Tag Archives: breast cancer

Quick Hits: New Breast Cancer Drugs Have Fewer Side Effects, Antidepressant Use in Pregnancy and Autism & More

A new class of oral drugs for treating the most common type of breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, appears to have fewer adverse events and side effects for most patients compared to other treatments. There are 2 CDK inhibitors currently on the market: Ibrance (palbociclib), approved in February 2015, and Kisqali (ribociclib), which was just approved in March. Both are used to treat hormone receptor-positive (HR+) metastatic breast cancer. A third CDK inhibitor, abemaciclib, is in late-stage development. Researchers examined all publicly available trials for the 3 drugs. The most common side effect was low white blood cells, a condition known as neutropenia that can lead to infection, though it was seen less in abemaciclib. However, neutropenia was usually temporary or resolved with a dose reduction. Other, more common side effects seen with the medications were diarrhea and fatigue. Less common side effects observed were nausea and alopecia (hair loss), though these were mild and treated through a dose reduction or a break from the drug. Posted July 14, 2017. Via The Oncologist.

Children exposed to antidepressants during pregnancy may have a slightly higher risk of developing autism than children of mothers with mental illness who didn’t receive the drugs. Researchers, however, stress that the absolute risk of autism was small, so the results should not be considered alarming. A team at the University of Bristol (UK) analyzed data from 254,610 individuals aged 4-17 of which 5,378 had autism. Of the 3,342 children exposed to antidepressants during pregnancy, 4.1% (136) had a diagnosis of autism compared with 2.9% (353) in 12,325 children not exposed to antidepressants whose mothers had a history of a psychiatric disorder. Researchers noted that overall, 95% of women who took antidepressants did not have a child with autism. An accompanying editorial noted that the results should not dissuade women with depression from using antidepressants in pregnancy since untreated depression can lead to “ substantial health consequences.” Posted July 19, 2017. Via The BMJ.

The FDA has approved a new hepatitis C (HCV) medication, Vosevi. The drug is actually a combination of two existing anti-viral treatments, sofosbuvir and velpatasvir (sold as Epclusa), and a new drug, voxilaprevir. Vosevi is for patients with HCV without liver disease (cirrhosis) or with a mild form of cirrhosis. Results from 2 late-stage trials demonstrated that 96-97% of patients who received Vosevi had no HCV detected in their blood 12 weeks after finishing treatment, an indication the infection has been cured. The most common side effects in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Posted July 18, 2017. Via FDA.

 

Mammogram Pros and Cons (Yes, There Are Cons)

Mammogram Pros: They save lives. Mammograms are estimated to reduce cancer rates by 15%. Translated, that means that over a 10-year period if 2,000 women get screening mammograms, 1 will have her life saved.

Mammogram Cons: They cause significant harm. Over those same 10 years, of those 2,000 women 10 will undergo treatment for no reason — because of a cancer that never would have grown. Further, 200 of those 2,000 women will “experience important psychological distress including anxiety and uncertainty for years because of false positive findings,” according to a Cochrane review on breast cancer screening with mammography published in 2013.

These pros and cons apply to screening mammograms, which are those conducted on healthy women with no symptoms or history of breast cancer.

The overtreatment of breast cancers might be acceptable if the treatment was simple, low cost and reasonably pain-free. However, that is not how cancer care is today. Cancer treatment is a life-altering invasion of women’s bodies that can harm nearby organs, increase her risk for a secondary cancer and make it more difficult to treat an actual or secondary breast cancer.

A new research paper based on a national survey just published in JAMA shows just how skewed women’s perceptions of the benefits and harms of mammograms are.

When asked, more than 90% of women knew the 4 benefits of mammograms listed in a recent study. The benefits were (in no order) that mammograms can:

  • Save lives: 92% had heard this before and 66% called it “very Important”
  • Lead to earlier treatment: 96.2% had heard before and two-thirds called it “very Important”
  • Peace of mind: 92.2% had heard this before and 56.5% called it “very Important”
  • Find cancer early: 91.2 had heard this before and 65.9% called it “very Important”

Looking at the 7 questions about mammogram harms, I found a very different picture. Fewer women knew there were potential harms and the women ranked them lower.

