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Adding Trastuzumab to Standard Chemotherapy Prolongs Lives in Patients with HER2-positive Stomach Cancer

March 18, 2009 -- Roche today announced results from a major international study which show that adding Herceptin (trastuzumab) to standard chemotherapy significantly prolongs lives of patients with HER2-positive stomach (gastric) cancer. The results are from ToGA, a large international Phase III trial investigating the benefit of Herceptin as the first therapy for patients with advanced and inoperable stomach cancer (first line). Full data will be presented at an upcoming medical meeting.

"Stomach cancer is often incredibly hard to treat, as it is frequently diagnosed at a late stage" said principal investigator Prof. Eric Van Cutsem, University Hospital Gasthuisberg in Leuven, Belgium. "Based on the clear positive outcome from this clinical study, the addition of Herceptin to chemotherapy offers a new important option for patients with HER2-positive stomach cancer as Herceptin extends survival and will bring this group of patients a significant benefit."

Stomach cancer is the second most common cause of cancer-related death in the world with over 900,000 new cases diagnosed each year. Early diagnosis is difficult because most patients do not show symptoms in the early stage. Advanced stomach cancer is associated with a poor prognosis, the average time patients survive after diagnosis is approximately 10 months with currently available therapies. Approximately 22% of stomach tumours overexpress HER2.

“Herceptin was a breakthrough treatment for patients with HER2-positive breast cancer and has become the foundation of care across all stages of HER2-positive breast cancer”, said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “The ToGA study shows for the first time that Herceptin extends the lives of patients in a cancer other than breast cancer. Advanced stomach cancer is a devastating disease for which there are currently few treatment options. Consequently, the targeted therapy Herceptin will become an integral part of treatment for this type of cancer.”

About the ToGA study
ToGA is the first randomised Phase III trial investigating the use of Herceptin in patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer. Approximately 3,800 patients were tested for HER2-positive tumours and 594 patients with HER2-positive disease were enrolled into the study. The rationale for conducting this trial was based on the knowledge that the targeted therapy Herceptin has demonstrated unprecedented efficacy in the treatment of HER2-positive breast cancer. In addition, the overexpression of HER2 was also observed in stomach cancer. A targeted anti-cancer therapy is a type of medication that blocks the growth of cancer cells by interfering with specific molecules which cause a tumor to grow.

In the ToGA study, patients were randomised to receive one of the following regimens as their first line of treatment:

  • A fluoropyrimidine (Xeloda or 5-FU) and cisplatin every 3 weeks for 6 cycles
  • Herceptin 6mg/kg every 3 weeks until progression in combination with a fluoropyrimidine and cisplatin for 6 cycles.
The primary objective of the study was to demonstrate superiority in overall survival of the Herceptin containing treatment arm compared to the chemotherapy alone arm. The pre-planned interim analysis was triggered by the occurrence of 347 events. Secondary endpoints for the study included progression-free survival, overall response rate, duration of response, safety and quality of life. In the ToGA study, no new or unexpected side effects were observed.

Source: Roche

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