Posts Tagged ‘research’

FDA approves new game changing drug to fight melanoma

The drug, Keytruda (pembrolizumab), was tested on more than 600 patients who had melanoma that had spread throughout their bodies. Because so many of the patients in the early testing showed significant long-lasting responses, the study was continued and the FDA granted the drug “breakthrough therapy” status, allowing it to be fast-tracked for approval.

The largest Phase 1 study in the history of oncology, the research was conducted at UCLA and 11 other sites in the U.S., Europe and Australia.

Keytruda, formerly known as MK-3475, is an antibody that targets a protein called PD-1 that is expressed by immune cells. The protein puts the immune system’s brakes on, keeping its T cells from recognizing and attacking cancer cells, said Dr. Antoni Ribas, the study’s principal investigator and a professor of medicine in the division of hematology-oncology at the David Geffen School of Medicine at UCLA.

For many years, when using immunotherapy to fight cancer, doctors’ strategy has been to bolster the immune system so it could kill the cancer cells. But the approach had limited success because PD-1 prevented the immune system from becoming active enough to attack the cancer.

Keytruda, in effect, cuts the brake lines, freeing up the immune system to attack the cancer.

“This drug is a game changer, a very significant advance in the treatment of melanoma,” said Ribas, who also is a researcher at UCLA’s Jonsson Comprehensive Cancer Center. “For patients who have not responded to prior therapies, this drug now provides a very real chance to shrink their tumors and the hope of a lasting response to treatment.”

Judith Gasson, senior associate dean for research at the David Geffen School of Medicine at UCLA and director of the Jonsson Cancer Center, said researchers have long hoped to develop an effective and lasting immunotherapy to fight cancer.

“We have long believed that harnessing the power of our own immune systems would dramatically alter cancer treatment,” she said. “Based upon work conducted over the past two decades, we are beginning to see the clinical benefits of this research in some of the most challenging cancers.”

Generally, about 1 in 10 patients responded to previous immunotherapy drugs. Some of those who responded, however, exhibited long-lived benefits, which sustained scientists’ interest in the method as an effective mechanism to fight cancer.

The response and duration rates for Keytruda were much greater than for previous drugs, Ribas said. In the new study, 72 percent of patients responded to the drug, meaning that their tumors shrank to some degree. Overall, 34 percent of patients showed an objective response, meaning that their tumors shrank by more than 30 percent, and did not re-grow.

Ribas said Keytruda has the potential to be used to treat other cancers that the immune system can recognize, including cancers of the lung, bladder, head and neck.

Survivors’ stories Kathy Thomas, 59, of Torrance, California, was diagnosed in September 2011 with melanoma that had spread to her liver and was invading her left breast. She underwent several therapies that did not work, and she was weakening fast.

“I lost weight. I threw up nearly every day,” Thomas said. “My hair was thinning. I just had no strength at all. I was so sick I had to use a wheelchair.”

Thomas met with Ribas in 2012 but was skeptical about enrolling in a trial to test an experimental therapy. She soon overcame her hesitation.

“I decided I wanted to survive,” she said. “I wasn’t going to let this disease beat me.”

Since enrolling in the study, Thomas’ tumors have shrunk. She regained her strength and her appetite. She’s out of her wheelchair and walking normally again. She said she has experienced no side effects from the therapy, and she travels monthly to San Francisco to visit her grandson.

“I just enjoy life now, really enjoy it,” she said.

Watch Kathy Thomas discuss her therapeutic experience: http://youtu.be/BOgw7mgQEdc

Tom Stutz, 74, of Sherman Oaks, California, was diagnosed in June 2011 with melanoma that had spread to his lung, liver and other parts of his body. He didn’t see how he could survive, but he decided to enroll in the clinical trial of Keytruda anyway.

“I wasn’t eating. I was on oxygen. I couldn’t walk,” he said. “When I went into the hospital at the end of May [2012], I didn’t think I was coming out.”

Gradually, though, Stutz started feeling better. Today, he’s no longer on oxygen and walks several miles every day.

