Friday, June 18, 2010
Chemo Drug Jevtana Wins FDA Approval
Today's Wall St Journal reports that the new chemo drug Jevtana, manufactured by the French drug company Sanofi-Aventis has received FDA approval under its priority review program, 3 months ahead of schedule. Its safety & effectiveness were established in a single 755-patient study. The goal of the study was human survival time. Jevtana along with a steroid achieved a survival time of 15.1 months, compared with only 12.7 months achieved with chemo drug mitroxantrone plus the same steroid
Friday, June 4, 2010
NIH Supporters Also Support FDA
ANALYSIS AND COMMENTARY
NIH-oriented patient and research advocacy groups were key to the founding of the Alliance for a Stronger FDA and make up a third of the Alliance’s board. Our membership from this stakeholder group has grown over the last couple of years as more organizations recognize that “the very best NIH, even well-funded” is still limited in its impact unless new therapies are approved by FDA. An Alliance member asked us this week if we could send over a few talking points on the theme: NIH advocates need to be FDA advocates. Here is an edited version of what we provided.
Billions of dollars are spent on biomedical research at NIH and academic health centers and by biopharmaceutical and medical device companies. While much remains to be done, there have been some great successes and a lot of progress. Patients, clinicians and researchers need to be leaders in advocating for increased funding of NIH.
Through public and private funding, patient care has also come a long way as a result of advances in medical knowledge derived from research. The combination of centers of excellence and networks of community providers has advanced treatment to the point that most patients can expect to receive treatment based on the latest research and up-to-date protocols. Patients, clinicians and researchers have also been strong supporters of efforts to translate new knowledge into better care.
In between the promise of research and the benefits of improved care … lies the US Food and Drug Administration, which must consider and approve all new medical therapies that involve drugs, biologics and devices.
The patient and research advocacy community have a large stake in a strong, well-funded and effective FDA. Patients and family members want breakthroughs to move quickly to the clinic, so improved care is available sooner. They also want thorough reviews to assure that patients are not exposed needlessly to treatments that don’t work or are unsafe.
To accomplish this, FDA needs to be strengthened as an institution to assure that there are more scientists, statisticians and clinicians at the agency to review applications for new treatments. Otherwise the fruits of research may never make their way to patient bedsides.
Leading the charge for better FDA funding is the Alliance for a Stronger FDA, a broad coalition of consumers, patients and industry that has come together to advocate for more appropriated funds for the Agency. Increases in FDA’s budget would:
allow the FDA to provide faster and safer approval of products that are saving lives and transforming health care;
promote new drug technologies that will revolutionize pharmaceutical therapies
ensure continued U.S. leadership in drug innovation;
enhance the surveillance capability over new drugs once they reach the market; and
further integrate emerging science into the regulatory process.
All patients benefit when FDA has more resources.
Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.
NIH-oriented patient and research advocacy groups were key to the founding of the Alliance for a Stronger FDA and make up a third of the Alliance’s board. Our membership from this stakeholder group has grown over the last couple of years as more organizations recognize that “the very best NIH, even well-funded” is still limited in its impact unless new therapies are approved by FDA. An Alliance member asked us this week if we could send over a few talking points on the theme: NIH advocates need to be FDA advocates. Here is an edited version of what we provided.
Billions of dollars are spent on biomedical research at NIH and academic health centers and by biopharmaceutical and medical device companies. While much remains to be done, there have been some great successes and a lot of progress. Patients, clinicians and researchers need to be leaders in advocating for increased funding of NIH.
Through public and private funding, patient care has also come a long way as a result of advances in medical knowledge derived from research. The combination of centers of excellence and networks of community providers has advanced treatment to the point that most patients can expect to receive treatment based on the latest research and up-to-date protocols. Patients, clinicians and researchers have also been strong supporters of efforts to translate new knowledge into better care.
In between the promise of research and the benefits of improved care … lies the US Food and Drug Administration, which must consider and approve all new medical therapies that involve drugs, biologics and devices.
The patient and research advocacy community have a large stake in a strong, well-funded and effective FDA. Patients and family members want breakthroughs to move quickly to the clinic, so improved care is available sooner. They also want thorough reviews to assure that patients are not exposed needlessly to treatments that don’t work or are unsafe.
