Lots of interesting news out of San Antonio this week....
"New breast cancer drug heralded as breakthrough
It’s being called one of the most promising breast cancer therapies to enter the research pipeline in decades.
A new drug being tested by California scientists is showing a four-fold increase in tumor suppression times for women with advanced forms of the disease and has the potential to surpass the success of Herceptin in prolonging the lives of breast cancer patients.
“I’d say this is groundbreaking,” says Dr. Richard Finn, a UCLA scientist who presented preliminary findings on the compound at a meeting of the American Association for Cancer Research in San Antonio Wednesday.
“This magnitude of benefit really is not seen with many drugs in cancer medicine. There are not many drugs that have preformed that way in any disease,” Finn says.
The drug — known now by the prosaic, pre-commercial name of PD 0332991 — has yet to enter the large-scale, Phase 3 trials that could send it into wide-spread clinical use.
But its success in the just-completed Phase-2 research being reported rivals the results shown by the miracle drug Herceptin at a similar stage of testing two decades ago.
However the new drug — which pushed tumor suppression times up to an average 26.1 months from the 7.5 months seen by patients given a standard treatment — can benefit a far larger breast cancer population than Herceptin, Finn says.
The drug, which was given in conjunction with the staple medication letrozole, targets women with estrogen receptor positive (ER+) tumors, which account for some 50 to 60 per cent of all breast cancer patients.
Herceptin works on cancers known as human epidermal growth factor 2 positive (HER2 +) tumors, which account for just 20-25 per cent of all cases.
Earlier, Phase 1 trials of the new drug showed it was safe for human usage and caused few of the harsh side effects associated with many chemotherapies.
For the most recent trial, some 160 patients with incurable breast cancer were split into two equal groups, with both receiving letrozole but only one the new, pill-delivered compound.
In other findings reported Wedneday, the new drug also brought the number of patients responding positively to chemotherapy to 45 per cent — up from the 31 per cent in those who were given letrozole alone.
Some 70 per cent of those on the drug had tumor shrinkage for at least six months compared to 44 per cent on the standard medication.
Because Herceptin showed such clear and substantial benefits for patients enrolled in early Phase 3 studies, those trials were halted in the late 1990s and the drug was fasttracked to market.
Finn, who will help launch large scale trials early next year, hopes the new drug could follow a similar approval pathway.
“I think that’s always possible in clinical studies,” he says.
Finn says traditional ER positive chemotherapies like letrozole — marketed as Femara — work by blocking the receptor sites on cancer cells that allow hormones like estrogen to latch on and feed the tumor.
He says PD 0332991 may enhance the effectiveness of these hormone- blocking drugs by amplifying their ability to cover receptors or by blocking different kinds of receptor sites not targeted by the older compounds.
Dr. Jawaid Younus, a top Western University cancer specialist, called the new drug promising, but had the normal reservations that are raised about the size and composition of almost any Phase 2 trial.
“This is definitely exciting. . . . It is certainly promising,” said Younus, an oncologist at the London Ont. school.
“But I think it is too early because of the lack of information that we have with the limited number of patients in a Phase 2 trial. But . . . we look forward to the Phase 3 trial.”
Younus’s key concern was that the patients entered in the recent study were selected by specific cancer markers that may have maximized the drug’s benefits — benefits that might be diluted in a broader ER positive population.
“They were selecting a group that could have imparted a huge clinical benefit and could have moved the progression free survival from a reasonable difference to a significant difference,” he says.
“You don’t know if this humongous difference is going to be sustained.”
Still, Younus says, he’s eager to follow the upcoming Phase 3 trials and hopes that the new drug can add to the limited armament of medications that are currently available for ER positive patients.
Finn says the new drug may work in conjunction with other breast cancer drugs and could transform the ER positive form of the disease into a chronic, treatable condition.
“That’s our hope. When you see this kind of remarkable data in a randomized Phase 2 study, we hope that’s what’s going to happen in the future,” he says.
The drug was originally developed by the pharmaceutical giant Pfizer for potential use in some forms of blood cancers like Myeloma."
