[Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancer
[Background] Neoadjuvant radiation and oxaliplatin-based systemic therapy (total neoadjuvant therapy, TNT) have been shown to increase response and organ-preservation rates in localized rectal cancer. However, trials have been heterogeneous regarding treatment protocols and few have used a watch-and...
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | zho |
| Published: |
Editorial Office of Journal of Colorectal & Anal Surgery
2024-08-01
|
| Series: | 结直肠肛门外科 |
| Subjects: | |
| Online Access: | https://jcas.gxmuyfy.cn/cn/wqll/paper.html?id=307&cateName=2024%E5%B9%B4%20%E7%AC%AC30%E5%8D%B7%20%E7%AC%AC4%E6%9C%9F |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849322686841356288 |
|---|---|
| author | Li Laiyuan Yang Xiongfei |
| author_facet | Li Laiyuan Yang Xiongfei |
| author_sort | Li Laiyuan |
| collection | DOAJ |
| description | [Background] Neoadjuvant radiation and oxaliplatin-based systemic therapy (total neoadjuvant therapy, TNT) have been shown to increase response and organ-preservation rates in localized rectal cancer. However, trials have been heterogeneous regarding treatment protocols and few have used a watch-and-wait (W&W) approach for complete responders. This trial evaluates if conventional long-term chemoradiation followed by consolidation of FOLFIRINOX increases complete response rates and the number of patients managed by W&W. [Methods] This was a pragmatic randomized phaseⅡ trial conducted in 2 Cancer Centers in Brazil that included patients with T3 or N+ rectal adenocarcinoma. After completing a long-course 54 Gy chemoradiation with capecitabine patients were randomized 1∶1 to 4 cycles of mFOLFIRINOX (Oxaliplatin 85, irinotecan 150, 5-FU 2400)-TNT-arm-or to the control arm, that did not include further neoadjuvant treatment. All patients were re-staged with dedicated pelvic magnetic resonance imaging and sigmoidoscopy 12 weeks after the end of radiation. Patients with a clinical complete response were followed using a W&W protocol. The primary endpoint was complete response: clinical complete response (cCR) or pathological response (pCR). [Results] Between April 2021 and June 2023, 55 patients were randomized to TNT and 53 to the control arm. Tumors were 74% stage 3, median distance from the anal verge was 6 cm, 63% had an at-risk circumferential margin, and 33% an involved sphincter. The rates of cCR + pCR were (31%) for TNT versus (17%) for controls [odds ratio (OR) 2.19, 95% CI 0.8-6.22, P=0.091) and rates of W&W were 16% and 9% (P>0.05). Median follow-up was 8.1 months and recurrence rates were 16% versus 21% for TNT and controls (P>0.05). [Conclusions] TNT with consolidation FOLFIRINOX is feasible and has high response rates, consistent with the current literature for TNT. |
| format | Article |
| id | doaj-art-3e2b8097d8514a0188f60b8fe0944cff |
| institution | Kabale University |
| issn | 1674-0491 |
| language | zho |
| publishDate | 2024-08-01 |
| publisher | Editorial Office of Journal of Colorectal & Anal Surgery |
| record_format | Article |
| series | 结直肠肛门外科 |
| spelling | doaj-art-3e2b8097d8514a0188f60b8fe0944cff2025-08-20T03:49:17ZzhoEditorial Office of Journal of Colorectal & Anal Surgery结直肠肛门外科1674-04912024-08-0130447747810.19668/j.cnki.issn1674-0491.2024.04.013[Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancerLi LaiyuanYang Xiongfei[Background] Neoadjuvant radiation and oxaliplatin-based systemic therapy (total neoadjuvant therapy, TNT) have been shown to increase response and organ-preservation rates in localized rectal cancer. However, trials have been heterogeneous regarding treatment protocols and few have used a watch-and-wait (W&W) approach for complete responders. This trial evaluates if conventional long-term chemoradiation followed by consolidation of FOLFIRINOX increases complete response rates and the number of patients managed by W&W. [Methods] This was a pragmatic randomized phaseⅡ trial conducted in 2 Cancer Centers in Brazil that included patients with T3 or N+ rectal adenocarcinoma. After completing a long-course 54 Gy chemoradiation with capecitabine patients were randomized 1∶1 to 4 cycles of mFOLFIRINOX (Oxaliplatin 85, irinotecan 150, 5-FU 2400)-TNT-arm-or to the control arm, that did not include further neoadjuvant treatment. All patients were re-staged with dedicated pelvic magnetic resonance imaging and sigmoidoscopy 12 weeks after the end of radiation. Patients with a clinical complete response were followed using a W&W protocol. The primary endpoint was complete response: clinical complete response (cCR) or pathological response (pCR). [Results] Between April 2021 and June 2023, 55 patients were randomized to TNT and 53 to the control arm. Tumors were 74% stage 3, median distance from the anal verge was 6 cm, 63% had an at-risk circumferential margin, and 33% an involved sphincter. The rates of cCR + pCR were (31%) for TNT versus (17%) for controls [odds ratio (OR) 2.19, 95% CI 0.8-6.22, P=0.091) and rates of W&W were 16% and 9% (P>0.05). Median follow-up was 8.1 months and recurrence rates were 16% versus 21% for TNT and controls (P>0.05). [Conclusions] TNT with consolidation FOLFIRINOX is feasible and has high response rates, consistent with the current literature for TNT.https://jcas.gxmuyfy.cn/cn/wqll/paper.html?id=307&cateName=2024%E5%B9%B4%20%E7%AC%AC30%E5%8D%B7%20%E7%AC%AC4%E6%9C%9Fchemoradiotherapycolorectal surgeryfolfirinoxneoadjuvant therapyrectal neoplasms |
| spellingShingle | Li Laiyuan Yang Xiongfei [Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancer 结直肠肛门外科 chemoradiotherapy colorectal surgery folfirinox neoadjuvant therapy rectal neoplasms |
| title | [Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancer |
| title_full | [Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancer |
| title_fullStr | [Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancer |
| title_full_unstemmed | [Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancer |
| title_short | [Comment] Brazil-TNT : a randomized phase 2 trial of neoadjuvant chemoradiation followed by FOLFIRINOX versus chemoradiation for stage Ⅱ/Ⅲ rectal cancer |
| title_sort | comment brazil tnt a randomized phase 2 trial of neoadjuvant chemoradiation followed by folfirinox versus chemoradiation for stage ii iii rectal cancer |
| topic | chemoradiotherapy colorectal surgery folfirinox neoadjuvant therapy rectal neoplasms |
| url | https://jcas.gxmuyfy.cn/cn/wqll/paper.html?id=307&cateName=2024%E5%B9%B4%20%E7%AC%AC30%E5%8D%B7%20%E7%AC%AC4%E6%9C%9F |
| work_keys_str_mv | AT lilaiyuan commentbraziltntarandomizedphase2trialofneoadjuvantchemoradiationfollowedbyfolfirinoxversuschemoradiationforstageiiiiirectalcancer AT yangxiongfei commentbraziltntarandomizedphase2trialofneoadjuvantchemoradiationfollowedbyfolfirinoxversuschemoradiationforstageiiiiirectalcancer |