Tag: Nexavar

In my earlier posting, I wrote about one “rotten” morning I experienced. Now, let me share with you what a “weird or cuckoo” morning was like.

AKS is a 57-year-old Indonesia. His problem started with a fever a few months ago. He went to a hospital in Jakarta for help. He was told nothing was wrong with him.

AKS was not satisfied and consulted another doctor — an internist. Again he was told there was nothing wrong with him. Still not satisfied, he consulted a stomach specialist. He was told something was in his liver!

AKS came to a private hospital in Penang for further consultation in February 2018. He saw one doctor and did an endoscopy. The result indicated esophageal varices, gastritis. Negative for Helicobacter pylori. 

A CT scan was done and showed the following:

• Coarse liver parenchyma suggestive of underlying cirrhosis.
• Ill-defined mass in the right lobe of liver measuring 10.5 x 9.5 x 7.8 cm.
• Smaller lesions scattered in both lobes of liver ranging from 1.0 to 3.5 cm in size.
• Features suggestive of multicentric hepatoma.
• Mild ascites.

Blood test results were as follows:

AKS was told to undergo a procedure called TACE (transarterial chemoembolization). He refused and went home to Jakarta.

In March 2018, AKS came back to Penang again. This time, he consulted an oncologist in another hospital.

His blood test showed deteriorating liver function.

AKS was prescribed Lenvima (or Lenvatinib). For 20 days the drug cost him RM5,000. The doctor said this drug would not cure him!

I asked AKS. The doctor did not ask you to take Nexavar? His reply, The doctor told me not to take Nexavar!

AKS took Lenvima for two days and felt nauseous and dizzy (as before). He and his family decided to seek our help.

Comments

1. AKS went to see two doctors. They couldn’t find anything wrong. The third doctor said there was something in this liver. Then he came to Penang and the first thing the doctor did was endoscopy! But there was something in his liver? Why endoscopy? Is this procedure just a matter of routine? More procedures better?

Do you think all these make sense? Ask again, do you really need an endoscopy?

2. As you can see, AKS went round and round, and only then a blood test and CT scan were done. Sure enough the results indicated tumours in his liver.

3. AKS was asked to go for TACE. AKS refused.

For whatever treatment suggested, it would be wise if patients were to ask their doctors these questions:

• What is this treatment for? Can cure you? Prolong life? Improve quality of life?
• How much does the procedure cost?

There is a 10.5 x 9.5 x 7.8 cm tumour in his liver. In addition, there are smaller lesions scattered in both lobes of the liver ranging from 1.0 to 3.5 cm in size. Do you think TACE can help the patient? In what way?

Over the years, I have come across many patients who did TACE but did not benefit from this treatment.

4. AKS was prescribed Lenvima (or Lenvatinib) for his liver cancer!

I have never heard of this drug before! I told AKS usually doctors would ask patients to take Nexavar. This was when I got a shocking reply. The doctor told AKS not to take Nexavar!

How could that be? What has happened? Does the doctor NOW know something about Nexavar that we all do not know?

For the past two months, I have liver patients coming to me and they were taking Nexavar — why the change of “heart”? There must be a reason for this change from the standard practice.

Let me say that those patients on Nexavar suffered severe side effects and gave up on the drug. That was why they came to us for help. I have written some cases about Nexavar and I am going to write more cases later.

There was one lady who paid RM 20,000 for a month supply of Nexavar. She was told that when she comes the next month, she will get one month supply of Nexavar for free (promotion — buy one, free one).  According to her son, after taking this drug for a week, she landed in the hospital and died.

So the question is, why was AKS told not to take Nexavar now? It is because of such experiences above or something else?

But  more tragedy to come. Instead of Nexavar, AKS was described Lenvima  or lenvatinib. I had to go into the net to find out what that is.

Lenvima, a drug made by Eisai Inc. was approved by US – FDA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

Lenvima is also used in combination with the drug everolimus, for the treatment of advanced renal cell carcinoma.

