Brazil-TNT: A Randomized Phase 2 Trial of Neoadjuvant Chemoradiation Followed by FOLFIRINOX Versus Chemoradiation for Stage II/III Rectal Cancer.

Autor: Bugano DDG; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil. Electronic address: diogo.gomes@einstein.br., Santos VM; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Campos-Bragagnoli A; Hospital do Cancer de Barretos, Barretos, Brazil., Melo JCM; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Romagnolo LGC; Hospital do Cancer de Barretos, Barretos, Brazil., Barbosa Neto O; Hospital Israelita Albert Einstein, São Paulo, Brazil., Carvalho IT; Hospital Israelita Albert Einstein, São Paulo, Brazil., Karassawa-Helito J; Hospital Israelita Albert Einstein, São Paulo, Brazil., Ortega CD; Hospital Israelita Albert Einstein, São Paulo, Brazil., Tridente CF; Hospital Israelita Albert Einstein, São Paulo, Brazil., Gerbasi LS; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Tustumi F; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Giovani Blasi PB; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Novaes Figueiredo de Araujo M; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Pandini RV; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Seid VE; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Portilho AS; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Buosso A; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Rolla F; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil., Schettino GPP; Hospital Israelita Albert Einstein, São Paulo, Brazil., Araujo SEA; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Municipal Vila Santa Catarina, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: Clinical colorectal cancer [Clin Colorectal Cancer] 2024 Sep; Vol. 23 (3), pp. 238-244. Date of Electronic Publication: 2024 Apr 16.
DOI: 10.1016/j.clcc.2024.03.003
Abstrakt: 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 (WW) 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 WW.
Methods: This was a pragmatic randomized phase II 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 WW 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 2.19, CI 95% 0.8-6.22 P = .091) and rates of WW were 16% and 9% (P = ns). Median follow-up was 8.1 months and recurrence rates were 16% versus 21% for TNT and controls (P = ns).
Conclusions: TNT with consolidation FOLFIRINOX is feasible and has high response rates, consistent with the current literature for TNT. This trial was supported by a grant from the Brazilian Government (PROADI-SUS - NUP 25000.164382/2020-81).
Competing Interests: Disclosure The authors have stated that they have no conflicts of interest.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: