Combination of neoadjuvant and adjuvant chemotherapy with FOLFOX compared with adjuvant chemotherapy in management of locally advanced rectal cancers: a randomized trial of a promising therapeutic approach

Q: How were patients allocated to the two treatment groups in the trial?

The trial randomly assigned 286 LARC patients into two parallel groups. Group A received six courses of neoadjuvant MFOLFOX with chemoradiation, surgery, and six adjuvant chemotherapy cycles, while Group B received concurrent chemoradiation, surgery, and twelve adjuvant chemotherapy cycles.

Q: What were the primary outcome differences between Group A and Group B?

Group A showed a significantly lower local recurrence rate (11.64% vs 21.74%, P=0.025). Distant metastasis was lower in Group A (8.90% vs 20.29%) but did not reach statistical significance (P=0.143). Group A also had higher downstaging, pCR rate, and three-year DFS.

Q: Were treatment side effects different between the two groups?

Treatment side effects were similar in both groups but less frequent in Group A. The most common hematological side effect was anemia, and the most common non-hematological complication was peripheral sensory neuropathy.

Sep 21, 2026

Uploaded by Noah

Colorectal cancer poses major challenges, and standard preoperative chemoradiation for locally advanced rectal cancer (LARC) has limited impact on disease-free survival and distant metastasis. This randomized clinical trial evaluated 286 LARC patients using two treatment strategies: neoadjuvant MFOLFOX plus chemoradiation and surgery followed by adjuvant cycles, versus concurrent chemoradiation and surgery followed by more adjuvant cycles. The neoadjuvant strategy reduced local recurrence, improved downstaging, increased pCR, and showed better three-year DFS with similar side-effect profiles.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusion

Introduction

Biniaz etal. BMC Cancer (2024) 24:863 [https://doi.org/10.1186/s12885-024-12634-7](https://doi.org/10.1186/s12885-024-12634-7) BMC Cancer RESEARCH Open Access Combination of neoadjuvant and adjuvant chemotherapy with FOLFOX compared with adjuvant chemotherapy in management of locally advanced rectal cancers: a randomized trial of a promising therapeutic approach Mandana Biniaz 1†, Arash Moradi2†, Manouchehr Ghorbanpour Basit3, Abdol‑Azim Seddighi Pashaki 1,4, Arash Dehghan5 and Kamal Mohammadian 1,4,6* Abstract Background Colorectal cancer (CRC) is a significant malignancy with widespread implications. Despite progress in surgical interventions for rectal cancer, improvements in overall prognosis remain disproportionate. Standard preoperative chemoradiation, while established as the standard treatment for the majority of rectal cancers, exhibits limited effectiveness in enhancing disease‑free survival (DFS) and mitigating distant metastases, particularly in cases of locally advanced rectal cancer (LARC) . Methods This randomised clinical trial assessed 286 patients with LARC in two paralleled groups. Group A under‑ went six courses of neoadjuvant MFOLFOX chemotherapy, chemoradiation, surgery, and six adjuvant chemotherapy cycles. Group B received concurrent chemoradiation, surgery, and twelve adjuvant chemotherapy cycles. Patient evaluations were achieved at multiple stages of treatment and follow‑up. Results Group A had significantly lower local recurrence (11 . 64%) than Group B (21 . 74%, P = 0 . 025) . The distant metastasis rate in Group A (8 . 90%) was lower than in Group B (20 . 29%) but was not significant (p = 0 . 143) . More patients in Group A experienced downstaging (80 . 82% vs. 60. 87%, p < 0. 001) . Specifically, 72. 60% demonstrated downstaging of tumour invasion and 54 . 79% downstaging of lymph node involvement, compared to 57. 25% and 41 . 30% in Group B (p = 0.009 and p = 0 . 025, respectively) as well as higher pCR rate (26 . 03% vs. 15. 25%, p = 0 . 030) and three‑year DFS rate (82 . 19% vs. 71. 01%, p = 0 . 035) in group A compare to group B. Conclusion This innovative strategy for LARC showed promising results with lower local recurrence and higher rates of downstaging and pCR. Treatment side effects were similar in both groups but less frequent in Group A. Anaemia was the most common haematological side effect (A: 58%, B: 68%), and peripheral sensory neuropathy was the most common non‑haematological complication (A: 63%, B: 64%) . These findings suggest this regimen could be a valuable therapeutic approach for LARC. †Mandana Biniaz and Arash Moradi contributed equally to this work. *Correspondence: Kamal Mohammadian [km_282@yahoo.com](km_282@yahoo.com) Full list of author information is available at the end of the article © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[. The Creative Commons Public Domain Dedication waiver (](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[http://creativecom](http://creativecom

FAQs

How were patients allocated to the two treatment groups in the trial?

The trial randomly assigned 286 LARC patients into two parallel groups. Group A received six courses of neoadjuvant MFOLFOX with chemoradiation, surgery, and six adjuvant chemotherapy cycles, while Group B received concurrent chemoradiation, surgery, and twelve adjuvant chemotherapy cycles.

What were the primary outcome differences between Group A and Group B?

Group A showed a significantly lower local recurrence rate (11.64% vs 21.74%, P=0.025). Distant metastasis was lower in Group A (8.90% vs 20.29%) but did not reach statistical significance (P=0.143). Group A also had higher downstaging, pCR rate, and three-year DFS.

Were treatment side effects different between the two groups?

Treatment side effects were similar in both groups but less frequent in Group A. The most common hematological side effect was anemia, and the most common non-hematological complication was peripheral sensory neuropathy.

Sep 21, 2026

Uploaded by Noah