Avastin Can Lengthen The Lives Of Advanced Cervical Cancer Patients

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Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Cancer / Oncology
Article Date: 03 Jun 2013 - 10:00 PDT Current ratings for:
Avastin Can Lengthen The Lives Of Advanced Cervical Cancer Patients

The addition of targeted therapy Avastin (bevacizumab) with chemotherapy can significantly lengthen the lives of women with advanced cervical cancer by close to 30%, according to research presented at the 2013 American Society of Clinical Oncology Congress.

The finding is an important discovery in the fight against cervical cancer - the most common cancer in women under the age of 35.

More than 3,000 women in the UK are diagnosed with cervical cancer annually, while 1,000 will die from it. Cervical cancer is normally treated with surgery, radiotherapy, and chemotherapy. If the cancer is detected early and treated promptly, the prognosis is generally good.

Screening and vaccination against the human papilloma virus is crucial in preventing cervical cancer altogether, as well as keeping it from reaching an advanced stage if it does develop. For those patients who are diagnosed at an advanced stage, it becomes harder to treat the disease.

The research presented from this study is known as GOG 240. GOG 240 is an independent, National Cancer Institute (NCI) -sponsored phase III trail examining the effectiveness and safety of Avastin with chemotherapy (paclitaxel and topotecan or cisplatin) to treat women with recurrent, persistent, or advanced cervical cancer (stage IVb), that was not cured by standard treatment methods.

The study consisted of 452 women in the U.S. and Spain who were randomly assigned to one of four treatment schedules: paclitaxel and cisplatinpaclitaxel, cisplatin and Avastin (15 mg/kg every three weeks)paclitaxel and topocetan paclitaxel, topotecan and AvastinThe research revealed that the women who underwent combination treatment with chemotherapy and Avastin lived almost 30% longer, and when compared to those who were just treated with chemotherapy alone: the median overall survival was of 17 months compared to 13.3 months, respectively.

Also, the percentage of patients who responded positively to therapy increased by a third from 36% to 48%. The participants who received bevacizumab had more side effects than those who did not, however, these side effects were consistent with those previously known to be linked to bevacizumab.

Professor Stan Kaye, Head of Clinical Studies at The Institute of Cancer Research, London, and Consultant Medical Oncologist in the Gynaecology Unit at The Royal Marsden Hospital, said:

"The improvements in overall survival achieved for women with advanced cervical cancer treated with Avastin are extremely encouraging. Thousands of women are diagnosed with cervical cancer every year in the UK and for those with recurrent disease there is a desperate need for more treatment options."

Bevacizumab has a well-confirmed tolerability profile with the most frequently seen adverse effects in clinical trials listed as: hypertensionpainproteinuria (abnormal amount of protein in the bloodneutropeniaThese side effects are generally easy to take care of. The study did not find any new adverse effects. Bevacizumab was also associated with higher rates of grade 3 bleeding, thrombosis embolism, and gastrointestinal fistula.

Robert Music, Director of Jo's Cervical Cancer Trust, said:

"For women who receive a late stage diagnosis of cervical cancer the prognosis can often be poor. The results of this research look promising and if this work can go some way in improving outcomes and overall survival rates in women with advanced cervical cancer then that is a positive step."

Bevacizumab is not currently licensed for the treatment of advanced cervical cancer.

Avastin is approved for four different types of cancers in the United States: mCRC (metastatic Colorectal Cancer), NSCLC (Non-Small Cell Lung Cancer), rGBM (recurrent Glioblastoma Multiforme) and RCC (Renal Cell Cancer).

In 2011, the FDA removed the approval of Avastin for the treatment of breast cancer. The regulating body explained that Avastin is not effective or safe for that type of cancer.

Written by Kelly Fitzgerald

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Avastin Update - November, 2012

Avastin Update - November, 2012 | Accelerate Brain Cancer Cure jQuery(document).ready(function(){ if(jQuery('#region-sidebar-first ul.menu li a.active')){ jQuery('#region-sidebar-first ul.menu li a.active').parent().append(''); } }); Skip to main content Accelerate Brain Cancer Cure

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Get InformedBrain Tumor FactsClinical TrialsNewsVideosSmarter ResearchWhat We FundHow We FundWho We FundScientific GatheringsGet InvolvedWays To GiveJoin An EventPersonal FundraisingAbout UsOur StoryOur TeamOur PartnersTHROUGH OUR EYES Avastin Update - November, 2012 Max Wallace, CEO of Accelerate Brain Cancer Cure, provides perspective on the latest Avastin trial results by Genentech. Article | November 25, 2012

Dear Friends,

I want to share with you the latest news on AvastinR (bevacizumab), a treatment for patients with glioblastoma, the most common and aggressive form of brain cancer.?

