Comparative Analysis Shows Chemotherapy Pill Xeloda Should Become Standard Of Care In Colon, Colorectal And Stomach Cancers

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 26 Jun 2008 - 3:00 PDT

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Results from a meta-analysis involving data from six phase III studies show that patients taking the chemotherapy pill Xeloda actually live longer than those receiving intravenous (IV) chemotherapy 5-FU/FA*. The pooled results showed that patients taking Xeloda survived for an average of 23.1 months while patients receiving the IV chemotherapy survived for an average of 22.5 months,. These findings reinforce extensive evidence that Xeloda either alone or in combination, is as effective as IV 5-FU/FA across different stages of colorectal cancer (CRC) and different gastrointestinal (GI) cancers, confirming that Xeloda should be used as the standard of care for all CRC patients.

"Time after time, Xeloda has proven to be effective at keeping patients with CRC, colon and stomach cancers alive, with the added benefit of being an oral treatment," said Professor Jim Cassidy, lead author of the study, Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland. "We should now accept Xeloda is as effective as infusional 5-FU and that Xeloda can be prescribed in any line and in any combination for the treatment of various GI cancers with added benefit that Xeloda allows patients to get on with their lives by reducing the time they spend in hospital for infusional therapy."

The meta-analysis evaluated data from six large randomised phase III studies involving 6171 patients including:

- 2 studies of Xeloda as a single agent in the first-line treatment of CRC that has spread to other parts of the body

- 2 studies of XELOX (Xeloda plus oxaliplaitin chemotherapy) in first and second-line treatment of CRC that has spread to other parts of the body

- 1 study of Xeloda as a single agent in treatment of colon cancer after-surgery

- 1 study of Xeloda in combination with another chemotherapy agent cisplatin in first-line treatment of stomach cancer

In all six of the studies patients taking the Xeloda tablets lived at least as long those receiving IV 5-FU/FA.

An update to one of the studies in the meta-analysis was also presented at the Congress. An additional pre-planned multivariate analysis of the X-ACT trial, looked at the effect of Xeloda on the survival of patients receiving the chemotherapy after surgery as treatment for colon cancer. Results showed that Xeloda chemotherapy is superior to IV 5-FU/FA in this setting. Data from the X-ACT trial is being presented at 15.20 on Saturday 28th June.

* FA: Folinic Acid

About the phase III meta-analysis

A meta-analysis of the efficacy of Xeloda versus that of IV 5-FU/FA was performed on the advice of European health authorities. The meta-analysis included 6171 patients (3074 treated with 5-FU-based regimens and 3097 treated with Xeloda) with colon, colorectal or gastric cancer from six large randomised phase III studies.

The unstratified meta-analysis demonstrated a median overall survival of 23.1 months (95% CI, 22.1-24.4) for the Xeloda based regimens versus 22.5 months (95% CI, 21.3-23.5) for 5-FU-based regimens (HR 0.96, 95% CI, 0.90-1.02). The same HR was observed in the stratified analysis.

About Xeloda (capecitabine)

Xeloda is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs. Xeloda uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells so avoiding damage to healthy cells. Xeloda tablets can be taken by patients in their own home, reducing the number of hospital visits.

Licensed in more than 100 countries worldwide, Xeloda has over ten years proven clinical experience providing an effective and flexible treatment option to over 1.5 million people with cancer. Xeloda is currently approved in:

-- Metastatic Colorectal Cancer

- Monotherapy 1st line (US & EU) - 2001
- In combination with any chemotherapy in all lines of treatment with or without Avastin (EU) - 2008

-- Metastatic Breast Cancer
- Monotherapy 1st line in patients with tumours resistant to other chemotherapy drugs such as paclitaxel and anthracyclines - (US) 1998 and (EU) 2002
- In combination with docetaxel in patients whose disease has progressed following iv chemotherapy with anthracyclines - (US) 2001 and (EU) 2002
- In patients with inoperable or recurrent breast cancer - (Japan) 2003

-- Adjuvant Colon Cancer

- Monotherapy (US & EU) - 2005
- Monotherapy (Japan) - 2007

-- Advanced Gastric Cancer

- 1st line treatment (South Korea) - 2002
- In combination with platinum-based chemotherapy 1st line (EU) - 2007

-- Metastatic Pancreatic Cancer

- In combination with gemcitabine 1st line (South Korea) - 2006

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics.

http://www.roche.com

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