To accomplish this, FDA needs to be strengthened as an institution to assure that there are more scientists, statisticians and clinicians at the agency to review applications for new treatments. Otherwise the fruits of research may never make their way to patient bedsides.
Leading the charge for better FDA funding is the Alliance for a Stronger FDA, a broad coalition of consumers, patients and industry that has come together to advocate for more appropriated funds for the Agency. Increases in FDA’s budget would:
allow the FDA to provide faster and safer approval of products that are saving lives and transforming health care;
promote new drug technologies that will revolutionize pharmaceutical therapies
ensure continued U.S. leadership in drug innovation;
enhance the surveillance capability over new drugs once they reach the market; and
further integrate emerging science into the regulatory process.
All patients benefit when FDA has more resources.
Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.
Tuesday, June 1, 2010
Low Dose Nitroglycerin for Prostate Cacer
KINGSTON, ONTARIO -- (Marketwire) -- 02/04/10 -- Treatment of prostate cancer using a very low dose of nitroglycerin may slow and even halt the progression of the disease without the severe side effects of current treatments, Queen's University researchers have discovered.
The findings are the result of the first-ever clinical trial using nitroglycerin to treat prostate cancer.
The 24-month, Phase II study targeted 29 men with increasing levels of prostate-specific antigen (PSA) following prostate surgery or radiation. PSA levels are a key predictor of cancer progression.
"We were very excited to see a significant slowing in the progression of the disease as evidenced by the men's PSA levels, and to see this result in many of the men who completed the study," says Dr. Robert Siemens of Queen's Department of Urology, who led the study.
The researchers are encouraged by the results, particularly because safe and effective treatments for men with rising PSA levels following surgery or radiation are limited. They note that further testing needs to be done to confirm the results of this very small study.
The men were treated with a low-dose, slow-release nitroglycerin skin patch and their PSA levels monitored. Of the 17 patients who completed the study, all but one showed a stabilization or decrease in the rate of cancer progression, as measured by their PSA Doubling Time.
Nitroglycerin has been used at significantly higher doses for more than a century to treat angina. This trial was based on a key finding from pre-clinical research carried out at Queen's, which showed that decreases in nitric oxide play an important role in tumor progression and that this progression can be stopped by low-dose nitroglycerin.
Prostate cancer is diagnosed in approximately 235,000 men per year in the United States and 20,700 in Canada. Of patients who have undergone radical prostatectomy and/or radiation treatment, it is estimated that 30 to 50 percent will experience a recurrence of cancer.
Results of the study, conducted by Queen's University researchers Robert Siemens, Jeremy Heaton, Michael Adams, Jun Kawakami and Charles Graham, appeared in a recent issue of the journal Urology.
Research into the use of nitroglycerin and similar compounds for the treatment of cancer by Drs. Adams, Graham and Heaton has resulted in the issue of 10 patents worldwide. PARTEQ Innovations, the technology transfer office of Queen's, has licensed some of this intellectual property to Nometics Inc., a Queen's spinoff company, which is developing products and therapies based on this and related research.
"This peer-reviewed research is our first clear clinical evidence that low-dose nitric oxide therapy offers prostate cancer patients a new non-invasive treatment option," says Robert Bender, CEO of Nometics. "It is our intention to start broader clinical trials in 2010 to confirm and expand these results."
Contacts:
PARTEQ Innovations
John Molloy
The findings are the result of the first-ever clinical trial using nitroglycerin to treat prostate cancer.
The 24-month, Phase II study targeted 29 men with increasing levels of prostate-specific antigen (PSA) following prostate surgery or radiation. PSA levels are a key predictor of cancer progression.
"We were very excited to see a significant slowing in the progression of the disease as evidenced by the men's PSA levels, and to see this result in many of the men who completed the study," says Dr. Robert Siemens of Queen's Department of Urology, who led the study.
The researchers are encouraged by the results, particularly because safe and effective treatments for men with rising PSA levels following surgery or radiation are limited. They note that further testing needs to be done to confirm the results of this very small study.
The men were treated with a low-dose, slow-release nitroglycerin skin patch and their PSA levels monitored. Of the 17 patients who completed the study, all but one showed a stabilization or decrease in the rate of cancer progression, as measured by their PSA Doubling Time.
Nitroglycerin has been used at significantly higher doses for more than a century to treat angina. This trial was based on a key finding from pre-clinical research carried out at Queen's, which showed that decreases in nitric oxide play an important role in tumor progression and that this progression can be stopped by low-dose nitroglycerin.