Here are the side effects of Lenvima:

• High blood pressure
• Diarrhea
• Fatigue
• Joint/muscle aches
• Decreased appetite
• Weight loss
• Nausea
• Stomatitis (mouth sores)
• Headache
• Vomiting
• Proteinuria (protein in the urine)
• Palmar-plantar erythrodysesthesia (hand-foot syndrome)
• Abdominal pain
• Dysphonia (difficulty speaking)

Less common side effects (occurring in about 10-29% of patients) are:

• Constipation
• Oral pain
• Cough
• Swelling
• Rash
• Taste changes
• Dry mouth
• Dizziness
• Heartburn
• Hair loss
• Nose bleed s
• Insomnia (trouble sleeping)
• Urinary tract infection
• Dental & oral infections

Source:

http://chemocare.com/chemotherapy/drug-info/lenvatinib.aspx

https://www.prnewswire.com/news-releases/fda-approves-eisais-lenvima-lenvatinib-for-the-treatment-of-patients-with-locally-recurrent-or-metastatic-progressive-radioactive-iodine-refractory-differentiated-thyroid-cancer-300036074.html

There is a fine note which says: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful. Is this not what is happening now? Liver patients is given a drug for thyroid or kidney cancer?

Its sounds like an “new experiment” on patients! Giving  a chemo-drug that is approved for the treatment of thyroid or kidney cancer to liver cancer patient … to see what happen?

I went cuckoo this morning! Oh, it is just a weird morning. My first time to learn such thing.

Mutu (not real name,H520) is a 48-year-old male. In November 2010 he had coughs with some phlegm. In late December 2010 he was admitted into a private hospital with complaints of right hypochondrial pain (i.e., pain under the rib-cage margin). He was nauseated but no vomiting. He also had post prandial dyspepsia (i.e., a medical term meaning feeling of unusual fullness, nausea, loss of appetite or belching following a meal).

CT scan of the abdomen showed multiple masses measuring 7.3 x 5.1 cm, 6.3 x 6.1 cm and 7.3 x 4.5 cm,   in the right lobe of his liver, suggestive of diffuse hepatocellular carcinoma or liver metastases. A biopsy was performed on 23 December 2010 and confirmed moderately differentiated infiltrating liver cancer.

A blood test results, done on 19 January 2011, are as follows:

Mutu was prescribed Nexavar – an oral chemo-drug that cost about RM20,000 per month.  He was told that Nexavar would not cure his cancer. It would only control it (whatever that means, see discussion later).

After taking Nexavar for a week, he suffered the following side effects:

1. Bloatedness
2. Shoulder muscle pain
3. Sleeping difficulty
4. Nausea and sometimes vomiting
5. Dizzy when walking
6. Loss of appetite due to bloatedness
7. Cramps of fingers and toes
8. Constipation

Listen to our conversation on 23 January 2011, the day he first visited us.

Comments

Let me highlight some of the important points of this case in a question-and-answer format.

1. Assuming for a moment that you are a medical expert. I believe you have seen hundreds or thousands of CT scans and blood test results. From your experience, what can you make out of this case by just looking at the scans and blood test results? The images are bad and the AFP (alpha-fetoprotein) exceeded a million points. Honestly, is a biopsy really necessary? So, after a biopsy, what can you offer to “cure” the patient?
2. It appears that all that modern medicine can offer is Nexavar. Would you as an expert offer this drug to the patient knowing that it cost about RM 20,000 per month and it does not cure? I guess you would if the patient is rich enough to pay for it or if his insurance covers the cost. This is a win-win situation you may say. After all this is what buying a health insurance is for! But hang on. In this case what if Mutu’s total medical cover is limited, assuming it is RM 100,000? That means the insurance pays for only five months’ supply of Nexavar. What happens after that? And within 8 to 11 months patient dies (see point 4 below)?
3. As an expert, would you admit to your patient that Nexavar cannot cure his cancer? Yes, you did in this case. That is honorable of you.  Obviously not many patients are going to pay that kind of money if there is no cure.  You justified by saying that Nexavar can control it. That sounds good, convincing and heroic  isn’t it? Especially if the patient is desperate and helpless. Such patients need that “last straw”. But what do you really mean by control?
4. Have you gone into the website of the drug company that sells Nexavar? If you do, you may find this very impressive table with equally impressive so-called “scientific” data.

