"These data support the use of organ preservation for patients considered unsuitable for primary total mesorectal excision due to the short-term risks associated with this surgery, and support further evaluation of short-course radiotherapy to achieve organ preservation in patients considered fit for total mesorectal excision," the study team concludes in The Lancet Gastroenterology and Hepatology.
Radical surgery to remove the rectum without preoperative radiotherapy, the current standard of care for early-stage rectal cancer, comes with substantial morbidity and impact on quality of life.
The TREC study was a randomized, open-label feasibility study testing a less radical approach. It recruited 55 adults with stage T2 or lower rectal adenocarcinoma and a maximum diameter of 30 mm or less, with no lymph-node involvement or metastases.
Twenty-seven underwent organ preservation with short-course radiotherapy followed by TREC after eight to 10 weeks and 28 underwent total mesorectal excision. Eight of the patients (30%) in the TREC group were converted to total excision.
Overall, organ preservation was achieved in 19 of 27 patients (70%), meaning their tumor was removed while preserving the rest of their rectum and their cancer did not return over three to five years of follow-up.
Radiotherapy plus TREC was associated with fewer side effects; serious side effects occurred in 15% of TREC patients compared with 39% of standard-surgery patients. Side effects with TREC were also less severe, most commonly bleeding or pain after the endoscopic surgery; side effects with radical surgery included anastomotic leakage (two patients), kidney injury (two patients), cardiac arrest (one patient), and pneumonia (two patients).
In a statement, co-author Dr. Alexandra Gilbert of the University of Leeds, in the U.K., said, "When talking about 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 organ preservation approach made a significant difference to people's quality of life. One of the most striking benefits was avoiding the need for a stoma bag, which we know is really important to our patients."
The researchers caution that results from larger randomized studies, including the ongoing STAR-TREC study, are needed to "more precisely determine oncological outcomes following different organ preservation treatment schedules."
The author of a comment published with the study says this small randomized, open-label trial on organ preservation in rectal cancer "deserves attention."
According to Dr. Geerard Beets of The Netherlands Cancer Institute, in Amsterdam, "A number of studies have shown that once a patient achieves a clinical complete response after chemoradiotherapy, a watch-and-wait policy is a good alternative to major rectal resection. Other reports have shown the feasibility of a local excision strategy after chemoradiotherapy."
"However, none of these studies addressed the most relevant clinical question for patients with a small or intermediate tumor - what is better, moving straight to a major rectal resection, or starting treatment with radiotherapy with the explicit goal of organ preservation? The TREC study is the first to address this question," Dr. Beets notes.
"Remarkably, despite its small size and exploratory nature, TREC already shows convincing evidence of better quality of life in the organ preservation group. This is both a blessing and a curse: a blessing because it shows that organ preservation lives up to its promise of benefit for the patient, but also a curse because it makes a large-scale randomized trial to provide solid evidence on oncological outcomes much harder to run. Given the high interest of patients in quality of life, many patients will have a clear preference for organ preservation when presented with the current data, and will object to randomization," Dr. Beets points out.
Based on the promising results in TREC, the study design for the STAR-TREC trial was changed into a partially randomized patient-preference study with the primary endpoint of successful organ preservation to accommodate the preferences of patients. Recruitment in STAR TREC will continue until 2024.
SOURCE: https://bit.ly/3axV81d Lancet Gastroenterology and Hepatology, online December 10, 2020.
By Reuters Staff
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