Roche Develop Breast Cancer Drug Innovation


Yogyakarta, breast cancer is still the highest position as the leading cancer killer of women around the world. However, the treatment given so far is still not optimal in relieving cancer growth.

Compared with other countries in Europe and the United States who have cancer incidence rates reaching 70-100 per 100,000 people, the incidence of cancer in Indonesia is still unclear because population-based study to find out it has never been held in Indonesia. But estimated the incidence of cancer in Indonesia is 17-25 per 100,000 people.

"Breast cancer alone there are three kinds, the first and most (around 60-70 percent) are caused by hormonal reactions, the latter is the result of the expression of a protein called HER2 cells splitting excess and the third did not get into them. However, the most severe is the result of overexpression of HER2 breast cancer because of more malignant, can develop faster, more prone to metastasis and more resistant to standard drugs, "said Dr. Johan Kurnianda, SpPD-KHOM told a media launch of a global study of the safety of Trastuzumab in the Hotel Novotel Yogyakarta, Thursday (09/08/2012).

Therefore, Roche Laboratories which have been experienced in the treatment of cancer (oncology) for 50 years launched a global study titled SafeHER which focuses on the treatment of breast cancer with positive HER2 protein.

This research emphasizes on innovation standard treatment of breast cancer is trastuzumab (anti-HER2). Trastuzumab has proven effective as monotherapy or in combination with standard chemotherapy because it can improve treatment response.

"Trastuzumab is administered in patients with early stage breast cancer can increase survival by 20 percent. In addition, actual patients who have metastatic breast cancer (spread to other organs) and anti-HER2 would not be able to survive less than 1 year but with the addition of Trastuzumab , the patient may live longer or approximately 3 years with a better quality of life, "said Dr. Johan is acting as principal investigator study SafeHER.

"But because this therapy is usually administered by intravenous infusion, the patient feels uncomfortable because their use is often more difficult to get patients to the hospital and there are some hospitals that have a policy if there are patients who infused the patients in question are required for the 'mole' or hospitalization that costs more money to spend, "said Dr. Johan.

"Not to mention if the patient had been undergoing chemotherapy for these patients has been frozen blood vessels, access to a small vein vessels that have been stabbed multiple times before finally infused," said one researcher Dr SafeHER of RS. Sardjito, Dr. Kartika Widayati, Sp.PD-KHOM.

Motivated by it, Roche developed the innovation of Trastuzumab in the form of subcutaneous injection. This injection is given by injection under the skin of the thighs, as well as insulin injections and is expected to be conducted independently by patients so that patients feel more comfortable.

"This study will use two methods, the first injection can be administered in just 5 minutes, certainly different from the infusion should be administered over 30-90 minutes. Then there is also a self-contained and automatic injection devices are also only be given for 5 minutes , "explained Dr. Arya Wibitomo as Head of Medical Management PT Roche Indonesia.

In Indonesia, SafeHER study will be conducted at five cancer centers and involved 60 patients and 15 experts in the field of oncology. The six cancer centers that include RS Dr. Sardjito (Yogyakarta), Hasan Sadikin Hospital (London), and RS Cipto Mangunkusumo Dharmais (Jakarta) and Dr RS. Soetomo (Surabaya).

For the first time, a study conducted at Hospital Dr. Sardjito Yogyakarta. In the hospital adjacent to the Faculty of Medicine, University of Gadjah Mada, breast cancer is the most existing cases. Dr RS annually. Sardjito received 200 new cases of breast cancer and 30 percent are classified as in the case of breast cancer with HER2.

"For its clinical trial we have obtained permission from the hospital and medical school ethics committee to protect the rights of patients," explained Dr. Kartika.

Patients will be included study had to meet the specific provisions are:
A. Breast cancer patients, both men and women who express the HER2 protein
2. Physical condition and still in good clinical performance
3. Still in early stage breast cancer (stage 1-3)
4. Have the status of cardiac function is still good
5. Willing and healthy enough to sign the agreement following the clinical trial

So far, the research team at the hospital Dr. Sardjito has gained 2 patients of 10 patients who were targeted in Yogyakarta. Both of these patients were both female sex and age under 50 years old.

The research team targeting studies in Yogyakarta to be completed within one year. Each patient who followed the clinical trial will be given subcutaneously Trastuzumab therapy as much as 18 times the frequency of injections 3 weeks. Along with the use of these new therapies, other treatments such as chemotherapy remains will be given.

SafeHER study emphasizes comfort and safety of breast cancer patients using trastuzumab therapy. Hopefully with a more practical method of treatment, duration of long-term treatment of breast cancer patients have to be faced was not so burdensome.

In addition in terms of security is expected to subcutaneous injection was attempted by Roche that could minimize the side effects of trastuzumab. As long as it is known that trastuzumab therapy by intravenous infusion it can interfere with heart function of the new drug is expected to minimize the risk of cardiac dysfunction.

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