New Avastin(R) (bevacizumab) Data Confirm Overall Survival Of Beyond Two Years In Patients With Metastatic Bowel Cancer

Main Category: Cancer / Oncology
Also Included In: GastroIntestinal / Gastroenterology;  Colorectal Cancer
Article Date: 21 Jan 2010 - 1:00 PDT

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Welwyn Garden City, 21st January 2010. New data from two large studies presented at the ASCO GI* congress in Orlando, USA, shows rates of tumour shrinkage, and median overall survival beyond two years when bevacizumab is combined with the most common chemotherapy regimens.1,2 This new data further validates the access to bevacizumab as a standard of care for metastatic bowel cancer patients throughout most of Europe for the last five years. Unfortunately patients in the UK still do not have universal access to this potentially life extending treatment. NICE issued preliminary guidance at the end of November 2009 that would deny patients access to bevacizumab for the treatment of metastatic bowel cancer on the NHS, but a final decision is expected shortly following NICE's Committee meeting next week.

Three out of five patients experienced tumour shrinkage1

- In a large, prospective German observational study, which included 1,620 patients, the average rate of tumour shrinkage (response rate) was 60% for bevacizumab combined with chemotherapy.

Survival in excess of 2 years, consistent across different chemotherapy regimens1,2

- In the same German study, median overall survival exceeded 25 months. In the group of patients treated with oxaliplatin-based chemotherapy, the most commonly used chemotherapy in this setting, median overall survival was 27 months.1 Historically, median overall survival with chemotherapy alone does not exceed 20 months.3

- A similarly sized (1,658 patients) observational study carried out in the Czech Republic showed that elderly patients treated with bevacizumab combined with chemotherapy achieved similar results. Patients over the age of 65 years had a median survival time of 29.5 months. Patients under 65 years old had a similar median survival of 29.3 months.2

"Since its introduction 5 years ago Avastin has changed the way metastatic colorectal cancer is treated and has become a standard of care", said Niko Andre, Global Medical Director for Avastin. "These results confirm survival in routine practice can now exceed 2 years, which is great news for patients".

In both studies bevacizumab's established side effect profile was confirmed and no new safety signals were identified. Bevacizumab has a well-established tolerability profile and the most frequently observed adverse drug reactions in clinical trials were hypertension, fatigue, neuropathy and proteinuria. The most common side effects are generally manageable, for example, hypertension can generally be managed with conventional antihypertensive treatment.4,5

About the German study1

The German community-based study is a large prospective observational cohort study and included 1,620 eligible patients, between January 2005 and June 2008, with previously untreated metastatic colorectal cancer. Patients in the study received Avastin, every 2 weeks, with various standard first-line chemotherapy regimens, the choice of which was at the physicians' discretion. The majority of chemotherapy regimens selected were oxaliplatin or irinotecan based. Patients were observed for up to 4 years after the initiation of treatment. Pre-defined efficacy endpoints were; response rate, PFS, and overall survival. Adverse events were recorded and assessed as potentially related to treatment or as severe.

About the Czech study2

The Czech study included 1,658 patients with previously untreated metastatic colorectal cancer who received Avastin, every 2 or 3 weeks, in combination with various chemotherapy regimens between October 2005 and October 2009. The study aimed to determine possible differences in efficacy and safety of Avastin between the age groups of <65 years and >65 years. In the study one-quarter of enrolled patients were 65 years of age or older. Patients received Avastin combined with chemotherapy at the physicians' discretion. The most common chemotherapy partners for Avastin were XELOX, FOLFOX and FOLFIRI with oxaliplatin-based regimens being the most frequent with more than 60%.

* ASCO GI is The American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

References:

1. Arnold D et al. Bevacizumab plus chemotherapy as first-line treatment for patients with metastatic colorectal cancer: First results from a large community-based observational cohort study in Germany. Poster number 439 at ASCO GI 2010.

2. Kubala E et al. Safety and effectiveness of bevacizumab in combination with chemotherapy in patients with metastatic colorectal cancer in elderly population : updated results from a large Czech observational registry. Poster at ASCO GI 2010.

3. Hurwitz 2004. Bevacizumab plus irinotecan, flurouracil and leucovorin for metastatic colorectal cancer. NEJM 2004; 350

4. Saltz 2008. Bevacizumab in combination with oxaliplatin based chemotherapy as a first line therapy in metastatic colorectal cancer: A randomized phase III study. JCO 2008; 350

5. Bevacizumab's Summary of Product Characteristics (SmPC)

Source
Roche

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