New drug in development shows improved survival for patients with advanced metastat

January 12, 2017

TAMPA, Fla. - A new therapy in development for the treatment of midgut neuroendocrine tumors, a rare type of cancer that occurs in the small intestine and colon, shows improved progression-free survival and response rates for patients with advanced disease. Results of the international phase 3 clinical trial of lutetium-177 (177Lu)-Dotatate compared to high-dose octreotide LAR were published in the Jan. 12 issue of the New England Journal of Medicine.

"Patients diagnosed with midgut neuroendocrine tumors often have advanced disease that has spread to other sites. Treatment options are limited. 177Lu-Dotatate is an effective option to delay tumor progression for patients with this disease," says Jonathan R. Strosberg, head of the Neuroendocrine Tumor Program at Moffitt Cancer Center. "There is also preliminary evidence of survival benefit that requires confirmation on final survival analysis, expected in several years."

Standard treatment for midgut neuroendocrine tumors is hormonal therapy using a somatostatin analog that blocks the growth of tumor cells and reduces the production of hormones that cause symptoms such as flushing and diarrhea. If a patient's tumors progress on somatostatin analog therapy, there are currently not many other treatment options.

Moffitt is one of 41 cancer centers worldwide to investigate a novel therapy, 177Lu-Dotatate. The drug consists of a radioactive molecule attached to a somatostatin analog, allowing for radiation to be directly targeted to somatostatin receptor expressing tumors. Patients with metastatic or locally advanced midgut neuroendocrine tumors that had disease progression during prior treatment with octreotide, a somatostatin analog, were enrolled in the trial.

Trial results showed that patients who were treated with 177Lu-Dotatate and octreotide had better outcomes than patients who were treated with high-dose octreotide alone. The 20-month progression-free survival rate was 65.2 percent in the 177Lu-Dotatate group and 10.8 percent in the control group. 177Lu-Dotatate-treated patients had a 79 percent lower risk of disease progression or death than the control patients over the follow-up period. Additionally, more patients treated with 177Lu-Dotatate achieved a radiographic response than patients in the control group (18 percent versus 3 percent).

"This is notable given that response rates above 5 percent have not been observed in large randomized clinical trials of other systemic therapies in this patient population," said Dr. Strosberg. "The clinically meaningful and statistically significant improvement in progression-free survival and response rates achieved with treatment of 177Lu-Dotatate when compared to high dose octreotide supports its use in the treatment of neuroendocrine tumor patients. As a clinician treating many patients with this condition, these results bring hope for our ability to improve lives."

The trial data showed that 177Lu-Dotatate-treated patients experienced more adverse events than control patients (86 percent versus 31 percent), but the toxicities were manageable and reversible. The most common adverse events with 177Lu-Dotatate were nausea and vomiting, but this was attributed to amino acid infusions that were given to the patients to relieve potential kidney toxicity. Toxicities that occurred more in the 177Lu-Dotatate-treated patients included thrombocytopenia, anemia, lymphopenia, and leukopenia.
-end-
The clinical trial was supported by Advanced Accelerator Applications, developer of 177Lu-Dotatate. A New Drug Application for 177Lu-Dotatate is currently being reviewed by the U.S. Food and Drug Administration.

About Moffitt Cancer Center

Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 47 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt's excellence in research, clinical trials, prevention and cancer control. Moffitt is the No. 6 cancer hospital in the nation and has been listed in U.S. News & World Report as one of the "Best Hospitals" for cancer care since 1999. Moffitt devotes more than 2.5 million square feet to research and patient care. Moffitt's expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 5,200 team members, Moffitt has an economic impact in the state of $2.1 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter and YouTube.

H. Lee Moffitt Cancer Center & Research Institute

Related Cancer Articles from Brightsurf:

New blood cancer treatment works by selectively interfering with cancer cell signalling
University of Alberta scientists have identified the mechanism of action behind a new type of precision cancer drug for blood cancers that is set for human trials, according to research published in Nature Communications.

UCI researchers uncover cancer cell vulnerabilities; may lead to better cancer therapies
A new University of California, Irvine-led study reveals a protein responsible for genetic changes resulting in a variety of cancers, may also be the key to more effective, targeted cancer therapy.

Breast cancer treatment costs highest among young women with metastic cancer
In a fight for their lives, young women, age 18-44, spend double the amount of older women to survive metastatic breast cancer, according to a large statewide study by the University of North Carolina at Chapel Hill.

Cancer mortality continues steady decline, driven by progress against lung cancer
The cancer death rate declined by 29% from 1991 to 2017, including a 2.2% drop from 2016 to 2017, the largest single-year drop in cancer mortality ever reported.

Stress in cervical cancer patients associated with higher risk of cancer-specific mortality
Psychological stress was associated with a higher risk of cancer-specific mortality in women diagnosed with cervical cancer.

Cancer-sniffing dogs 97% accurate in identifying lung cancer, according to study in JAOA
The next step will be to further fractionate the samples based on chemical and physical properties, presenting them back to the dogs until the specific biomarkers for each cancer are identified.

Moffitt Cancer Center researchers identify one way T cell function may fail in cancer
Moffitt Cancer Center researchers have discovered a mechanism by which one type of immune cell, CD8+ T cells, can become dysfunctional, impeding its ability to seek and kill cancer cells.

More cancer survivors, fewer cancer specialists point to challenge in meeting care needs
An aging population, a growing number of cancer survivors, and a projected shortage of cancer care providers will result in a challenge in delivering the care for cancer survivors in the United States if systemic changes are not made.

New cancer vaccine platform a potential tool for efficacious targeted cancer therapy
Researchers at the University of Helsinki have discovered a solution in the form of a cancer vaccine platform for improving the efficacy of oncolytic viruses used in cancer treatment.

American Cancer Society outlines blueprint for cancer control in the 21st century
The American Cancer Society is outlining its vision for cancer control in the decades ahead in a series of articles that forms the basis of a national cancer control plan.

Read More: Cancer News and Cancer Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.