From: http://www.therecord.com/news/world/article/848744--new-breast-cancer-drug-heralded-as-breakthrough
Comments
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We are getting there
I believe we will see this beast beaten down! Thanks for the info.. much better hope than some crap that has been thrown around the board here lately! Praying no one fall for that foolish Sh&t and does not quit treatment! Thanks as always Cynthia.. you are such a great wealth of helpful information!
Sandy0 -
CC ...salls41 said:We are getting there
I believe we will see this beast beaten down! Thanks for the info.. much better hope than some crap that has been thrown around the board here lately! Praying no one fall for that foolish Sh&t and does not quit treatment! Thanks as always Cynthia.. you are such a great wealth of helpful information!
Sandy
Thank you for bringing this information forward - there is HOPE.
Strength, Courage and HOPE for a Cure.
Vicki Sam0 -
Wow--this is very encouragingVickiSam said:CC ...
Thank you for bringing this information forward - there is HOPE.
Strength, Courage and HOPE for a Cure.
Vicki Sam
I appreciate your bringing the info to us. Hope springs eternal. And, please, everyone--whenever anyone asks "what can I do for you?" please answer with, "Keep Funding the Research!!!"
Hugs, Renee0 -
I am very excited aboutmissrenee said:Wow--this is very encouraging
I appreciate your bringing the info to us. Hope springs eternal. And, please, everyone--whenever anyone asks "what can I do for you?" please answer with, "Keep Funding the Research!!!"
Hugs, Renee
I am very excited about this. It is a drug for advanced cancer and we really need more drugs in our toolbox for advanced disease. The drug is being trialed by Pfizer.0 -
Thanks Cynthia!CypressCynthia said:I am very excited about
I am very excited about this. It is a drug for advanced cancer and we really need more drugs in our toolbox for advanced disease. The drug is being trialed by Pfizer.
I live in San Antonio and my Oncologist, Dr. Amy Lang is always at these conferences. I think we are all so ready for these miracle drugs to surface and prove safe and effective.0 -
great newsCypressCynthia said:I am very excited about
I am very excited about this. It is a drug for advanced cancer and we really need more drugs in our toolbox for advanced disease. The drug is being trialed by Pfizer.
That is so good to hear Cynthia. There's a few at my chemo shop that need that.0 -
More New from the MBC Page, I receive as an emailCypressCynthia said:I am very excited about
I am very excited about this. It is a drug for advanced cancer and we really need more drugs in our toolbox for advanced disease. The drug is being trialed by Pfizer.
Shirley and I are here in San Antonio at SABCS (San Antonio Breast Cancer Symposium), a premier conference for oncologists and researchers from around the world with an attendance of about 7000 people.
AN INTERNATIONAL EXPERIENCE
It’s my first experience, but Shirley is a veteran and has been here six times. She was surprised and happy to see metastatic presentations throughout the four day conference. “Years ago” she said, “it seemed like metastatic was relegated to the last day.” We have met many people — researchers, oncologists, radiation oncologists and advocates–from the US and internationally– and have had some significant and interesting conversations. Getting a world perspective is particularly eye opening: A breast surgeon from Iran pointed out to me that metastatic breast cancer in Iran is not usually treated, since it is a terminal disease. In India, Her2 treatments are rare because of the costs. In Colombia and Brazil, breast cancer advocacy groups exist, but do not usually include metastatic. In many parts of the world, there is still a stigma associated with cancer and particularly breast cancer.
BONE MODIFYING AGENTS
Many of us with bone mets are familiar with bisphosphonate drugs like zometa and xgeva that strengthen bones and are usually taken every few weeks initially and then every couple of months after a year or two. I did attend a wonderful session on Bone Metastases and Bone Modifying Agents. Speaker Alison Stopeck MD from University of Arizona in Tucson offered arguments and evidence of the superiority of denosumab (xgeva) over zoledronic acid (zometa) in terms of longer time to a first SRE (skeletal related event) meaning a fracture; better control of pain and fewer side effects. So that is something I added to my list to discuss with my oncologist.
