Big Promise In Two New Breast Cancer Drugs

[KDR]

http://abclocal.go.com/wabc/story?section=news/health&id=8459318'

As noted on Channel 7 (WABC), 12/7/11.

Best to all,
Karen

[Ellie F]

Hi Karen
The link says it's not available, is there any other way to get it?
Really wanted to read some good news.
Thanks
Ellie

[KDR]

Big promise is seen in 2 new breast cancer drugs



Updated at 08:42 AM today

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http://cdn.abclocal.go.com/static/art/global/icon_ap_byline.gif By MARILYNN MARCHIONE
SAN ANTONIO -- 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.

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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 They come a few weeks after federal approval was revoked for another Genentech drug, Avastin, that did not meaningfully help breast cancer patients.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.

(Copyright ©2011 by The Associated Press. All Rights Reserved.)

[Ellie F]

Thanks Karen
I really hope we soon get to the point where some of these new drugs will cure us. In the meantime living with less toxic treatments that enable a good quality of life is so important.
Hugs
Ellie

[ElaineM]

Thanks for sharing this. Petuzamab is a very promising
drug.

[KaiM]

Thanks for posting Karen! I hope pertuzumab comes available very soon, like now. I'm just starting my chemo and would have loved to include this drug in my treatment.

[KDR]

Hi, KaiM,
I have not "seen" you before! Welcome to our wonderful area of sharing, caring, befriending and support. Sorry you had to come,
Karen

[KaiM]

Thanks KDR! Yes, I'm new here having recently been dx after the birth of my 2nd child. So far I have found a wealth of information here and hope to find much support in the coming months/years. Thanks for the warm welcome.

[hutchibk]

I am in SA and will be heading over in 30 min to hear about all CLEOPATRA though the press releases are out and most everyone knows the up shot now! This is the pertuzamab trial that they hope the FDA will give them 6-12 months to approval once it is submitted (quickly!). I am very excited about pertuzamab... was speaking last night with the medical directors for it and the developing scientists ~ they are even more excited. It shuts down the Her 3 pathway to Her 2 in a way that hasn't been done before... I can't wait. For us stage IVers it's more good news to have in our pipeline. And it's the big news apparently out of SA. Yippee!

[Ellie F]

Thanks Brenda
Have a great time in SA, I hope we keep on getting more good news.
Love and thanks to you all for keeping us informed.

Ellie

[Mtngrl]

Yay!! So happy to see breakthroughs!!

[schoolteacher]

You are my hero, Brenda.
I am excitied about this drug also.

Amelia

[Mandamoo]

Don't forget Everolimus also - while he above study is in Her2 neg women the Bolero 1 and 3 trials are in her2 women. No results yet but my onc who is heading the trial at my centre says they are seeing great results so far too in her2 women but need more participants. I haven't seen anyone here on Bolero trials. I'm on Bolero 3 and currently stable. There are women at my centre who have been on it for more than 18months - some NED and others stable.

[Jackie07]

This article (with an abc news clip) has stories/names of some of the patients participating in the Bolero trials:

http://abcnews.go.com/Health/breast-cancer-drug-shows-higher-progression-free-survival/story?id=15104140&page=2

[katsc49]

Hi, everyone,
Merry Christmas.
Thanks for all the info concernibng the new drugs. I had to be taken off taxol because it caused neuropathy in my hands. I am now on xeloda just starting it this week. I will be on it 2 weeks on, one week off with Hercepton which I have been on for 5t years. My cancer is bc with mets to lung.
Have any of you been on xeloda. My onco scared me with it because I am also on coumadin and the xeloda will increase the effects of the coumadin which makes it a deadly combination.
Herception /taxol was he best combo concerning counts.
Hope each one has a wonderful, blessed Christmas.
kathy

[karen z]

Perhaps one of the most talked about studies at the San Antonio Breast Cancer Symposium (CLEOPATRA)- see complete article published on Dec. 7th, 2011 (link below). The HER2 gals got to hear the basics of this study the day before it was formally presented. The lead investigator indicated that the effects were the largest ever found in the history of bc research.

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1113216

[Mtngrl]

Let's hear it for exciting new drugs! We stage 4 folks especially like seeing new treatments in the pipeline!