Big promise is seen in 2 new breast cancer drugs
In this photo taken Sunday, Dec. 4, 2011, Rachel Midgett of Houston, Texas, foreground, stretches with Heather Keister of Lubbock, Texas before heading to the start line to run in the half marathon of the Las Vegas Marathon, in Las Vegas. Afflicted with breast cancer, Midgett has been taking the drug Afinitor for the last nine months and said that the cancer has not progressed in that time period, longer than other cancer drugs she has taken in the past. (AP Photo/Julie Jacobson)
(AP) -- Breast cancer experts are cheering what could be some of the biggest advances in more than a decade: two new medicines that significantly delay the time until women with very advanced cases get worse.
In a large international study, an experimental drug from Genentech called pertuzumab held cancer at bay for a median of 18 months when given with standard treatment, versus 12 months for others given only the usual treatment. It also strongly appears to be improving survival, and follow-up is continuing to see if it does.
"You don't see that very often. ... It's a spectacular result," said one study leader, Dr. Sandra Swain, medical director of Washington Hospital Center's cancer institute.
In a second study, another drug long used in organ transplants but not tried against breast cancer - everolimus, sold as Afinitor by Novartis AG - kept cancer in check for a median of 7 months in women whose disease was worsening despite treatment with hormone-blocking drugs. A comparison group that received only hormonal medicine had just a 3-month delay in disease progression.
Afinitor works in a novel way, seems "unusually effective" and sets a new standard of care, said Dr. Peter Ravdin, breast cancer chief at the UT Health Science Center in San Antonio. He has no role in the work or ties to drugmakers. Most patients have tumors like those in this study - their growth is fueled by estrogen.
Results were released Wednesday at the San Antonio Breast Cancer Symposium and some were published online by the New England Journal of Medicine. They come a few weeks after federal approval was revoked for another Genentech drug, Avastin, that did not meaningfully help breast cancer patients. It still is sold for other tumor types.
The new drugs are some of the first major developments since Herceptin came out in 1998. It has become standard treatment for a certain type of breast cancer.
"These are powerful advances ... an important step forward," said Dr. Harold Burstein, a breast expert at Dana-Farber Cancer Institute in Boston who had no role in the studies.
A reality check: The new drugs are likely to be very expensive - up to $10,000 a month - and so far have not proved to be cures. Doctors hope they might be when given to women with early-stage cancers when cure is possible, rather than the very advanced cases treated in these studies.
Even short of a cure, about 40,000 U.S. women each year have cancer that spreads beyond the breast, and treatment can make a big difference in their lives.
Rachel Midgett is an example. The 39-year-old Houston woman has breast cancer that spread to multiple parts of her liver, yet she ran a half-marathon in Las Vegas on Sunday. She has had three scans since starting on Afinitor nine months ago, and "every time, my liver lesions keep shrinking," she said.
"My quality of life has been wonderful. It's amazing. I have my hair. ... If you saw me you wouldn't even know I have cancer."
Genentech, part of the Switzerland-based Roche Group, applied Tuesday to the federal Food and Drug Administration for permission to sell pertuzumab (per-TOO-zoo-mab) as initial treatment for women like those in the study.
The drug targets cells that make too much of a protein called HER2 - about one of every four or five breast cancer cases. Herceptin attacks the same target but in a different way, and the two medicines complement each other.
The study tested the combination in 808 women from Europe, North and South America and Asia and found a 6-month advantage in how long the cancer stayed stable. All women also received a chemotherapy drug, docetaxel.
"That's a huge improvement" in such advanced cases, said study leader Dr. Jose Baselga, associate director of the Massachusetts General Hospital Cancer Center. He is a paid consultant for Roche.
So far, 165 deaths have occurred - 96 among the 406 women given Herceptin and chemo alone, and only 69 among the 402 women also given pertuzumab. Doctors won't know whether the drug affects survival until there are more deaths.
The most common side effects were diarrhea, rash and low white blood cell counts, which often occur with cancer treatment. The dual treatment did not cause more heart problems - an issue with other Herceptin combinations.
"We're really pleased that there were no new safety signals" and that pertuzumab is so promising, said Dr. Sandra Horning, Genentech's global development chief of cancer drugs.
Another study is testing pertuzumab in 3,800 women with early breast cancer. Genentech says it has not set a price for pertuzumab, but sells Herceptin for $4,500 a month to doctors, who mark it up and add fees to infuse it. Herceptin's U.S. patent expires in 2019, so combination treatment might be more affordable once generic Herceptin is available.
"Pertuzumab is a winner" and should win government approval, said Dr. Eric Winer of the Dana-Farber cancer center.
Dr. Gary Lyman, a treatment effectiveness researcher at Duke University, called the results "quite impressive," unlike what turned out to be the case for Avastin. He was on an FDA panel that recommended accelerated approval for Avastin as well as the recent panel that urged revoking its use for breast cancer because later studies did not bear out its early promise.
