Top line:
Patients with locally advanced disease rectal cancer Standard preoperative chemoradiotherapy followed by surgery is better than primary surgery and postoperative chemoradiotherapy, with better disease-free survival and lower recurrence rates.
methodology:
- The standard treatment for locally advanced rectal cancer is chemoradiotherapy followed by surgery, which is known to reduce the chance of local recurrence. However, it is also associated with negative effects such as: fecal incontinence Bowel/sexual dysfunction.
- Previous studies have shown that preoperative MRI can depict tumor involvement of the mesorectal fascia (MRF).
- This Chinese non-inferiority trial tested whether preoperative chemoradiotherapy could be omitted in patients with locally advanced rectal cancer who had a predicted negative MRF on MRI.
- This study included 275 patients with T3-4aN0 or T1-4aN1-2 rectal adenocarcinoma, lower edge of tumor 6 to 12 cm from the anal verge, and gross primary or nodal disease >1 mm from the MRF. included, all based on preoperative MRI.
- 140 patients in the intervention group were assigned to neoadjuvant chemoradiotherapy (50.4 Gy in 28 fractions). capecitabine followed by capecitabine/Oxaliplatin (starting at 4 weeks postoperatively), and the remaining 135 underwent upfront surgery, followed by adjuvant chemotherapy/chemoradiation if the tumor was within 1 mm of the circumferential margin.
remove:
- After a median follow-up of 34.6 months, there were 6 local recurrences (4.4%) in the intervention group and none in the control group.
- Three-year disease-free survival in the intention-to-treat population was 81.8% in the intervention group and 85.4% in the control group (hazard ratio) [HR]1.76).
- In the on-protocol dataset, 3-year disease-free survival was 81.1% in the initial surgery group and 86.6% in the neoadjuvant chemoradiotherapy group, a difference of -5.4% (HR, 2.02), the researchers said. I was urged to cancel the surgery. Early trial.
in fact:
“This trial was stopped early because there were too many participants. [disease-free survival] Local recurrence events observed in the primary surgery intervention group. Based on our findings, [locally advanced rectal cancer] For high-risk patients, even if the MRF is negative, initial surgery can potentially compromise their health. [disease-free survival] Fee. Therefore, primary surgery is an inferior strategy compared to preoperative surgery. [chemoradiation] Because surgery is required afterwards, it is not recommended for the following people: [locally advanced rectal cancer] patients in clinical practice,” the authors concluded.
sauce:
of studylead author Jun Li, MD, Department of Colorectal Surgery and Oncology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, was published online on January 5, 2024. International Journal of Radiation Oncology, Biology, Physics.
Limitations:
Limited sample size compromises stratified randomization and reduces the power of survival analyses. A relatively high proportion of patients (n = 32) crossed over from the neoadjuvant (chemoradiotherapy) group to the primary surgery group. The follow-up period was relatively short, with only 43% of patients completing 3 years of follow-up.
Disclosure:
This research received no commercial funding. The authors had no relevant conflicts of interest.