Prostate cancer is diagnosed in approximately 235,000 men per year in the United States and 20,700 in Canada. Of patients who have undergone radical prostatectomy and/or radiation treatment, it is estimated that 30 to 50 percent will experience a recurrence of cancer.
Results of the study, conducted by Queen's University researchers Robert Siemens, Jeremy Heaton, Michael Adams, Jun Kawakami and Charles Graham, appeared in a recent issue of the journal Urology.
Research into the use of nitroglycerin and similar compounds for the treatment of cancer by Drs. Adams, Graham and Heaton has resulted in the issue of 10 patents worldwide. PARTEQ Innovations, the technology transfer office of Queen's, has licensed some of this intellectual property to Nometics Inc., a Queen's spinoff company, which is developing products and therapies based on this and related research.
"This peer-reviewed research is our first clear clinical evidence that low-dose nitric oxide therapy offers prostate cancer patients a new non-invasive treatment option," says Robert Bender, CEO of Nometics. "It is our intention to start broader clinical trials in 2010 to confirm and expand these results."
Contacts:
PARTEQ Innovations
John Molloy
Wednesday, May 26, 2010
Provenge Update
Thursday, April 29 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday granted approval to Provenge, a therapeutic vaccine aimed at preventing the spread of prostate cancer in men with an advanced form of the disease.
The new approval is limited to "the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment," the FDA said.
"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release.
Proveneg appears to extend survival in men with advanced prostate cancer, and it does so without the serious side effects associated with chemotherapy, radiation and hormone therapy.
The vaccine is not aimed at preventing prostate cancer in men who have not developed the disease, and it is far from a cure for those who have it, Lichtenfeld stressed. "Provenge represents a modest advance in survival for patients with advanced prostate cancer, but the drug doesn't delay the progression of the disease," he said.
The hope is if a vaccine is effective in late-stage disease that it is going to be even more effective in the earlier treatment of that same disease," he said.
It will only have a modest impact on prostate cancer survival, but it's small changes in treatments over time that add up to a major improvement. So I wouldn't be discouraged by what is a small increment in survival.
Provenge is a therapeutic (not preventative) vaccine that is made from the patient's own white blood cells. Once removed from the patient, the cells are treated with the drug and placed back into the patient. These treated cells then cause an immune response, which in turn kills cancer cells, while leaving normal cells unharmed.
According to the FDA, Provenge is given intravenously in a three-dose schedule delivered in two-week intervals.
The vaccine was developed by Seattle-based Dendreon Corp., which conducted initial studies among men with advanced prostate cancer who had already failed standard hormone treatment. Among these men, Provenge extended life by an average of 4.5 months, although some patients saw their lives extended by two to three years. The only side effects were mild flu-like symptoms, according to the study results.
The FDA noted that in one study, men taking Provenge had a slightly higher risk for cerebrovascular events, such as stroke, with 3.5 percent of those taking Provenge suffering such events versus 2.6 percent of those who did not take the drug.
Dr. Mark Soloway, professor and chair of urology at the University of Miami Miller School of Medicine, said that "we certainly need the opportunity for our patients to have alternatives. The big question, according to Soloway, is when do you use Provenge? Whether it should be used before chemotherapy or hormone therapy isn't clear,
"There are problems with Provenge," Soloway said. "One is that it's very cumbersome, because patients have to provide their white cells, and I think that's on a regular basis. And two, it's likely to be very expensive." Costs are expected to total $75,000 for the full regimen, experts say.
Soloway agreed that Provenge might also be useful in earlier-stage prostate cancer, but studies are needed to prove that.
However, "once it's approved, it's on the market, and with proper informed consent you can use it for localized [early stage] prostate cancer. Whether insurance companies will pay for it is also not known," Soloway said.
Other new drugs to treat prostate cancer, such as Abiraterone, which prevents the production of the male hormone testosterone, are on the horizon and will compete with Provenge for new treatment regimens, he added.
According to American Cancer Society estimates, more than 192,000 new cases of prostate cancer are diagnosed in the United States each year, and 27,360 men die from the disease.
Prostate cancer is the most common form of cancer diagnosed in American men, after skin cancer. More than 2 million American men who have had prostate cancer at some point are still alive today. The death rate is going down, and the disease is being found earlier, according to the cancer society.
