Intensity modulated radiotherapy used in the STAR TREC study to treat the tumor (red) and surrounding rectal tissues (green) while sparing surrounding normal tissues. Credit: Dr. Ane Appelt
A new and less invasive treatment developed by researchers at Cancer Research UK is safer than standard major surgery for early stage rectal cancer, giving patients a better quality of life with fewer life-changing side effects.
At present, the standard treatment is major surgery to remove the entire rectum, even if the cancer is in its early stages. But the results of the TREC study, published today in The Lancet Gastroenterology & Hepatology, could change that. The trial showed that a new combination of local keyhole surgery and radiotherapy can prevent debilitating side effects such as diarrhea or the need for a permanent ostomy pouch.
Patients reported a better quality of life with the new treatment, with less impact on their family and social lives, and felt more positive about their body image and the way their gut works.
A clinical trial is now open to eligible patients who wish to receive this new treatment.
“This new treatment could be life-changing for people diagnosed with early-stage cancer. Diagnosing colon cancer earlier increases the likelihood that treatments will work, so we encourage eligible people to participate in colon cancer screening when they receive their test kit, and for anyone who notices changes in their body to tell their GP about it.” – Martin Ledwick, Cancer Research UK’s chief information nurse.
A new approach
Every year 11,500 people in the UK are diagnosed with a tumor in the rectum, the last part of the gut that connects to the anus.
About 4 in 10 (43%) rectal cancers are detected at an early stage (stages 1 and 2) and doctors need better, less invasive treatments for these tumors. Currently, about a quarter of major surgeries for rectal cancer are performed on small tumors at an early stage and, while effective, the surgery can lead to long-term side effects that severely affect the quality of life of survivors.
Simon Bach and his team at the University of Birmingham, along with collaborators from the University of Leeds, were responsible for developing the new treatment approach for early stage rectal cancer. This approach is called ‘organ preservation’ and uses radiotherapy followed by local keyhole surgery 8 to 10 weeks later to remove only the part of the rectum affected by cancer.
“We took a lot of inspiration from the advances against breast cancer,” Bach said. “In the early 1990s, most people with breast cancer would have had a mastectomy, with the entire breast removed, as the first part of their treatment. But now, thanks to awareness campaigns, the breast screening program and new treatments, mastectomy is much rarer. We wanted to test a similar approach for our rectal cancer patients.”
To test whether organ preservation treatment could be a suitable alternative to major surgery for early-stage rectal cancer, 123 patients participated in the TREC study, which was led from Queen Elizabeth Hospital in Birmingham, the Birmingham Clinical Trials Unit and the Cancer Research Unit. UK Clinical Trials Unit.
Doctors gave the new treatment to 61 patients for whom the major surgery would be considered unsafe. In addition, 55 patients were randomized to the two treatment approaches, with 28 receiving major surgery and 27 receiving the new organ-sparing treatment.
Of those randomized to receive the new organ-sparing approach, 70% were treated successfully, meaning their tumor was removed while preserving the rest of their rectum and their cancer did not return during the 3 to 5 follow-up period year.
People who received the new treatment also reported fewer side effects than people who had major surgery.
“If people with cancer end their cancer therapy, that’s not the end of the ordeal. The physical and emotional strain from the effects of the treatment can last for years or even a lifetime.” – Michelle Mitchell, Chief Executive of Cancer Research UK
Improve quality of life
People who received the new treatment also did better in the long run, according to patient-reported quality of life data. They reported less diarrhea, less shame about their bowel functions, more satisfied with their body image and feeling that their treatment is less disruptive to their family and social lives compared to those who had major surgery.
Similar results were also seen in the 61 patients for whom the standard surgery would be considered unsafe, demonstrating that the new treatment could be a safe and effective option.
Co-author Dr Alexandra Gilbert, of the University of Leeds and Leeds Teaching Hospitals NHS Trust, said when it comes to cancer treatment, the focus is rarely on how severe the effects can be for patients. “But we studied this in detail and found that our approach to organ preservation made a significant difference to people’s quality of life. One of the most notable benefits has been the avoidance of an ostomy pouch, which we know is very important for our patients.”
Bach and his team are now conducting an international, larger version of their study, called STAR TREC, in the United Kingdom, the Netherlands and Denmark. The trial will help decide whether the new treatment should become the new standard of care for early rectal cancer. This follow-up study is currently open for recruitment and, most importantly, patients can decide whether they prefer organ preservation.
The researchers encourage people who have been diagnosed with an early rectal tumor to discuss their options with their surgeon if they want to consider participating in the ongoing study.
“Patients are at the heart of what we do, which is why the results of studies like TREC are such good news,” Mitchell said. “If we can find less intensive treatments with fewer side effects, patients will feel stronger, more confident, and in a better place to socialize, enjoy time with their friends and family, and enjoy life to the fullest.”
Bach, SP et al (2020) Radical surgery versus organ preservation via short-term radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomized, open-label feasibility study. The Lancet Gastroenterology & Hepatology. DOI:https://doi.org/10.1016/S2468-1253(20)30333-2
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