29 October 2014

Regorafenib : New Hopes in Medical Treatment for Advanced Stage Colorectal Cancer

PT Bayer Indonesia, Bayer Health Care Pharmaceuticals on a media education forum in Jakarta today officially launched Regorafenib in Indonesia as the latest medical treatment breakthrough for advanced stage colorectal cancer patient

PT Bayer Indonesia, Bayer Health Care Pharmaceuticals on a media education forum in Jakarta today officially launched Regorafenib in Indonesia as the latest medical treatment breakthrough for advanced stage colorectal cancer patient.


Regorafenib is the only oral treatment for advanced stage colorectal cancer that has experienced refrakter to standard treatment and targeted treatment that works by inhibiting several targeted kinase. Besides, Regorafenib enables single oral therapy.


Based on data from World Health Organization (WHO) colorectal cancer held the third place (more than 940.000 cases) after lung cancer (1,2 million cases per year), and breast cancer (1 million cases). In Indonesia, colorectal cancer also held the third place of most encountered after breast cancer and lung cancer. Colorectal cancer is a cancer develops from colon and rectum. According to Jemal A et al. CA Cancer J Clin 2011; 61:69–90, this cancer mostly found in developing countries. Based on data from 2012, there were 27.600 colorectal cancer cases in Indonesia.


Meanwhile in Jakarta,  results from Jakarta Cancer on 2005 – 2007 show that colorectal cancer held the 4th (3,15 per 100.000) after breast cancer (18,6 per 100.000), cervix cancer (9,25 per  100.000), and ovarian cancer (4,27 per 100.000) on women.


“Align with Bayer’s mission, “Science for Better Life”, each product Bayer manufactured is always oriented in innovation and life quality of human,” said Ashraf Al-Ouf, Chief Director of PT Bayer Indonesia, in today’s discussion with the media. Ashraf also added that Food and Drug Administration (FDA) has approved Regorafenib as the therapy for patient with mCRC (Metastatic Colorectal Cancer) in 2012. In Indonesia Institution of Drug and Food Inspector (BPOM) has given the approval letter in October 16th, 2014.


Regoragenib has several advantages, which are, the one and only multikinase inhibitor that proven to control the disease, in form of oral supply with adjustable dose, and used for treatment at the third line for colorectal cancer and three times higher control level towards the disease compared to placebo.


 “Cancer on human mostly caused by accumulation of genetic mutations as cell division occurs (oncogenesis). Cancer cell is formed with a supporting during oncogenesis process, tumor microenvironment and Angiogenesis. Nowadays, one of the most elaborate cancer therapies is targeted therapy where kinase inhibitors are the most examined class. A lot of kinase inhibitors only works on one target. But, cancer can still slip off with only one kinase inhibitor by activating the replacement kinase of targeted kinase, or activating mutation under the drug’s line.  It causes resistance towards the kinase inhibitor drugs,” explained Prof. Dr. Arry Harryanto, SpPD KHOM. “It is known that there are five stages of colorectal cancer. From stadium 0 where new cancer cells are found inside the deepest layer of colon or rectum, to stadium IV where the cancer cells are already spread to other organs,” he added.


This cancer that mostly found in people aged 50 years or above, generally related to various factor, include: age ( 9 of 10 patients are above 50 years), genetic disorder, family history (20% of colorectal cancer patient have family with colorectal cancer too), polyp, and type 2 diabetes sufferer. Meanwhile, obesity factor, smoking, diet (red meat diet increases the risk 3x higher for male), and liquor consumptions also added the risk.


 Symptoms of colorectal cancer are various, beside the visible symptoms, divided into non-gastrointestinal symptom and gastrointestinal symptom. Non-gastrointestinal symptoms include fatigue, anemia, palpitation, lower appetite, weight lost, faded skin tone, and blood blockage. Meanwhile, gastrointestinal symptoms include ulceration, peritonitis, dyspepsia, abdominal pain, and blood in feces. 


Meanwhile, survival rate of colorectal cancer very depends on the stage being diagnosed. If it is diagnosed on early stadium, patient’s survival rate is quite good, even 6% from the patient diagnosed on stadium 4 survived for the next 5 years.


 “Average 5 years survival rate for the patient diagnosed at early stage touches 74% with proper treatment. According to guidance of European Society for Medical Oncology (ESMO) and National Comprehensive Cancer Network (NCCN), if the treatment of line 1 and 2 are not successfully done, advanced stage colorectal cancer patients will be treated with palliative care including targeted therapy, drugs consumptions or substances that can block the growth and spread of cancer by interfering with specific molecules ("molecular targets") that are involved in the growth, progression, and spread of cancer. Based on research from CORRECT (Colorectal Cancer Treated with Regorafenib or Placebo after Failure of Standard Therapy), Regorafenib as the latest treatment for colorectal cancer patient is proven to push down the death risk by 23%. Regorafenib has the molecules that can block the growth of cancer cell VEGF, PDGF, TIE, KIT, RET, RAF and BRAF. Besides, on CONCUR (an international*, randomized, double-blind, placebo-controlled phase III study of Regorafenib plus Best Supportive Care (BSC) versus placebo plus BSC in Asian patients with mCRC who have progressed after standard therapy) research where Regorafenib as single oral therapy in Asia shows that the death risk can be pushed down by 45%. The aim of this treatment is to leverage the life expectation while maintaining the life quality itself as well as possible,” said Prof. Dr. Abdul Muthalib, SpPD-KHOM.


“For metastasis colorectal cancer that is unresponsive for standard therapy, targeted therapy with Regorafenib is allowed. And, given the very high price of cancer treatment, the role from the government is very much needed, especially in this era of National Health Assurance (JKN),” added Prof. Muthalib.