Avastin (bevacizumab) now approved for use in combination with docetaxel for the first line treatment of metastatic breast cancer in the UK

More patients with metastatic breast cancer could benefit from Avastin (bevacizumab) as a result of a broader label announced by the European Commission that allows bevacizumab to be combined with either docetaxel or paclitaxel chemotherapy1. This is an important announcement, as although bevacizumab has been approved for use in the UK in combination with paclitaxel for the treatment of metastatic breast cancer since March 2007, a higher proportion of metastatic breast cancer patients in the UK are treated with docetaxel.

This new licence extension provides physicians who may have used docetaxel alone to treat their metastatic breast cancer patients with an additional treatment option - the data for which show that half of patients were alive without their disease progressing for at least 10 months when treated with bevacizumab plus docetaxel (compared to 8 months with docetaxel alone). Nearly two thirds of patients (64%) receiving bevacizumab-based therapy also experienced major shrinkage in their tumour2. These data re-enforce previous findings that show bevacizumab in addition to paclitaxel increased progression free survival to 11.3 months compared to 5.8 months with paclitaxel alone3.

'Bevacizumab is changing the way cancer is treated, and it has already demonstrated significant benefits across multiple tumour types including breast cancer,' said William M. Burns, CEO of Roche's Pharmaceuticals Division. 'This approval is positive news as more patients with advanced breast cancer could benefit from bevacizumab since physicians will now have more treatment options.'

Breast cancer is the most common cancer in the UK (excluding non-melanoma skin cancer) and the treatment aims for metastatic breast cancer are to control rather than cure the disease; prolong life, improve symptoms and maintain quality of life4. Despite earlier diagnosis and the treatment improvements that have already been made, there are still around 12,000 breast cancer deaths in the UK each year4.

Bevacizumab has a well-established tolerability profile and the most frequently observed drug reactions in clinical trials were hypertension, fatigue, neuropathy and proteinuria. Bevacizumab does not markedly increase chemotherapy-related toxicities, and the most common side effects are generally manageable.

AVADO (BO17708)2

AVADO is an international phase III trial where 736 patients who did not receive previous chemotherapy for their metastatic breast cancer were randomised to one of three treatment groups:

-Bevacizumab 15 mg/kg every 3 weeks in combination with docetaxel 100 mg/m2

-Bevacizumab 7.5 mg/kg every 3 weeks in combination with docetaxel 100 mg/m2

-Placebo in combination with docetaxel 100 mg/m2 as control arm

The primary objective of the study was to demonstrate superiority in progression free survival in one or both of bevacizumab containing treatment arms compared to the control arm. Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, 1-year survival, quality of life, safety and tolerability. Based on the updated analysis the combination of bevacizumab and docetaxel resulted in:

- Nearly two thirds of patients (64%) receiving bevacizumab based therapy experienced major shrinkage in their tumour.

- Half the patients were alive without their disease progressing for more than 10 months when treated with bevacizumab plus docetaxel compared to 8 months with docetaxel alone.

- In the 1-year survival analysis there were significantly more patients alive when treated with bevacizumab + docetaxel (84%) compared to docetaxel alone (76%).

- Overall survival data, reflecting ~ 45% of events, show no difference between the treatment arms.

- No new safety signals, confirming the safety and tolerability profile seen in previous studies. Furthermore, bevacizumab had only a limited impact on the known toxicity profile of docetaxel.

References

1. CHMP bevacizumab metastatic breast cancer positive opinion 29 July 2009

2. Roche Products Ltd, Data on File BO17708 001/09.

3. Cameron D. Bevacizumab in the first-line treatment of metastatic breast cancer. European journal of cancer, supplement, 2008, 6: 21-8

4. Cancer Research UK - Breast cancer - UK accessed on 29 July 2009

Source: Roche