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Last Updated: Nov 17th, 2006 - 22:35:04

Pharmacotherapy Channel
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Latest Research : Cancer : Therapy : Pharmacotherapy

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Capecitabine as a Convenient Oral Treatment for Colon Cancer Patients
May 23, 2005, 10:28, Reviewed by: Dr.

"Like many colon cancer patients I dreaded the idea of undergoing chemotherapy in hospital but my experience with Xeloda was very positive. It is an oral medication and I could take it at home. Xeloda gave me the freedom to continue working and maintain a normal life during this difficult time."

Data presented this week further strengthens the wealth of evidence showing that Xeloda(R) (capecitabine), an innovative oral chemotherapy, should replace the current standard treatment of intravenous 5-fluorouracil/leucovorin (i.v. 5-FU/LV) for colon cancer patients in the adjuvant (post-surgery) setting. In March 2005, Roche received approval from the European authorities for Xeloda to be used as a post-surgery treatment in colon cancer patients.

The data, in the adjuvant setting, presented at ASCO demonstrate that Xeloda provides a unique treatment option with unsurpassed benefits for colon cancer patients. Specifically it offers patients:

* Proven efficacy: confirmed to be at least as effective as standard chemotherapy

* A prolonged cancer-free life: relapse-free survival rates are significantly higher with Xeloda than with standard intravenous chemotherapy. There is a strong trend towards disease-free survival with Xeloda

* Tolerability: less serious and more manageable side effects reported with Xeloda than with standard chemotherapy

* Cost-effectiveness: on average, with Xeloda a patient only needs 8 hospital visits compared to 30 if treated with standard chemotherapy1

* Convenience: as Xeloda is a tablet, patients can take it in the comfort of their own home and not have to travel to cancer centres for treatment

"Being diagnosed with colon cancer is a traumatic, life-changing experience that you cannot prepare for," said Andy Griffin, a colon cancer patient based in the UK. "Like many colon cancer patients I dreaded the idea of undergoing chemotherapy in hospital but my experience with Xeloda was very positive. It is an oral medication and I could take it at home. Xeloda gave me the freedom to continue working and maintain a normal life during this difficult time."

"This new data confirming that Xeloda should replace standard 5FU/LV chemotherapy is exciting news for patients and their doctors alike," Professor Chris Twelves, University of Leeds and Tom Connors Cancer Research Centre, Bradford, UK. "It gives colon cancer patients the freedom to use an effective, tolerable, and convenient oral treatment that is as at least effective as traditional intravenous chemotherapy but has fewer side effects and avoids the burden of frequent and expensive hospital visits."

- These data were presented at various meetings at ASCO this month.


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Roche in Oncology:

The Roche Group, including its members Genentech in the United States and Chugai in Japan, is the world's leading provider of cancer care products, including anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products proven to provide survival benefit in different major tumour indications: Avastin, Herceptin, and Xeloda in advanced-stage breast cancer, Herceptin in early- stage HER2-positive breast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xeloda in colorectal cancer, Avastin and Tarceva in non-small cell lung cancer and Tarceva in pancreatic cancer.

In addition to these anti-cancer agents, the Roche oncology portfolio includes a comprehensive collection of medicines that can help improve the quality of life of cancer patients: Bondronat ( for prevention of skeletal events in patients with breast cancer and bone metastases, hypercalcaemia of malignancy ), Kytril ( for chemotherapy and radiotherapy-induced nausea and vomiting ), Neupogen ( for cancer-related neutropenia ), and NeoRecormon ( for anaemia in various cancer settings ). CERA is the most recent demonstration of Roche's commitment to anaemia management. Other oncology products include Furtulon ( for colorectal cancer ) and Roferon-A ( for hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma ). The Roche Group's cancer medicines generated sales of more than 7.7 billion Swiss francs in 2004.

In addition to the medicines, Roche is developing new diagnostic tests that 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, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.

The unmatched Roche oncology portfolio as well as an extensive external innovation base through collaborations with companies and academia is what makes it possible for Roche to provide more effective cancer therapies. In the United States Herceptin, MabThera ( Rituxan ), Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. ( MabThera ) and OSI ( Tarceva ). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.

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. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are legally protected. References:

1. McKendrick, J.J, Cassidy, J, et al. Capecitabine ( x ) is resource saving compared with i.v. bolus 5-FU/LV in adjuvant chemotherapy for Dukes' C colon cancer patients: Medical resource utilization ( MRU ) data from large phase III trial ( X-ACT ). Journ of Clin Oncol, 2004 ASCO Annual Meeting Proceedings ( Post Meeting Edition ). Vol 22, No 14S ( July supplement ), 2004: 3578
New Data Highlights Presented at ASCO ( May 13-17, 2005 )

Xeloda efficacy data

Updated efficacy findings from the X-ACT phase III trial of capecitabine ( X ) versus bolus 5-FU/LV as adjuvant therapy for patients with Dukes' C colon cancer ( C. Twelves, A. Wong, M.P. Nowacki, J. et al )
Abstract 3521 presented at ASCO 2005 ( 17/05/2005 08.00-12.15 hrs ).

An updated study of the landmark X-ACT trial, tracking data at 4.3 years ( 51 months ) and evaluating Xeloda versus 5-FU/LV as adjuvant treatment for colon cancer, demonstrated that:

* Xeloda was at least equivalent to 5-FU/LV in terms of disease-free survival but had a strong trend towards superior disease-free survival compared with 5-FU/LV ( HR=0.87 [95% CI, 0.75-1.00], p=0.0525 )

* Relapse-free survival was significantly superior for Xeloda compared to 5-FU/LV ( ITT: HR=0.86 [95% CI, 0.74-0.996], p=0.044 )

* Xeloda should replace 5-FU/LV for the treatment of patients with colon cancer after surgery

Analysis of post-study chemotherapy in patients enrolled in the X-ACT phase III trial of capecitabine vs. bolus 5-FU/LV as adjuvant therapy for Dukes' C colon cancer: no differences in treatment arms that could influence survival outcome ( J. Cassidy, A. Cervantes, P. Koralewski et al ) Abstract 3586 presented at ASCO 2005 ( 14/05/2005 14.00-18.00 hrs )

An analysis of post-study chemotherapy in the two treatment arms in the X-ACT trial, examining any differences that could influence survival outcome, demonstrated that:

* There are no differences in post-study chemotherapy that could influence survival outcome in patients who received either Xeloda of 5-FU/LV as adjuvant therapy on the X-ACT trial

Xeloda in combination ... safety data

Safety findings from a phase III trial of capecitabine plus oxaliplatin ( XELOX ) versus bolus 5-FU/LV as adjuvant therapy for patients with stage III colon cancer ( HJ Schmoll, J Tabernero, M Nowacki et al )
Abstract 3523, presented at ASCO 2005 ( 17/05/2005 08.00-12.15 hrs ).

* In the largest population of patients treated with XELOX ( Xeloda plus oxaliplatin ), early safety data indicate that it is well tolerated in comparison to monotherapy, furthermore, Xelox demonstrated a safety profile in line with the FOLFOX ( oxaliplatin + 5-FU/LV ) combination

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