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Q&A Session – May 11 2008

Question & Answer Session
between FOM Mumbai and Dr. M B Aggarwal
Held at Bombay Hospital on 11th May, 2008
 

Q) Can I take Crocin (Metacin, Paracetamol) while I’m on Glivec?
A) Yes you can.  Crocin is the safest and effective medicine for fever and it can be taken once every 6 hourly.  However, if fever persists, you must consult your doctor as excessive use of Crocin can be unsafe for liver, especially while taking Glivec. 

Q) Can I take herbal medicine as supplement to Glivec for treatment of CML?
A) Yes. Herbal medication is a matter of faith and you can take herbal medications.  However, you must consult your doctor before doing so. 

Q) Doctor, I get  swelling of my face .  Why does this happen and is there anything I can do about it?
A) While taking Glivec, swelling of the face, especially around the eyes, occurs due to water retention. One can also get swelling of the legs or even the whole body. Some of the patients gain couple of kilos of weight due to water retention. Simplest solution is to decrease water and salt intake. Sometimes, we use, what is called – Diuretics, by which water can be removed from the body through urination.

Q) Doctor, I get Diarrhea – is it a side effect of Glivec ? 
A) Diarrhea can occur in patients on Glivec.  Diarrhoea can be managed by taking Lomotil or Imodium. However, if the diarrhea is severe, one can stop Glivec for a day or two (but not more).  Sometimes, there may be infection causing diarrhoea. This will need antibiotics. Hence, you should contact your doctor.

Q) Doctor, why do I vomit after taking Glivec ? 
A) Vomiting can be prevented by taking Glivec with a glass of water and after a decent, full  meal. Usually this happens to a new patient who has just started Glivec therapy. Over the time, this side effect eases out.  However, if the problem persists, one must consult the doctor. 

Q) Doctor, I get tired.  My feet and sometimes the whole body aches
A) Muscle cramps, fatigue and  aches in lower limbs  are common side effects on Glivec. Most of these are manageable. Ten years of data have shown that only occasional patient had to stop Glivec due to these side effects.  However, If the side effects are severe and persistent, one must consult the doctor for possibility of dose reduction which should never be below 300mg.  Calcium and Magnesium supplements are helpful in reducing muscle cramps. 

Q) Doctor, my platelet & WBC count have reduced significantly .
A) Hemoglobin (Hb), WBC and Platelets are important markers for monitoring CML patients while taking Glivec.  A CML patient has two types of stem cells :
(1) Normal Stem Cells & (2) CML stem cells
Glivec takes care of the CML stem cells but in the process, it also harms the normal stem cells and hence the Hb, Platelet and WBC can drop. Blood counts need to be monitored for a patient on Glivec.  Your doctors will advise you if you need to stop Glivec for a while or continue the same despite low blood counts. One can also use what is called growth factors (G-CSF) intermittently to keep the WBC count up while continuing to take full dose Glivec.  

Q) Doctor, can I take antibiotics while on Glivec?
A) Like a normal person, a patient of CML can get any infection needing antibiotics. Most of the time, there is no problem. Antibiotics and most of the other drugs can be taken with Glivec. Still, it is safer to inform your doctor about CML and Glivec therapy. Some of the drugs decrease the efficacy of Glivec and one has to increase the dose. For example, while treating TB (tuberculosis) in a patient of CML, a drug called Rifampicin is used. In this case, Glivec dose has to be increased to 600mg/day.

Q) Doctor, are frequent bone marrow tests necessary during the follow up ?
A) Bone marrow test is often needed to monitor the response to Glivec therapy. Unfortunately, it is painful and hence patients feel uncomfortable.
There are 4 ways to assess the response to Glivec : 
(1) Clinical i.e. by noting the reduction in spleen size
(2)  Haematological i.e. by doing a total WBC count which should comeback to normal.

(3) Bone marrow test to check for the Ph Chromosome which should disappear &
(4) Molecular tests like FISH & RQ-PCR. The later i.e. RQ-PCR is  the best test to assess the response. FISH and PCR tests can be done from blood and hence they are more convenient. Unfortunately, they cost more than the cytogenetics from marrow.

Q)  How often should one do a test like RQ-PCR, FISH or bone marrow – cytogenetics ?
A) These tests are usually recommended every 3 months. However, at a later stage, we often reduce the frequency to once every 4 or even 6 months.