• In a study of 602 people … Nexavar helped slow cancer growth and helped extend the lives of patients compared with patients who did not receive Nexavar.
• Nexavar extended overall survival by 44%.
• See the diagram below (from: http://www.nexavar.com/scripts/pages/en/index.php. Accessed on 1 February 2011)

For the benefit of those who are not used to reading and interpreting research data, let me explain a bit more. From the diagram above, we know that there were 299 patients taking Nexavar (n= 299) and the  median overall survival is 10.7 months. Compare this to 303 patients who did not take Nexavar (group called Placebo, n = 303) which had a median overall survival of 7.9 months.

The glaring facts of this study showed that:

• By taking Nexavar patients lived longer by 2.8 months. Take note that they were not cured at all. Eventually patients died. The median survival ranged from about 8 to 11 months, irrespective of whether they take Nexavar or not.

So based on the above experimental data, ask this question. Would you spend RM 20,000 per month and for every month, to live 3 months longer? Again, take note that the price of Nexavar varies –  depending on  where you buy it and whether you pay cash or pay through insurance claim. Obviously the price is higher when your insurance pays for it.

Of course, if this point is crudely presented like I did above, extending life by 2.8 months is not impressive at all!  The educated people deviced a better way of saying things in a nicer, attractive but deceptive way. Another way of saying is:  Nexavar extended overall survival by 44%. Increasing survival by 44% is very impressive indeed.

Mark Twain (of the USA) made famous this phrase:  “There are three kinds of lies: lies, damned lies and statistics.” This phrase is now used to describe “ the use of statistics to bolster weak arguments, and the tendency of people to disparage statistics that do not support their positions”. In simple language, the   statisticians (the experts of numbers) “massage” the data to make what seems ugly to look pretty. Take note also this “manipulation or massage” of data is not wrong – it is academically legitimate!

So take it from me that “Extending life by 2.8 months” or “Extending overall survival by 44%” are both right and academically acceptable. Unfortunately I still cannot figure out how they come up with the 44 percentage figure. I need a bit more time to learn this “art of stretching the truth with numbers.”

With a simple mind like common folks, I would have just do this: I would take 10.7 minus 7.9 = 2.8. Then I would divide 2.8 by 7.9 and multiple by 100 to convert it into a percentage. If I did this, I ended up with only 35%. To avoid having to explain “the confusing concept of statistics”  let us give the benefit of the doubt to the experts and the drug manufacturer and accept what they say: Nexavar extended overall survival by 44%.

But folks let’s concentrate on what matters most.  You can choose between these two “options” below. But know that both mean the same thing!

• As a patient if you are told that Nexavar can extend survival by 44%, what would be your reaction?
• On the other hand, if you are told that Nexavar can extend your life by only 2.8 months, what would be your reaction?

Having got over this, what if you are clearly told that the extension of survival by 2.8 months is no free lunch.  Apart from having to pay RM 20,000 per month, there are a variety of side effects you may have to endure. In this case, Mutu suffered eight side effects after consuming Nexavar for a week.