HER2: Perjeta and TDM-1
Last night was the most hopeful and exhilarating presentation–a panel of experts on Her2+ breast cancer. Among them were Dennis Slamon, MD from UCLA, the original researcher and 20 year crusader for herceptin research and Kimberly Blackwell, MD from Duke University, one of the researchers on TDM-1 . The panel of clinician/researchers were enthusiastic about the range of options now available for Her2+ metastatic disease and the excitement was contagious. Dr. Slamon spoke about the potential of HER2+ MBC becoming a chronic disease in the near future. Dr. Blackwell urged patients to rethink a “cure” for cancer, pointing out that in most fields of medicine, except for infectious diseases like pneumonia or smallpox or tuberculosis, diseases are managed and not cured. People are treated chronically in the US for cholesterol, hypertension, diabetes, arthritis, etc and hopefully HER2+ metastatic breast cancer will soon be included in this list.
ER+ NEWS
Using higher doses of fulvestrant (faslodex) provided longer overall survival without adding to toxicity for metastatic ER+ patients. Results were from the phase 3 CONFIRM trial, so check with your oncologist, if this applies to you.
NO METASTATIC BREAKTHROUGHS
There’s been no groundbreaking announcement or significant finding for metastatic disease, other than the HER2 advances, which were already known. We are expecting the announcement this evening on the final data for OS (overall survival) for perjeta and TDM-1 is expected to be approved in January or February by the FDA.
As someone living with Triple Negative Breast Cancer, I was hoping for more progress reported on novel treatments, but perhaps I’m a bit naive. There is a veritable alphabet soup of pathways and molecules being investigated. When I met Dr. Slamon last night I said, “I hope there is someone out there with your dedication and determination who is studying TNBC.”
“Oh, there is,” he said, “there definitely is.”
Ginny Knackmuhs, MBCN
http://mbcnbuzz.wordpress.com/2012/12/07/report-from-sabcs-from-a-patient-advocate/0 -
IranSIROD said:More New from the MBC Page, I receive as an email
Shirley and I are here in San Antonio at SABCS (San Antonio Breast Cancer Symposium), a premier conference for oncologists and researchers from around the world with an attendance of about 7000 people.
AN INTERNATIONAL EXPERIENCE
It’s my first experience, but Shirley is a veteran and has been here six times. She was surprised and happy to see metastatic presentations throughout the four day conference. “Years ago” she said, “it seemed like metastatic was relegated to the last day.” We have met many people — researchers, oncologists, radiation oncologists and advocates–from the US and internationally– and have had some significant and interesting conversations. Getting a world perspective is particularly eye opening: A breast surgeon from Iran pointed out to me that metastatic breast cancer in Iran is not usually treated, since it is a terminal disease. In India, Her2 treatments are rare because of the costs. In Colombia and Brazil, breast cancer advocacy groups exist, but do not usually include metastatic. In many parts of the world, there is still a stigma associated with cancer and particularly breast cancer.
BONE MODIFYING AGENTS
Many of us with bone mets are familiar with bisphosphonate drugs like zometa and xgeva that strengthen bones and are usually taken every few weeks initially and then every couple of months after a year or two. I did attend a wonderful session on Bone Metastases and Bone Modifying Agents. Speaker Alison Stopeck MD from University of Arizona in Tucson offered arguments and evidence of the superiority of denosumab (xgeva) over zoledronic acid (zometa) in terms of longer time to a first SRE (skeletal related event) meaning a fracture; better control of pain and fewer side effects. So that is something I added to my list to discuss with my oncologist.
HER2: Perjeta and TDM-1
Last night was the most hopeful and exhilarating presentation–a panel of experts on Her2+ breast cancer. Among them were Dennis Slamon, MD from UCLA, the original researcher and 20 year crusader for herceptin research and Kimberly Blackwell, MD from Duke University, one of the researchers on TDM-1 . The panel of clinician/researchers were enthusiastic about the range of options now available for Her2+ metastatic disease and the excitement was contagious. Dr. Slamon spoke about the potential of HER2+ MBC becoming a chronic disease in the near future. Dr. Blackwell urged patients to rethink a “cure” for cancer, pointing out that in most fields of medicine, except for infectious diseases like pneumonia or smallpox or tuberculosis, diseases are managed and not cured. People are treated chronically in the US for cholesterol, hypertension, diabetes, arthritis, etc and hopefully HER2+ metastatic breast cancer will soon be included in this list.
