked an MD friend who has done research on the pharmacokinetics of epilepsy drugs (not for […]

i think bexxar is a miracle drug.i was one of the first to recieve it where i liveas second line treatment. i was concerned that insurance would not cover the cost because i was not refractory to a chemo treatment. My first chemo was FND and was a new treatment for my doctor in 2001 It was very mild and easily tolerated and lasted four years. During this time i had watched the development of bexxar and zevlin and had decided that the next time i needed treatment i would go for one of these. it was complicated to find where to go for the treatment and my oncologist didn’t know much about it. By educating myself
i coordinated most of what needed to happen. The Bexxar process was painless and easy the worst side effect was being sleepy from the benadryl. I hope that more people who are diagnosed with follicular lymphoma have the chance to receive bexxar or zevlin at the start of their treatment.There is no comparison in disease free years .i never read about people who have had 8 or 9 years complete remission from chemo, but ther are hundreds of them who have had bexxar or zevlin. Start early and you might find your cure.

Valid points have been made about the NYTImes article and the cautions Dr. Williams pointed out. I received Bexxar as a front line treatment in 1996: 11 years ago. I’m fine. I’m active. I was happily and peacefully living my life, thinking that my doctor’s amazing discovery would soon be used for all unlucky people who met the “protocol” (non-hodgkin’s lymphoma, follicular, etc). I don’t have experience of going through chemotherapy, going into remission, and having to look for the best treatment available. I realize now how lucky I was! (am!). Wouldn’t you rather take a one-time treatment, with minimal side-effects, than go through weeks, months, of chemotherapy and all of its awful side effects? $40,000. seems like a lot for a treatment. What about the number ($160,000.) Betsy mentioned in her comments? Dr. Williams says the NY Times is trying to “spin” the situation. Market forces may be one barrier, yes. But the larger issue is: why don’t more oncologists tell patients about RIT? If they could administer the treatment, they may be more inclined to use it. NRC (nuclear regulatory commission) needs to require less continuing ed. hours for oncologists to administer the radioactive materials used in RIT. (Endocrinologists who use radioactive iodine for thyroid treatment require fewer hours of cont ed. credits to do so). So I think it’s worth the Times printing this article if only to make people aware of the treatment, and for more questions to be addressed. Why allow a treatment to go into obsolescence before its potential is realized? Let’s keep the pressure on Congress to vote for Medicare/Medicaid coverage for new cancer treatments like RIT.

I COULDN’T HELP BUT RESPONF TO THE PREVIOUS ARTICLES. I’M OUTRAGED THAT A DOCTOR WOULD CHOOSE NOT TO USE BEXXAR SIMPLY BECAUSE HE’S MORE FAMILIAR WITH OTHER TYPES OF CHEMOTHERAPY. I WAS DIAGNOSED WITH NHL IN 1992 AT THE AGE OF 46. I HAD TRADITIONAL CHEMOTHERAPY WITH ALL IT’S NASTY AND DEGRADING SIDE EFFECTS. I RELAPSED AFTER ALMOST 5 YEARS AND THEN WAS GIVEN FLUDARABENE WHICH PROVED TO BE PRETTY INEFFECTIVE. I RELAPSE AFTER 14 MONTHS. THEN IN 1999 I TOOK PART IN DR. JOHN LEONARD’S CLINICAL TRIAL FOR BEXXAR. IT TOOK SEVERAL YEARS FOR THE FDA TO APPROVE THIS DRUG, BUT I THANK GOD EVERY DAY THAT I WAS FORTUNATE ENOUGH TO BE IN ON THIS TRIAL. I AM 9 YEARS POST BEXXAR AND DISEASE FREE. I AM HAPPY AND ACTIVE AND THANK ALL THE DOCTORS INVOLVED IN MY CARE. I CONSIDER MYSELF TO BE ONE OF THE LUCKIEST PEOPLE ALIVE. I CONTINUE MY CARE WITH MY ONCOLOGIST ( DR MARC ZIMMERMAN) WHO THINKS I’M DOING EXTREMELY WELL. TO ALL THE DOCTORS THAT PUT THEIR PATIENT’S CARE FIRST, THANK YOU FROM THE BOTTOM OF MY HEART.
MARCY MARTIN

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