Chemotalk Newsletter, Vol. 9: February 1, 2009
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February ... Already! Let's get right to it...
As few relevant studies as there are for certain cancers, there are even less having to do with organ transplants. So when one shows up, and even better, the news is encouraging, I know it's worth passing on:
CANCER DRUG MAY HELP WITH KIDNEY TRANSPLANTS
The cancer drug bortezomib (known commercially as Velcade) may also be effective at treating and reversing the rejection of transplanted kidneys, a new study finds.
Bortezomib, used to treat cancer of the plasma cells, seems to target antibody-producing plasma cells that can cause organ rejection, according to the study, published in the Dec. 27 issue of the journal Transplantation.
"It has become clear that plasma cells and the antibodies they produce play a bigger role in rejection than previously thought, and the development of therapies targeting these cells has lagged," study lead author Dr. Steve Woodle, chief of transplant surgery at University of Cincinnati, said in a news release issued by the school. "We realized that current therapies don't target the plasma cells which may produce the antibody, in general," he said.
In the study, all six kidney TRANSPLANT RECIPIENTS with treatment-resistant organ rejection who received bortezomib experienced prompt rejection reversal, long-term reductions in antibody levels and improved organ function with suppression of recurrent rejection for at least five months.
The toxicities of bortezomib were at expected and manageable levels that were less than those of other anti-cancer agents, study co-author Jason Everly, an oncology pharmacist in the division of transplant surgery at UC, said in the same news release.
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PREOPERATIVE RADIATION MAY IMPROVE SURVIVAL RATES
FOR ADVANCED RECTAL PATIENTS
Patients treated with radiation prior to surgery for ADVANCED RECTAL CANCER have fewer instances of cancer recurrence and better overall survival rates, according to a recent Geisinger report.
The report examined a treatment called neoadjuvant therapy, which can reduce cancerous tumor size or limit the spread of cancer, before surgery to remove the tumor. Neoadjuvant therapy may include chemotherapy and/or radiation.
Neoadjuvant therapy should not be considered a "one size fits all" approach for rectal cancer patients, said the report's primary author, Mohammed Mohiuddin, MD, FRCR, FACR.
"Physicians need to consider a variety of factors such as tumor size, cancer stage and patient preference before deciding on the course of preoperative treatment," said Dr. Mohiuddin, who has published extensively on the topic of radiation oncology.
The report compared the results of nine recently published research studies involving several thousand cancer patients in Europe and the United States.
Giving comparatively higher dosages of radiation reduces the likelihood that the cancer returns to the same place in the body, the report said. Short-term radiation therapy in some patients may be more convenient because it reduces the number of trips to the hospital.
In patients with late stage rectal cancer, the report supports the pre-surgical practice of combining chemotherapy with smaller radiation dosages over several weeks.
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MERCK AND NOVARTIS DEVELOP PROMISING NEW MS DRUG
In a recently released press statement, Merck announced that it was one step closer to releasing the first pill to treat MULTIPLE SCLEROSIS.
The company said that patients taking cladribine tablets had a nearly 60 percent lower relapse rate than those on placebo pills. The two-year study included 1,326 MS patients who were randomly divided into three groups. Two groups received different doses of cladribine and one group received fake pills.
Patients on cladribine had up to a 60 percent reduced chance of having a relapse compared to patients on placebo. The study was paid for by Merck.
"This is promising news," said Dr. Lee Dunster, head of research for the Multiple Sclerosis Society in the United Kingdom. Dunster was not linked to the Merck study. He said cladribine appeared to be twice as effective as current primary treatments for MS. Current treatments for MS must be given by injections and have varying success rates.
Cladribine is already used to treat leukemia, but only for short periods of time. Doctors said more information was needed about the potential side effects from taking the drug in the long term, since multiple sclerosis is a lifelong condition. Known side effects from cladribine include fatigue, an increased chance of infections, and anemia.
