Rectal cancer researchers have pulled off a formidable feat, showing in a large clinical trial that patients do just as well without radiation therapy.
The results, published Sunday at the annual meeting of the American Society of Clinical Oncology, and A paper In the New England Journal of Medicine, more than 10,000 patients in the United States each year may be given the option of forgoing cancer treatment that can have serious side effects.
The study is part of a new direction for cancer researchers, said Dr. Eric Wiener, who is president of the oncology association but was not involved in the trial.
“Now that cancer treatments have improved, researchers are starting to ask different questions,” he said. “Instead of asking how to intensify cancer therapy, they are asking if there are elements of successful treatment that can be eliminated to provide patients with a better quality of life.”
That’s why researchers took another look at standard treatments for rectal cancer.
For decades, the use of pelvic radiation was common. But radiation puts women into early menopause and impairs sexual function in men and women. It can damage the intestines, causing problems like chronic diarrhea. Patients are at risk of pelvic fracture and radiation can cause additional cancer.
Yet radiation treatment, the study found, did not improve outcomes. After a median follow-up of five years, there were no differences in the key measures — length of survival without signs that the cancer had returned, and overall survival — between the group that received treatment and the group that did not. And, after 18 months, there was no difference between the two groups in quality of life.
For colon and rectal cancer specialists, the findings could change the lives of their patients, said Dr. Kimi Ng, co-director of the Colon and Rectal Cancer Center at the Dana-Farber Cancer Institute, who was not an author of the study.
“Now, especially with younger patients, do they really need radiation?” she asked. “Can we choose which patients can get away without this highly toxic treatment that can have lifelong consequences, such as infertility and sexual dysfunction?”
Dr. John Plasteras, a radiation oncologist at Penn Medicine Abramson Cancer Center, said the results were “certainly interesting,” but added that he wanted to follow patients longer before concluding the results with the two treatment options. was equivalent.
The trial focused on patients whose tumors had spread to lymph nodes or tissue around the bowel, but not to other organs. This subset of patients, whose cancer is considered locally advanced, accounts for about half of the 800,000 newly diagnosed rectal cancer patients worldwide.
In the study, 1,194 patients were randomly assigned to one of two groups. One group received standard treatment, a long and arduous ordeal that began with radiation, followed by surgery and then, after patients recovered from surgery, chemotherapy at their doctor’s discretion.
The other group received experimental treatment, which first consisted of chemotherapy, followed by surgery. At their doctor’s discretion, another round of chemotherapy may be given. These patients had radiation only if initial chemotherapy failed to shrink their tumors—which happened only 9 percent of the time.
Not all patients were eligible for the trial. The researchers excluded those whose tumors seemed too dangerous for chemotherapy and surgery alone.
“We said, ‘Oh, no — it’s too risky,'” says Dr. Deborah Schrag of Memorial Sloan Kettering Cancer Center. Those patients received standard radiation treatment.
Dr. Schrag and Dr. Ethan Bash of the University of North Carolina at Chapel Hill also took the additional step of asking patients to report on their quality of life: How much pain were they in? How tired were they? How much diarrhea? Did they have neuropathy—limbs that tremble and lose feeling? How was their sex life? Have the symptoms resolved? How long did it take for the symptoms to subside?
“When 80 percent of patients are alive after five years, we want to say they’re alive well,” Dr. Schrag says.
There were two groups Various symptoms At different times. But after two years, there was a trend toward a better quality of life in the chemotherapy group. And on one measure — male and female sexual function — the chemotherapy group was clearly better.
Early on, those who received chemotherapy without radiation had more nausea, vomiting, and fatigue. A year later, Dr. Bash said, the radiation group suffered more, including fatigue, impaired sexual function and neuropathy.
“Now patients trying to decide whether they want radiation or chemotherapy can look at how the test subjects did and decide which symptoms are most important to them,” Dr. Bash said.
This type of clinical trial is very challenging. This is known as a de-escalation study because it leads to a standard treatment to see if it is needed. No company will pay for such trials. And, as the rectal cancer researchers discovered, even the National Institutes of Health were hesitant to support their studies, arguing that investigators would never persuade enough doctors to enroll patients, and even if they did, few patients would agree to participate. Afraid it will risk their health.
Although the NIH eventually agreed to sponsor the study, his misgivings were justified—it took researchers eight years to enroll 1,194 patients at 200 medical centers.
“It was brutally difficult,” said Dr. Alan Venuk of the University of California, San Francisco, who helped design the study.
Dr Schrag noted that this required “incredibly brave patients” and doctors who were confident that the research was ethical.
“You take it on your conscience,” says Dr. Schrag.
Radiation has long been used as a way to prevent recurrence of rectal cancer. Chemotherapy and surgery often control the disease, but often, pelvic cancer returns. Terrible effects can follow – tumors that erode the bladder, uterus, vagina.
The addition of radiation addresses recurrence in the pelvis but poses its own problems.
As the years went by, some researchers began to wonder if radiation was still necessary. Chemotherapy, surgery, and medical imaging have improved, and patients are being diagnosed before their cancer is as advanced as it is.
Dr. Schrag and his colleagues decided to test the idea of eliminating radiation with a pilot study called “30 Brave Patients.” The results were encouraging enough to make the case for a wider study.
Dr Venuk says the research is a victory in more ways than one.
“In rectal cancer, there are mindsets,” he said. “People think they know what the right answer is.”
So, for the study to be successful, he added, “surgeons, oncologists and radiation oncologists all need to buy into the protocol.”
And so, of course, did patients like Awilda Pena, 43, who lives in Boston. He was diagnosed with rectal cancer at the age of 38.
“I couldn’t believe it,” she said.
He agreed to participate in the trial because, he said, “I was inspired by the hope” that he could avoid radiation and be cured.
Her hopes were fulfilled: she was randomized to the group that did not have radiation and was reassured when the researchers told her they would monitor her closely for five years. “It gave me strength,” said Ms. Pena, who is now cancer-free.
“You’re not just doing it for yourself,” he said. “You are helping the best scientists and researchers. You’re taking a risk but you’re contributing something.”
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