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A targeted drug called pazopanib could prove effective against difficult-to-treat cases of thyroid cancer cases, researchers say.
Most thyroid cancers can be treated with surgery or radioiodine, but about 5 percent of patients will develop an aggressive, life-threatening form of the disease.
Pazopanib (Votrient), already approved by the U.S. Food and Drug Administration for treating advanced kidney cancer, works by inhibiting growth of blood vessels essential for tumor growth and survival.
“Thyroid cancers, when they grow, they need to form a lot of blood vessels,” explained researcher Dr. Julian Molina, an assistant professor of oncology at the Mayo Clinic and co-author of the study. “For blood vessels to grow, the growth factor VEGF is required, and the drug targets this protein,” he said.
Not only does the drug block production of new blood vessels, it also interferes with the tumor cells’ ability to continue growing, Molina said.
Pazopanib, a pill that’s taken daily, doesn’t have the severe side effects of standard chemotherapy, Molina said. But it is expensive. According to the U.S. Department of Health and Human Services, the average wholesale price, which is used to set drug reimbursements, is $6,595 a month.
For this phase 2 study, published in the Sept. 17 online edition of The Lancet Oncology, Molina and colleagues tested the efficacy and safety of pazopanib in 37 patients with advanced, rapidly progressing thyroid cancer.
About half of the patients –18 — had a partial response to the drug, meaning their tumor shrank 30 percent or more, Molina said. None had a complete response, in which the tumor disappears completely, he added.
Twelve patients are still responding to the drug about a year later. “Patients take the drug until the drug is no longer effective,” Molina said, noting these patients still take pazopanib every day.
Side effects were commonplace but typically mild. The most usual were diarrhea, hypertension, and an increase in a liver enzyme called aminotransferase. However, 15 patients had to have their dose lowered because of side effects, the researchers note.
The U.S. National Cancer Institute funded the study.
Molina noted that larger phase 3 trials will start soon, and he hopes the drug, made by GlaxoSmithKline, will be approved for treating advanced thyroid cancer.
“One of the goals in cancer care is to make cancer a chronic disease,” Molina said. “If we can make cancer something like that, where your pills keep your disease controlled, that’s a good goal,” he said.
One expert said that any effective therapy would be welcome.
“There are not a lot of treatment options available for people with advanced thyroid cancer,” said Dr. Leonard Lichtenfeld, deputy chief medical officer at the American Cancer Society.
While the study results will need to be replicated and tested against other treatment options before pazopanib can be approved as a therapy for thyroid cancer, he agreed that the drug shows promise.
“Targeted therapies are providing some effective treatment options for patients with diseases that traditionally have been difficult to treat,” he said. “I find that very helpful and very exciting.”
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U.S. inspections of overseas pharmaceutical plants would increase and regulators would gain new recall power under proposals unveiled by Democrats in the House of Representatives on Monday.
Representatives Henry Waxman, Frank Pallone, John Dingell and Bart Stupak said they released the measures to open discussion on ways to help the Food and Drug Administration better police the increasingly global marketplace for prescription drugs.
The draft legislation is a response in part to tainted heparin from China blamed for dozens of deaths in 2008.
“Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how,” Dingell said in a statement.
The draft legislation would require “parity” between inspections of foreign and domestic drug manufacturing plants. Now, overseas production sites are inspected much less often than U.S.-based facilities.
It also would require that manufacturers “ensure the safety of their supply chain” and would give the FDA power to mandate recalls of unsafe medicines.
The Democratic lawmakers said their proposal “reflects the reasoned priorities and recommendations of” the FDA.
Waxman, chairman of the House Energy and Commerce Committee, said he would work with the FDA “and all stakeholders to move this legislation forward as soon as possible.” But time for action in the current Congress is running short ahead of the November elections.
With no initial Republican supporters, the measure’s fate is unclear if Republicans take control of the House next year.
Concerns about the quality of medicines heightened in 2008 when dozens of deaths were blamed on contaminated ingredients from China used in Baxter International Inc’s blood-thinner heparin.
(Reporting by Lisa Richwine; Editing by Gary Hill)
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By testing pregnant women’s triglyceride levels and keeping track of large waistlines, doctors may be able to tell much sooner than before whether the women will develop gestational diabetes, a new study suggests.
Because gestational diabetes is often diagnosed late – at around six months into pregnancy – and tests are costly and time-consuming, the findings could mean earlier intervention for moms-to-be who want to keep their health in check, researchers from University of Montreal and Chicoutimi Hospital in Canada said in a statement.
