The global study successfully met its primary endpoint of demonstrating at least equivalent disease free survival. More remarkably, the study highlights that Xeloda reduces the risk of tumours coming back (relapse-free survival) by an impressive 14% compared to i.v. 5-FU/LV. This means that, each year, if treated with Xeloda, nearly 4,000 additional patients worldwide would not hear the dreaded words "Your cancer has come back."
"This data shows the significant potential of Xeloda to cure more patients with early stage colon cancer," said Professor Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, and University of Glasgow in Glasgow, Scotland, presenter of the X-ACT data at ASCO. He added, "The results of the trial further justify the ongoing and planned adjuvant studies of Xeloda in combination with other chemotherapies and targeted therapy such as Avastin."
Stefan Manth, Roche's Business Director in Oncology said, "The results of this trial offer new hope to patients and their families and represent a significant opportunity for Roche. We presently support studies of Xeloda on a global level enrolling over 6,000 patients per year which will further establish the importance of Xeloda in the fight against cancer."
In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide. It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease, and it is one of the most common cancers in developed countries1. Chemotherapy following surgery (adjuvant therapy) is one of the most common treatment approaches in patients diagnosed with the disease.
Roche in Oncology
Within the last five years the Roche Group has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit: Herceptin, MabThera, Xeloda and Avastin, which has been launched by Genentech in the US recently that treat a range of malignancies such as breast cancer, non-Hodgkin's lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). Roche¡¦s cancer medicines generated sales of more than 6 billion Swiss francs in 2003.
In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer.
Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.
Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).
All trademarks used or mentioned in this release are legally protected.
For further information and/or interview with a X-ACT principal investigator, please contact:
Roche
Martin McInally
Onsite contact number: 41-797-888-208
Office: 41-61-688-49-75
Martin.McInally@roche.com
Shire Health
Jonathan Kearney
Jonathan.kearney@shirehealthinternational.com
Naomi Mermod
Onsite contact number: 1-646-642-7075
Office: 1-212-725-7522
Naomi.mermod@shirehealthinternational.com
Reference
1 World Health Organisation. Globocan 2000: Cancer Incidence, Mortality and Prevalence Worldwide. 2000