On November 17th, Genentech released the results of their Phase III clinical trial looking at the use of Avastin in newly diagnosed GBM patients.? This was the first time interim results for overall survival (OS) were provided. The study showed that Avastin, in combination with radiation and temozolomide chemotherapy, reduced the risk of cancer worsening or death (progression-free survival; PFS) by 36 percent compared to radiation and temozolomide plus placebo in people with newly diagnosed glioblastoma.? The interim results for overall survival, the other co-primary endpoint, did not reach statistical significance. The data were presented at the 17th Annual Meeting of the Society for Neuro-Oncology in Washington, D.C.

Click here for the Genentech press release.

From our perspective, the news on progression-free survival is positive.? While we would also have liked to see a corresponding increase in overall survival (OS), the interim data showed no such increase.? Final data on OS are expected in 2013. ?Avastin is currently being marketed under an accelerated approval by the FDA and Genentech/Roche will likely go back before the FDA with these data to get ongoing approval.? To the best of our knowledge, no date has yet been set for such an action.

A big medical story last year was the FDA’s revocation of the accelerated approval of Avastin for advanced breast cancer. There, the clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors (different than announced data on GBM), and the FDA felt that the data showed that the use of Avastin exposed patients to potentially serious side effects like severe high blood pressure and hemorrhaging.? That revocation decision by the FDA was quite controversial and there is an effort now underway to have Avastin re-approved for early stage breast cancer where the data is more convincing.?

In the case of GBM, we have talked with our scientific friends and advisors and they believe that Avastin is an important part of the current limited treatment mix available.? There is no other new GBM drug that has been able to show an improvement in overall survival and the physicians believe that in this environment a significant improvement in progression-free survival alone makes Avastin an important tool for them to be able to use in treating their patients.?? Also, there is some thinking that as Avastin is used in combination with a range of other treatments, we may see greater efficacy going forward.? For now, what we have is a drug that has shown significant improvement in progression free survival for GBM patients and that alone is a good and important start.

As developments unfold, I will continue to keep you updated on this important issue to our community.

Sincerely,

Max Wallace

Newsletter Issue:?November 2012 Share| More News April 2, 2013 10:00 AM White House Announces BRAIN Initiative The BRAIN Initiative Challenges Researchers to Unlock Mysteries of Human Mind. February 20, 2013 02:32 PM Improving The Lives Of Those Affected By Brain Tumors Ashley Varner guest blogs about her social work pilot study on the lived experience of family members who live with someone diagnosed with a primary malignant brain tumor. February 1, 2013 06:12 PM Low Grade Glioma Research Workshop In partnership with UCSF and MD Anderson, ABC2 brought together researchers from leading medical centers and biotech companies to strategize new therapeutic paths to treat Low Grade Gliomas. Join us in our fight for a cure! This form needs Javascript to display, which your browser doesn't support. Sign up here insteadTo sign up to receive our emails, fill in the following fields and hit submit. Thanks, and welcome!first namelast name* email* required ? Links HomeDonateGet InformedSmarter ResearchGet InvolvedAbout us Get Involved DonateWays to GiveJoin an EventPersonal Fundraising Twitter Connect With Us Contact UsGet in touch with usFacebookMeet new friends and join the discussion in FacebookTwitterTweet and follow us. News, press & infoRSS Feeds Subscribe to News Copyright 2011 ABC2 All Rights Reserved.Privacy Policy

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Avastin May Improve Breast Cancer Response Rates

Among women with HER2-negative breast cancer that has not spread to distant sites in the body, the addition of Avastin to neoadjuvant (before-surgery) chemotherapy may increase the likelihood of a complete response to treatment (a disappearance of detectable cancer). These results were published in the New England Journal of Medicine.