ER+ NEWS
Using higher doses of fulvestrant (faslodex) provided longer overall survival without adding to toxicity for metastatic ER+ patients. Results were from the phase 3 CONFIRM trial, so check with your oncologist, if this applies to you.
NO METASTATIC BREAKTHROUGHS
There’s been no groundbreaking announcement or significant finding for metastatic disease, other than the HER2 advances, which were already known. We are expecting the announcement this evening on the final data for OS (overall survival) for perjeta and TDM-1 is expected to be approved in January or February by the FDA.
As someone living with Triple Negative Breast Cancer, I was hoping for more progress reported on novel treatments, but perhaps I’m a bit naive. There is a veritable alphabet soup of pathways and molecules being investigated. When I met Dr. Slamon last night I said, “I hope there is someone out there with your dedication and determination who is studying TNBC.”
“Oh, there is,” he said, “there definitely is.”
Ginny Knackmuhs, MBCN
http://mbcnbuzz.wordpress.com/2012/12/07/report-from-sabcs-from-a-patient-advocate/
Getting a world perspective is particularly eye opening: A breast surgeon from Iran pointed out to me that metastatic breast cancer in Iran is not usually treated, since it is a terminal disease.
I was surprise at the comment on Iran. About 9 or 10 years ago, on my old support forum, we had a young man trying to understand MBC on behalf of his mother. She needed Herceptin but it wasn't available for them but other things were tried. His mother did receive treatment of some sort. She did eventually die but when I read this, I remembered him.
His English was not very good but was able to communicate and be understood by all of us on the forum. I wonder what happen in the 10 years that made them stop treating women with MBC. At the time, I felt bad for him not to be able to have all the information and the drugs that were available to us, here in the US, Canada and the western world.''
The statement really upset me. I hope that he is not entirely correct.
Doris0 -
Thank you CC I am alwaysSIROD said:Iran
Getting a world perspective is particularly eye opening: A breast surgeon from Iran pointed out to me that metastatic breast cancer in Iran is not usually treated, since it is a terminal disease.
I was surprise at the comment on Iran. About 9 or 10 years ago, on my old support forum, we had a young man trying to understand MBC on behalf of his mother. She needed Herceptin but it wasn't available for them but other things were tried. His mother did receive treatment of some sort. She did eventually die but when I read this, I remembered him.
His English was not very good but was able to communicate and be understood by all of us on the forum. I wonder what happen in the 10 years that made them stop treating women with MBC. At the time, I felt bad for him not to be able to have all the information and the drugs that were available to us, here in the US, Canada and the western world.''
The statement really upset me. I hope that he is not entirely correct.
Doris
Thank you CC I am always excited when you post. My doc also goes to SanAntonio. He lectures around the counry.
I would suspect metastatic is not treated becasue of cost. This is a scary reality that we dont always understand because we are fortunate in this country. In other countries if you are 55 you are considered too old for dalysis. Anyway this is digressing. Thanks CC0 -
Thank you CC I am alwaysSIROD said:Iran
Getting a world perspective is particularly eye opening: A breast surgeon from Iran pointed out to me that metastatic breast cancer in Iran is not usually treated, since it is a terminal disease.
I was surprise at the comment on Iran. About 9 or 10 years ago, on my old support forum, we had a young man trying to understand MBC on behalf of his mother. She needed Herceptin but it wasn't available for them but other things were tried. His mother did receive treatment of some sort. She did eventually die but when I read this, I remembered him.
His English was not very good but was able to communicate and be understood by all of us on the forum. I wonder what happen in the 10 years that made them stop treating women with MBC. At the time, I felt bad for him not to be able to have all the information and the drugs that were available to us, here in the US, Canada and the western world.''
The statement really upset me. I hope that he is not entirely correct.
Doris
Thank you CC I am always excited when you post. My doc also goes to SanAntonio. He lectures around the counry.
I would suspect metastatic is not treated becasue of cost. This is a scary reality that we dont always understand because we are fortunate in this country. In other countries if you are 55 you are considered too old for dalysis. Anyway this is digressing. Thanks CC0
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