Thank you Pat!!! Very helpful! Beth
-----Original Message----- From: Pat Elliott <[email protected]> To: cmlhope <[email protected]> Sent: Mon, Jul 15, 2013 7:44 pm Subject: RE: [CMLHope] Hi all – The International Scale (IS) is preferred, but there are still many places that are not using it. The move to the International scale is due to the need for uniformity, the availability of more sensitive testing and the belief that one day patients may not have to take these drugs for life, but will instead be able to be stop treatment on the basis of how deep the patient’s response is to treatment. In the past, the ultimate patient goal was a complete molecular response, which was known as “PCRU.” The use of “PCRU” is going away, in favor of a new, much more specific MR (Molecular Response) scale. (In labs that are not using the IS, the equipment is only able to detect up to a 3.5 log reduction.) 0.1% BCR-ABL = MR 3 (3 log reduction from 100% - IRIS) 0.01% BCR-ABL = MR 4 0.0032% BCR-ABL = MR 4.5 0.001% BCR-ABL = MR 5 Getting to this level is the ideal, but not all patients get there. Higher levels, known as MMR or Major Molecular Response, indicate low levels of BCR-ABL and many patients remain in that status for years. Hope this helps, and please share with others who can benefit. Pat FAQ on International Scale (IS) PCR by Dr. Michael Mauro The International Scale (IS) PCR specific Frequently Asked Questions (FAQs) was created by Dr. Michael Mauro, a professor and leading expert in the field of chronic myeloid leukemia (CML). In this FAQ, Dr. Mauro explains the importance of International Scale (IS) for PCR, a scale for standardizing PCR testing across laboratories. 1. What is the IS? 2. Why is it important to standardize PCR labs? 3. What happens if my PCR is not standardized? 4. What should I ask of my doctor with regards to IS PCR? What is the IS? The ‘IS’ stands for ‘International Scale’. International Scale is a means for standardizing and validating a patient’s PCR test results. It refers to a reference range developed for reporting of quantitative PCR results for Bcr-Abl for patients with Ph+ (Bcr-Abl+) leukemias. The International Scale (IS) was developed as a result of the landmark IRIS trial. In this trial, untreated blood samples of 30 patients were shared between three precise and experienced PCR laboratories (Seattle, London, Adelaide), using the same control gene (BCR) to establish a typical starting point (untreated level) as well as a point which represented a 1000-fold reduction (3-log reduction) from the starting point. The mean untreated level was defined as 100% and a ‘major molecular response’, or MMR, was defined at 0.1% in these labs. MMR, a further improvement over complete cytogenetic response (CCyR), is an important landmark for patients. >From this starting point, other labs using different systems could normalize >their results so the scale used around the world would be the same: at >diagnosis a CML patient’s PCR value would be in the range of 100% (+/-) and a >major molecular response would come in at 0.1%. Back to the top Why is it important to standardize PCR labs? It is important to standardize PCR labs so that physicians in different medical centers or offices can all ‘speak the same language’ and ‘use the same tool to measure’. Results can be compared between labs and centers and response milestones understood and confirmed. Without standardization of PCR for Bcr-Abl it is hard to know how to interpret changes in Bcr-Abl levels- for example, does the change represent loss of a treatment milestone? Is the change the result of variations in the instrument used to run the PCR test? PCR monitoring of Bcr-Abl is a crucial part of monitoring response to treatment for Chronic Myeloid Leukemia (CML). Guidelines describing the best way to navigate treatment options, especially early in treatment, are based on PCR results reported on the International Scale. For example, the first milestone in updated guidelines for management of CML treatment suggest PCR testing at three months of treatment looking for a reduction in Bcr-Abl to less than 10% in the ‘IS’. Without IS standardization, deciding if milestones are met or not, or lost, are challenging if not impossible! Back to the top What happens if my PCR is not standardized? Indeed many quality medical centers and CML experts do not have access yet to ‘IS PCR’. In the absence of results reported using this scale, treating physicians can inquire for key details about the way the test was run and the parameters of the assay to accurately quantify response and potentially estimate depth of response as is done with IS reporting. It is somewhat unreliable and