  • Some breast cancers found by mammograms are treated with potentially risky surgeries or meds that would not have needed such treatment after all. 39.7% had heard of this before and 28.7% said it was “very Important”
  • Some breast cancers that are found by mammograms are so slow-growing that they would not have caused any health problems for women in their lifetime. 26.5% had heard of this and 21.5% called it “very Important”
  • Women who receive positive mammogram results, even if eventually it turns out they do not have cancer, may feel anxious and stressed. 77.6% had heard before and 23.5% found this “very Important”
  • Mammograms, like all x-rays, expose women to very small doses of radiation, which could increase risk for cancer. 67.4% had heard of this and 19.6% said it was “very Important”
  • Mammograms can find something that looks like cancer but eventually turns out not to be cancer. This is called a “false-positive” or “false alarm.” 75.4% had heard before and 23.4% called it “very Important”
  • Mammograms can lead to increased costs to women because of follow-up tests and procedures. 50.1% had heard this before and 18.8% said it was “very Important”
  • Mammograms can lead to increased costs to the health care system because of follow-up tests and procedures. 42.7% had heard before and 15.1% said it was “very Important”

Needing Few Slogans, More Science

The benefits of mammograms can by synthesized down to 2-3 word slogans like “Mammograms Save Lives” which is true, but it’s also true that “Mammograms have risks of harms.”

Face it, everyone knows someone who has had a breast cancer diagnosis. Between the education campaigns, the pink ribbons and the walks, the fear and loathing of breast cancers surround women and create an atmosphere of mammogram worship. “If I get a mammogram,” I think to myself, “then I won’t die of breast cancer.” Unfortunately, that’s not true. Some breast cancers are too aggressive and virulent to control or “beat,” no matter how early caught.

Somehow the message in America has changed from “Mammograms might help find cancer at a time when medicine can fight it,” to “If you get a mammogram every year you can prevent or avert breast cancer.” And that’s silly. At this point we don’t understand how and why breast cancer occurs so we can’t promise anyone that anything you do will let you avoid it.

It’s a challenge in a world of threats to maintain rationality instead of placing undue faith in a screening program that has plenty of flaws. It may be the best we’ve got, but after 30 years of “early detection saves lives,” don’t we deserve better? How about a screening program that can detect the difference between a cancer or pre-cancer that is a danger and those cancers that will never grow into a threat?

‘Cooling Cap’ May Lessen Hair Loss in Women Undergoing Chemo

For women undergoing chemotherapy, losing one’s hair is one of the treatment’s most devastating side effects. However, researchers have discovered a “cooling cap” that is placed on the scalp may help women with breast cancer lose less hair as a result of chemotherapy.

Researchers, led by those at the Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine, enrolled 182 women with either stage I or II breast cancer who planned to have at least 4 cycles of either taxane or anthracycline-based chemotherapy. The women were randomly chosen to receive the scalp cooling device or not cooling therapy.

The main purpose of the trial, appropriately named SCALP, was determine the safety and efficacy of the device in reducing hair loss (alopecia) in patients undergoing chemotherapy. Secondary endpoints were whether patients in the device arm needed a wig or scarf and overall quality of life.

Slight more than half of the participants in the cooling group didn’t need a wig or a scarf, while everyone in the control group did, the researchers reported in JAMA.

“With scalp cooling, we are lowering the temperature of the scalp, thereby constricting the blood vessels and reducing the flow of blood to the hair follicles, which will help reduce hair loss by limiting the amount of chemo drugs reaching the follicles,” lead study author Julie Nangia, MD, said in a statement.

View a video about the cooling cap and research on it from Dr. Nangia.

Quick Hits: Safety Issues for Hep C Drugs, Breast Cancer Treatment Side Effects & More

More than 1,500 additional cases of liver injury have been discovered that are associated with the newest class of hepatitis C drugs. In October, the FDA first identified 24 cases involving safety issues related to the 9 new antiviral drugs for hepatitis C, including Harvoni (ledipasvir-sofosbuvir), Olysio (simeprevir) and Sovaldi (sofosbuvir). While these drugs appeared to lower the hep C virus to undetectable levels in the majority of patients, some of them experienced reactivation of hepatitis B that had serious health consequences, including liver transplant and death. An investigation by the Institute for Safe Medicine Practices of FDA adverse events data identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of liver injury. In a further 761 cases, the adverse event was failure of the antiviral drug against the virus. Posted January 25, 2017. Via ISMP.

