The Leukemia & Lymphoma Society - Fighting Blood Cancers
14 Replies Latest reply: Aug 1, 2012 8:50 AM by Mona2 RSS

Question for Karen

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Hi Karen,

 

I read the following in one of your posts and had a few questions.

 

"I know of someone who had been treated at one of the most famous cancer centers, but they refused to take her insurance for a transplant.  I happen to know that she is a very high-risk patient, and I bet your bottom dollar that they just didn't want to take the risk.  Fortunately for her, another equally famous center did."

 

What do you mean by "...and I bet your bottom dollar that they just didn't want to take the risk".

 

Also, while I am a bit familiar with Memorial Sloan Kettering being a very good general cancer center, I wanted to get your thoughts on the similarities and differences between Sloan Kettering and New York Presbyterian Weill Cornell as relates to AML treatment.

 

Mona

  • Re: Question for Karen
    Tex Registered Users
    Currently Being Moderated

    I think Karen's not able to be online as much right now so I'll take on the first question and you'll get two (or more) answers if she's able to get here.

     

    What Karen was referring to is the idea, probably very real, that many hospitals/doctors won't accept patients to do high risk procedures on if the patient is also a high risk.  It's about keeping the practice's success numbers high so they'll compare favorably with the places that will accept the high risks.  Doesn't always work out that way.

     

    Anyway, that's the thinking behind the common observation and I'm betting that is what Karen was referring to, as well.  I don't personally know that hospitals and/or docs do this but when one looks at the numbers, it certainly seems that way.

     

    I know nothing about MSK or the other hospitals.  If Karen's not able to answer soon, I think there are some other New Yorkers who could offer some insight here.

     

    Blessings

  • Re: Question for Karen
    felursus Registered Users
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    Hi, I am here.  I've been too wrapped up with my own issues for the past couple of weeks.  See my thread: My Next Step for the full, sad story.

     

    I wasn't treated at Weill Cornell.  You may be aware that the hospital conglomerate is "New York Presbyterian Hospital", and they do sub-titles of "Columbia University Medical Center" (where I was treated) and "Weill-Cornell Medical Center" - which is the center on E. 68th Street.  I WAS going to do the Vosaroxin study there last summer, but I decided against it for a number of reasons then - and decided against it again recently when offered the opportunity through MSK.  (FYI, I think the study is poorly designed so it will guarantee good results for the trial drug.   On that assumption, and per Sunesis' - the drug company's - literature, once they analyze the data through the end of this month, I bet they will unblind the study before the end of this year.)

     

    Anyway: I'm a PT and I've worked at MSK, so I know the "routine" and a lot of staff there.  Right now, as you can see if you check my thread: My Next Step, I'm really angry with them.  (Got to go to sleep or I'd write in tonight.).  The patient to whom I referred had been originally treated at a local hospital, and they screwed up her chemo, and she nearly died.  She did get into remission but later went out of remission and was subsequently treated at another well-known cancer center (not in NYC).  She told me she was in the hospital for 100 days, and they took her insurance just fine for that but refused to accept it for a transplant.  Now I have NO first-hand knowledge of what insurance company/what the policy is like, but I rather think like Tex: the center wanted to keep its stats up, and she was high-risk because or organ damage from the screwed-up initial induction.  As an aside: she's had her transplant, is 100% donor and is working through some GVH issues but is doing much, much better - although still in the hospital.

     

    Is this going to be an initial treatment for AML?  Or are you seeking someone who is doing studies in the sub-type you?/your family member? has.  Both hospitals list the specialties - within the specialty that their doctors have.  The MSK site, once you have got to the "Adult Leukemia" page and from there to the AML page has a link to "our team of specialists".  All you have to do is call the "new patient" number.  If you/the patient has had previous BMBs, they will want the slides.  I'm sure it works pretty much the same at Weill-Cornell.  I will say that back last June, when I'd been told I'd "flunked chemo 101", I was sent to see the transplant guy at Weill, Dr, Mayer, and he/his staff did a donor search for me, so if I ever do go into remission, I fortunate enough to know I have (at least) 3 12:12 potential donors. The only other MD I ever saw there was Dr. Ellen Ritchie who is conducting their Vosaroxin study.  I've never been up to one of their units (one of the few hospitals in NYC where I haven't worked), so I can't talk about that either.  I picked my MD at MSK because he's the head of the leukemia service - and I really like him.  I have some other things to say about some of his staff (something to do with lack of communication), but of course he's one of the top experts in the world - and of course there ARE other people there as well.  You can make appointments to see different people and see what your "gut" feeling is.  You have to feel comfortable with the person.  I will say that if you/the patient has the ultimate goal of doing a transplant, I'd feel better about doing it at MSK.  The head of transplant, Dr. Giralt, is one of the best, and I would say they do far more of them there than at Weill-Cornell.  It pays to be very pro-active and do research: on the sub-type, on the cytogenetics - and MAKE someone check out for any chromosomal abnormalities.  It's one of the things on which they are more and more basing treatment choices.

