About fourteen months ago Kostantinos Christou?s body barely worked. Only if he focused could he force one leg at a time to climb the stairs. When he walked, he staggered as if he were drunk.
Christou (not his real name) hails from Limassol, has two adult children, and is almost 68 years old.
About four years ago he learned that he had prostate cancer.
It was too late for surgery that is an option for early prostate cancer, and he was not a candidate for radiation therapy, which aims to kill cancer cells via targeted radioactive exposure.?
Christou?s cancer had metastasised, i.e. it had advanced beyond the prostate area.
?The chemotherapy had worn him down.
?After about six months I got to the point of dragging my feet. I would put one leg in front of the other go climb the stairs,? Christou said.?
The side effects of chemotherapy - which can kill normal cells along with cancer cells -include hair loss, nausea and vomiting, diarrhoea and fatigue.
?I could only walk about ten metres on my own like a drunken man,? Christou said.?
The prostate is part of the male reproductive system. It is a small, walnut-sized gland sitting below the bladder. If the cancer spreads beyond the gland, i.e. metastasises - usually to the bones - treatment can only prolong life and alleviate symptoms but cannot cure the cancer.?
Prostate cancer is a leading cause of death worldwide and the most common cause of cancer in men, claiming about 27 per cent of cancer cases in Cyprus, according to data collected by the health ministry?s Health Monitoring unit (HMU).?
The cancer?s growth is fuelled by testosterone production, making it hard to treat if it metastasises because testosterone continues being produced by the adrenal glands and the tumour.
In Cyprus, 56 people died from prostate cancer in 2010, according to HMU?s the latest available data.
Christou should have been part of the following year?s statistics but his doctor got him on an early treatment programme for a drug that was not yet marketed.
The drug Zytiga or abiraterone acetane, sold by Johnson and Johnson?s Janssen, is a kind of hormone therapy authorised for market use in September last year by the European Medicines Agency?s (EMA) committee for medicinal products for human use (CHMP).
It has been recommended for the treatment of cancer that has metastasised beyond the prostate and continues growing despite conventional hormone therapies, called metastatic castration resistant prostate cancer.
It is taken as a pill along with steroids prednisolone or prednisone.
The patients who have been given Zytiga live on average for 4.6 months longer than those given a placebo instead, based on a study on 1195 people.
Christou has so far lived well beyond the average, and 14 months later says that he is ?well but not completely well?.
?But I?m telling you I reached the end [of my life], when I say the end I mean the end,? he said, commenting on his health over a year ago.
Zytiga works by bringing testosterone production down to a trickle by blocking enzyme CYP17, and so staving the cancer?s growth which is fuelled by testosterone production.
Its most common side-effects are hypertension, urinary tract infections, fluid retention, and a drop in potassium levels.
At present, the CHMP recommends Zytiga only for use ?in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen?.
Docetaxel or taxotere, the chemotherapy drug, disrupts tumour growth, prolongs life for two to three months and is also taken with prednisolone or prednisone.?
Janssen is now doing a study to get Zytiga approved for use in cancer patients before ?gruelling courses of chemotherapy have been tried out and where the cancer has spread and continues growing.
Initial results have been positive and the US regulatory Food and Drugs Administration body, FDA, granted in late August Janssen?s application for priority review of the medicine, aiming to review the product in six months.
Janssen also submitted an application to the EMA to extend Zytiga?s use in June, when it lodged the FDA application.
Christou?s doctor, the oncologist George Orphanos, said that his small experience with the drug showed him patients responded well to Zytiga.
?It is much better to have a pill rather than chemotherapy,? Orphanos said.
??The worst thing is to waiting to die. Zytiga brings results without the side effects of chemotherapy,? Janssen?s sales manager Nicolas Christodoulides said.
He knows what he?s talking about. Christodoulides watched his brother, Angelos, undergoing the horrors of chemotherapy before he died of cancer last year at the age of 52.
He talks of his brother?s anxiety over whether he would make it to his daughter?s graduation ceremony (he didn?t), how his brother hated chemotherapy and what it did to his body, how he worried that he would lose his job.
Christodoulides talks of a moral requirement to provide patients with the best possible quality of life.
He still keeps his brother?s business card in a drawer in his office.
Christou - who is understandably biased because Zytiga keeps him alive - thinks everyone should be given it.?
?If I wasn?t given the medicine, I would be dead. I want to tell people about the good it did to me. If it does the same to them they will be saved,? Christou said.
But Zytiga is extremely expensive, retailing at ?5,400 per bottle (making it ?3942 wholesale). A bottle lasts a month and Christou says he would not be able to afford it if he wasn?t sponsored by Janssen. ?
Christodoulides says that [patented] cancer meditation is expensive across the board, citing breast cancer medication as an example.?
Despite the high cost, Janssen?s Christodoulides argues hard for Zytiga?s benefits and extending its usage and making it available to men before the chemotherapy option has been exhausted. He has a point, of course. You take a pill at home, with less severe side effects.
?Cancer patients are insecure and depressed. They want hope. They want to live longer to see their children graduate, get married,? he said.
Despite the price, the state?s pharmaceutical services? head, Arthur Issseyegh said Zytiga has been approved and they are in the midst of a tender procurement with Janssen.
The state should be able to negotiate a better price for Zytiga.?
But Isseyegh said the services will follow a ?strict protocol? in terms of who gets the medicine.
The UK?s healthcare guidance body, NICE, has recommended Zytiga in the UK, where about 10,000 die from prostate cancer annually according to the National Health Service.
?It will be available under a patient access scheme offering it at a discount, according to NICE?s appraisal guidance issued in June.?
But Zytiga is also facing direct competition from a medicine called Xtandi - also taken as a pill and priced similarly to Zytiga - which the FDA approved on August 31, three months ahead of schedule.?
Xtandi or enzalutamide is recommended for use in post-chemotherapy (docetaxel) patients just like Zytiga. Like Zytiga, it also interferes with the testosterone production that feeds cancer cells.
The company has also filed for EMA approval and is being tested in men with earlier stage cancer. ?
Worldwide Zytiga sales in the first six months of the year have come to $432 million (about ?338m).
As others are counting numbers, Christou is counting the difference as in ?miles apart. I was dead and now I?m alive.?
?Praise God, I?m back to normal,? he said.?
Source: http://www.cyprus-mail.com/drug/pricey-lifeline-prostate-cancer-victims/20120916
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