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New breakthrough for women with advanced cervical cancer, Avastin (bevacizumab) can extend lives

New data showing cancer treatment Avastin® (bevacizumab) can extend the lives of women with advanced compared to chemotherapy alone has been published in the New England Journal of Medicine. In the last decade the incidence of cervical cancer has risen by approximately 15% in the UK with 2,900 women diagnosed in 2010.2 Until now there have been limited clinical advances with patients only having a choice of traditional chemotherapies.

The data from a study known as GOG240 show that the addition of targeted therapy Avastin to chemotherapy (paclitaxel and topotecan or cisplatin) significantly extends the lives of women with advanced cervical cancer (stage IVB, recurrent or persistent cervical carcinoma) by nearly four months and almost 30% compared to chemotherapy alone (median overall survival of 17 months compared to 13.3 months, respectively; HR=0.71, p=0.0035).3

In addition, the percentage of patients who responded to therapy increased by a third from 36% to 48% (p= 0.0078) with the addition of Avastin compared to chemotherapy alone.3 Patients receiving Avastin experienced more side effects than those who did not, but they were consistent with those previously associated with Avastin and did not impair patients’ quality of life.1,4 Avastin is not currently licenced for the treatment of advanced cervical cancer.4

Dr Mary McCormack, Consultant Clinical Oncologist at University College London Hospitals NHS Foundation Trust said: “There is a desperate need for more treatment options for advanced cervical cancer, so it is very encouraging to see that Avastin given with chemotherapy extends survival by four months without compromising patients’ quality of life.”

Robert Music, Chief Executive of Jo’s Cervical Cancer Trust, said: “For women who receive a late stage diagnosis of cervical cancer the prognosis can often be poor. Any advances that can help improve outcomes and overall survival rates in women with advanced cervical cancer are welcome.”

GOG240 is an independent phase III trial sponsored by the US National Cancer Institute (NCI) and is the first study to show a targeted therapy significantly improves overall survival in gynaecological cancer.3 It was conducted by a network of researchers led by the US Gynecologic Oncology Group (GOG).3

Roche remains committed to improving outcomes for cancer sufferers and while GOG240 is not a Roche study we are working with regulatory authorities to seek a licence for Avastin in advanced cervical cancer.

Cervical cancer by numbers:2

  • Around 2,900 women in the UK were diagnosed with cervical cancer in 2010.
  • Approximately 1,000 women died from the disease in 2011.
  • Cervical cancer is the most common cancer in UK women aged 35 and under.

The New England Journal of Medicine also published data from two studies known as AVAglio and RTOG 0825 on the treatment of newly diagnosed aggressive brain cancer glioblastoma (GBM) with Avastin.5,6 There are limited treatment options for newly diagnosed GBM and prognosis is extremely poor.7 As previously reported, the AVAglio study investigators observed a statistically significant improvement in progression free survival (PFS),8 which is important for patients as it preserves neurological function and effectively extending the time between first diagnosis and progression is a key goal for oncologists. The latest results of the AVAglio study show a trend towards improved overall survival when Avastin is added to standard treatment (11% reduction in risk of dying) but this was not significant.5The results of the RTOG 0825 study showed an improvement in PFS from 7.3 to 10.7 months (HR=0.79, p=0.007), however this improvement did not reach the level of significance pre-specified in the study.9 Avastin is not licenced for newly diagnosed GBM.4

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.4 The most common side effects are generally manageable, for example, hypertension can usually be managed with conventional antihypertensive treatment.4

Source

1 Tewari KS et al. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med 2014 DOI: 10.1056/NEJMoa1309748

2 Cancer Research UK. Cervical Cancer Factsheet. January 2014. Available at: http://publications.cancerresearchuk.org/downloads/Product/CS_KF_CERVICAL.pdf (Last accessed February 2014)

3 Tewari KS et al. Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: A phase III randomized trial of the Gynecologic Oncology Group. Abstract #3. Plenary Session, Sunday June 2, N Hall B1, 2:50 PM – 3:05 PM

4 Electronic Medicines Compendium. Avastin Summary of Product Characteristics (Last accessed February 2014)

5 NEJM AVAglio data publication 2014

6 NEJM RTOG publication 2014

7 Stupp R et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med (2005) 352:987-96

8 Chinot O et al. Phase III trial of bevacizumab added to standard radiotherapy and temozolomide for newly diagnosed glioblastoma: final 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

9 Gilbert M R et al. RTOG 0825: Phase III double-blind placebo-controlled trial evaluating bevacizumab (Bev) in patients (Pts) with newly diagnosed glioblastoma (GBM). Presented at the American Society of Clinical Oncology Annual Meeting, Chicago, USA. J Clin Oncol 31, 2013 (suppl; abstr 1)

10 NHS Choices, Cervical Cancer – Treatment (Last accessed February 2014)

11 Jo’s Cervical Cancer Trust, Cervical Cancer (Last accessed February 2014)

12 Data on file RXUKDONF00210

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