     

    Sorry if this is all garbled/confused.  It's 1:30 a.m. here now.  If you "friend" me, I'll give you my email and phone number.  I live in Upper Manhattan.

    Hugs,

    Karen

    • Re: Question for Karen
      Registered Users
      Currently Being Moderated

      Hi Karen,

       

      I hope you are feeling better and a had a good nites rest.

       

      I asked my questions for a few reasons. Since you worked at Sloan Kettering and now are being treated there and Weill Cornell is across the street (for those of you that did not know), I thought you might have an opinion on the comparison of the two as relates to AML care and treatment.

       

      In November 2010 I brought my mother up from Florida to Weill Cornell when her AML came out of remission. I did so at the recommendation of a cousin who does cancer research at Duke. It was her opinion that Roboz, Ritchie, Feldman, et al. had as much or more experience in treating AML in the elderly as any group of physicians in the country. My mother was under the care of Roboz for three months (I was with my mother in excess of 90% of the time) and I found her kind, compassionate, caring, and brilliant. I came to know Ritchie as well and found her equally as competent.

       

      In addition, the leukemia program at Weill Cornell was accommodating to my mother and the family. About half of my mother's treatment was as an outpatient. Through the efforts of a philanthropist, my mother had a room at the Helmsley Medical Tower (gratis) for the three moth period. I gather this made financial sense to the hospital and the program as they were able to put another patient in the second bed in the hospital room. As I'm sure you remember, 2010 was terrible winter, and with my mother's blood thin from the Florida weather, at 84, the cold was difficult on her. Fortunately we had use along with the doctors and nurses of the underground tunnel from the Helmsley to the hospital.

       

      Regarding "high risk" or what I would call "tainted" patients (already treated for leukemia), this morning I had the opportunity to check with what I feel is a highly reliable resource (not the leukemia group physicians at Weill Cornell) and was told that Sloan Kettering is highly discriminating on the profile of a patient they will accept. The explanation I received was all about showing positive numbers. I would like to believe that the opinion I received was inaccurate, for if not, I would find it highly disturbing and borderline criminal.

       

      Mona

      • Re: Question for Karen
        felursus Registered Users
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        I would have no way of knowing anything about any kind of admissions policies.  I'm considerably younger than your mom - although still considered "geriatric".  I have the other advantage of not having any co-morbidities. In a sense, I'm a "tainted" patient, since I had been told I had not responded to induction chemo - although my counts subsequently returned to normal.   I simply called Dr. Tallman's office and made an appointment to see him.  I had a few admin hurdles I had to go through - but that was it. Dr. Tallman's take on my situation was that I had a delayed response to induction.   Although when I worked at MSK I did work on the L&L floor, I wasn't there a huge percentage of my time, and I didn't particularly pay attention to patient ages or specific diagnoses.  Come to think back on it, I do remember some elderly patients - but I have no idea how long they had been under the care of an MSK physician: once treated for anything at MSK, they follow you for life.  There are people now in their 80s who had a pediatric cancer and still go there for treatments totally unrelated to their primary cancer.  They are considered "pediatric" patients for life!  Really. I would assume that it's up to each physician to determine whom he/she will/will not accept as a patient.  I would be horrified to learn that they had specific "quotas".  I'll do some "snooping".  I have seen them take really desperate patients in other departments.  (I spent most of my time at MSK working with patients with solid tumors, colon cancer, and hepato-biliary tumors.)