Avastin is a targeted therapy that blocks a protein known as VEGF. VEGF plays a key role in the development of new blood vessels. By blocking VEGF, Avastin deprives the cancer of nutrients and oxygen and inhibits its growth. Avastin is used in the treatment of several types of cancer, but its approval for breast cancer was revoked by the US Food and Drug Administration (FDA) in November, 2011.??

Avastin was originally for breast cancer in 2008 under the FDA’s accelerated approval program. The accelerated approval program provides earlier access to promising drugs for life-threatening health conditions while confirmatory studies are conducted. The approval was for use of Avastin in combination with chemotherapy for women with metastatic, HER2-negative breast cancer. The approval was based on the finding that Avastin delayed the progression (worsening) of metastatic breast cancer. There was no evidence that Avastin improved overall survival.??

After 2008, additional studies were reported to the FDA. These studies found that Avastin had only a small effect on rate of cancer progression and no effect on overall survival. The FDA concluded that the potential benefits of Avastin for breast cancer did not outweigh the risks, and revoked Avastin’s approval for breast cancer. Risks of Avastin include severe high blood pressure; bleeding problems; the development of perforations (holes) in the nose, stomach, and intestines; and heart attack or heart failure. It remains possible that Avastin will be found to benefit specific subgroups of breast cancer patients, and the FDA noted that it is open to considering data from additional studies that address this question.???

Results from Avastin clinical trials continue to be reported. Two of these were published in the New England Journal of Medicine and address the use of Avastin in women with earlier-stage (nonmetastatic), HER2-negative breast cancer.?

The first study—the Phase III GeparQuinto trial—enrolled 1,948 women with nonmetastatic, HER2-negative breast cancer.[1] Study participants received neoadjuvant treatment with chemotherapy alone or in combination with Avastin. The primary outcome of interest was a complete response, which was defined in this study as no detectable cancer in the breast or axillary (under-the-arm) lymph nodes.????

A complete response to treatment occurred in 14.9 percent of women treated with chemotherapy alone and 18.4 percent of women treated with chemotherapy plus Avastin.?The greatest benefit of Avastin was observed among women with triple-negative breast cancer (breast cancer that is HER2-negative, estrogen receptor-negative, and progesterone receptor-negative). Among these women, the complete response rates were 27.9 percent with chemotherapy alone and 39.3 percent with chemotherapy plus Avastin.?Serious side effects that were more common in the Avastin group included febrile neutropenia (low white-blood cell counts accompanied by fever), mouth sores, hand-foot syndrome, infection, and high blood pressure.?

The second study—the Phase III NSABP B-40 trial—involved 1,206 women with nonmetastatic, HER2-negative breast cancer.[2] Once again, study participants received neoadjuvant treatment with chemotherapy alone or in combination with Avastin. In this study, a complete response was defined as no detectable cancer in the breast; this is a less stringent definition than was used by the GeparQuinto study, which required no detectable cancer in the breast or axillary lymph nodes.????

A complete response to treatment occurred in 28.2 percent of women treated with chemotherapy alone and 34.5 percent of women treated with chemotherapy plus Avastin.?When a more stringent definition of complete response was used (similar to what was used in the GeparQuinto study), the difference between study groups was not statistically significant, suggesting that it could have occurred by chance alone.?The greatest benefit of Avastin was observed among women with estrogen receptor-positive cancer. This differs from what was found in the GeparQuinto study.?Side effects that were more common in the Avastin group included high blood pressure, heart problems, hand-foot syndrome, and mouth sores.?

These results suggest that the addition of Avastin to neoadjuvant chemotherapy may increase the likelihood of a complete response among women with nonmetastatic, HER2-negative breast cancer. Whether this will ultimately translate into improved survival, however, remains uncertain. Overall survival results are not yet available from these studies. The question of whether certain subgroups of patients are more likely to benefit from Avastin than others also remains unanswered, but research is ongoing. Outside of a clinical trial, Avastin should not be used in the preoperative setting; neither of these studies is practice-changing at this time.?

Posted January 30, 2012?

References:?
?[1] von Minckwitz G, Eidtmann H, Rezai M et al. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast cancer. New England Journal of Medicine. 2012;366:299-309.?

?[2] Bear HD, Tang G, Rastogi P et al. Bevacizumab added to neoadjuvant chemotherapy for breast cancer. New England Journal of Medicine. 2012;366:310-20.?

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