Almost half of women undergoing treatment for breast cancer experience side effects. Researchers in a study asked 1,945 women with early-stage breast cancer about 7 treatment side effects: nausea and vomiting, diarrhea, constipation, pain, arm swelling, shortness of breath and breast skin irritation. About 45% reported at least one of the side effects was severe or very severe. And when women got chemotherapy, the risk of severe side effects doubled. However, when chemo was conducted with radiation, the odds of severe side effects were just 30% higher. Posted January 24, 2017. Via Cancer.

Last year, the FDA approved only 22 new drugs, a sharp drop from the 45 that were given the green light in 2015. The 22 new medicines are the lowest number approved since 2010. There are several reasons for the decline, according to John Jenkins, director of the FDA Office of New Drugs. There were fewer drug applications filed before the FDA and the agency either delayed or rejected more applications last year compared to the prior 2 years. In addition, 5 drugs whose approval was expected in 2016 ended up winning approval in late 2015. Posted January 2, 2017. Via Reuters.

Are New Cancer Drugs Really Medical Miracles?

We live in an age of miracles. New drugs reach the market with mind-dulling frequency. Diseases and conditions that used to kill can now be cured or managed as a chronic disease. Hepatitis C and AIDS are good examples. Because of these breakthroughs, there is a perception that death should be fought in every circumstance and every death is preventable.

Cancer drugs are an area where we are seeing a lot of new therapies rushed to market. On Dec. 4, the New York Times ran an article about cancer and immunotherapy. Immunotherapy was and still is expected to be the path to “beating cancer.” Very generally speaking, a healthy immune system has a built-in shut-off valve so that it will stop before attacking healthy cells. Cancer cleverly masquerades as healthy cells so that they don’t trigger the immune system. Immunotherapy takes the brakes off of the immune system to wonderful effect — in some cases, cancerous tumors shrink and even disappear within weeks.

Although the FDA has fast-tracked many immunotherapy drugs, the excitement is slowly dissolving into horror at the unanticipated outcomes. People who should be healthy and cancer free are dying of immunotherapy side effects that might be preventable. Immunotherapy drugs perform as wanted, but don’t stop. They attack all the body’s systems and can destroy healthy organs. With criminally few follow-up studies to identify the side effects, long-term effects and interactions with other drugs, doctors are unprepared for what might and is happening to these patients. As many as 20% of patients are suffering and succumbing to organ failure, high fevers and more, according to the Times article. Doctors are reaching out almost randomly to other doctors to try to compare reactions, find patterns and manage deadly side effects.

This isn’t the first time cancer drugs have been offered too quickly based on short or unsubstantiated research. Ethical medical scientists know that new protocols can’t be based on a single study, particularly one that has substantially different results than ones testing similar methods. Werner Bezwoda, a doctor in South Africa in the early 1990s, presented a study at the American Society of Clinical Oncology’s meeting and published the same study in major journals. He claimed that a regimen of high dose chemo (enough to bring women to the edge of death) followed by stem cell transplants (to bring them back) cured late-stage breast cancers.

Not surprisingly, women facing death from breast cancer demanded this “life saving” protocol. It was soon found that Bezwoda had faked reports and treated women without consent and without appropriate oversight. The study was quickly withdrawn.

It’s estimated that between 4,000 and 9,000 women died worldwide directly due to doctors following this faked research. It took only a few years before better constructed studies proved that aggressive treatment with chemo and stem cell replacement offered no better outcomes and much worse quality of life compared to standard treatment. Waiting those few years, denying those women the protocol they thought would save them would have been by far the better course. Women died unnecessarily and painfully. They would have been better served to have used the existing regimen.

Saving lives is every doctor’s goals. Living longer is all most cancer patients want to do. But proper testing demands that enough people are enrolled in trials so that side effects can be found and a reasonable level of efficacy is proven. Does the drug work or will it kill you after it kills the cancer?

We aren’t going to be able to stop “fast tracking” of drugs — that genie is out of the bottle. But we can and should demand ongoing and robust (more than one study) aftermarket testing to find out if the drug actually saves lives and what the longer-term side effects so they can possibly be neutralized.

Every drug has potential side effects. But without a reasonable idea of it will work and what the side effects and long-term effects are, how can it be fair to offer that drug to a dying person? It’s just like snake oil, offering false hope, and in some cases, even shortening the patient’s life.