Copyright © 2010 ScoutNews, LLC. All rights reserved.
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State of the Science Report
Discovery & Challenge: The State of Prostate Cancer Research
PCF Guides
Report to the Nation on Prostate Cancer: A Guide for Men and Their Families
Nutrition, Exercise and Prostate Cancer
More
DR. GERHARDT ATTARD ON ABIRATERONE
WATCH THIS
PCF-funded researcher discusses Abiraterone, a drug currently in trials for use in advanced prostate. Watch this.
© 2010 prostate cancer foundation
Media Center | Terms of Use | Privacy Policy | Site Map |
The new approval is limited to "the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment," the FDA said.
"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release.
Proveneg appears to extend survival in men with advanced prostate cancer, and it does so without the serious side effects associated with chemotherapy, radiation and hormone therapy.
The vaccine is not aimed at preventing prostate cancer in men who have not developed the disease, and it is far from a cure for those who have it, Lichtenfeld stressed. "Provenge represents a modest advance in survival for patients with advanced prostate cancer, but the drug doesn't delay the progression of the disease," he said.
The hope is if a vaccine is effective in late-stage disease that it is going to be even more effective in the earlier treatment of that same disease," he said.
It will only have a modest impact on prostate cancer survival, but it's small changes in treatments over time that add up to a major improvement. So I wouldn't be discouraged by what is a small increment in survival.
Provenge is a therapeutic (not preventative) vaccine that is made from the patient's own white blood cells. Once removed from the patient, the cells are treated with the drug and placed back into the patient. These treated cells then cause an immune response, which in turn kills cancer cells, while leaving normal cells unharmed.
According to the FDA, Provenge is given intravenously in a three-dose schedule delivered in two-week intervals.
The vaccine was developed by Seattle-based Dendreon Corp., which conducted initial studies among men with advanced prostate cancer who had already failed standard hormone treatment. Among these men, Provenge extended life by an average of 4.5 months, although some patients saw their lives extended by two to three years. The only side effects were mild flu-like symptoms, according to the study results.
The FDA noted that in one study, men taking Provenge had a slightly higher risk for cerebrovascular events, such as stroke, with 3.5 percent of those taking Provenge suffering such events versus 2.6 percent of those who did not take the drug.
Dr. Mark Soloway, professor and chair of urology at the University of Miami Miller School of Medicine, said that "we certainly need the opportunity for our patients to have alternatives. The big question, according to Soloway, is when do you use Provenge? Whether it should be used before chemotherapy or hormone therapy isn't clear,
"There are problems with Provenge," Soloway said. "One is that it's very cumbersome, because patients have to provide their white cells, and I think that's on a regular basis. And two, it's likely to be very expensive." Costs are expected to total $75,000 for the full regimen, experts say.
Soloway agreed that Provenge might also be useful in earlier-stage prostate cancer, but studies are needed to prove that.
However, "once it's approved, it's on the market, and with proper informed consent you can use it for localized [early stage] prostate cancer. Whether insurance companies will pay for it is also not known," Soloway said.
Other new drugs to treat prostate cancer, such as Abiraterone, which prevents the production of the male hormone testosterone, are on the horizon and will compete with Provenge for new treatment regimens, he added.
According to American Cancer Society estimates, more than 192,000 new cases of prostate cancer are diagnosed in the United States each year, and 27,360 men die from the disease.
Prostate cancer is the most common form of cancer diagnosed in American men, after skin cancer. More than 2 million American men who have had prostate cancer at some point are still alive today. The death rate is going down, and the disease is being found earlier, according to the cancer society.
Copyright © 2010 ScoutNews, LLC. All rights reserved.
Print |
Donate >Help PCF fund research to find better treatments and a cure.
Get Involved >Discover other ways you can help make a difference.
Stay InformedSign up to receive our monthly newsletters.
Enter Email Address Go
State of the Science Report
Discovery & Challenge: The State of Prostate Cancer Research
PCF Guides
Report to the Nation on Prostate Cancer: A Guide for Men and Their Families
Nutrition, Exercise and Prostate Cancer
More
DR. GERHARDT ATTARD ON ABIRATERONE
WATCH THIS
PCF-funded researcher discusses Abiraterone, a drug currently in trials for use in advanced prostate. Watch this.