Merck has already asked American and European drug regulators to fast-track the drug to the market. In their press statement, Merck said they will submit cladribine for registration in the U.S. and Europe later this year.
Swiss pharmaceutical giant Novartis AG is also working on a pill to treat MS.
Though Merck's study showed that cladribine reduced the relapse rate, Dunster said the real question was whether the drug slowed the disease's progression. He expected that data to be released in the next few months.
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CHEMO BEADS BOOST LIVER CANCER OUTCOMES
A minimally invasive therapy that uses beads soaked with anti-cancer agents has been successful at halting liver tumors, according to new studies released by the International Symposium on Endovascular Therapy.
Transarterial chemoembolization (TACE) attacks liver tumors on two fronts. Microspheres, or beads, combined with cancer-killing chemotherapeutic agents are delivered to the blood vessel feeding the tumor. While the chemo attacks the cancer, the microspheres get stuck in the vessels and choke off the blood supply to the tumor -- a process called embolization.
While surgically removing a tumor is the most effective way to treat one, this is not an option for most LIVER CANCER patients. In two out of three instances, the size or location of the liver cancer prevents surgery, or the tumor has grown into the blood vessels. Typically, only a quarter of people with liver cancer survive two years after diagnosis.
TACE holds promise, because the tumor, rather than the entire body, receives the chemotherapy directly. It is used to slow, not cure, the disease, but successful improvements in the beads and the procedure were expected to be presented in three separate trials this week at the annual International Symposium on Endovascular Therapy (ISET) in Hollywood, Fla.
In the first study, done at St. Joseph's Hospital and Medical Center in Tampa, Fla., 10 of 11 liver cancer patients given beads that released the chemo drug doxorubicin were alive two years after the procedure. Ten of the 13 people patients who had colorectal cancer that spread to the liver and were given the same treatment also were alive after two years.
The "LC Beads," as they were called, also did not cause systemic side effects.
"There is definitely a chance of cancer cure with this procedure beyond just palliation," sad Dr. Glenn Stambo, vascular and interventional radiologist at St. Joseph's. "The more isolated the tumor and its blood vessel feeders, the better the chance for a complete cure."
An Italian study showed positive results with "HepaSphere" beads, which expand once stuck in the vessels to better block blood flow while also delivering chemo agents directly into the tumor. More than 86 percent of the 53 liver cancer patients in that trial showed a complete response to the therapy after six months.
"Patients who still had good liver function and who had tumors in only one lobe of the liver did better with this treatment,"said Dr. Maurizio Grosso, chairman of the department of radiology at Santa Croce and Carle Hospital in Cuneo, Italy. "We're hopeful that treatment with HepaSphere will be an improvement over traditional chemoembolization."
Even without chemotherapy added to the beads, the embolization technique showed promise in a different Italian study. About half of 34 primary liver tumors shrunk within one month in patients given non-chemo "Embozene" microspheres alone. The other half showed no signs of tumor growth. In a group of 16 tumors observed over the next six to 12 months, two completely disappeared, seven shrunk, two remained the same size, and five grew. Those that grew, though, were still small enough for additional localized treatments to be tried.
"One of the main benefits of Embozene microspheres is the precise, well-calibrated sizing, which match the small blood vessels that feed the tumors. The larger the particles used, the further away the embolization from the tumor and the less effective the treatment will be," said Dr. Franco Orsi, chief of interventional radiology at the European Institute of Oncology in Italy. "Moreover, embolization without drugs usually causes few or no post-treatment side effects, and patient can usually be discharged the next day."
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NATIONAL INSTITUTE OF CLINICAL EVIDENCE (NICE) TO ISSUE RA GUIDELINES
Following concerns that RHEUMATOID ARTHRITIS patients are not receiving early diagosis of their condition, the National Institute of Clinical Evidence, based in the UK, will soon issue guidance to help rectify this problem.
A recent report by the Kings Fund has suggested that RA patients often have to make a number of trips to their general practitioners before they receive a referral to a specialist. However, the report recognizes that ‘the nature of the symptoms and range of inflammatory conditions mean it is often difficult for GPs to identify RA, particularly as the number of patients with RA in one practice may be small’.