Among the 144 pregnant women in the study, women with waistlines larger than 33.5 inches (85 centimeters) and high levels of triglycerides – fats found in the blood that are used for energy – during their first trimester were more likely to score higher on a blood glucose test taken after the second trimester, the researchers said. Almost all of the women began the study with normal glucose levels.
A high level of glucose, or sugar, in the blood is an indicator of gestational diabetes, which occurs when pregnant women’s bodies don’t make enough insulin to signal the body’s cells to take up glucose from bloodstream.
High triglycerides and a large waistline are markers for obesity, a known risk factor for gestational diabetes, the researchers said.
Gestational diabetes can lead to health problems for the baby, including jaundice, low blood sugar levels, low blood mineral levels, trouble breathing and a larger-than-normal body that could require delivery by Caesarean section, according to the National Institute of Child Health and Human Development.
However, the condition can be managed by eating healthily, exercising and taking medication as needed, according to the Mayo Clinic.
Because of the modest sample size, researchers said they will replicate the study with a larger, more diverse group of women.
The study was published today (Sept. 20) in the Canadian Medical Association Journal.
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Women who undergo fertility treatment with drugs known as GnRH-agonists run a risk of depression and anxiety symptoms, even if they have a relatively shorter course of therapy, a new study suggests.
Published in the journal of Fertility and Sterility, the report concludes that the medications themselves may not be triggering mood symptoms, but that another factor — like the stress of infertility treatment — may be at work.
The study followed 108 Israeli women undergoing in-vitro fertilization (IVF) at one infertility treatment center. As part of the treatment, the women received injections of a gonadotropin-releasing hormone agonist (GnRH-a), one of the drugs used to help stimulate the ovaries to produce eggs.
The agonists act by first boosting the body’s production of two hormones that stimulate the ovaries to churn out estrogen; after that initial surge, however, a woman’s estrogen levels drop for a time.
This estrogen depletion can trigger temporary menopause-like symptoms like hot flashes, vaginal dryness and mood disturbances.
Women in the current study were randomly assigned to have either a “short” or “long” treatment protocol — under the theory that the shorter course would be less likely to increase depression and anxiety symptoms if the drugs were indeed responsible for them.
Forty-eight women were randomly assigned to the long course, beginning with GnRH-agonist injections for two weeks, which caused the women’s levels of estrogen and progesterone to drop. The subjects then began additional hormonal drugs to stimulate egg production.
The remaining 60 women underwent the short protocol, which bypassed the initial GnRH-only, estrogen-depleted phase. The long IVF course lasted about six weeks total, and the shorter one about four weeks.
Using standard questionnaires on depression and anxiety, the researchers found that the average symptom scores increased in both groups during the second half of the treatment — after the women had received the hormone gonadotropin and their estrogen levels were elevated.
The findings “strongly argue against the possibility that GnRH-a exacerbates or induces mood symptoms during (IVF) cycles,” write the researchers, led by Dr. Miki Bloch of Tel Aviv Sourasky Medical Center in Israel.
Instead, Bloch told Reuters Health in an e-mail, it may be that “the emotional response to the fertility treatment and the stress involved is a strong enough trigger to induce significant mood symptoms in many women, and this is irrespective of the short-term use of a (GnHR-agonist).”
Bloch added, however, that none of this means that in other treatment contexts — including with longer-term use — GnHR-agonists would not affect mood, as “they obviously do.”
The paper also notes that in other situations — premenstrual dysphoric disorder, postpartum depression and perimenopause — mood syndromes are often related to hormone fluctuations, rather than just low hormone levels.
In this light, the lack of a connection between the GnHR-agonists and mood problems, the authors speculate, may be that it’s not the extremely low estrogen levels the drugs induce, but rather the “rapidity and magnitude” of changes in hormonal levels inherent in the IVF process that might contribute to mood symptoms.
In the study, the changes in depression and anxiety scores in both treatment groups were small, and would not be considered “very robust clinically,” according to Bloch. However, he pointed out that the study looked at the two groups’ average scores, so the increases would indicate that some women did have a meaningful change in symptoms of depression and anxiety.
The bottom line for women having IVF, according to Bloch, is that they should anticipate some effects on mood.
“However,” he added, “there seems to be no advantage from the emotional point of view to the shorter protocol that ‘bypasses’ the (low hormone) state.”
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