challenging, however, to make such estimations and this can often lead to under- or over-estimation of response; thus caution is recommended for any extrapolation. At the very least, in the absence of IS reporting it is recommended that a patient’s PCR is always done in the same lab to minimize variations and to improve the ability to interpret changes over time. Back to the top What should I ask of my doctor with regards to IS PCR? ASK WHAT YOUR PCR RESULTS ARE ON THE IS SCALE! Physicians caring for those with CML should know the important role PCR testing has in making the diagnosis and more importantly in following someone’s response to treatment. If results are reported on the IS it is much easier to convey how someone is doing relative to well-established ‘milestones’ of treatment response. Patients should ask their physicians if there is an IS standardized lab available to run their PCR, and to use it preferentially and consistently. In some countries there are resources available to help patients access IS PCR. For country specific inquires, contact us. If you are a provider caring for a person living with CML: Our goal should be to provide IS PCR for our patients as best practice; if you are a patient with CML: It is YOUR CML and YOUR RESPONSE, so you ALWAYS DESERVE TO KNOW! For more information visit the “What is My PCR?” website: http://www.whatismypcr.org/ It was developed by and for patients. From: [email protected] [mailto:[email protected]] On Behalf Of [email protected] Sent: Monday, July 15, 2013 5:40 PM To: [email protected] Subject: Re: [CMLHope] HI all, I just want to clarify something about numbers...I think Pat may be able to help us more with this question...but there is an international scale for CML measuring, and then there are all the places that do not use the international scale. so, I think it's comparing apples and oranges yes? Then Peter's question about 3 log reduction.....what is important is that the number stays at or below .1% on the international scale??? Thanks. Beth -----Original Message----- From: Peter <[email protected]> To: cmlhope <[email protected]> Sent: Mon, Jul 15, 2013 7:36 am Subject: Re: [CMLHope] Hi Richard. Wow, five years off Gleevec - that's wonderful! What confuses me though, is this: My doc freaks out when I drop below a 3-log reduction, which, as I understand it, is equal to 0.1%, yet your doc does not get worried until you hit 10%. So, I am really wondering if I understand the relationship between percentage reading and log reduction. My understanding is: 10% = 1 log, 1% = 2 log, 0.1% = 3 log, etc.... Do I have this totally wrong or are we looking at two doctors with very different points of view? On Sunday, July 14, 2013 11:47:30 PM UTC-4, Richard H wrote: Sorry abouy my twisted mind. I have been off 400mg Gleevec for 5 years and hoping my christmas present will be to continue to 6 years. I am detectable but the low. I had my first scare in April when the reading spiked to 9.475% (Gleevec starts when we see 10%) and the retest dropped back to 4.57% in June. Dr. said your guess is as mine as to why, do you want to test in 3, 6, or 8 months. Richard H. On Saturday, July 13, 2013 11:28:58 PM UTC-5, Beth wrote: Dear Richard, I hope you can go down to 400 too! And as for the steel trap comment...it's nice to know ther eare some kindred spirits out there...let us know what the verdict is about lowering your dose! Have a good weekend, Beth -----Original Message----- From: Richard H <[email protected]> To: cmlhope <[email protected]> Sent: Sat, Jul 13, 2013 10:11 pm Subject: Re: [CMLHope] I love to use this statement "I had a mind like a steel trap" when I speak of my memory loss. I now add "and now it make a good strainer". I hope tou get a chance to go down to 400mg Gleevec. Richard H. On Saturday, July 13, 2013 8:10:09 AM UTC-5, caselmar wrote: Hi Millie: I've lost a lot of eyelashes and brows, too. Even have done false lashes when I had a wedding to go to. Part of the problem I see with people is that almost everyone knows someone who has had cancer. Most of those patients either had infused chemo and/or radiation. So they were bad but a point came where they recovered and life went on. For us, at least for me, there is no chance in the near future that I'll be off of Gleevec. Our problems and side effects often take time to occur, memory loss is one for me. I had a mind like a steel trap. Now, I can remember long term things but short term is going faster than a speeding bullet. People who don't get it tell me it is normal at my age to start losing your memory. I know that as you age your memory may worsen but at 61, I don't think so. Plus, I can tell it is a rapid increase in what I am