“It’s the little things that make me happy now,” Stutz said. “I’m very appreciative that I get to get up in the morning, go into my backyard and see my garden. I’m able to be with my children and grandchildren, go on vacations with them. I was close to the end of the road, as far as you can get to the edge of the cliff, and I was pulled back by this treatment.”

Watch Tom Stutz discuss his therapeutic experience: http://youtu.be/-HV2W5XrOZY

Melanoma incidence rates have been increasing for at least 30 years. An estimated 76,100 new cases of melanoma will be diagnosed in the U.S. in 2014, and nearly 10,000 Americans will die from the disease this year. While melanoma accounts for less than 2 percent of all skin cancer cases, it is responsible for the vast majority of skin cancer deaths, according to the American Cancer Society.

source : http://www.sciencedaily.com/releases/2014/09/140904183602.htm

No association found between wearing bra, breast cancer

“There have been some concerns that one of the reasons why breast cancer may be more common in developed countries compared with developing countries is differences in bra-wearing patterns,” said Lu Chen, MPH, a researcher in the Public Health Sciences Division at Fred Hutchinson Cancer Research Center and a doctoral student in the Department of Epidemiology at the University of Washington School of Public Health. “Given how common bra wearing is, we thought this was an important question to address.

“Our study found no evidence that wearing a bra increases a woman’s risk for breast cancer. The risk was similar no matter how many hours per day women wore a bra, whether they wore a bra with an underwire, or at what age they first began wearing a bra,” said Chen.

“There has been some suggestion in the lay media that bra wearing may be a risk factor for breast cancer. Some have hypothesized that drainage of waste products in and around the breast may be hampered by bra wearing. Given very limited biological evidence supporting such a link between bra wearing and breast cancer risk, our results were not surprising,” Chen added.

According to the study authors, this study characterizes various bra-wearing habits in relation to breast cancer risk using a rigorous epidemiological study design. “The findings provide reassurance to women that wearing a bra does not appear to increase the risk for the most common histological types of postmenopausal breast cancer,” the authors noted.

Study participants were 454 women with invasive ductal carcinoma (IDC) and 590 women with invasive lobular carcinoma (ILC), the two most common subtypes of breast cancer, from the Seattle-Puget Sound metropolitan area; 469 women who did not have breast cancer served as controls. All women were postmenopausal, ages 55 to 74.

The researchers conducted in-person interviews and obtained information on demographics, family history, and reproductive history. They also asked a series of structured questions to assess lifetime patterns of bra wearing. Questions included age at which the study participant started wearing a bra, whether she wore a bra with an underwire, her bra cup size and band size, the number of hours per day and number of days per week she wore a bra, and if her bra-wearing patterns ever changed at different times in her life.

No aspect of wearing a bra was associated with an increased risk for either IDC or ILC.

source : http://www.sciencedaily.com/releases/2014/09/140905090615.htm

Minimally invasive, high-performance intervention for staging lung cancer

Endoscopic biopsy of the lymph nodes is a minimally invasive, non-surgical intervention that has recently begun to be used to stage lung cancer. The study conducted by Dr. Liberman’s team involved 166 patients with confirmed or suspected non small cell lung cancer, and was designed to compare the new approach to surgical staging under general anesthesia, as prescribed in current guidelines for this type of cancer. The findings, which were recently published in CHEST Journal, the official publication of the American College of Chest Physicians, show that the endoscopy approach is not only sensitive and accurate, but also leads to improved staging compared to surgical staging due to its ability to biopsy lymph nodes and metastases not attainable with surgical techniques.

Research protocol

All patients underwent endobronchial ultrasound (EBUS), endoscopic ultrasound (EUS) and surgical mediastinal staging (SMS) during a single procedure. Each subject served as his or her own control. The results of the EBUS, EUS and combined EBUS/EUS were compared to SMS (gold standard) results and, in patients with negative lymph node staging, to lymph node sampling at pulmonary resection.

source : http://www.sciencedaily.com/releases/2014/09/140904141807.htm