But don’t fault the drug company. You have been forewarned. Patients taking Nexavar may suffer the following side effects (according to the company’s website):

1. Decreased blood flow to the heart and heart attack.
2. Bleeding problems. Nexavar may increase your chance of bleeding.
3. High blood pressure.
4. A skin problem called hand-foot skin reaction. This causes redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
5. Perforation of the bowel.
6. Possible wound healing problems. You may need to have a surgical or dental procedure.
7. Birth defects or death of an unborn baby.
8. Rash, redness, itching, or peeling of your skin
9. Hair thinning or patchy hair loss
10. Diarrhea
11. Nausea or vomiting
12. Mouth sores
13. Weakness
14. Loss of appetite
15. Numbness, tingling, or pain in your hands and feet
16. Abdominal pain
17. Fatigue
18. Weight loss

Those medically trained may find the following list of side effects more exacting:

Very common: lymphopenia, hypophosphataemia, haemorrhage (incl. gastrointestinal, respiratory tract, cerebral), hypertension, diarrhoea, nausea, vomiting, rash, alopecia, hand-foot syndrome (palmar plantar erythrodysaesthesia syndrome), erythema, pruritus, fatigue, pain (mouth, abdominal, bone, tumour, headache), increased amylase and lipase.

Common: leucopenia, neutropenia, anaemia, thrombocytopenia, anorexia, depression, peripheral sensory neuropathy, tinnitus, congestive heart failure, hoarseness, constipation, stomatitis (including dry mouth and glossodynia), dyspepsia, dysphagia, dry skin, dermatitis exfoliative, acne, skin desquamation, arthralgia, myalgia, renal failure, erectile dysfunction, asthenia, fever, influenza like illness, weight decrease, transient increase in transaminases. Uncommon: folliculitis, infection, hypersensitivity reactions (including skin reactions and urticaria), hypothyroidism, hyperthyroidism, hyponatraemia, dehydration, reversible posterior leukoencephalopathy, myocardial ischaemia and infarction, hypertensive crisis, rhinorrhea, interstitial lung disease–like events (pneumonitis, radiation pneumonitis, acute respiratory distress, etc), gastro oesophageal reflux disease, pancreatitis, gastritis, gastrointestinal perforations, increase in bilirubin, jaundice, cholecystitis, cholangitis, eczema, erythema multiforme, keratoacanthoma / squamous cell cancer of the skin, Stevens-Johnson syndrome, gynaecomastia, increase in alkaline phosphatase, INR abnormality, prothrombin level abnormality.

Rare: QT prolongation. Not known (cannot be estimated from the data available): angioedema, drug induced hepatitis, radiation recall dermatitis.

Date of Revision of the Text: November 2010

5. Solutions?

The lady was indeed sharp. She asked me: “Then, that are the solutions?” I must admit I cannot guarantee any cure. We know that in cancer there is no such thing as a cure (meaning, real cure, not just surviving 5 years). In the case of advanced liver cancer, we all know that survival is only in terms of months. So, we are faced with a difficult case. This is the first time that a patient came in with his alpha-fetoprotein reading well over a million. The highest we have ever seen in 14 years is about half that value.

We have two suggestions for Mutu.

a)      Take care of your diet. He was given a list of food that he can and cannot eat. Unfortunately this list is way off the mark compared to our recommendation.

b)       Take herbs and hope for the best. If a patient has no pain, can eat and sleep – these are about all we can hope for. How long to live is not ours to decide.

It is up to Mutu to decide if he wants to continue taking the Nexavar and reap whatever benefits (and also side effects) that are associated with it. But ask this: Is it worth it?

Some of you may say: Ah, you snake oil peddler – you and your herbs and dietary fad – these are just quackery. They are not proven and not scientific. Hang on, before you cast the first stone, take time to read the following ten stories. Tell us where we go wrong if you think that we are wrong!

1.  Liver Cancer: Two months to live yet still fine after one and a half years!

2.  Liver-Bile Duct Cancer: Herbs Kept Him In Excellent Health

3.  Only On Herbs And She Lives More Than Five Years!

4.  He Declined Medical Treatment

5.  Hepatoma – He Refused Chemotherapy

6.  Healing of Metastatic Liver Cancer

7.  The Story of Tony

8.  Colon-Liver Cancer: Seven Years On The Herbs

9.  The Story of Goh

10. The Story of My Buddy: Colon-Liver Cancer