SIRT Plus FOLFOX Not Recommended for Colorectal Cancer With Liver Metastasis
SIRT plus first-line FOLFOX chemotherapy does not improve overall survival among patients with metastatic colorectal cancer.
Selective internal radiotherapy (SIRT) plus leucovorin, fluorouracil, and oxaliplatin (FOLFOX) does not improve overall survival among patients with liver-only and liver-dominant metastatic colorectal cancer compared with FOLFOX alone, according to a study published in The Lancet Oncology.1
Evidence from previous studies suggested that SIRT could provide clinical benefit if given after chemotherapy. The efficacy of administering SIRT with first-line chemotherapy was investigated in the phase 3 FOXFIRE, SIRFLOX (ClinicalTrials.gov Identifier: NCT00724503), and FOXFIRE-Global (ClinicalTrials.gov Identifier: NCT01721954) studies.
Researchers assigned treatment-naive patients to receive FOLFOX or a single treatment of SIRT concurrently with cycle 1 or 2 of FOLFOX. Median follow-up was 43.3 months.
No difference was observed in overall survival between the 2 study groups; 411 (75%) patients receiving FOLFOX alone died, and 433 (78%) patients receiving FOLFOX plus SIRT died (hazard ratio [HR], 1.04; 95% CI, 0.90-1.19; P = .61).
The median survival was 23.3 months (95% CI, 21.8-24.7) in the FOLFOX alone arm vs 22.6 months (95% CI, 21.0-24.5) in the FOLFOX plus SIRT arm.
The most frequently reported grade 3 to 4 adverse event (AE) was neutropenia, occurring in 24% and 37% of patients receiving FOLFOX alone and FOLFOX plus SIRT, respectively. All-grade serious AEs occurred in 43% and 54% of patients receiving FOLFOX alone and FOLFOX plus SIRT, respectively.
There were 8 treatment-related deaths in the FOLFOX plus SIRT arm vs 3 in the FOLFOX alone group.
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The authors concluded that “the routine early integration of SIRT in combination with oxaliplatin-based, first-line chemotherapy cannot be recommended as therapy for metastatic colorectal cancer.”
- Wasan HS, Gibbs P, Sharma NK, et al. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX and FOXFIRE-Global): a combined analysis of three multicentre, randomized, phase 3 trials. Lancet Oncol. 2017 Aug 3. doi: 10.1016/S1470-2045(17)30457-6 [Epub ahead of print]