Data from 4 eligible trials (n=1196) comparing observation with adjuvant chemotherapy after preoperative (chemo) radiotherapy and surgery for patients with non-metastatic rectal cancer were evaluated. No statistically significant differences in overall survival between patients who received adjuvant chemotherapy and those who underwent observation (hazard ratio [HR] 0.97, 95% CI 0.81–1.17; p=0.775) were noted.Overall, adjuvant chemotherapy did not significantly improve disease-free survival (HR 0•91, 95% CI 0•77–1•07; p=0•230) or distant recurrences (0•94, 0•78–1•14; p=0•523) compared with observation.
The analysis concluded that fluorouracil-based adjuvant chemotherapy has no benefit on overall survival, disease-free survival, and distant recurrences after a median follow-up of 7 years in patients with (y)pTNM stage II or III rectal cancer, who had an R0 resection, had a low anterior resection or an abdominoperineal resection, and had a tumour located within 15 cm of the anal verge.
Existing NICE guidance for adjuvant chemotherapy in rectal cancer recommends the following: • Assess pathological staging after surgery, before deciding whether to offeradjuvant chemotherapy• Consider adjuvant chemotherapy for patients with high-risk stage II and all stage III rectal cancer to reduce the risk of local and systemic recurrence.