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A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Speedy
Date: June 06, 2022 10:44AM
[www.nytimes.com]

The study was small, and experts say it needs to be replicated. But for 18 people with rectal cancer, the outcome led to “happy tears.”

It was a small trial, just 18 rectal cancer patients, every one of whom took the same drug.

But the results were astonishing. The cancer vanished in every single patient, undetectable by physical exam, endoscopy, PET scans or M.R.I. scans.

Dr. Luis A. Diaz Jr. of Memorial Sloan Kettering Cancer Center, an author of a paper published Sunday in the New England Journal of Medicine describing the results, which were sponsored by the drug company GlaxoSmithKline, said he knew of no other study in which a treatment completely obliterated a cancer in every patient.

“I believe this is the first time this has happened in the history of cancer,” Dr. Diaz said.

Dr. Alan P. Venook, a colorectal cancer specialist at the University of California, San Francisco, who was not involved with the study, said he also thought this was a first.

A complete remission in every single patient is “unheard-of,” he said.

These rectal cancer patients had faced grueling treatments — chemotherapy, radiation and, most likely, life-altering surgery that could result in bowel, urinary and sexual dysfunction. Some would need colostomy bags.

They entered the study thinking that, when it was over, they would have to undergo those procedures because no one really expected their tumors to disappear.

But they got a surprise: No further treatment was necessary.

“There were a lot of happy tears,” said Dr. Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and a co-author of the paper, which was presented Sunday at the annual meeting of the American Society of Clinical Oncology.

Another surprise, Dr. Venook added, was that none of the patients had clinically significant complications.

On average, one in five patients have some sort of adverse reaction to drugs like the one the patients took, dostarlimab, known as checkpoint inhibitors. The medication was given every three weeks for six months and cost about $11,000 per dose. It unmasks cancer cells, allowing the immune system to identify and destroy them.

While most adverse reactions are easily managed, as many as 3 percent to 5 percent of patients who take checkpoint inhibitors have more severe complications that, in some cases, result in muscle weakness and difficulty swallowing and chewing.

The absence of significant side effects, Dr. Venook said, means “either they did not treat enough patients or, somehow, these cancers are just plain different.”

In an editorial accompanying the paper, Dr. Hanna K. Sanoff of the University of North Carolina’s Lineberger Comprehensive Cancer Center, who was not involved in the study, called it “small but compelling.” She added, though, that it is not clear if the patients are cured.

“Very little is known about the duration of time needed to find out whether a clinical complete response to dostarlimab equates to cure,” Dr. Sanoff said in the editorial.

Dr. Kimmie Ng, a colorectal cancer expert at Harvard Medical School, said that while the results were “remarkable” and “unprecedented,” they would need to be replicated.

The inspiration for the rectal cancer study came from a clinical trial Dr. Diaz led in 2017 that Merck, the drugmaker, funded. It involved 86 people with metastatic cancer that originated in various parts of their bodies. But the cancers all shared a gene mutation that prevented cells from repairing damage to DNA. These mutations occur in 4 percent of all cancer patients.

Patients in that trial took a Merck checkpoint inhibitor, pembrolizumab, for up to two years. Tumors shrank or stabilized in about one-third to one-half of the patients, and they lived longer. Tumors vanished in 10 percent of the trial’s participants.

That led Dr. Cercek and Dr. Diaz to ask: What would happen if the drug were used much earlier in the course of disease, before the cancer had a chance to spread?

They settled on a study of patients with locally advanced rectal cancer — tumors that had spread in the rectum and sometimes to the lymph nodes but not to other organs. Dr. Cercek had noticed that chemotherapy was not helping a portion of patients who had the same mutations that affected the patients in the 2017 trial. Instead of shrinking during treatment, their rectal tumors grew.

Perhaps, Dr. Cercek and Dr. Diaz reasoned, immunotherapy with a checkpoint inhibitor would allow such patients to avoid chemotherapy, radiation and surgery.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: rgG
Date: June 06, 2022 10:51AM
Wow





Roswell, GA (Atlanta suburb)
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: MindMeld
Date: June 06, 2022 10:58AM
Amazing! I hope these results hold up in future trials.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Dennis R
Date: June 06, 2022 10:58AM
Fantastic news! Hope it holds true in bigger tests!
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: GGD
Date: June 06, 2022 10:59AM
It was a small trial, just 18 rectal cancer patients, every one of whom took the same drug.


So nobody got a placebo in this study.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: d4
Date: June 06, 2022 11:08AM
Quote
GGD
It was a small trial, just 18 rectal cancer patients, every one of whom took the same drug. So nobody got a placebo in this study.

Giving a placebo to a cancer patient is incredibly cruel.



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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: NewtonMP2100
Date: June 06, 2022 11:08AM
.....a placebo.....??

....as if.....??



_____________________________________

I reject your reality and substitute my own!
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Lew Zealand
Date: June 06, 2022 11:20AM
I agree that placebo is the ideal way to test this (and everything, it's the gold standard). However with life-altering and -threatening diseases, giving a treatment that has a good chance of working to everyone, especially if you already know what the natural course is for that disease, is the most ethical way to start out.

