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Putting cancer on trial

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Clinical trials are sometimes the only option for cancer patients to access newer drugs when standard treatment has been exhausted. Express Pharma presents three perspectives: a patient, a caregiver and an oncologist

‘Patients have to develop the courage to fight the disease and take a chance’

Lets call him Raj. A sprightly 72-year-old, one of the many patients for whom big hospitals in the city represent the last chance of a cure. Raj was detected with lung cancer, in the fourth stage, in September 2011. Today his cancer is controlled. His zest for life remains intact; enthusiasm and wit defy his age and medical records. Against all odds, he has survived more than 30 months when the average life of a patient with his is 8-10 months? This is Raj’s story

I came to one of the country’s largest hospitals, known for treatment of cancer patients, in September 2011 after I was diagnosed with stage 4 lung cancer. According to the doctors, the disease was so advanced that I had only nine to 10 months to live. Hearing this, my family members broke down and there were many tears shed, as no one expected me to survive.

But I have trained myself not to fear death. So when I was told of a new drug, being tried on a few patients like me, which might be also effective on my cancer and could prolong my life, I decided to take a chance.

My doctors informed me about the new medicine, explaining the number of times I would have to come to the hospital to take it, the possible side effects, and how it might prolong my life. After discussing with my family, I decided to join the trial and signed the informed consent forms.

The trial started in (month, year). Almost a year, after two doses, the doctors give me the good news. They explained to me that my tumour had responded to the treatment. As my cancer was diagnosed in stage 4, I understand I can never completely recover from it, but the medication helped in reducing the cancer cells and containing it.

For the past six months, I have been coming for my regular check ups and post recovery drugs. I can do my daily exercises regularly and feel strong enough to carry two men on my shoulders!

I do not know what is happening within my body but I trust my doctors; they are the experts. What I do know is that I feel healthy enough to live till I am 90!

My advice to other patients faced with the same choice, is that they have to develop the courage; to fight the disease and take a chance. Courage cannot come from a medicine; that has to come from within. They should not be afraid of death. This is vital for a cancer patient. The mind has to believe that cancer can be fought. And secondly, I have faith in process followed at the hospital and my doctors. I believe that they have done their best and therefore I encourage more patients to participate in such studies.

(As narrated to Viveka Roychowdhury)

I am glad my mother could benefit from a clinical trial

A daughter relives the story of her mother, who was diagnosed breast cancer type Her2+ve, in the fourth stage but is today cancer free, after she was able to access treatment and benefit from a clinical trial

It was in May 2012 that my mother was diagnosed with cancer. My mother stays in Mysore and in early 2012, at the age of 59, was diagnosed with diabetes. When we went to visit her in May, she looked considerably weak and complained of a persistent cough. She also mentioned that she felt a lump in her breast.

I was concerned as my mother-in-law had also gone through a similar experience. I brought her with me to Bangalore. My husband runs a diagnostic centre, so we did an initial X-ray, in which secondary cancer cells were detected in her lungs.

We immediately took her to Dr P P Bapsy, Senior Consultant – Medical Oncologist, at Apollo Hospital, who had also treated my mother-in-law. We had complete trust in her diagnosis and treatment as she had cured my mother-in-law.

The test results indicated that my mother had breast cancer Type Her2+ve. She was in the fourth stage and the cancer had spread completely to her lungs. It could not be operated upon. We were very worried and anxious for my mother’s health and her life.

That was when Dr Bapsy mentioned that there was a trial going on for Her2+ve and suggested that my mother might want to consider participating in the trial. We were desperate for a cure. So we discussed this with my mother and my younger brother and sister. Dr Bapsy explained the Informed Consent Process and the pros and cons of the trial. She gave us an information sheet which explained in detail the benefits and the side effects of the trial. She explained everything to my mother and took time to discuss the process in detail. She then gave us the information to take home and read thoroughly and discuss it with the family. We took a few days to understand everything after which we were convinced that this was the best way forward. We then enrolled my mother for the trial.

The trial consisted of injection and chemotherapy in regular intervals of 21 days. After four cycles, a CT scan was done which showed that the cancer cells were in remission. We were so happy to hear this. After the eight sitting, the end of the trial, a PET scan was done at the Bangalore Institute of Oncology which showed that her tumour had almost gone and her lungs had cleared.

We were overjoyed to hear this. Dr Bapsy then advised us that in order for my mother to be completely cancer free, she would need to continue the HER2+ve treatment which was currently available in the market. This was supplemented along with hormone therapy.

My mother is now cancer free since March and is only on maintenance hormone therapy and calcium tablets. She is getting healthier every day. I am so glad that my mother was able to access this treatment and benefit from a clinical trial.

Clinical trials are one way to ensure that newer drugs are available or accessible to more patients

Dr Kumar Prabhash

Clinical trials are very important for patient care, apart from the development of newer drugs and science. There is enough data to prove that the best care you can get is on a clinical trial. I recommend that people should read the The National Comprehensive Cancer Network (NCCN) site: to get more information.

But when I say this, I mean a properly run clinical trial. There are enough checks and balances built into the process to make it as transparent as possible. For instance, if a trial is ethics committee- approved, if it listed on, approved by the Drug Controller General (India) then one can be reasonably reassured that it is a good clinical trial. In addition, the patient will need to go through the informed consent process, and then after understanding the process, decide regarding participation in the study.

Now in the Indian context, not only does the care of the patient improve during the clinical trial, but it also leads to access to many drugs which are not yet available in India. Clinical trials are one way to ensure that newer drugs are available or accessible to more patients. Every week I encounter patients who have no option because they have exhausted the standard treatment and its not effective. If there are no clinical trials, they have no more options left even though these may be available to patients in the western world. So my message to patients is that if they are eligible to participate in a clinical trial, the chance of benefit is more than the chance of harm.

My message to clinicians, both in government as well as private hospitals, is that there should be as many more clinicians participating in clinical trials. Apart from conducting trials sponsored by pharma companies, we should also be doing much more investigator-driven trials where we bring up many questions which a pharma company may not be interested in, but which are important for our patients’ health. And my message to pharma companies is that they should do as many clinical trials as possible in our country in spite of the current situation. They should be positive and hope that things will improve.

Dr Kumar Prabhash, Associate Professor and Medical Oncologist, Tata Memorial Hospital, Mumbai

(As narrated to Viveka Roychowdhury)

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