© 2010 prostate cancer foundation
Media Center | Terms of Use | Privacy Policy | Site Map |
PCF Report on Gene Fusion as Cause of PCa
"Our study shows the underlying problem in prostate cancer is the presence of a gene fusion, not the androgen receptor," Chinnaiyan said in the news release. "In many contexts, androgen signaling is actually a good thing, but the presence of the gene fusion blocks androgen receptor signaling, which alters normal prostate cell development. While current treatments for advanced prostate cancer are focused on hormone deprivation and are quite effective, at least initially, future therapies need to be developed that target the prostate cancer gene fusion."
By using high-tech genetic mapping techniques, the research team found that once fusion takes place, androgen receptors get blocked, in turn cutting off normal prostate cell growth while permitting cancer to spread.
Back to Research
By using high-tech genetic mapping techniques, the research team found that once fusion takes place, androgen receptors get blocked, in turn cutting off normal prostate cell growth while permitting cancer to spread.
Back to Research
Wednesday, May 19, 2010
Dr Walsh on Selecting a Surgeon for Your PCa
Johns Hopkins Health Alert
Advice From Dr. Walsh on Finding the Right Prostate Cancer Surgeon
Comments (1)
Dr. Patrick Walsh, former director of Johns Hopkins’s Brady Urological Institute, shares his insights on choosing a doctor for your cancer surgery.
Dr. Patrick Walsh, dean of prostate cancer surgeons, has performed the technically challenging radical prostatectomy procedure thousands of times, and has personally schooled hundreds of surgeons in the finer points of the difficult nerve-sparing cancer operation. He certainly knows what it takes to be an expert in curing a man of cancer, preserving bladder function, and maintaining the nerves responsible for erections. What about the doctor you’re considering for your own prostate cancer surgery?
“Your doctor may be nice and personable,” says Dr. Walsh, “a practitioner whose empathy for your condition appeals to you, which is great. But what do you know about him? He’s got a terrific bedside manner, but is he a board-certified urologist? What training has he had? Does he know and use the nerve-sparing cancer surgery techniques -- the anatomical approach to radical prostatectomy? How many of these cancer surgeries does he perform annually? What success has he had in preserving potency and continence? If he can’t or won’t give you his rate of success as compared to reports from other surgeons, or to results published in medical journals, this may be a red flag, and perhaps you should look elsewhere for your cancer surgeon.
“You should be able to get a good idea of his success rate in numbers or percentages. In addition, if he hasn’t done very many of these cancer operations -- ideally, hundreds -- you might want to find a more experienced surgeon. Look at it this way: Do you want to be one of the patients he’s learning on? Do you want to be part of someone’s learning curve?
“Remember: You don’t want a surgeon who’s ‘pretty good’ at removing the prostate. There are no second chances here: This is a one-shot operation. You are looking for the one surgeon who will perform the one radical prostatectomy you will ever receive in your life, the one operation that will cure your cancer.
“You want a surgeon who is going to make sure that no cancer is left behind, and who knows how to minimize trauma to your body during surgery so you don’t wind up with incontinence, erectile dysfunction, or both.
“Finding the right surgeon may mean that you must travel to a major medical center in another city. This may mean that you’ll be away from home for four days. But after that, even though you may need to wear a catheter for a week or two, the recovery from the operation is usually speedy, and follow- up communication can be carried out over the telephone.
Advice From Dr. Walsh on Finding the Right Prostate Cancer Surgeon
Comments (1)
Dr. Patrick Walsh, former director of Johns Hopkins’s Brady Urological Institute, shares his insights on choosing a doctor for your cancer surgery.
Dr. Patrick Walsh, dean of prostate cancer surgeons, has performed the technically challenging radical prostatectomy procedure thousands of times, and has personally schooled hundreds of surgeons in the finer points of the difficult nerve-sparing cancer operation. He certainly knows what it takes to be an expert in curing a man of cancer, preserving bladder function, and maintaining the nerves responsible for erections. What about the doctor you’re considering for your own prostate cancer surgery?
“Your doctor may be nice and personable,” says Dr. Walsh, “a practitioner whose empathy for your condition appeals to you, which is great. But what do you know about him? He’s got a terrific bedside manner, but is he a board-certified urologist? What training has he had? Does he know and use the nerve-sparing cancer surgery techniques -- the anatomical approach to radical prostatectomy? How many of these cancer surgeries does he perform annually? What success has he had in preserving potency and continence? If he can’t or won’t give you his rate of success as compared to reports from other surgeons, or to results published in medical journals, this may be a red flag, and perhaps you should look elsewhere for your cancer surgeon.