Q) Doctor, I have been on 400mg of Glivec and I’ve been advised to increase the dose to 600mg.  With that, I get blisters in my mouth.
A) It is extremely important  to keep the CML under control. For this, sometimes one has to increase the dose of Glivec to 600 mg or even 800 mg. These higher doses of Glivec do cause more side-effects.  It’s better to try and manage the side effects of higher dose of Glivec rather than to go for alternative medicines like Sprycel (Dasatinib) or Nilotinib. Glivec even in the higher dose is provided by Max Foundation and Novartis free of cost while the alternative drugs are expensive and hence often not affordable. In addition, Novartis is not yet available in India. Another alternative is to take Interferon, which is the older medicine for CML, however, it is an injection which has to be taken daily or at least 3 times a week for lifelong. It also has side-effects.

Q)  Doctor, despite taking Glivec – 400mg, my WBC and platelet counts remain higher than normal. What should I do ?
A) This amounts to uncontrolled CML and my answer will be identical to the one above i.e. using higher dose of Glivec or changing to Dasatinib or Nilotinib or even Interferno.

Q) Do I have to take Glivec for life? 
A) Yes. Glivec has to be taken lifelong. If you stop Glivec, CML comes back. The WBC count increases. Spleen enlarges. The risk of progression of the disease to acute leukaemia becomes real and that is dangerous to life.

Q)  Is Glivec safe for heart ?
A) Yes. Glivec is safe for heart. It was first given to a CML patient way back i.e. in 1998.  Now, we have 10 years data. MD Anderson Cancer Centre at USA has studied a large number of patients for 10 years and concluded that Glivec has no significant side-effects on heart. It is also safe for kidney. Occasionally, its known to affect liver and hence regular monitoring of liver function is required. 

Q) Doctor, can you tell us about Bone Marrow Transplantation (BMT), cure rates and the expenses involved?
A) Before Glivec, BMT was the usual therapeutic option for CML (apart from Interferon and Hydrea).  With introduction of Glivec, which has gradually become the best, most effective and safest first line therapy for patients of CML, BMT as the first line treatment for CML is hardly ever carried out. Unlike Glivec, which has to be taken lifelong, BMT can cure CML, however,  it has inherent risks.  The cure rate is only about 65-70%.  The rest can get relapse of CML, other serious complications due to BMT and some can even succumb. This is why BMT has been moved to the second line therapy for CML and it is now offered to only those who do not respond to Glivec or are totally intolerant to Glivec.  

Q)  Tell us more about BMT for treating CML
 
A) First of all, you need t have a HLA-matched donor. Usually, such matched donors are available from the family itself, very often the siblings i.e. brother or sister. The procedure is expensive and costs about 10-15 lakhs. The methodology is available at about 10-15 centres in India. The marrow transplantation is not a surgery. It is usually administered as blood transfusion (intravenously). Prior to this, CML patient’s own bone marrow is cleared with the help of chemotherapy or radiotherapy. This is called conditioning. The infused marrow can take up to 3-4 weeks to start working. It is the interim period which is risky as patients can develop serious infections which can be fatal. Age is also an important factor. Younger patients can tolerate BMT safely while it is usually not done after the age of 50 years, due to the risks involved including the risk to life.

Q) What is accelerated phase ? How is it detected ?
A) During accelerated phase, patients often become symptomatic. Spleen increases. Hb can drop. WBC count increases. Response to medication becomes inadequate.

Q) What is meant by MRD – Minimal Residual Disease ?
A) MRD stands for an extremely small amount of leukaemic cells that remain in the patients of CML, despite various medical treatments including Glivec. The goal of Glivec therapy is to reduce the leukaemic cells burden by 4-log. If not, it should be at least a reduction by 3-log. Anything less than that allows the disease to progress to accelerated phase or even blast crises.

Q) If one wants to have children while taking Glivec therapy, what are the recommendations ?
A) A male patient can continue to take Glivec while planning children. A woman can continue to take Glivec until she becomes pregnant. However, Glivec should be stopped immediately after pregnancy is diagnosed. It should only be restarted after the delivery. Some recommend stoppage of breast feeding during Glivec therapy which is probably correct. During pregnancy, one can take Interferon injections to keep the CML under control. The safest recommendation is to avoid pregnancy during Glivec therapy.

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