This will sometimes happen during a clinical trial where the treatment group is doing so well that it becomes unethical to withhold treatment from the control wing and they will start receiving the treatment.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: anonymouse1
Date: June 06, 2022 11:23AM
Saw that, and my jaw dropped.

From what I can tell, if the cancer is treatable via checkpoint inhibitors, it's a gamechanger.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: ztirffritz
Date: June 06, 2022 11:29AM
I invested in a pharmaceutical company that had similar results but because of a technicality in how the FDA defined the results they couldn't say that they'd cured people. They had a drug that would specifically target the blood vessels feeding tumors. It would cause the tumor to die from lack of blood. The tumor would either be dissolved or become scar tissue that didn't go away. If it didn't go away they couldn't claim that the tumor was cleared, but it wasn't really a tumor any more either.



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MacResource User Map: [www.zeemaps.com]#
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: zachdog
Date: June 06, 2022 12:32PM
From my understanding, placebos are not used in cancer trials. My mother-in-law participated in a cancer drug trial. She had labs two or three times a week, and they recorded an extraordinary amount of data.

Either the drug works or it doesn't. In her case, it didn't, but she is glad she tried.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: freeradical
Date: June 06, 2022 02:06PM
Quote
zachdog
From my understanding, placebos are not used in cancer trials. My mother-in-law participated in a cancer drug trial. She had labs two or three times a week, and they recorded an extraordinary amount of data.

Either the drug works or it doesn't. In her case, it didn't, but she is glad she tried.

My understanding is that placebos are never the sole treatment in any kind of drug trial.

Everyone gets the standard treatment, and on top of that, half the people get the experimental drug, and the other half get a placebo.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Diana
Date: June 06, 2022 03:05PM
Quote
freeradical
Quote
zachdog
From my understanding, placebos are not used in cancer trials. My mother-in-law participated in a cancer drug trial. She had labs two or three times a week, and they recorded an extraordinary amount of data.

Either the drug works or it doesn't. In her case, it didn't, but she is glad she tried.

My understanding is that placebos are never the sole treatment in any kind of drug trial.

Everyone gets the standard treatment, and on top of that, half the people get the experimental drug, and the other half get a placebo.

I don't think that withholding a potentially successful drug from a patient is something that would pass the Ethics Committee, especially for something that is as life-threatening as cancer. Perhaps if it was to treat something that is chronic but not life-threatening, you might be able to get it approved.

If you are looking at side effects, you have an experimental group, a placebo group, and a control group. In healthy adults, the control group may either be a "no treatment" or a "standard treatment" depending on what the question happens to be: treatment vs. new drug (to see how the two treatments compare), new drug vs. no treatment (how it differs if you don't treat at all), and of course the confounder of "yeah it worked" when you didn't get it at all (the mental thing). I didn't dive into it to see what stage of study this report came from.

I'm sure that PeterB can give you a better answer.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Buzz
Date: June 06, 2022 03:06PM
Quote
   rgG
  Wow


hot smiley smiley-score010 agree smiley nicethread bubb rubb smiley
==
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: anonymouse1
Date: June 06, 2022 04:21PM
Re placebo, etc.:

Increasingly, when it's not life and death, you'll see a "crossover". In part 1 Group A gets the drug and Group B gets placebo. In part 2, Group A gets placebo and Group B gets the drug.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: $tevie
Date: June 06, 2022 04:41PM
I hope this is the start of something big!



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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: N-OS X-tasy!
Date: June 06, 2022 05:27PM
Saw this on Reddit last night. Remarkable outcome - here's hoping it's repeatable.



It is what it is.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Wags
Date: June 07, 2022 10:10AM
Hate to rain on the parade, especially since I am a cancer survivor, but:

[www.justice.gov]
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: N-OS X-tasy!
Date: June 07, 2022 10:54AM
Quote
Wags
Hate to rain on the parade, especially since I am a cancer survivor, but:

[www.justice.gov]

What's your point?



It is what it is.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Fritz
Date: June 07, 2022 11:04AM
Quote
Wags
Hate to rain on the parade, especially since I am a cancer survivor, but:

[www.justice.gov]

pocket change



!#$@@$#!

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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Wags
Date: June 07, 2022 08:27PM
Quote
N-OS X-tasy!
Quote
Wags
Hate to rain on the parade, especially since I am a cancer survivor, but:

[www.justice.gov]

What's your point?

The point is that they'll charge so much only the wealthy will reap the benefit.
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Re: A Cancer Trial’s Unexpected Result: Remission in Every Patient
Posted by: Speedy
Date: June 08, 2022 10:09AM
Quote
Wags
Quote
N-OS X-tasy!
Quote
Wags
Hate to rain on the parade, especially since I am a cancer survivor, but:

[www.justice.gov]

What's your point?

The point is that they'll charge so much only the wealthy will reap the benefit.

Or those with health insurance if the insurers deem it cheaper in the long run.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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