eP815 - Brazil-TNT: A randomized phase 2 trial of neo-adjuvant chemoradiation followed by FOLFIRINOX vs chemoradiation for stage II/III rectal cancer

Senior Author(s)

• DB

  Diogo Bugano Diniz Gomes, MD

  Physician assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.

ePoster Presenter(s)

• EO

  Elis Oliveira, MD

  Physicaln Assistent
  Albert Einstein Israelita Hospital
  Sao Paulo, Sao Paulo, Brazil

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no financial relationships with ineligible companies.

Author(s)

• AS

  Ana Sarah Portilho, MD

  Physicaln Assistent
  Albert Einstein Israelita Hospital
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• RV

  Rafael Vaz Pandini, MD

  Physician Assistant
  Albert Einstein Israelita Hospital
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• MN

  Marleny Novaes Figueiredo de Araujo, MD

  Physician Assistant
  Albert Einstein Israelita Hospital
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• VE

  Victor Edmond Seid, MD

  Physician Assistant
  Albert Einstein Israelita Hospital
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• JC

  Julia Carole Medeiros de Melo, MD

  Physician assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• VM

  Vanessa Montes Santos, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• OS

  Osmar Silva Barbosa Neto, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• IT

  Icaro Thiago de Carvalho, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• CD

  Cinthia Denise Ortega, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• CF

  Cassia Franco Tridente, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• JK

  Juliana Karassawa Helito, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• LG

  Luiz Gustavo Capochin Romagnolo, MD

  Physician Assistant
  Hospital do Amor de Barretos
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• AC

  Arinilda Campos Bragagnoli, MD

  Physician Assistant
  Hospital do Amor de Barretos
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• FR

  Fabiana Rolla, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• AB

  Albert Buosso, MD

  Physician Assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.
• SE

  Sergio Eduardo Alonso Araujo, MD

  Physician assistant
  Hospital Israelita Albert Einstein
  Sao Paulo, Sao Paulo, Brazil

  Disclosure information not submitted.

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Purpose/Background: : Neoadjuvant radiation and oxaliplatin-based systemic therapy (Total Neoadjuvant Therapy – TNT) has 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 FOLFIRINOX increases complete response rates and number of patients managed by WWMethods/Interventions: This was a pragmatic randomized phase II trial conducted in 2 Cancer Centers in Brazil that included patients with T3+ or N+ rectal adenocarcioma. After completing long-course 54Gy chemoradiation with capecitabine patients were randomized 1:1 to observation or 1-4 cycles of mFOLFIRINOX (Oxaliplatin 85, irinotecan 150, 5-FU 2400). All patients were re-staged with dedicated pelvic MRI and sigmoidoscopy 12 weeks after the end of radiation. Patients with a clinical complete response were followed using a WW protocol. Primary enpoint was complete response: complete clinical response (cCR) or pathological response(pCR).Results/Outcomes: Between Apr 2021 and Jun 2023, 55 patients were randomized to TNT and 53 to standard of care. Tumors were 74% stage 3, median distance from anal verge was 6cm, 63% had at-risk circumferential margin and 33% involved sphincter. The rates of cCR+pCR were (31%) for TNT vs (17%) for controls (OR 2.19, CI95% 0.8-6.22 p=0.091) and rates of WW were 16%% and 9% (p=ns). Median follow-up has been 8.1% months and recurrence rates were 16% vs 21% for TNT and controls (p=ns).Conclusion/

Discussion: : 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)Figure 01 Patient AllocationTable 02Main outcomes