Saturday, October 21, 2017

$373,000 per regimen for new treatment

FDA gives its okay to a second gene therapy that can send blood cancer into remission


The FDA has approved a new gene therapy for adults with aggressive non-Hodgkin's lymphoma.

According to a recent story by Denise Grady in The New York Times, Yescarta was okayed for patients who've undergone two regimens of chemotherapy that failed.

The Times article notes that the therapy "is part of the rapidly growing field of immunotherapy, which uses drugs or genetic tinkering to turbocharge the immune system to fight disease. In some cases the treatments have led to long remissions."

The therapy, which turns cells into "living drugs," is made by Kite Pharma.

Approval by the Federal Drug Administration was its "second in a radically new class of treatments that genetically reboot a patient's own immune cells to kill cancer."

The first was Kymriah, made by Novartis. It was okayed in August "for children and young adults with an aggressive type of acute leukemia."

That one costs $475,000 per dose, although the company has said "it will not charge patients who do not respond within the first month after treatment."

Yescarta isn't quite as expensive — $373,000 per treatment.
Dr. Frederick L. Locke
Dr. Frederick L. Locke, a leader of a study of Yescarta (and a specialist at the Moffitt Cancer Center in Tampa in blood cancers), is quoted as saying, "We're excited. We think there are many patients who may need this therapy."

Grady's story says "about 3,500 people a year in the United States may be candidates for Yescarta," which is intended "to be given once, infused into a vein, and must be manufactured individually for each patient."

Side effects, as with many therapies, can be daunting.

Life-threatening issues that stem from the Yescarta treatment can include "high fevers, crashing blood pressure, lung congestion and neurological problems," the story indicates.

According to Grady, two patients in the study that led to the drug's approval, "died from side effects," although doctors — through training and experience — apparently "have learned to manage them better."

The study, which was conducted at the Dana-Farber Cancer institute and Brigham and Women's Cancer Center in Boston, involved 111 patients at 22 hospitals.

"Initially," Grady's piece delineates, "54 percent [of the 101 who received Yescarta] had complete remissions…Another 28 percent had partial remissions [and] after six months, 80 percent…were still alive. With a median follow-up of 8.7 months, 39 percent of the 101 were still in complete remission — a much higher rate that achieved with earlier treatments — and 5 percent still had partial remissions."
Dr. Caron A. Jacobson

Says Dr. Caron A. Jacobson, who helped do the study: "You're really seeing people get their life back. After a couple weeks in the hospital and a couple weeks at home, they go back to work. On its face, it's quite remarkable and revolutionary."

The treatment, the Times explains, "was originally developed at the National Cancer Institute, by a team Dr. Steven Rosenberg led. The institute entered an agreement with Kite in 2012, in which the company helped pay for research and received rights to commercialize the results."


The drug giant Gilead reportedly bought Kite two months ago for $11.9 billion.

"In just several decades, said Dr. Scott Gottlieb, the FDA commissioner, "gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer."

A look at many treatments and clinical trials can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at caregivers.

Thursday, October 12, 2017

African-American health care being undermined

Breast cancer mortality rate remains higher for whites than blacks, new study shows


Despite strides in meds and treatments, black women are still at a much greater risk of dying from breast cancer.

A recent story on the Huffington Post website by Suzy Strutner points out that while total survival rates for the disease are improving, a new study shows a huge gap remains. 

The new report, from the American Cancer Society, finds that "breast cancer death rates declined 39 percent between 1989 and 2015" but whites have a 39 percent greater chance of survival than blacks."

The gap, the study says, "emerged in the early '80s, widened through 2015 and has remained steady since."

Why the gap?

Because of "biological differences in breast cancer tumors, along with health care policy."

Regarding the latter, Strutner's story indicates that "unequal access to preventive screenings and treatment" includes black women getting mammograms "slightly more often than white women nowadays, but they had lower screening rates in the past, which 'may be one possible reason for the difference in survival rates today,' according to the Susan G. Komen website."

Not to mention "access to follow-up care [possibly differing] among the races."


Beth Glenn, Ph.D.
The HuffPost story goes on to explain that "less screening means black women might wait longer between  mammograms, be diagnosed late or be unable to follow up altogether when a mammogram comes back abnormal," according to Beth Glenn, Ph.D. associate director for the UCLA Kaiser Permanente Center for Health Equity.

Besides, "for black women who live in poverty, clinics might be too far away," the story adds. 


Christine Ambrosone, Ph.d.
The story also quotes Christine Ambrosone, cancer prevention chair at the Roswell Park Cancer Institute, about poverty blocking black women from care: "Things like transportation for cancer treatment can be a barrier, particularly for women who need radiation therapy, a treatment that needs to be given daily, and who cannot get that time off from work."

Strutner also cites "racial discrimination in health care settings."

As to the biological differences, her HuffPost story says "black women are twice as likely to be diagnosed with triple negative breast cancer, an aggressive form that's harder to treat. And tamoxifen, a drug that's hugely responsible for the overall improvement in death rates, treats another type of breast cancer, called hormone-receptor-positive breast cancer, that black women are less likely to get."

At the same time, Strutner's story indicates, Native American, Latina and Asian women all have lower rates of breast cancer and death from the disease than white women.

It also cites the report mentioning the states of Massachusetts, Connecticut and Delaware as managing to "close the gap, likely by widening health care access so it's easier for everyone to get treatment when they need it" — including Massachusetts passing "a health care reform that requires all residents to have health insurance and offering free health insurance to poor residents who qualify."

The story quotes Glenn as saying that "in general, states with more coverage for low-income women tend to have better outcomes."

Further information on different situations for different races can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

Friday, October 6, 2017

How high-risk men's lives may be extended 37%

UK clinical trial shows that two prostate cancer therapies can be much better than one


Can combining two existing therapies extend the life of men with advanced, high-risk prostate cancer by 37%?

A new study seems to answer that question with a "yes."
Nicholas James
"These are the most powerful results I've seen from a prostate cancer trial," reported Nicholas James, professor of clinical oncology at Queen Elizabeth Hospital in Birmingham, United Kingdom, lead author of an abstract presented to the American Society of Clinical Oncology, in a recent story by Jessica Glenza in The Guardian. 

It's a "once in a career feeling," he noted. "This is one of the biggest reductions in death I've seen in any clinical trial for adult cancers."

Researchers, the Glenza story indicated, "combined standard hormone therapy with a drug called abiraterone, which is typically used only for cancer patients whose disease has stopped responding to standard hormone therapy."

Patients who received both medications did have "slightly stronger side effects," however — "especially cardiovascular and liver problems."

The study, which looked at a group of 2,000 men, was done as part of an ongoing randomized trial conducted in the United Kingdom and Switzerland.

James also was quoted as saying that "abiraterone not only prolonged life, but also lowered the chance of relapse by 70% and reduced the chance of serious bone complications by 50%."

More than 27,000 men in the United States, and 11,000 men in the UK, die of prostate cancer each year.

Details about many clinical studies on cancer can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.