FOxTROT
Trial question
What is the role of neoadjuvant chemotherapy in patients with operable colon cancer?
Study design
Multi-center
Open label
RCT
Population
1053 patients.
Inclusion criteria: patients with radiologically staged T3-4, N0-2, M0 colon cancer.
Key exclusion criteria: strong evidence of distant metastases or peritoneal nodules; peritonitis; colonic obstruction that has not been defunctioned; serious medical comorbidity; malignant disease within the preceding 5 years.
Interventions
N=699 neoadjuvant chemotherapy (oxaliplatin-fluoropyrimidine 6 weeks preoperatively plus 18 weeks postoperatively).
N=354 standard postoperative chemotherapy (postoperative chemotherapy for 24 weeks).
Primary outcome
Rate of residual disease or recurrence within 2 years
16.9%
21.5%
21.5 %
16.1 %
10.8 %
5.4 %
0.0 %
Neoadjuvant
chemotherapy
Standard postoperative
chemotherapy
Significant
decrease ▼
NNT = 21
Significant decrease in the rate of residual disease or recurrence within 2 years (16.9% vs. 21.5%; RR 0.72, 95% CI 0.54 to 0.98).
Secondary outcomes
Significant increase in mild or moderate tumor regression (58% vs. 18%; RR 3.22, 95% CI 1.31 to 5.13).
No significant difference in death from colon cancer (12.3% vs. 15.3%; RR 0.74, 95% CI 0.5 to 1.05).
No significant difference in all-cause mortality (15% vs. 17.8%; RR 0.76, 95% CI 0.55 to 1.06).
Safety outcomes
No significant differences in anastomotic leak or intra-abdominal abscess, wound infection, bronchopneumonia, rash, neutropenia.
Significant differences in requirement of further abdominal surgery (4.3% vs. 7.1%), PE or DVT (2.5% vs. 0.6%).
Conclusion
In patients with radiologically staged T3-4, N0-2, M0 colon cancer, neoadjuvant chemotherapy was superior to standard postoperative chemotherapy with respect to the rate of residual disease or recurrence within 2 years.
Reference
Dion Morton, Matthew Seymour, Laura Magill et al. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552.
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