Clinical trial of new drug for metastatic breast cancer patient shows 'unheard of' survival rates

A new clinical breast cancer drug trial has resulted in "unheard of" survival rates.

According to a recent story by Gina Kolata in The New York Times, for some patients with metastatic tumors that were not significantly affected by other forms of chemotherapy, the treatment halted their cancer's growth.

The findings of a new study, published in the New England Journal of Medicine, might "change how medicine [is] practiced," the article indicates.

Dr. Eric Winer, who was not involved in the study but who is director of the Yale Cancer Center and head of the American Society of Clinical Oncology, is quoted as saying that "this is a new standard of care. It affects a huge number of patients."

The Times piece notes that the new treatment, using an experimental drug (trastuzumab deruxtecan, sold as Enhehru) "that targeted cancer cells with laser like precision" was "stunningly successful, slowing tumor growth and extending life to an extent rarely seen with advanced cancers."

The trial, which focused on a mutant protein known as HER2, involved 557 patients. Tumors in those who took the experimental drug stopped growing for about 10 months, twice the length of those who took only standard chemotherapy. Those patients survived for almost two years, compared to less than a year and a half for those who received standard chemo.

Dr. Halle Moore

"It is unheard of for chemotherapy trials in metastatic breast cancer to improve survival in patients by six months," the story quotes Dr. Halle Moore, director of breast cancer oncology at the Cleveland Clinic, as saying.

Dr. Susan Domchek, a breast cancer specialist at the University of Pennsylvania's Abramson Cancer Center, also is quoted to the effect that she plans to see — even before the Food and Drug Administration approves the drug, which has a wholesale price of about $14,000 every three weeks — if the data from the study will be sufficient to convince insurers to approve it.

More information about successful clinical trials can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Docs wary about study showing cancer drug might cut Covid deaths for patients in hospitals

A new study found that an experimental cancer drug reduces death in hospitalized Covid patients by 55 percent.

According to a story this week by Carl Zimmer in The New York Times, however, some experts are cautious about over-interpreting the results of the study.

Veru, the Miami company that developed the drug, sabizbulin, has applied to the federal Food and Drug Administration (FDA) for emergency authorization to use it.

Dr. Ilan Schartz

The story quotes Dr. Ilan Schwartz, infectious disease expert at the University of Alberta who wasn't involved in the study, as saying, "This looks super-impressive. We have a small number of treatments for patients with a severe disease that improve mortality, but another treatment that can further reduce deaths would be very welcome."

He cautioned, though, that the clinical trial was relatively small — only 134 patients receiving the drug while 70 got a placebo over a course of 60 days — and said he'd "welcome large and independent confirmatory studies."

Researchers hypothesize, among other things, that the drug, which is taken in pill form, helps Covid patients fight potentially life-threatening lung inflammation.

Dr. David Boulware, an infectious disease expert at the University of Minnesota, also cautioned about the impact of the study. He suggested the large 45 percent mortality rate in the placebo control group might be a sign the study was too small to draw firm conclusions. The death rate, he was quoted as saying, "jumps out at me as rather high."

In addition, he observed, "trials which are stopped early routinely overestimate the effect." He predicted a similar fate as what happened with the drug molnupiravir, which initially appeared to reduce the risk of hospitalization from Covid by 50 percent but settled for a more realistic figure of 30 percent in the final analysis.

More information on clinical trials can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, its author, aimed at male caregivers.

Smaller studies can mean missed side effects

Pharmaceutical companies can't find patients for trials of experimental cancer drugs 

Dr. Peter Bach

Too few patients are available to cover all the clinical cancer drug trials being conducted.

That, at least, is the conclusion of a recent story by Gina Kolata in The New York Times.

Her article notes that the problem "is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients."

There currently are more than 1,000 immunology trials underway, for example.

But Kolata says "immunotherapy trials have proliferated so quickly that major medical centers are declining to furnish patients to them. The Yale Cancer Center participates in fewer than 10 percent of [those] it is asked to join." 

The writer cites words of Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center: "I think there is a lot of exuberant rush to market. And we are squandering our most precious resource — patients."

Dr. Roy Herbst

She also quotes Dr. Roy Herbst, the Yale center's chief of medical oncology, to the effect that the companies sponsoring the trials aren't addressing new research questions but are merely "trying to get proprietary drugs approved."

Some companies are working on experimental drugs that attack and block mutations that tumors need to grow and thrive. The mutations sought by those targeted therapies, however, are extremely rare so pharmaceutical companies "may be forced to undertake a worldwide search for subjects that can last for years."

It took Pfizer three years, for example, "to locate 50 lung cancer patients who carried a rare aberration called ROS1, found in just 1 percent of patients."

Many new trials involve a limited number of patients, which can be risky.

Bach, according to Kolata, maintains that "the smaller the study and the shorter its duration, the more likely that what looks like an effect in a trial might simply be the result of chance" — which "leaves some of us evidence geeks wondering if it works."

Dr. Scott Ramsey

The writer also quotes Dr. Scott Ramsey, an oncologist at the Fred Hutchinson Cancer Research Center, that "in tiny studies, serious side effects can be missed."

Details of many 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 male caregivers.