         

        I'm glad your mom received good care at Weill-Cornell.  I've never met Gail Roboz - I know she does a lot of studies with the elderly.  I have met Dr Ritchie, since she is conducting the Vosaroxin study there.  She used to be a Fellow at Presbyterian.  There is no tunnel from the Helmsley to MSK - although, come to think about it, there IS one from Weill-Cornell to MSK, because some of the MSK patients go over there for certain tests. (I'm not sure what, but I remember being told about it, and I recall actually having seen where the tunnel is at the MSK end, so I guess it would be possible to go from the Helmsley to MSK without going outdoors.

         

        How is your mom doing now?  I shall be admitted to MSK on Monday.

        Karen

    • Re: Question for Karen
      Tex Registered Users
      Currently Being Moderated

      I have some pretty strong doubts that a hospital would be able to legally deny treatment to a high-risk patient based on non-acceptance of insurance.  That would have to be a highly litigious action.  Transplants are done under contract that kind of follows a different process (?) than typical insurance billing.  It could be that the adjustments the insurance company demands to do the contract were financially unsuitable to the hospital.

       

      Thing is that most transplant patients have to be approved as a candidate by a panel of doctors (and others?).  If they wanted to duck it, they could just deny her candidacy.  Messing with people through their insurance is just too blatant and, IMO, amateur night.

      • Re: Question for Karen
        felursus Registered Users
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        I would "get it" if the insurance policy didn't cover transplants altogether - in which case it wouldn't matter where a patient went.  As both MSK and the other hospital were "out of state" for the patient, that issue doesn't hold water either.  It's a weird case.  It also shows how when one hospital says "no" there may well be another that says "yes".  I do know that the patient was very nervous about being turned down at MSK - but for medical reasons not insurance..

        • Re: Question for Karen
          Tex Registered Users
          Currently Being Moderated

          Well, if they accept the insurance for one patient, they have to do so for all.  That would have to be the law.

           

          Insurance is pretty intricate stuff.  I used to have to clear things up for clients even 30+ years ago when I briefly sold the stuff.  It's certainly not better to day.  Not much anyway, if at all.

           

          Again, the likelihood is that when they began to negotiate transplant contracts the insurance company wanted to set the price lower than the hospital found acceptable and they determined not to work with that company on transplants.  It's just the nature of the bidness.  Keep in mind that there are hospitals which insurance companies won't deal with for transplant where they'd definitely pay for more common treatment.

           

          For example, if I'd gone to Memorial OKC (OU's hospital) my insurer would have been glad to pay my for induction and related expenses.  There isn't a chance in hell I could have talked them into underwriting my transplant there.  (Not that I would have wanted to do so).  So, it makes sense a hospital could decline to enter into the specialized contract with an insurer who didn't want to pay too much. 

           

          Or, it could be a way of saving face because the insurer wouldn't enter into a contract with them.  There's just no way of knowing how to interpret this unless one was sitting in on the negotiations.  And I promise you, they've negotiated.

           

          But this isn't really the important issue at the moment.  I'm sorry that the communications with Tallman's office haven't been what you want them to be,  I think that's important.  On the other hand, every doctor's office I've been at has dropped the ball at one time or another.  Maybe they just got yours out of the way at the beginning?  I hope so.  It seems you really want to work with this guy.

           

          Hang in there.  You're going to make it through this smelling like a rose.

           

          Blessings

    • Re: Question for Karen
      Registered Users
      Currently Being Moderated

      Hi Karen,

       

      I hope things are better for you this morning.

       

      Speaking of the Vosaroxin study, I came across this piece and thought the group may be interested. Since it was written by Sunesis Pharmaceuticals, it should be take n with a grain of salt.

       

      Mona

       

      Sunesis Pharmaceuticals Receives European Orphan Drug Designation for Vosaroxin to Treat Acute Myeloid Leukemia

       


      SOUTH SAN FRANCISCO, Calif., May 3, 2012 (GlobeNewswire via COMTEX) --Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the European Commission has granted orphan drug designation to vosaroxin, the Company's lead development candidate, for the treatment of acute myeloid leukemia (AML). The designation provides for 10 years of marketing exclusivity in all EU member countries following product approval. Vosaroxin has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA).

