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]