“You should be able to get a good idea of his success rate in numbers or percentages. In addition, if he hasn’t done very many of these cancer operations -- ideally, hundreds -- you might want to find a more experienced surgeon. Look at it this way: Do you want to be one of the patients he’s learning on? Do you want to be part of someone’s learning curve?
“Remember: You don’t want a surgeon who’s ‘pretty good’ at removing the prostate. There are no second chances here: This is a one-shot operation. You are looking for the one surgeon who will perform the one radical prostatectomy you will ever receive in your life, the one operation that will cure your cancer.
“You want a surgeon who is going to make sure that no cancer is left behind, and who knows how to minimize trauma to your body during surgery so you don’t wind up with incontinence, erectile dysfunction, or both.
“Finding the right surgeon may mean that you must travel to a major medical center in another city. This may mean that you’ll be away from home for four days. But after that, even though you may need to wear a catheter for a week or two, the recovery from the operation is usually speedy, and follow- up communication can be carried out over the telephone.
Proton Beam Therpy, Pros & Cons
Despite the considerable costs and specific-use controversies (especially regarding prostate cancer), proton beam radiation therapy (PBRT) remains a much sought-after technology for certain cancer centers, as well as some institutions that don't even have any direct health care affiliations.
PROTON BEAM RT...
Image ToolsAs reported in Part 3 of this series in the April 25th issue, the current PBRT club consists of only seven members providing clinical care with a few other facilities either already under construction or being considered so for the future, often depending more on financing than medical science.
OT requested interviews over several weeks from various institutions to discuss how PBRT was being utilized in today's competitive health care environment
Interestingly some of those centers without the technology declined to discuss the matter at all, as did the granddaddy of proton therapy centers, Loma Linda University Medical Center.
For example, after learning from several sources about a proposed consortium among several prominent academic cancer centers in New York City, I hoped to speak with Simon N. Powell, MD, PhD, Chair of the Department of Radiation Oncology at Memorial Sloan-Kettering Cancer Center (MSKCC), to learn more about the concept—which seemed to be a very cost-effective and collegial attempt at making this expensive technology available to more patients without any single institution incurring the crushing costs—as well as to find out where MSKCC might refer its patients who could benefit from proton therapy.
Via the Cancer Center's Public Affairs Office, though, Dr. Powell declined to be interviewed, saying that it was too early and premature to discuss either PBRT or the consortium.
JAMES D. COX, MD Pro...
Image ToolsDr. Powell's counterpart at Roswell Park Cancer Institute, Michael R. Kuettel, MD, PhD, MBA, President of the American College of Radiation Oncology (ACRO), also declined, replying through Public Affairs that he was not an expert on proton beam radiation therapy and that any questions regarding ACRO's position would have to be submitted in writing for review by the association's board.
Johns Hopkins Cancer Center said it would not refer any prostate cancer patients for proton therapy, but did send some pediatric sarcoma patients to Massachusetts General Hospital for a specific clinical trial.
I called Jerry D. Slater, MD, Professor and Chairman of the Department of Radiation at Loma Linda, home of the James M. Slater, MD, Proton Treatment and Research Center, named for his father, and operating since 1990. I was told that Dr. Slater was unreachable until more than week after this article was to be submitted, and then asked the public affairs department for another expert. They insisted on a list of specific questions, which I sent, but no one followed up by the deadline.
Back to Top | Article Outline
Baby & Bath Water
In the PBRT article in the April 25th OT, Anthony L. Zietman, MBBS, MD, President of the American Society for Radiation Oncology and the Jenot and William Shipley Professor of Radiation Oncology at Harvard Medical School and Director of the Radiation Oncology Residency Program at Massachusetts General Hospital, commented that he was “afraid that the prostate issue will cause proton therapy to be discredited and the baby will be thrown out with the bath water.”
He was referring to the lack of any clinical evidence that proton therapy was better than some other more readily available radiation therapies for prostate cancer, and that some centers were treating men for prostate cancer because it was easier and more lucrative and they could handle up to six men in the same time it took to treat a single pediatric patient under anesthesia, a much better candidate for PBRT.