NICE will release guidance on the management and treatment of RA in adults next month.
Speaking at the launch of the Kings Fund report in central London, Ros Meek, director of Arthritis and Musculoskeletal Alliance Standards of Care <http://www.rheumatoid.org.uk/article.php?article_id=617> , said that the use of guidelines to improve RA care was ‘paramount’. "The earlier RA is diagnosed the less joint replacements and flare ups a patient will suffer," she said.
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DEPARTMENT OF "YOU'VE GOT TO BE KIDDING!"
A recently published study done in West Virginia showed that doctors have to work harder to get smokers to quit during CANCER treatment. And if this is true for one state, the information can most likely be extrapolated to encompass the rest of the country.
According to a new study conducted at West Virginia University, not enough doctors are urging their cancer patients to quit smoking. The chief of hematology oncology at WVU Mary Babb Randolph Cancer Center has made some frightening discoveries about smokers and cancer treatments.
Dr. Jame Abraham is familiar with tobacco's connection to cancer. But when he asked one thousand cancer patients who was still smoking after being diagnosed with cancer, the answer was more than half.
Here's the part that's really important, a reason to quit if ever there was one: some studies show continued smoking actually can change the effectiveness of the chemotherapy.
Nowhere in the news release did it refer to specific types of cancer - or specific courses of chemo, for that matter. But it stands to reason that a patient can drastically raise his or her chances of recovery ...and avoid other problems, like heart and lung disease.
Less than two thirds of the smokers surveyed said their doctor advised them against smoking during cancer treatments. "I think this is giving us a real snapshot of what's happening, and based upon this info, we'll heighten our efforts to educate the doctors about stopping smoking," says Abraham.
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DO WOMEN DIAGNOSED WITH ENDOMETRIAL CANCER HAVE TO REMOVE THEIR OVARIES?
Maybe not. Ovary Removal May Not Be Needed in Endometrial Cancer
In women 45 and younger, study finds no survival difference when ovaries left intact.
The largest study to date has found no difference in five-year survival rates among women who kept their ovaries and those who did not. Removal of the ovaries, called an oophorectomy, has long been a standard part of therapy for endometrial cancer.
As always, though, no one decision is right for all women all the time.
The benefits of preserving the ovaries would be considerable. Young women would be spared the discomfort of hot flashes, vaginal dryness and other symptoms of induced menopause before their time. Also, avoiding the procedure would reduce the risk of cardiac disease and bone loss and would probably result in a longer life span.
The findings were published online Jan. 26 in the Journal of Clinical Oncology.
About 5 percent of endometrial cancer cases occur in women younger than 40. The average age is 60, and removing the ovaries is not really an issue for women after about age 50 because they have already undergone natural menopause, said Dr. Jeffrey Fowler, director of gynecologic oncology at the James Cancer Hospital and Solove Research Institute at Ohio State University in Columbus.
A hysterectomy and often an oophorectomy as well, has been standard with this type of cancer, largely because of concerns that the cancer might also affect the ovaries and that continued production of estrogen could fuel tumor growth.
The study spanned the years 1988 to 2004 and ultimately involved 3,269 women age 45 or younger who had stage I endometrial cancer. All of the women were registered in a national cancer database. All women had a hysterectomy, and the 12 percent who kept their ovaries tended to be younger, to have been diagnosed later in the span of the study, to have a low tumor grade and to live in the eastern United States.
Removing the ovaries had virtually no effect on five-year survival rates, the study found. Among women who underwent the procedure, 98 percent of those with stage IA cancer, 96 percent who had stage IB disease and 89 percent with stage IC disease lived at least five years, compared with 98, 100 and 86 percent, respectively, of women who did not have their ovaries removed.
Family history of cancer, stage and grade of the tumor and how aggressive the cancer is should all factor into treatment decisions. So should the person's genetic vulnerability: Women carrying the BRCA cancer gene, for instance, probably have increased survival after undergoing ovary removal.
