An oral targeted therapy proven to extend overall survival in patients with advanced colorectal cancer is now available in Malaysia.
IT has been estimated that one in 33 Malaysians is at risk of developing colorectal cancer, making it the second most common form of cancer affecting Malaysians today.
Colorectal cancer is the world’s third-most common cancer, with an estimated 1.23 million people diagnosed in 2008. The global incidence is found to be higher in men by 1.4 times compared to women.
Colorectal cancer occurs when small growths known as polyps turn cancerous. These small growths come from the cells lining the colon and rectum.
Polyps begin as benign (non-cancerous) growths, and may gradually enlarge and develop into cancer over a prolonged period of time.
It is difficult to identify which polyps would eventually become cancerous; hence it is recommended that polyps should be removed immediately when they are detected.
For most individuals, colorectal cancer begins in the inner lining of the colon or rectum and progresses into a tumour over several years. Colorectal cancer often has no symptoms in the early stages; the severity of the cancer is measured by the stage of the disease and the spread of the cancer to other parts of the body.
About 50-60% of colorectal cancer patients will develop metastases, the process of cancerous cells spreading to distant tissues. Once colorectal cancer spreads to other parts of the body, the patient’s survival rate dramatically declines.
When colorectal cancer is at the metastatic stage, the prognosis is very poor, with an estimated survival rate of less than 10%.
Treatment for metastatic colorectal cancer varies, from surgery, chemotherapy, radiotherapy and other alternative targeted therapies.
The particular choice of treatment chosen for metastatic colorectal cancer differs from patient to patient, depending on factors such as the size, location, and number of metastatic tumours; the patient’s age, etc.
“The majority of colon cancer patients discover the disease only in its later stages, when the five-year survival rate is less than 10%,” said consultant clinical oncologist Datuk Dr Mohamed Ibrahim Wahid.
“Treatment options for advanced colorectal cancer patients with metastatic disease are limited, especially after standard approaches have been exhausted.
“A treatment option such as regorafenib (Stivarga) will surely be welcome, as it can give patients more precious time to spend with their loved ones, with the added advantage of it being oral, unlike the intravenous administration of other available therapies.”
Stivarga or regorafenib is an oral multikinase inhibitor, which acts on multiple pathways involved in cancer progression, and is the first single agent of its kind to demonstrate significant survival benefit in patients with metastatic colorectal cancer.
As an oral monotherapy agent, regorafenib offers improved convenience for patients by eliminating the need for, and cost associated with, IV infusion therapies.
The drug inhibits a number of protein kinases (enzymes which act to transfer chemical signals) involved in cancer progression.
With a different mode of action and multiple targets of inhibition, the drug may provide an important treatment advancement for those patients with metastatic colorectal cancer who have no further approved options.
The approval of the drug in Malaysia brings new hope to advanced colorectal cancer patients who have previously been treated with standard therapies.
Regorafenib is the first oral targeted therapy that has been proven to extend survival, provide tumour control and keep the cancer from progressing.
The approval of the drug is based on positive results from a global landmark Phase III CORRECT (COloRectal cancer treated with Regorafenib or plaCebo after failure of standard Therapy) trial, which involved 760 patients, 15% of whom were from Asia.
The CORRECT study demonstrated that treatment with regorafenib, plus best supportive care, significantly improved both overall survival and progression-free survival, compared to placebo in patients with metastatic colorectal cancer whose disease had progressed after approved standard therapies.
“The CORRECT study has demonstrated regorafenib’s ability to improve tumour control and the survival of a large number of patients who previously had no treatment options.
“This is an important advance in the treatment of advanced colorectal cancer,” said Australian medical oncologist Dr Peter Gibbs.
According to Thomas Steffen, managing director for Bayer Co (Malaysia) Sdn Bhd, “The approval of Stivarga recognises the potential benefits it brings to colorectal cancer patients who need more treatment options and time with their loved ones.”
He added, “Today’s announcement is an important milestone for Bayer in our ongoing effort to develop novel therapies for unmet medical needs, particularly in the area of oncology.”
The drug was approved for use by the Malaysian Health Ministry in June, for the treatment of advanced colorectal cancer with metastatic disease.
It has also been approved for this indication in several other countries, including the US, Canada, Japan and Singapore.
1. Grothey A, Van Custem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicenter, randomized, placebo-controlled, phase 3 trial. Lancet 2013:381:303-312.
2. Ministry of Health Malaysia. National Cancer Registry Report: Malaysia Cancer Statistics-Data and Figure 2007.
3. Ministry of Health. Health Facts 2012
4. WHO GLOBOCON 2008. Colorectal cancer on the rise. New Straits Times, 30/09/12. Avalable at
http://www.nst.com.my/nation/general/colorectal-cancer-on-the-rise-1.150298. Accessed 25/08/13
5. GLOBOCAN 2008 Fast Stats. Malaysia. Available at http://globocan.iarc.fr/factsheet.asp. Accessed 23/09/13
6. Wilkes, G.M. Metastatic Colorectal Cancer: Management Challenges and Opportunities. Oncology Nurse Edition, 2011. 25(7). Available at www.cancernetwork.com/colorectal-cancer/content/article/10165/1902212?pageNumber=1. Retrieved 29/07/13
8. American Cancer Society. Colorectal Cancer. 2010
Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003096-pdf.pdf Accessed Jan 2013
9. http://www.cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional/page9#Section_369. Retrieved 14 August 2013