Optimizing treatment sequencing of chemotherapy for patients with rectal cancer: The KIR randomized phase II trial

Aurelie Garant, Petr Kavan, André Guy Martin, Laurent Azoulay, Véronique Vendrely, Caroline Lavoie, Carol Ann Vasilevsky, Marylise Boutros, Julio Faria, Trung Nghia Nguyen, Emery Ferland, Sylvain Des Groseilliers, Alexis Simon Cloutier, Hugo Diec, Sébastien Drolet, Carole Richard, Gerald Batist, Té Vuong

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Randomized studies have shown low compliance to adjuvant chemotherapy in rectal cancer patients receiving preoperative chemotherapy and external beam radiation (CT/EBRT) with total mesorectal excision. We hypothesize that giving neoadjuvant CT before local treatment would improve CT compliance. Methods: Between 2010–2017, 180 patients were randomized (2:1) to either Arm A (AA) with FOLFOX x6 cycles prior to high dose rate brachytherapy (HDRBT) and surgery plus adjuvant FOLFOX x6 cycles, or Arm B (AB), with neoadjuvant HDRBT with surgery and adjuvant FOLFOX x12 cycles. The primary endpoint was CT compliance to ≥85% of full-dose CT for the first six cycles. Secondary endpoints were ypT0N0, five-year disease free survival (DFS), local control and overall survival (OS). Results: Patients were randomized to either AA (n = 120, median age (MA) 62 years) or AB (n = 60, MA 63 years). 175/180 patients completed HDRBT as planned (97.2%). In AA, two patients expired during CT; three patients post-randomization received short course EBRT because of progression under CT (n = 2, AA) or personal preference (n = 1, AB). ypT0N0 was 31% in AA and 28% in AB (p = 0.7). CT Compliance was 80% in AA and 53% in AB (p = 0.0002). Acute G3/G4 toxicity was 35.8% in AA and 27.6% in AB (p = 0.23). With a median follow-up of 48.5 months (IQR 33–72), the five-year DFS was 72.3% with AA and 68.3% with AB (p = 0.74), the five-year OS 83.8% for AA and 82.2% for AB (p = 0.53), and the five-year local recurrence was 6.3% for AA and 5.8% for AB (p = 0.71). Conclusion: We confirmed improved compliance to neoadjuvant CT in this study. Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.

Original languageEnglish (US)
Pages (from-to)237-245
Number of pages9
JournalRadiotherapy and Oncology
Volume155
DOIs
StatePublished - Feb 2021
Externally publishedYes

Keywords

  • Brachytherapy
  • Colorectal neoplasms
  • Induction chemotherapy trial
  • Oxaliplatin
  • Rectum cancer

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Radiology Nuclear Medicine and imaging

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