Researchers who study rectal cancer have accomplished a difficult task by proving, in a big clinical trial, that patients with rectal cancer fare just as well without radiation treatment as they do with it.
The findings, which were presented on Sunday at the annual conference of the American Society of Clinical Oncology and published in a report in the New England Journal of Medicine, have the potential to provide more than 10,000 patients each year in the United States the choice to forego a cancer therapy that may have major adverse effects.
According to Dr. Eric Winer, who is the president of the oncology organisation but did not participate in the experiment, the study represents a step in a new direction for researchers looking into cancer.
Because of this, researchers decided to take a fresh look at the conventional therapy for rectal cancer, which affects 47,500 individuals each year in the United States (although the type of illness that was the focus of the study affects around 25,000 Americans each year).
For a number of years, pelvic radiotherapy was considered standard procedure. However, women who are exposed to the radiation go through an early onset of menopause, and both men and women suffer impairment to their sexual function. It is also possible for it to cause damage to the intestine, which may lead to concerns such as diarrhoea that is persistent. Patients run the danger of fractures in the pelvic area, and the radiation treatment may also trigger new malignancies.
Despite this, the research indicated that radiation therapy did not enhance patient outcomes. There was no significant difference in critical indicators between the group that had received the therapy and the group that had not received the treatment after a median follow-up of five years. These variables included the duration of life without any evidence that the cancer has returned as well as overall survival. In addition, after 18 months, there was no discernible change in the quality of life between the two groups.
Patients whose tumours had progressed to lymph nodes or tissues around the intestine but had not migrated to any other organs were the primary focus of the experiment. The subgroup of individuals whose disease is considered to be at an advanced stage locally accounts for about half of the newly diagnosed cases of rectal cancer that are recorded globally each year.
The research included 1,194 patients who were each given a random assignment to one of two groups. One group was given the normal treatment, which consisted of a lengthy and difficult journey beginning with radiation therapy, then moving on to surgery, and then, after the patients had recovered from surgery, receiving chemotherapy at the discretion of their doctor.
The second group had the investigational treatment, which began with chemotherapy and was then followed by surgical procedures. It is up to the patient’s physician to decide whether or not they need another round of chemotherapy. Only nine percent of these individuals required further radiation treatment after the first chemotherapy treatment did not result in a reduction in the size of their tumours.
She said that the reason she consented to take part in the research was because “I was motivated by hope” that she may be healed without having to undergo radiation treatment.
She was assigned at random to the group that would not be exposed to radiation, and she felt encouraged when the researchers informed her that they would be carefully monitoring her for the next five years. Her wish was ultimately realised. “That gave me strength,” said Ms. Pea, who is now cancer-free. “That gave me strength.”
After a number of years had passed, a number of academics started to question whether or not radiation was still required. Patients were being diagnosed sooner, before their disease had progressed as far, which led to improvements in chemotherapy treatment, surgical procedures, and medical imaging.
Dr. Schrag and her colleagues came to the conclusion that they should put the concept of removing radiation to the test by conducting a pilot study with what she referred to as “30 courageous patients.” The findings were positive enough to argue in favour of conducting a more extensive investigation.
Rectal cancer is often treated with radiation as a means of reducing the risk of the disease returning. In many cases, chemotherapy and surgery were able to manage the illness; nevertheless, in far too many cases, the cancer returned in the pelvis. Horrific outcomes might be the result, such as tumours that eroded the bladder, uterus, and vagina.
This kind of clinical experiment presents a number of difficult challenges. This kind of research is referred to as a “de-escalation study” since it eliminates one of the typical treatments in order to determine whether or not it is required. No business will ever agree to fund such a test. And as the rectal cancer scientists discovered, even the National Institutes for Health was reluctant to support their study. They argued that the researchers would never be able to persuade enough doctors to enrol patients, and even if they did, too few patients might agree to join because they were afraid it would put their health at risk. In addition, the National Institutes of Health argued that the investigators would never be able to persuade enough patients to join the study.