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New data show that Avastin improves overall survival (OS) in women with high risk advanced ovarian cancer - the deadliest gynaecological cancer in the UK2 - offering hope for thousands of women diagnosed with the disease each year.3
Final data have been presented at the European Society of Gynaecological Oncology (ESGO) meeting in Liverpool from the international phase III ICON7 study, led by Leeds-based Dr Timothy Perren, which included 46 trial centres in the UK. The data demonstrate that when women at highest risk of their cancer recurring* received Avastin in combination with chemotherapy, and then continued maintenance Avastin, they lived on average 9.4 months longer than those who received chemotherapy alone (median OS 39.7 months vs. 30.3 months, HR= 0.78, p=0.03).1
Dr Timothy Perren, from Leeds Teaching Hospitals NHS Trust commented: "The improvements in overall survival for women with high risk advanced ovarian cancer treated with Avastin are a real breakthrough. We already knew Avastin delays the time to disease progression for women with this disease. We now know Avastin also significantly extends some patient's lives. Avastin is well tolerated and although treatment has to continue for a total of 12 months this is acceptable to most patients."
The licensed dose of Avastin is 15 mg/kg for up to 15 months following the positive GOG-0218 trial4 and these new data from ICON7 provide further supportive evidence. ICON7 recruited a broader group of patients than those covered in the licence as it included women at an earlier stage of their ovarian cancer in addition to those with advanced disease. The data demonstrate that Avastin did not improve survival for the whole population of patients recruited into the trial. The new overall survival data support the significant primary progression free survival endpoint of the study, which was presented at the European Society of Medical Oncology meeting in 20105 and the interim overall survival analysis that was presented at the American Society of Clinical Oncology meeting in 2011.6
These data are a significant development in advanced ovarian cancer, a field where, until the approval of Avastin in 2012, there had been limited progress with treatment options since the mid-1990s. Ovarian cancer is diagnosed in 7,000 UK women each year.3 It is known as the 'silent killer' due to poor recognition of symptoms delaying diagnosis. Sadly, 85% of cases are diagnosed when the disease has already spread beyond the ovaries.7
Avastin is the first drug that has been shown to improve outcomes for women with advanced ovarian cancer for the past 15 years,4,8 and can halt the progression of first-line disease for an average of an additional six months4,8 and an average of four months in platinum-sensitive recurrent** disease when used in combination with chemotherapy, compared to chemotherapy alone.9
Earlier this year, the National Institute for Health and Care Excellence (NICE) rejected Avastin for use in ovarian cancer. However, Avastin is available in England*** through the Cancer Drug Fund (CDF) for women with newly-diagnosed and recurrent advanced ovarian cancer, should their clinician feel it is a suitable treatment for them.10 The Prime Minister recently announced the temporary extension of the CDF for a further two years, which will benefit thousands of cancer patients.
Women in the UK suffer a disproportionate burden of ovarian cancer, with the UK experiencing one of the highest incidences in Europe, as well as one of the highest mortality rates from the disease.3 Ovarian cancer is the fourth highest cause of female cancer mortality (after lung, breast and colorectal cancer), and results in over 4,300 deaths among UK women each year.3
Avastin has a well-established tolerability profile in the treatment of cancer; the most frequently observed adverse drug reactions in clinical trials of Avastin were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.11 The most common side effects are generally manageable, for example, hypertension can usually be managed with conventional antihypertensive treatment.
*Stage 3 ovarian cancer patients with greater than 1cm visible residual tumour remaining after surgery, those with stage 4 disease, and those in whom surgery was not possible
**Platinum-sensitive ovarian cancer is disease that has responded to initial chemotherapy but demonstrates recurrence six months or more after the completion of treatment
***There is no CDF access for patients in Wales, Scotland and Northern Ireland
1 Pujade-Lauraine E et al. ICON7: Final overall survival results in the GCIG phase III randomised trial of bevacizumab in newly diagnosed ovarian cancer. ESGO 2013;PS11 (oral presentation)
2 Cancer Research. Key facts, Ovarian Cancer. Available at: UK http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/ovarian-cancer/ [Last accessed October 2013]
3 Ovarian Cancer Awareness Month Facts and Figures. Available at: http://www.ocam.org.uk/page.aspx?sitesectionid=26&sitesectiontitle=Facts+and+figures [Last accessed October 2013]
4 Burger RA et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. New England Journal of Medicine 2011; 365:2473-83
5 Perren, T. et al. ICON7, Abstract presented at ESMO 2010, Abstract LBA4
6 Kristensen, G et al. ICON7, Abstract presented at ASCO 2011, Abstract LBA5006 http://abstract.asco.org/AbstView_102_82361.html
7 Ovacome: Staging and Grades. Available at: http://www.ovacome.org.uk/about-ovarian-cancer/staging-and-grades.aspx [Last accessed October 2013]
8 Perren TJ et al. A phase 3 trial of bevacizumab in ovarian cancer. New England Journal of Medicine 2011; 365: 2484-96.
9 Aghajanian C et al. OCEANS: a randomised, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. Journal of Clinical Oncology 2012;30(17):2039-45.
10 NHS England. National Cancer Drugs Fund List. Available at: http://www.england.nhs.uk/wp-content/uploads/2013/05/ncdf-list.pdf [Last accessed October 2013]
11 Electronic Medicines Compendium. Avastin Summary of Product Characteristics. Available at: http://www.medicines.org.uk/ [Last accessed October 2013]
12 Data on file RXUKDONF00210.
13 European Medicines Agency. Avastin. Available at:http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000582/smops/Positive/human_smop_000367.jsp&mid=WC0b01ac058001d127. [Last accessed: October 2013]
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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5 Dec. 2013. <http://www.medicalnewstoday.com/releases/267819>
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