There is dignity and value in having time to prepare for a death. It’s heartbreaking to watch a parent or friend die and I would never advocate for giving up. But it’s the patient’s determination when aggressive, low probability and painful care is too much. Without honest assessments and clear information on the often deadly side effects of medicines, the patient’s values are lost.

Quick Hits: Hormone Replacement Therapy Cancer Risk, Metformin and Weight Loss, & More

Hormone replacement therapy (HRT), which is used to treat the symptoms of menopause, may increase breast cancer risk dramatically. A new study that followed more than 100,000 women over 40 years found that women who took HRT (an estrogen and progestin pill) for about 5 years were nearly 3 times more likely to develop breast cancer compared to those who were just taking an estrogen pill, or nothing at all. And the longer a woman was on HRT, the higher the cancer risk became, according to data published in the British Journal of Cancer. For example, the breast cancer risk was 3.3 times higher for women on HRT for 15 years. While about 14 in 1,000 women in their 50s are expected to develop breast cancer, the rate is 34 in 1,000 for women on HRT, the study argues. Posted August 22, 2016. Via The Telegraph.

A common diabetes drug may help to reduce weight gain that results from atypical antipsychotic use in children with autism. The atypical antipsychotics Risperdal (risperidone) and Abilify (aripiprazole) are approved by the FDA to treat irritability in children with autism. A research team enrolled 60 children and adolescents between the ages of 6 and 17 with autism. Children were also taking an atypical antipsychotic for at least a month and experienced at least a 7% increase in body mass index (BMI) since starting the medication. The children were then randomized to receive either placebo or metformin. Those on the placebo saw no change in the BMI, while those on metformin experienced a statistically significant change, the researchers reported in JAMA Psychiatry. Posted August 24, 2016. Via JAMA Psychiatry.

The severity of side effects from breast cancer hormone treatments may be influenced by whether a patient expects side effects to occur. A new study examined 111 women who had undergone surgery for breast cancer and were about to start hormone therapy with tamoxifen or aromatase inhibitors. At that point, the women were asked about their expectations of side effects. They were then asked again after 3 months and 2 years of treatment. At the beginning, 8% expected no side effects, 63% expected mild side effects and 29% said moderate to severe effects. The results, published in Annals of Oncology, showed that women who expected side effects to be bad had nearly twice as many side effects after 2 years than women who expected no side effects or mild ones. In addition, the women who expected severe side effects tended to have lower quality of life during treatment. Posted August 24, 2016. Via Medical News Today.

MS Drug May Boost Risk of Some Types of Cancer

A drug used to treat multiple sclerosis (MS) has been linked to an increased risk of colorectal cancer and leukemia.

People who were treated with Novantrone (mitoxantrone), had colorectal cancer rates that were 3x higher than the general population, according to an analysis by German researchers. Even more disturbing, the rate of leukemia in patients that took mitoxantrone was 10x higher than the general population of Germany

However, for breast cancer and other types of cancer, people who had taken mitoxantrone were no more likely to develop those diseases than the general population.

German researchers, led by Mathias Buttmann, MD, of the University of Würzburg, examined 676 people with MS treated with Novantrone from 1994 to 2007 and followed them until 2010. 37 people (5.5%) were diagnosed with cancer after taking the drug: 9 people with breast cancer, 4 with colorectal cancer and 4 with acute myeloid leukemia. Results were published in the journal Neurology.

3 out of the 7 people with colorectal cancer died from the cancer during the study, while the 4 people with leukemia went into remission after treatment and remained alive through the study’s conclusion.

Incidentally, Novantrone is also approved as a chemotherapy agent to treat breast cancer, leukemia and non-Hodgkin’s lymphoma.

Factors such as how much Novantrone and whether patients were taking another immunosuppressant drug were also looked at to see if they influenced the risk of developing cancer. However, only being older when starting the drug was associated with a higher risk of developing cancer.

“Despite an increased risk of acute myeloid leukemia and colorectal cancer, the overall rate of cancer was low enough to justify still using this drug for people severely affected by MS if no better treatment is available,” Buttmann said in a statement. “Novantrone is the only approved treatment for people with secondary progressive MS without relapses and should be considered in people where the disease is evolving quickly.

“Also, many of the new and highly effective MS drugs are not available to people in a number of countries for economic reasons, so Novantrone is being used for people with very active relapsing forms of the disease.”