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As usual, stories like the following one that appeared recently in BusinessWeek are written to capitalize on our fears. So keep a careful perspective, realizing that they sell more papers by enhancing the facts with a good dose of fear:
RISING CANCER DRUG COSTS MAY CRIPPLE MEDICARE
A new report says laws crimp Medicare's ability to control costs on cancer, leading to a 267% increase in drug spending over seven years. Medicare spending on cancer drugs has skyrocketed in recent years, and Congress has severely limited the program's ability to do anything about it, says a report in the Feb. 7 issue of The New England Journal of Medicine.
Although it is not the case with other drugs, Medicare must reimburse doctors or patients for virtually all cancer drug uses, even those not yet approved by the Food & Drug Administration. And it is not permitted to favor the lowest-cost treatment. As a result, says author Dr. Peter Bach of Memorial Sloan-Kettering Cancer Center in New York, "the prices of cancer drugs appear to be rising faster than the health benefits associated with them."
Bach notes that Medicare spending on drugs administered in a doctor's office, the vast majority of which are cancer treatments, rose from $3 billion in 1997 to $11 billion in 2004, a 267% increase. Overall Medicare spending rose by only 47% over the same period. Spending on cancer drugs is likely to rise even faster in coming years since a November decision by the agency that greatly expands patient access to cancer drugs as required by law.
Medicare now allows reimbursement for an extremely broad range of "off-label" cancer treatments (meaning the drugs are used in ways that have not yet been approved by the FDA). Off-label uses are incredibly common in cancer therapy because oncologists often try a broad range of drugs against a tumor until they find one that works.
But Bach argues that the high spending on cancer drugs has brought little advantage to patients. Several studies have shown, for example, that the magnitude of the cost increase for each new drug for colon cancer exceeded the magnitude of improvement in efficacy. "It's pretty clear with many of these new drugs, their cost effectiveness is lower than previous drugs," Bach told BusinessWeek. "For each extra day or year of life they give, we're paying more than we did for the last one."
Cancer drugs, long a backwater of the pharmaceutical market, have become incredibly lucrative over the past decade as a new generation of treatments arrived with fewer side effects and better outcomes—but only for some patients.
Medicare is barred by law from negotiating with drug companies on prices, but it can hold the line when it concludes that several drugs are virtually interchangeable. In that case, the agency can reimburse for the least costly alternative, no matter which drug is used, or choose a weighted average of prices for that class of drug. When it comes to cancer drugs, however, Congress requires Medicare to pay for any drug used "for a medically accepted indication," or for which the treated condition is major or life-threatening.
Bach recommends that Congress rectify the situation by establishing a center for comparative effectiveness—a concept embraced by President Obama's Administration—that would determine when a cancer drug's use is reasonable and necessary, based on clinical research. However, Bach acknowledges that patients may not be keen on this solution, as an authority other than their oncologist would end up restricting their access to some treatments. "This is going to be tough going," he says. "But that is maybe one of the trade-offs we need to make to bring prices under control."
(Personally, I find these kinds of conclusions both dangerous and misleading. Patients "may not be keen on this solution"? When lives are on the line, it's a bit more consequential than an intellectual argument presented by a doctor who wants to balance his books. Lives are at stake. I'm one of those cancer patients who may one day warrant a prescription of a drug not yet approved by the FDA for that particular treatment. Or I might be one of the relatively few patients for whom a certain combination of expensive drugs works. Like every other cancer patient, I want my doctor to be able to make the choices - the "tough choices" referred to by Dr. Bach - that she feels appropriate for me based on her medical opinion, not the cost of the drugs. The "expanded patient access to cancer drugs required by law" is a blessing. "Reasonable and necessary" is in the eyes of the beholder.)
If you have an opinion about this, let me know.
See you next month ....
And if you have any thoughts of how this newsletter could be
improved, please email me directly, at email@example.com
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