Aurelie Garant1, Petr Kavan2, André-Guy Martin3, Laurent Azoulay4, Véronique Vendrely1, Caroline Lavoie3, Carol-Ann Vasilevsky5, Marylise Boutros5, Julio Faria6, Trung Nghia Nguyen7, Emery Ferland8, Sylvain Des Groseilliers9, Alexis-Simon Cloutier9, Hugo Diec9, Sébastien Drolet10, Carole Richard11, Gerald Batist2, Té Vuong12. 1. Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada. 2. Department of Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada. 3. Department of Radiation Oncology, Centre hospitalier universitaire de Québec, Université Laval, Quebec City, Canada. 4. Department of Epidemiology, Biostatistics, and Occupational Health, and Gerald Bronfman Department of Oncology, McGill University, Montreal, Canada. 5. Department of Surgery, Division of Colon and Rectal Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada. 6. Department of Surgery, Division of General Surgery and Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada. 7. Department of Hematology, Medical Oncology, Hôpital Charles-LeMoyne, Greenfield Park, Canada. 8. Department of Hematology, Medical Oncology, Hôpital Pierre-Boucher, Longueuil, Canada. 9. Department of Surgery, Hôpital Pierre-Boucher, Longueuil, Canada. 10. Department Surgery, Division of Colorectal Surgery, Hôpital Saint-François D'Assise, Quebec City, Canada. 11. Department of Surgery, Division of Colon and Rectal Surgery, Centre hospitalier de l'Université de Montréal, Montreal, Canada. 12. Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada. Electronic address: tvuong@jgh.mcgill.ca.
Abstract
BACKGROUND: Randomized studies have shown low compliance to adjuvant chemotherapy in rectal cancer patients receivingpreoperative 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.
RCT Entities:
BACKGROUND: Randomized studies have shown low compliance to adjuvant chemotherapy in rectal cancerpatients 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/G4toxicity 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.