forgetting. My bone pain and muscle cramps are very severe, and naturally the fatigue is far worse. I wonder if one day sooner rather than later I'll be in a wheelchair or on a walker. Sometimes I can't zip up a dress or coat, even if it is front zip. If it is a back zip, forget it. My husband needs to be here to help with that. I can't hook bracelets or necklaces. None of this is major because I'm so grateful to be alive. But it is still a quality of life issue. I tend to have bad Gleevec stomach. I try to stay away from foods that trigger it. But being from Maryland, I love steamed crabs. I eat them but somewhere within a 15 minute drive to my house so I can use my own bathroom when the diarrhea hits. There is no spontaneous planning because I always have to look at how far I'll be from home because of this. That's the kind of stuff I'm talking about that people don't get. They see me and think, well she works, she looks pretty good for someone with leukemia, must not be too bad. And for the most part, they are correct. I have a positive attitude and feel very blessed to have an illness that is manageable. CML has made me appreciate every single day. Hope your results from the biopsy come in quickly. I know my bone marrow results came in yesterday but my onc didn't call. He and I have a wonderful relationship so I'm assuming that he just didn't get a chance to look them over. He is one of the team doctors for the Baltimore Orioles and he may have been at the game yesterday. Normally I don't worry about the results but he has agreed that if they are good, he's going to try and take me down from 600 mg of Gleevec to 400 for a trial period of 3 months. Hoping that will help with the side effects. If not, I'll just deal with it. Best of luck, have a great weekend, and I think you are a wonderful person and terrific friend! Marcie -----Original Message----- From: C.M. Houtz <[email protected]> To: cmlhope <[email protected]> Sent: Fri, Jul 12, 2013 10:08 pm Subject: Re: [CMLHope] Hi Marcie I also wear a wig when I go out, and at times around the house, but don't cook with one, and, usually, don't wear one around close friends. My hair is a mass of fuzz and I do have a gal that comes to my house and trims it every 6 weeks, but there isn't much to take off...Mostly in the back. My eyelashes are gone, and my eyebrows thinning a lot. No, most people don't understand how we feel, and on here, we can share these things. I have a friend....who told me once that if I'd take long walks it would be good for me. Well, I'm sure that it would, and I would love to be doing that, but my legs won't , so I'm stuck in my jazzy (elec chair) most of the time. I still can manage some with a walker, but it's getting to the point where I have to have a transport chair...and someone to push it when I go out. That makes it difficult for me to attend things with my friends, etc. My arms don't work well either...about the same as my legs. I can't lift my arms, especially the left one without a lot of pain. I do what I can do, but, unless you have these health issues, you don't understand that it isn't something that we choose to have. My friend meant well, but just doesn't get it. Most of my very dear close friends have suffered from some type of Cancer. They understand much better. I love turbans, but have trouble putting them on and keeping them on. I think they look neat. I wouldn't wear them out, but around the house I would. I've never tried to bake with my wig on, but will think about it now that you've warned me. Mostly, I just laugh at how I look as I can't do much about it. Tasigna has left my skin so dry and wearing makeup just doesn't work. Oh well, it is what it is.....right? We just do the best that we can. My oncologist is going to be upset as I didn't get the results of the biopsy yet and I must see him on Monday. He's such a love, and would hate to ever change doctors. You don't find doctors that call you when they need to talk to you (they have their staff do that), but since all of this liver stuff has come up, he calls me often. I also can call him and actually get to talk to him. I am truly a lucky lady. You take care of yourself, and I'm so glad that we can share things with one another. Many hugs, Millie -- -- [CMLHope] A support group of http://cmlhope.com ------------------------------------------------- You received this message because you are subscribed to the Google Groups "CMLHope" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/CMLHope --- You received this message because you are subscribed to the Google Groups "CMLHope" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. 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