Avastin® (Bevacizumab) Stalls Most Common And Most Aggressive Brain Cancer For Over Four Months Longer Than Current Standard Of Care
Adding Avastin to the current standard of care for newly diagnosed aggressive brain cancer (glioblastoma multiforme, GBM) can significantly extend the time people live without their disease worsening, by 4.4 months (progression free survival of 10.6 months compared to 6.2 months with radiation and chemotherapy plus placebo, HR =0 .64, p<0.0001), reducing the risk of progression by 36%.1
Data from the phase III AVAglio trial, which evaluated Avastin in combination with standard treatment (radiation and a chemotherapy called temozolomide) was presented for the first time at the Society for Neuro-Oncology (SNO) Annual Meeting in Washington.1
The AVAglio study also demonstrated that the addition of Avastin to standard of care maintained a number of health-related quality of life measures for longer compared to standard treatment, including maintenance of functional independence. 1 In addition, those treated with Avastin required less corticosteroids than those treated with standard treatment.1 Because of the impact that the symptoms of GBM can have on patients, their family and caregivers, maintaining quality of life through symptom management is a critical goal in the treatment of the disease.
Kirsten Hopkins, consultant clinical oncologist and AVAglio study investigator at Bristol Haematology and Oncology Centre, one of eight trial centres in England, commented on the results, “Glioblastoma is a devastating and aggressive form of brain cancer. Symptoms, including those which affect speech, motor function and behaviour are distressing to patients and their families, and can negatively impact on quality of life. Furthermore, when the disease progresses, patients often rapidly get worse, so stalling the disease – effectively extending the time between first diagnosis and progression – is a key goal for oncologists to ensure patients maintain their best quality of life for as long as possible. There are currently very few treatment options for GBM, so it is exciting to see the potential that Avastin may bring in this setting.”
GBM is the most common, most aggressive form of malignant brain tumour2, representing over half of the 4,500 primary brain tumours diagnosed in the UK each year.3 With only limited treatment options, prognosis is extremely poor. The majority of patients do not survive for more than two years following diagnosis, and median survival is generally less than a year, 4 making the findings of AVAglio an important step forward in the treatment of patients with newly diagnosed GBM.
Avastin is not currently licenced for the treatment of newly diagnosed GBM. Based on the results of the AVAglio study, Roche will submit a licence application to the regulatory authorities. Full data for final overall survival (OS), the other co-primary endpoint of AVAglio, are expected in 2013.
Adverse events in AVAglio were generally manageable with no new safety findings being observed for Avastin.1 Avastin has a well-established tolerability profile; the most frequently observed adverse drug reactions in clinical trials for GBM were hypertension, fistulae, wound healing complications, proteinuria, arterial and venous thromboembolisms, haemorrhage and congestive heart failure. 1,5
About the AVAglio study
AVAglio is a phase III, randomised, double-blind, placebo controlled, multi-center trial that assessed the efficacy and safety profile of Avastin in combination with radiation and temozolomide chemotherapy following surgery or biopsy in patients with newly diagnosed glioblastoma multiforme (GBM). Patients were randomised to receive either:
Avastin plus radiation and temozolomide chemotherapy for six weeks followed by a four-week break. Patients then received Avastin and temozolomide for up to six cycles, followed by Avastin alone until disease progression, or
Radiation, temozolomide and placebo for six weeks followed by a four-week break. Patients then received temozolomide and placebo for up to six cycles, followed by placebo until disease progression.
The co-primary endpoints of the study were OS and PFS as assessed by trial investigators. Secondary endpoints included one- and two-year survival rates, PFS as assessed by an independent review committee, safety profile, and quality of life measures. A total of 921 patients were treated as part of the trial.
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.5 More than 1.3 million patients have been treated with Avastin so far. 6 Please refer to the Avastin Summary of Product Characteristics for full details, available at: http://www.emc.medicines.org.uk5
1 Chinot O et al. Phase III trial of bevacizumab added to standard radiotherapy and temozolomide for newly diagnosed glioblastoma: mature progression-free survival and preliminary overall survival results in AVAglio. Presented in Plenary Session 5 at the 17th Annual Meeting of the Society of Neuro-Oncology (SNO), Washington DC, USA. 17th November 2012
2 Bleeker et al. Recent advances in the molecular understanding of glioblastoma. J Neurooncol (2012) 108:11–27
3 NHS Choices: Malignant brain tumour (cancerous). Accessed via www.nhs.uk (Last accessed 1 November 2012).
4 Stupp R et al. N Engl J Med (2005) 352:987-96
5 Avastin Summary of Product Characteristics. Accessed via www.medicines.org.uk (Last accessed 1 November 2012).
6 Roche Data on file RXUKDONF00210
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