       

      "The European Commission's decision reinforces the global potential of vosaroxin and recognizes the desperate need for new treatment options in AML, an indication for which treatment standards have not changed appreciably in the past thirty years," said Dr. Adam Craig, EVP Development & CMO of Sunesis. "European orphan drug designation is the latest in a series of regulatory milestones that have strengthened the commercial opportunity for vosaroxin on both sides of the Atlantic. These include the potential for market exclusivity to 2030 and an expedited review process in the U.S., as well as new patents issued in the European Union with exclusivity to 2025."

       

      As established by the European Medicines Agency (EMA), orphan designation is granted to product candidates intended for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. It also provides for scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and certain financial incentives for companies developing orphan drug candidates. Orphan drugs are eligible for a reduction of fees associated with pre-authorization inspections, as well as marketing authorization application fees and certain other fees for qualifying companies.

       

      Sunesis is currently enrolling patients in its VALOR trial, a Phase 3, multinational, randomized, double-blind, placebo-controlled, pivotal clinical trial of vosaroxin in combination with cytarabine in first relapsed or refractory acute myeloid leukemia.

       

      About VALOR

       

      VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at approximately 110 leading sites in the U.S., Canada, Europe, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broader range of survival outcomes. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com.

       

      The VALOR logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8774

       

      About Vosaroxin

       

      Vosaroxin is a first-in-class anti-cancer quinolone derivative, (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.

       

      About Sunesis Pharmaceuticals

       

      Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com

      • Re: Question for Karen
        felursus Registered Users
        Currently Being Moderated

        I was offered two opportunities to be in the study.  I declined both times.  Here's why:  1) there is no study of the efficacy of IDAC alone although HIDAC is used in consolidation for those in remission.  The head-to-head study of IDAC vs. HIDAC + Idarubicin demonstrated good efficacy of IDAC with fewer side-effects than HIDAC, but HIDAC had increased benefit for younger patients.  I can't remember now, but I think it was for those under 45.  2) The experimental group gets IDAC + Vosaroxsin on Days 1 + 4 while the control gets IDAC + placebo on Days 1 + 4.  The study is double-blinded.  Participants have a 50% chance of receiving Vosaroxin.  Vosaroxin is intended to replace an anthracycline in induction chemo.  It is demonstrated to have less cardio-toxicity, so if proven effective, it would be of significant benefit to those who are older or who may have some cardiac issues.  Since all the participants have failed to achieve remission through standard induction - which uses low-dose ARA-C - the comparison should, more fairly be between IDAC + Vosaroxin and IDAC + Ida/Daunarubicin.  I think the study is stacked to demonstrate increased benefit from IDAC + Vosaroxin over the control group.  This leaves those in the control arm having had chemo for potentially no benefit.  According to a Sunesis presentation, they are going to review the data produced through the middle of this year (i.e. now), and if the results for the experimental group are outstanding, they will unblind the study.  If the results are merely "okay" , they will continue the blinded study through 2013.  An analysis of the Sunesis study by a bio-chemist discusses this point and says that in his opinion, Sunesis will have problems recruiting enough subjects in Western Europe and North America because of the probable perception that those in the control arm will receive sub-standard treatment.  In his opinion they will most probably need to find a lot of subjects in countries such as India where there may be fewer choices/available treatments.

        • Re: Question for Karen
          jimbinsc Registered Users
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          How are you doing now? I was also offered the Valorous trial today and declined as well. Not sure why. It seemed like standard therapy plus a 50/50 shot at receiving the drug versus placebo.  Possible side effects probably had something to do with it, I tolerated the 7 and 3 so well I thought I got placebo drugs then since I was a trial already.  M my wife is fairly set against it as well. Waiting now for the high dose cytarabine.