Dr. Zietman also said that as soon as its $10 million NCI grant was approved, Mass General and the University of Pennsylvania Cancer Center would immediately begin a collaborative randomized clinical trial comparing PBRT with intensity modulated radiation therapy (IMRT) for prostate cancer, with quality of life as the endpoint.
Back to Top | Article Outline
‘Very Complicated Question’
Jay S. Loeffler, MD, Chair of Radiation Oncology at Mass General, and the Herman and Joan Suit Professor of Radiation Oncology at Harvard Medical School, called discussing the use of PBRT “a very complicated question—It shouldn't be, but it is,” he said.
“Protons produce a better dose distribution compared with x-rays, so if you take the fanciest x-ray dose, then protons are always superior to them. The problem in the field of proton therapy is that there has never been a randomized trial comparing the best of x-rays with the best of protons. Radiation oncology is a funny field because we make decisions about treatment delivery based on computer-graphics and a summation of the dose distribution and we adopt new technologies based on improvement of dose distribution.”
JAY S. LOEFFLER, MD ...
Image ToolsHe noted that the FDA requires clinical trials for drug development to show how safe the drug is and how it compares with other available drugs, and that a comparable system does not exist in radiation oncology. “If you have a new technology where the dose distribution is better than other technologies, we assume that it provides better therapy—and it might, but there's no evidence to support it.”
He added that many people would now argue that proton therapy will be obviously superior in children because the amount of radiation outside the target volume is reduced, a situation that also reduces the potential late effects in a developing child such as organ function, growth, and risk of second tumors.
“In the pediatric world there is very little debate that protons are a technology that should be associated with better long-term outcomes, but you need about 20 or 30 years of outcomes to prove that.
“There are also subsets of tumors of the eye where proton therapy appears better than any other radiation technology—particularly ocular melanomas where patients can have tumors controlled and can keep useful vision, which would not be feasible if more common types of radiation were used.”
And Dr. Loeffler said there is also little argument that patients with certain tumors of the skull base that require enormous controlled doses of radiation would also be better off if treated with protons.
However, he noted that where proton therapy “gets fuzzy” is in treating prostate cancer: “We have not turned this place into a prostate cancer treatment factory like some other proton centers have. We treat selective patients on protocol asking questions, but we certainly don't routinely offer all our prostate cancer patients proton therapy.”
Dr. Loeffler said that there was also an issue when treating an elderly group of prostate cancer patients who might not have the life span to prove that decreasing the dose outside the prostate makes a substantial difference.
“It might, but we may never be able to prove that, and I think that while we might find that protons are the standard of care for the cancers I've mentioned, we are more dedicated to quantifying the potential gain by designing studies to document potential proven outcomes of protons versus x-rays.”
He said that in addition to the proposed randomized clinical trial for prostate cancer with Penn, Mass General was involved in another trial in collaboration with M.D. Anderson that was looking at lung, liver, head and neck, and a variety of pediatric cancers.
Back to Top | Article Outline
Longest
PROTON BEAM RT...
Image ToolsAs reported in Part 3 of this series in the April 25th issue, the current PBRT club consists of only seven members providing clinical care with a few other facilities either already under construction or being considered so for the future, often depending more on financing than medical science.
OT requested interviews over several weeks from various institutions to discuss how PBRT was being utilized in today's competitive health care environment
Interestingly some of those centers without the technology declined to discuss the matter at all, as did the granddaddy of proton therapy centers, Loma Linda University Medical Center.
For example, after learning from several sources about a proposed consortium among several prominent academic cancer centers in New York City, I hoped to speak with Simon N. Powell, MD, PhD, Chair of the Department of Radiation Oncology at Memorial Sloan-Kettering Cancer Center (MSKCC), to learn more about the concept—which seemed to be a very cost-effective and collegial attempt at making this expensive technology available to more patients without any single institution incurring the crushing costs—as well as to find out where MSKCC might refer its patients who could benefit from proton therapy.
Via the Cancer Center's Public Affairs Office, though, Dr. Powell declined to be interviewed, saying that it was too early and premature to discuss either PBRT or the consortium.
JAMES D. COX, MD Pro...
Image ToolsDr. Powell's counterpart at Roswell Park Cancer Institute, Michael R. Kuettel, MD, PhD, MBA, President of the American College of Radiation Oncology (ACRO), also declined, replying through Public Affairs that he was not an expert on proton beam radiation therapy and that any questions regarding ACRO's position would have to be submitted in writing for review by the association's board.
