Final conclusions of TOGA, the largest randomized trial of a form of stomach cancer agreesive have shown that adding Herceptin – the drug against breast cancer – to standard chemotherapy extends the lives of patients with gastric cancer more aggressive four months to 16 months. This represents a 35% increase in survival compared to chemotherapy alone.

The study included Jeff Evans, Professor of Translational Cancer Research at the university. Drug manufacturers hope the findings will mean patients with advanced gastric cancer will be able to receive Herceptin as part of their treatment. Herceptin, also known by the chemical name of trastuzumab is currently approved for the treatment of gastric cancer or stomach cancer.

Based on the results, Herceptin manufacturer Roche has submitted a label extension with the health authorities of the EU so that the medicine is used in HER2-positive advanced gastric cancer and a decision is expected in early 2010.

“Trastuzumab impressive effectiveness in improving patient survival represents a significant advance in how we treat patients with this aggressive type of advanced gastric cancer,” said British researcher Professor Evans. He added: “The results of the study means that we must establish accurate HER2 testing of all patients with advanced gastric cancer.

The results were presented today (Friday 25 September) at the 15th joint congress of the European Cancer Organization (ECCO) and the 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany.

To date HER2 testing for patients with gastric cancer in the UK is not routine and should be initiated prior to the prescription of Herceptin in this patient group.

The sub-analysis of the international phase III study is among the group of patients whose tumors express high levels of HER2, the same criteria currently recommended to identify patients with breast cancer who are HER2-positive tumors.

Herceptin was the focus of media attention in 2005 when Patricia Hewitt, then Secretary of Health, called for women with HER2 in early breast cancer positive for access to treatment and following HER2 test data presented in American Society for Clinical Oncology (ASCO) meeting, showing that gives women the unprecedented survival benefit.

The drug efficacy in patients with gastric cancer demonstrates a significant chance that a drug targeted may offer patients and reinforces the principle that HER2-positive aim is not limited to breast cancer.

Gastric cancer is the most common cause of cancer death sessions in the UK, with nearly 8,000 new cases diagnosed each year. It is associated with poor prognosis and early diagnosis is difficult because most patients have no symptoms at the initial stage. Nearly 17% of stomach tumors express higher levels of HER2 based on the TOGA study, the largest prospective study to assess HER2 status in patients with advanced gastric cancer using a validated methodology.

”We are pleased to see the amazing benefit that offers targeted therapy trastuzumab for patients with stomach cancer HER2-positive,”said William Burns, CEO Roche Pharmaceuticals Division.
“Trastuzumab will become the new standard of care and make an important contribution to help these patients.”

In the TOGA study, there were no new or unexpected adverse effects. The most common side effects were diarrhea (4.8%) and febrile neutropenia (3.4%).

Trastuzumab is already well established as the basis of care for patients with HER2-positive breast cancer and now, based on the results of TOGA, Roche has filed in Europe for use in the treatment of HER2-positive gastric cancer.

The TOGA study is the first randomized Phase III trial investigating the use of trastuzumab in patients with inoperable locally advanced, recurrent or metastatic HER2-positive gastric cancer. About 3,800 patients were evaluated for HER2-positive tumors and 594 patients with HER2-positive were included in the study.

The rationale for conducting this test is based on the knowledge that the targeted therapy trastuzumab has demonstrated unprecedented efficacy in treating HER2-positive breast cancer. Furthermore, overexpression of HER2 is also observed in stomach cancer. Targeted cancer therapies are drugs or other substances that block the growth and spread of cancer by interfering with specific molecules involved in tumor growth and progression.

In the TOGA study, patients were randomized to receive one of the following regimens as first line treatment:

• A fluoropyrimidine (capecitabine or intravenous 5-FU) and cisplatin every 3 weeks for 6 cycles. Most patients received capecitabine and cisplatin chemotherapy

• Trastuzumab 6 mg / kg every 3 weeks until disease progression in combination with fluoropyrimidine and cisplatin was stopped after a maximum of 6 cycles

The primary study objective was to demonstrate superiority in overall survival with trastuzumab treatment arm compared with chemotherapy alone arm. The pre-planned interim analysis was due to the occurrence of 347 events. The Secondary endpoints included progression-free survival, overall response rate, response duration, safety and quality of life. In the TOGA study, there were no new or unexpected adverse effects.

Provided by the University of Glasgow