          • Re: Question for Karen
            felursus Registered Users
            Currently Being Moderated

            Do you mean Vosaroxin/Valor?  The MDs all thought I was correct to decline to participate, and if you Google around, you'll find a pdf presentation by someone who is a PhD bio-chemist who now advises people on investments in drug companies.  The issue is that they are not even comparing comparable treatments.  Vosaroxin is intended to replace one of the Rubicin "sisters" in induction, because it has, in previous trials, been shown to have less cardio-toxic properties, so it is designed not only for those resistant to regular 7+3, but for those with cardiac issues - particularly older patients or those not considered eligible for standard induction because of a previous cardiac history.  Now the study involves ARA-C at 1g/m2 - much higher than the dose used in standard induction, but NO ONE has ever demonstrated that IDAC on its own is effective.  So to make a valid comparison, they should use IDAC + Vosaroxin vs. IDAC + a Rubicin.  Since the rubicin is administered differently (on 3 days), they would have to give a placebo infusion to the "experimental group" (Vosaroxin vs. placebo in the study is administered on Days 1 + 4) on days 2 and 3, and to the "control group" on Day 4.  (So everyone gets something every day.)  How to do that: pre-assemble the drug "packets" and label them Day 1, 2 - etc.)   

             

            My MD agreed that Sunesis, the drug company that makes the Vosaroxin, has skewed the study in favor of the drug.  It's like comparing apples (Vosaroxin) + broccoli (ARA-C) vs. broccoli alone.  (My analogy.)  In any case, if you look at the pdf put out by Sunesis, they are going to review the data through the middle of this year (presumably through June 30th), and if the results are "excellent" - which they basically can't help but be - they are going to unblind the study by the end of the year, but if the results are merely "good" they will continue through 2013.  Now the bio-chemist analyser did comment that he thought they'd have problems finding enough subjects in the US, because of the perception that the control goup would not receive a "standard and proven" treatment, but he added that he thought they'd find some more subjects  in places like India where there may be fewer available treatment options.

             

            How many inductions have you had to date?  There's the Elacytarabine study: it's supposed to act on people with cellular resistance to ARA-C.  You can look it up.  If you are eligible, your MD has to pick one of a list of 7 treatments (HIDAC is one) that he/she enters into the computer prior to the patient being randomized into the experimental or the control group.  You'd obviously know which you are getting - it's not a blinded study at all (wouldn't be possible given the 7 alternative possibilities).  I'm going to start the study probably next week, and the alternative treatment for me will be Ida-FLAG. 

             

            Good luck with the HIDAC!  As you see from the above, I certainly think you made the right decision. 

            Karen

            • Re: Question for Karen
              jimbinsc Registered Users
              Currently Being Moderated

              Hi, yes I mean the Valor trial. The Kindle keyboard autocorrects words sometimes, changing Valor to Valorous.  I have had one induction of 7 plus 3. In a way I am glad I refused the trial,  I thought I would only get high dose cytarabine but the docs will give me the FLAG - IDA Protocol. Consisting of Fludarabine 30mg/m2 followed by cytarabine 2gm/m2 and idarubicin 10mg/m2 the first 2 are over 5 days and last one is for 3 days. Then G -CSF injections until the counts recover.  The docs almost seemed relieved at my choice as well. He kept saying how much more familiar they are with FLAG-IDA. It starts tomorrow,  we will see what it brings. thanks so much for your reply.

              • Re: Question for Karen
                felursus Registered Users
                Currently Being Moderated

                I know - my iPhone does that too.  I'm tempted to turn off the feature, but it also helps with my "touch" errors on such a small keypad.  Good luck and let me know how it goes.  If I'm randomized to the control group, I, too, will get Ida-FLAG.  I know there are HIDAC regimens at 3g/m2 (or maybe even higher - I didn't research it much, as they won't give me "ultra-high" HIDAC because of my age, and they are probably only doing this because I tolerated IDAC so well.  I guess I should do the research - I've been lazy.  Mea culpa!  I'm not sure of the exact protocol they will use: I have to go in for my BMB on Thursday morning, so I'll ask then,  I do know that in Britain they give one Filgastrim shot on Day 1 and on Day 7, and the other drugs on Days 2-6.  Interesting.  Where are you being treated?  As far as the Vosaroxin study goes, most MDs agree it's a bad study (unless, I guess, the MD is in charge of it!) 

                 

                Hugs,

                Karen

                • Re: Question for Karen
                  Mona2 Registered Users
                  Currently Being Moderated

                  As far as the Vosaroxin study goes, most MDs agree it's a bad study (unless, I guess, the MD is in charge of it!)  

                   

                  Or Sunesis Pharmaceuticals

                   

                  Mona

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