Winer and Lyman have no role in the new studies or financial ties to any drug companies.
The other study tested Novartis AG's Afinitor, which has long been sold for preventing organ rejection after transplants and to treat a few less common cancers including the type of pancreatic tumor that killed Apple founder Steve Jobs. It blocks one pathway cancer uses to spread. A one-month supply costs $11,000.
The 724 women in the study were worsening despite treatment with hormone-blocking medicines. They all were given one they had not taken before, and some also got Afinitor.
After about a year of follow-up, cancer progression was delayed 7 months in the group getting Afinitor and 3 months in the others.
"The two together have a much greater effect than you would expect from either alone," said study leader Dr. Gabriel Hortobagyi, breast cancer research chief at the University of Texas MD Anderson Cancer Center in Houston. "They snip two wires that are critical" for growth signals to continue, he said.
However, the combo led to more side effects - mouth sores, anemia, shortness of breath, high blood sugar, fatigue and lung inflammation.
"I have patients who tell me how long they live is not as important as the quality of the remainder of their life, where other patients will do just about anything and will tolerate any toxic levels or side effects," Hortobagyi said. "This is clearly one additional option for patients."
The cancer conference is sponsored by the American Association for Cancer Research, Baylor College of Medicine and the UT Health Science Center.
More information: Cancer conference: http://www.sabcs.org
©2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- Novel drug combo improves breast cancer survival Dec 11, 2009 | not rated yet | 0
- Dual HER2 blockade significantly extends progression-free survival Dec 08, 2011 | not rated yet | 0
- US revokes Roche's Avastin for breast cancer Nov 18, 2011 | not rated yet | 0
- Targeted agent addition to herceptin has positive effect on metastatic HER-2 breast cancer Jul 08, 2011 | not rated yet | 0
- Drug boosts survival when breast cancer spreads to brain Nov 30, 2011 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Why is zone 1 in liver more prone to ischemic injury?
May 23, 2013 Hi, Is it because around central vein, there is only deoxygenated blood from the vein where as in the periphery there is hepatic artery. Also why...
How can there be villous adenoma in colon, if there are no villi there
May 22, 2013 As title suggest. Thanks :smile:
How can there be a term called "intestinal metaplasia" of stomach
May 21, 2013 Hello everyone, Ok Stomach's normal epithelium is simple columnar, now in intestinal type of adenocarcinoma of stomach it undergoes "intestinal...
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
- More from Physics Forums - Medical Sciences
More news stories
In recent years, microRNAs (miRNAs) and other non-coding RNAs are small molecules that help control the expression of specific proteins. In recent years they have emerged as disease biomarkers. miRNA profiles have been used ...
Cancer May 24, 2013 | not rated yet | 0
Cancer cells spread and grow by avoiding detection and destruction by the immune system. Stimulation of the immune system can help to eliminate cancer cells; however, there are many factors that cause the immune system to ...
Cancer May 24, 2013 | 5 / 5 (1) | 0
Researchers from London's Kingston University have begun a two-year study which could help prolong the lives of people with colorectal tumours.
Cancer May 24, 2013 | 5 / 5 (1) | 0
Transformative research from Western University has identified new hormones in the body which may suppress breast cancer and stimulate the regression of breast tumors.
Cancer May 24, 2013 | 5 / 5 (2) | 0
(Medical Xpress)—Curtin University researchers have found evidence that targeting specific cells in the body can reverse the effects of cancer on the immune system.
Cancer May 24, 2013 | 5 / 5 (4) | 0
Coenzyme Q10 decreases all cause mortality by half, according to the results of a multicentre randomised double blind trial presented today at Heart Failure 2013 congress. It is the first drug to improve heart failure mortality ...
5 hours ago | 5 / 5 (1) | 4
Heart failure accelerates the aging process and brings on early andropausal syndrome (AS), according to research presented today at the Heart Failure Congress 2013. AS, also referred to as male 'menopause', was four times ...
5 hours ago | not rated yet | 1
Mortality and length of stay are highest in heart failure patients admitted in January, on Friday, and overnight, according to research presented today at the Heart Failure Congress 2013. The analysis of nearly 1 million ...
5 hours ago | not rated yet | 0
(AP)—Department of Justice lawyers have again asked a federal appeals court in New York to delay lifting age restrictions and prescription requirements on an emergency contraceptive popularly known as the morning-after ...
5 hours ago | not rated yet | 0
Two mutations central to the development of infantile myofibromatosis (IM)—a disorder characterized by multiple tumors involving the skin, bone, and soft tissue—may provide new therapeutic targets, according to researchers ...
21 hours ago | 3 / 5 (2) | 0 |
Talking on a hands-free device while behind the wheel can lead to a sharp increase in errors that could imperil other drivers on the road, according to new research from the University of Alberta.
21 hours ago | not rated yet | 0