There is no benefit from adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and total mesorectal excision (TME) in patients with rectal cancer, a study published in the journal Annals of Oncology has shown.

For the multicenter, phase III PROCTOR-SCRIPT trial, researchers enrolled 470 patients from 52 hospitals with histologically proven stage II or III rectal adenocarcinoma. Patients were randomly assigned 1:1 to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME.

Patients who had radiotherapy received 5 x 5 Gy. Patients who had chemoradiotherapy received 25 x 1.8-2 Gy plus fluorouracil-based chemotherapy. Adjuvant chemotherapy consisted of fluorouracil plus leucovorin or eight cycles of capecitabine.

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Results showed that after a median follow-up of 5.0 years, the 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group (HR = 0.93; 95% CI: 0.62 – 1.39; = 0.73). Researchers found that the HR for disease-free survival was 0.80 (95% CI: 0.60 – 1.07; = 0.13).

Both groups had a 7.8% 5-year cumulative incidence for locoregional recurrences, and there was no statistical difference between the two groups for 5-year cumulative incidence for distant recurrences.

The trial was closed early due to slow patient accrual.


  1. Breugom AJ, van Gign W, Muller EW, et al. Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial. Ann Oncol. 2015; 26(4):696-701.