Navigation Links
Everolimus prolongs progression-free survival for patients with neuroendocrine tumors
Date:11/29/2011

HOUSTON -- Combination treatment with everolimus, an inhibitor of the mammalian target rapamycin (mTOR), and octreotide has shown to improve progression-free survival for patients with advanced neuroendocrine tumors and a history of carcinoid syndrome, according to researchers at The University of Texas MD Anderson Cancer Center.

Results of the international, randomized, placebo-controlled Phase III study were published today in the journal Lancet.

The treatment combination of everolimus and octreotide long-acting repeatable (LAR), a somatostatin analogue that has shown antitumor activity, led to a clinically meaningful five-month delay in tumor growth, compared to octreotide alone.

Neuroendocrine tumors, also known as carcinoids, are uncommon tumors arising from various primary sites. Frequently, carcinoids spread to the liver, causing a variety of symptoms termed carcinoid syndrome.

"There are currently no Food and Drug Administration (FDA) approved drugs for oncologic control of most neuroendocrine tumors," said James C. Yao, M.D., associate professor in MD Anderson's Department of Gastrointestinal Medical Oncology. "This research offers a promising option where there were limited options previously."

Dangerous and rare tumors

According to Yao, the number of people diagnosed with neuroendocrine tumors has increased more than five-fold over the past 30 years, from one in 100,000 people per year to 5.25 in 100,000 people per year. Nearly half of patients have regional or distant metastatic disease and 65 percent of those with advanced disease die within five years of diagnosis.

Everolimus, an immunosupressant agent used to prevent rejection of organ transplants, inhibits the mTOR protein, a central regulator of tumor cell division and blood vessel growth in cancer cells. Overaction of mTOR has been implicated in the pathogenesis of neuroendocrine tumors.

Preclinical studies have shown that mTOR inhibition may control growth of neuroendocrine tumors, and an earlier Phase II study at MD Anderson showed promising anti-cancer activity for everolimus in neuroendocrine tumors.

In May of this year, an international randomized Phase III study showed everolimus improved progression-free survival in pancreatic neuroendocrine tumors, a related disease, leading to its FDA approval for treatment of those rare tumors.

Somatostatin analogues, such as octreotide, improve hormone-related symptoms associated with neuroendocrine tumors. Octreotide LAR has also shown antitumor activity, prolonging time to disease progression in patients with certain types of neuroendocrine tumors.

Increase in progression-free survival

The study, named RADIANT-2, enrolled 429 participants with low-grade or intermediate-grade advanced (unresectable locally advanced or distant metastatic) neuroendocrine tumors and a history of carcinoid syndrome. Disease progression had been established by radiological assessment within the past 12 months.

Patients were given either 10 mg per day oral everolimus or placebo, both in conjunction with 30 mg intramuscular octreotide LAR, every 28 days. Treatment was continued until disease progression, withdrawal from treatment because of adverse effects or withdrawal of consent.

Median progression-free survival by was 16.4 months in the everolimus plus octreotide LAR group and 11.2 months in the placebo plus octreotide LAR group.

Side effects were higher but manageable in the combination arm. They included stomatitis (62 percent vs. 14 percent), fatigue (31 percent vs. 23 percent) and diarrhea (27 percent vs. 16 percent).

Next steps

Yao said additional exploratory analyses to adjust for the effect of randomization imbalances will be presented at American Society of Clinical Oncology (ASCO) gastrointestinal annual meeting in 2012.

"We are working with industry sponsor [Novartis] to develop a confirmatory study in neuroendocrine tumors," he said.
'/>"/>

Contact: Laura Sussman
lsussman@mdanderson.org
713-792-0655
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert

Related medicine news :

1. An important reduction in risk of stent thrombosis with everolimus-eluting stent
2. Clinical outcomes in PCI patients given sirolimus-eluting and everolimus-eluting stents
3. Everolimus improves progression-free survival for patients with rare pancreatic cancer
4. Studies show everolimus-eluting stent implantation reduces restenosis and repeat revasculariztion
5. Phase III study shows everolimus delays tumor progression in hard-to-treat neuroendocrine tumors
6. Study finds everolimus-eluting stent safer, more effective than paclitaxel-eluting stent
7. How to recognize at an early stage whether a new cancer therapy prolongs life
8. Amrubicin improved response rate and progression-free survival vs. topotecan in Phase III trial
9. EURTAC Phase III study: Erlotinib nearly doubles progression-free survival vs. chemotherapy
10. Therapeutic melanoma vaccine improves response rate, progression-free survival
11. Adding topotecan to standard treatment for ovarian cancer does not improve progression-free survival
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... ... its strategic partnership with Connance, a healthcare industry leader providing predictive analytics ... proprietary technology combine to provide health systems, hospitals and ambulatory surgical centers ...
(Date:6/26/2016)... ... , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... a whole new perspective by using the title layers in ProSlice Levels to ... ProSlice Levels contains over 30 Different presets to choose from. FCPX users ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle Cell Observance ... and the benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, ... Disease. , Sickle Cell Disease (SCD) is a disorder of the red blood cells, ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Research and Markets has ... Market Analysis 2016 - Forecast to 2022" report to ... report contains up to date financial data derived from varied ... major trends with potential impact on the market during the ... segmentation which comprises of sub markets, regional and country level ...
(Date:6/23/2016)... WAYNE, Pa. , June 23, 2016 ... provider, will launch its next generation clinical outcomes platform, Bracket ... DIA Meeting held on June 26 – 30, 2016 in ... 6.0, the first electronic Clinical Outcome Assessment product of its ... DIA Booth #715. Bracket eCOA 6.0 is a ...
(Date:6/23/2016)... June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations ... Latin America . ... ... ... ...
Breaking Medicine Technology: