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Elderly People With Advanced Bowel Cancer Do Just As Well As Younger People When Treated With Avastin® (Bevacizumab) With Chemotherapy

First randomized study prospectively evaluating Avastin in combination with chemotherapy specifically in with advanced shows it can significantly stall more than chemotherapy alone

Just a month after a leading charity warned that ageism in the NHS is stopping older getting better treatments1 and the Health Secretary pledged to improve for those over 70,2 new data shows that elderly people with advanced bowel cancer, a disease which disproportionally affects older people, can benefit from treatment to the same degree as younger patients as demonstrated in previous clinical trials.3,4,5

The results of the phase III AVEX trial, presented today at the Gastrointestinal Cancer Symposium in San Francisco, show that Avastin in combination with Xeloda® (capecitabine) can significantly extend the time people aged over 70 live without their previously untreated advanced bowel cancer worsening – by 4 months – compared to Xeloda alone (median progression free survival of 9.1 months compared to 5.1 months respectively, HR =0 .53, p<0.001), reducing the risk of progression by 47%.3 The new data also shows that older patients are able to tolerate Avastin as an initial treatment after diagnosis without experiencing any new side effects.

Median overall survival in those treated with Avastin and Xeloda was 20.7 compared with 16.8 months in those treated with Xeloda alone, although this difference was not statistically significant and not a primary endpoint of the trial.3

Professor David Cunningham, Consultant Medical Oncologist, Director of Clinical Research and Head of the Gastrointestinal Unit at The Royal Marsden NHS Foundation Trust, London, and primary study investigator in the AVEX trial, commented: “The results of the AVEX trial show that in patients over the age of 70 with advanced bowel cancer, chemotherapy with capecitabine and is a valuable treatment option which is well tolerated and can be administered as an outpatient. Improving outcomes in older patients with cancer is a high priority for clinicians and the AVEX trial provides solid evidence that such trials are feasible and impact on patient care.”

Avastin was generally well tolerated in the AVEX trial and the safety profile consistent with previously reported data for Avastin in combination with Xeloda.3,6 Avastin has a well-established tolerability profile and the most frequently observed adverse drug reactions in clinical trials for metastatic colorectal cancer were hypertension, fatigue, diarrhoea and proteinuria. The most common side effects are generally manageable, for example, hypertension can generally be managed with conventional antihypertensive treatment.6

The number of people diagnosed with colorectal cancer each day in the UK totals 115, and the disease is responsible for 16,000 deaths a year.7

About the AVEX trial

Patients ≥70 years with mCRC, for whom single-agent chemotherapy (i.e. Xeloda) was deemed appropriate, were randomized 1:1 to receive first-line Xeloda(1000 mg/m2 bid days 1-14) as monotherapy or in combination with Avastin (7.5 mg/kg every three weeks). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), overall response rate (ORR), and safety. The study was powered to show a difference in PFS, but not OS, between treatment arms. PFS and OS estimates were calculated using Kaplan-Meier methods. The study included 280 patients across 10 countries. Median age at enrollment was 76 years (range, 70-87), and 91.1% had an ECOG performance status of 0-1. Baseline patient and disease characteristics were well balanced between arms.

About Avastin

Avastin is approved in the EU for the treatment of the advanced stages of five common cancer types: colorectal cancer, breast cancer, lung cancer, kidney cancer and ovarian cancer.6 More than 1.3 million patients have been treated with Avastin so far.8 Please refer to the Avastin Summary of Product Characteristics for full details, available here. 6


1 Macmillan Cancer Support. Ageism in NHS stopping older cancer patients getting treatment. 20th December 2012. Accessible here (Last accessed 18th January 2013)

2 Daily Mail Online. Older cancer patients are being denied the best treatments due to age discrimination, warns charity. 20th December 2012. Accessible here (Last accessed 18th January 2013)

3 Cunningham, D et al. Bevacizumab in combination with capecitabine for the first-line treatment of elderly patients with metastatic colorectal cancer (mCRC): Results of a randomized international phase III trial (AVEX). Abstract presented at Gastrointestinal Cancer Symposium, San Francisco, 26 January 2013

4 Hurwitz H et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. New England Journal of Medicine 2004;350:2335-42

5 Saltz, L et al. Bevacizumab in Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study. Journal of Clinical Oncology 2008; 26(12):2013-2019

6 Avastin Summary of Product Characteristics. Accessed here.

7 Beating Bowel Cancer. Facts and Figures. (Last accessed 18th January 2013)

8 Roche Data on file RXUKDONF00210

Source: Roche