Johns Hopkins Cancer Center said it would not refer any prostate cancer patients for proton therapy, but did send some pediatric sarcoma patients to Massachusetts General Hospital for a specific clinical trial.
I called Jerry D. Slater, MD, Professor and Chairman of the Department of Radiation at Loma Linda, home of the James M. Slater, MD, Proton Treatment and Research Center, named for his father, and operating since 1990. I was told that Dr. Slater was unreachable until more than week after this article was to be submitted, and then asked the public affairs department for another expert. They insisted on a list of specific questions, which I sent, but no one followed up by the deadline.
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Baby & Bath Water
In the PBRT article in the April 25th OT, Anthony L. Zietman, MBBS, MD, President of the American Society for Radiation Oncology and the Jenot and William Shipley Professor of Radiation Oncology at Harvard Medical School and Director of the Radiation Oncology Residency Program at Massachusetts General Hospital, commented that he was “afraid that the prostate issue will cause proton therapy to be discredited and the baby will be thrown out with the bath water.”
He was referring to the lack of any clinical evidence that proton therapy was better than some other more readily available radiation therapies for prostate cancer, and that some centers were treating men for prostate cancer because it was easier and more lucrative and they could handle up to six men in the same time it took to treat a single pediatric patient under anesthesia, a much better candidate for PBRT.
Dr. Zietman also said that as soon as its $10 million NCI grant was approved, Mass General and the University of Pennsylvania Cancer Center would immediately begin a collaborative randomized clinical trial comparing PBRT with intensity modulated radiation therapy (IMRT) for prostate cancer, with quality of life as the endpoint.
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‘Very Complicated Question’
Jay S. Loeffler, MD, Chair of Radiation Oncology at Mass General, and the Herman and Joan Suit Professor of Radiation Oncology at Harvard Medical School, called discussing the use of PBRT “a very complicated question—It shouldn't be, but it is,” he said.
“Protons produce a better dose distribution compared with x-rays, so if you take the fanciest x-ray dose, then protons are always superior to them. The problem in the field of proton therapy is that there has never been a randomized trial comparing the best of x-rays with the best of protons. Radiation oncology is a funny field because we make decisions about treatment delivery based on computer-graphics and a summation of the dose distribution and we adopt new technologies based on improvement of dose distribution.”
JAY S. LOEFFLER, MD ...
Image ToolsHe noted that the FDA requires clinical trials for drug development to show how safe the drug is and how it compares with other available drugs, and that a comparable system does not exist in radiation oncology. “If you have a new technology where the dose distribution is better than other technologies, we assume that it provides better therapy—and it might, but there's no evidence to support it.”
He added that many people would now argue that proton therapy will be obviously superior in children because the amount of radiation outside the target volume is reduced, a situation that also reduces the potential late effects in a developing child such as organ function, growth, and risk of second tumors.
“In the pediatric world there is very little debate that protons are a technology that should be associated with better long-term outcomes, but you need about 20 or 30 years of outcomes to prove that.
“There are also subsets of tumors of the eye where proton therapy appears better than any other radiation technology—particularly ocular melanomas where patients can have tumors controlled and can keep useful vision, which would not be feasible if more common types of radiation were used.”
And Dr. Loeffler said there is also little argument that patients with certain tumors of the skull base that require enormous controlled doses of radiation would also be better off if treated with protons.
However, he noted that where proton therapy “gets fuzzy” is in treating prostate cancer: “We have not turned this place into a prostate cancer treatment factory like some other proton centers have. We treat selective patients on protocol asking questions, but we certainly don't routinely offer all our prostate cancer patients proton therapy.”
Dr. Loeffler said that there was also an issue when treating an elderly group of prostate cancer patients who might not have the life span to prove that decreasing the dose outside the prostate makes a substantial difference.
“It might, but we may never be able to prove that, and I think that while we might find that protons are the standard of care for the cancers I've mentioned, we are more dedicated to quantifying the potential gain by designing studies to document potential proven outcomes of protons versus x-rays.”
He said that in addition to the proposed randomized clinical trial for prostate cancer with Penn, Mass General was involved in another trial in collaboration with M.D. Anderson that was looking at lung, liver, head and neck, and a variety of pediatric cancers.
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