Navigation Links
Trial Therapy Improves Melanoma Survival

By Amanda Gardner
HealthDay Reporter

WEDNESDAY, Aug. 18 (HealthDay News) -- An experimental drug for metastatic melanoma prolonged median survival from 6.4 months to 10 months, which, although seemingly small, represents a significant extension of life for this normally intractable disease, a new study found.

And a subgroup of patients given the drug, known as ipilimumab, lived as long as six years, according to research published in the Aug. 19 issue of the New England Journal of Medicine.

This type of skin cancer has an average survival time of six to nine months.

"This is the first drug that's ever been shown in a randomized, controlled trial to offer a survival benefit for patients," said study lead author Dr. F. Stephen Hodi, director of the melanoma disease center at Dana Farber Cancer Institute in Boston.

The findings were first reported in June at the annual meeting of the American Society of Clinical Oncology in Chicago. The study was funded by Bristol-Myers Squibb and its biotechnology subsidiary Medarex, which makes ipilimumab.

Only two drugs have been approved by the U.S. Food and Drug Administration to treat melanoma that has spread beyond its original site: interleukin 2, or IL-2, and dacarbazine. IL-2 is a drug that affects the immune system while dacarbazine is a chemotherapy agent.

There have been no new FDA approvals of drugs for metastatic melanoma in more than a decade.

Ipilimumab is a human monoclonal antibody, which targets an antigen known as CTLA-4 that is found on the surface of T cells, which are blood cells that protect the body from infection.

CTLA-4 inhibits the immune system and "ipilimumab releases the brakes to the immune system," Hodi explained. That way, T cells are free to move throughout the body and attack the melanoma cells.

For this study, 676 patients with advanced melanoma were randomly chosen to receive either ipilimumab plus gp100 (an experimental vaccine that had previously shown some benefit in melanoma cases), ipilimumab alone, or gp100 alone. The study did not have a normal control group in which the survival of patients on ipilimumab was compared to the survival of patients on standard treatment.

Participants received a total of four infusions, at three-week intervals, a much shorter course of therapy than currently available, the study authors said.

"With melanoma there are few approved options for therapy and when we use agents like chemotherapy, people are on drugs forever and there's [only] a short-term benefit," explained Dr. Kari Kendra, a medical oncologist with the Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus. "With immune modulators like IL-2 or ipilimumab, there's a potential for durable responses."

There was essentially no difference in median survival between the groups taking ipilimumab with or without gp100: about 10 months. This compared with only 6.4 months for those taking gp100 alone, a 68 percent improvement.

"The gp100 vaccine didn't seem to add much to the treatment," Hodi said.

But receiving the IV infusion again if the melanoma looked like it was coming back also provided some benefit, Hodi said.

Fifteen percent of patients receiving ipilimumab experienced serious side effects, compared to only 3 percent receiving gp100 on its own. There were 14 deaths related to the drugs used in the study, and seven of the patients died from problems with their immune system, the researchers reported.

The researchers are now focusing their attention on the patients who survived sometimes as long as six years.

"We're looking at predictive biomarkers to see why some get a greater benefit than others," Hodi said.

Ipilimumab is not yet FDA-approved, so there's no price tag associated with it, although Kendra said she "would anticipate it being high."

More information

The Skin Cancer Foundation has more on melanoma.

SOURCES: F. Stephen Hodi, M.D., director, melanoma disease center, Dana Farber Cancer Institute, Boston; Kari Kendra, M.D., Ph.D., medical oncologist, the Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus; Aug. 19, 2010, New England Journal of Medicine

Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. CRF announces featured clinical trials to be presented at TCT 2010
2. Clinical trials: Comprehension unaffected by simplified consent forms or payment
3. Clinical trials abroad: Making non-English language consent forms readable
4. Human clinical trial of NIH-developed dengue vaccine begins
5. CRF announces late breaking trials and first report investigations to be presented at TCT 2010
6. Drug trials funded by industry are more likely to publish favorable results
7. Clinical trials can be improved by managing the learning curve
8. Sickle cell treatment developed at LA BioMed enters Phase 3 clinical trial
9. Microbicide trial results a turning point for HIV prevention, says team testing same gel
10. Many False-Positive HIV Test Results for Those in AIDS Vaccine Trials
11. BioSTARTM device achieves 90 percent closure rate for atrial septal defect in children
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health Partners, ... new Wimbledon Athletics Facebook page to educate the public, parents and ... abnormalities. About 2,000 people under the age of 25 die from sudden cardiac ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for the ... of the benefits of Botox® in the treatment of moderate facial wrinkling, few have ... pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism (the ...
(Date:11/25/2015)... ... 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical show, will ... Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this final production ... been a treasured tradition for numerous families in the Evanston community. Over the ...
(Date:11/25/2015)... D.C. (PRWEB) , ... November 25, 2015 , ... Today, ... fatalities on our nation’s roadways has dropped below 10,000 for the first time since ... 10,076 in 2013. , According to data released by the National Highway Traffic Safety ...
(Date:11/25/2015)... ... November 25, 2015 , ... "When I ... regular bras were incredibly uncomfortable," said an inventor from Bronx, N.Y. "In order ... developed the patent-pending RECOVERY BRA for added comfort and support. The bra is ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 --> ... combineert immunotherapie met Bremachlorin-photodynamische therapie voor de ... ) --> ... ) Uit een ... (LUMC) blijkt dat ...
(Date:11/26/2015)... , November 26, 2015 ... addition of the "2016 Future Horizons ... of Abuse Testing Market: Supplier Shares, Country ... report to their offering. --> ... the "2016 Future Horizons and Growth ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Therapeutic Drug Monitoring (TDM) Market: Supplier ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
Breaking Medicine Technology: