Regimen ‘one of the best options’ for locally advanced rectal cancer
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Key takeaways:
- The addition of modified FOLFIRINOX induction chemotherapy to standard care improved metastasis-free survival.
- The regimen also extended DFS and OS.
Modified FOLFIRINOX induction chemotherapy prior to standard chemoradiation, surgery and adjuvant chemotherapy improved outcomes for patients with locally advanced rectal cancer, according to a long-term analysis of a randomized phase 3 trial.
The PRODIGE-23 trial included 461 adults (age range, 18 to 75 years) with stage cT3 or cT4, M0 rectal cancer treated at one of 35 centers. All participants had WHO performance scores of 1 or less.
Researchers randomly assigned 230 patients (median age, 62 years) preoperative chemoradiotherapy, surgery, and 12 cycles of adjuvant chemotherapy.
The other 231 patients (median age, 61 years) received six cycles of neoadjuvant chemotherapy with modified FOLFIRINOX, followed by chemoradiotherapy, surgery and six cycles of adjuvant chemotherapy.
DFS served as the primary endpoint. OS, metastasis-free survival, and local and metastatic recurrence rates served as secondary endpoints.
Researchers stratified randomization by center, T stage, N status, location of the tumor and tumor extramural spread. They used a stratified Cox proportional hazard model to estimate HRs and 95% CIs for survival outcomes. However, they observed nonproportional hazard, which may have made use of the HR estimate misleading. Consequently, they decided to evaluate treatment effect by analyzing restricted mean survival time (RMST).
Median follow-up was 82.2 months (95% CI, 79.8-83.5).
Researchers reported a statistically significant improvement in 7-year DFS among those who received modified FOLFIRINOX (67.6% vs. 62.5%), with an RMST difference of 5.73 months (95% CI, 0.05-11.41).
Researchers also reported higher rates of 7-year metastasis-free survival (79.2% vs. 72.3%; RMST difference, 6.1 months; 95% CI, 0.93-11.37) and 7-year OS (81.9% vs. 76.1%; RMST difference, 4.37 months; 95% CI, 0.83-8.38) with modified FOLFIRINOX.
Investigators observed no new safety signals with longer follow-up.
“Neoadjuvant chemotherapy with [modified] FOLFIRINOX followed by chemoradiotherapy ... should be considered as one of the best options of care” for patients with locally advanced rectal cancer,” researchers wrote.
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Conroy T, et al. Ann Oncol. 2024;doi:10.1016/j.annonc.2024.06.019.
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