Clinical Study

Association between adjuvant chemotherapy and survival in patients with rectal cancer and pathological complete response after neoadjuvant chemoradiotherapy and resection



For patients with locally advanced rectal cancer (LARC), it is unclear whether neoadjuvant chemoradiotherapy-induced pathologic complete response (pCR) individuals would further benefit from adjuvant chemotherapy (ACT).


The pCR individuals who received different ACT cycles were paired by propensity score matching. Overall survival (OS), disease-free survival (DFS), local recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) were calculated by Kaplan–Meier and log-rank test.


In total, 1041 pCR individuals were identified from 5567 LARC cases. Specifically, 303 pCR cases had no ACT treatment, and 738 pCR patients received fluoropyrimidine-based ACT (median, 4 cycles) treatment. After 1:3 propensity score matching, 297 cases without ACT treatment were matched to 712 cases who received ACT treatment. Kaplan–Meier analysis showed that pCR individuals treated with or without ACT had the similar 3-year outcome (OS, DFS, LRFS and DMFS) (all P > 0.05). Moreover, the pCR patients received different ACT cycle(s) (0 vs. 1–4 cycles, 0 vs. ≥5 cycles) had comparable 3-year OS, DFS, LRFS and DMFS (all P > 0.05). In stratified analysis, ACT treatment did not improve 3-year survival (OS, DFS, LRFS and DMFS) for the baseline high-risk (cT3–4/cN1–2) subgroup patients (all P > 0.05).


ACT, which did not improve survival, is unnecessary to neoadjuvant treatment-induced pCR LARC patients.

Trial registration

2019ZSLYEC-136 (24-6-2019).

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Author information




X.-B.W. and J.A.A. was the principal investigator and designed the study. F.H. performed contouring, treatment planning, and statistical analysis. H.-Q.J., Y.D., Z.J., Z.L., B.H., X.W., Y.Z., Y.L., B.Q., J.Z., Z.Z., Q.P., J.W. and W.L. provided patient data. F.H., H.C., X.P., and S.L. reviewed the data. All authors discussed the data. X.-B.W. and F.H. wrote the original manuscript and subsequent revisions, which were reviewed by all other authors. All authors read and approved the final manuscript.

Corresponding authors

Correspondence to Jaffer A. Ajani or Xiang-Bo Wan.

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Ethics approval and consent to participate

This study was approved by the central ethics committee of the Sixth Affiliated Hospital, Sun Yat-sen University in accordance with the Declaration of Helsinki (No. 2019ZSLYEC-136). The written consent of patients was waived by the ethical committee of the Sixth Affiliated Hospital, Sun Yat-sen University.

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Not applicable.

Data availability

The datasets used during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare no competing interests.

Funding information

This study was supported by International Centre for Genetic Engineering and Biotechnology Research Grant (No. CRP/CHN16-04_EC) and Natural Science Foundation of China (Nos. 81872188 and 81703080).

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He, F., Ju, H., Ding, Y. et al. Association between adjuvant chemotherapy and survival in patients with rectal cancer and pathological complete response after neoadjuvant chemoradiotherapy and resection. Br J Cancer 123, 1244–1252 (2020).

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