Hepatic arterial infusion chemotherapy (HAIC) using oxaliplatin, fluorouracil and leucovorin (FOLFOX) significantly improved overall survival (OS) compared with current standard-of-care in patients with primary unresectable hepatocellular carcinoma (HCC), according to an ongoing phase III study reported at ESMO Virtual Congress 2020 today (Abstract 981O).
This open-label study, conducted in China, compared the efficacy and safety of HAIC using FOLFOX versus transarterial chemoembolisation (TACE) in 315 patients with primary unresectable HCC (Barcelona-Clinic Liver Cancer stage A or B, largest diameter ≥7cm), without macrovascular invasion or extrahepatic spread. Patients were randomised to HAIC, administered as oxaliplatin 130 mg/m², leucovorin 400 mg/m², fluorouracil bolus 400 mg/m² on day 1, and fluorouracil infusion 2400 mg/m², every 3 weeks via repeated catheterisation, or TACE (epirubicin 50 mg, lobaplatin 50 mg, and lipiodol and polyvinyl alcohol particles).
As of April 2020, median OS – the primary endpoint – was significantly longer with HAIC using FOLFOX versus TACE (23.10 months versus 16.07 months; hazard ratio, 0.58; 95% confidence interval [CI], 0.45–0.75; p<0.001). Median progression-free survival (PFS) was 9.63 months (95% CI, 7.40−11.86) with HAIC using FOLFOX and 5.40 months (95% CI, 3.82−6.98) with TACE (p<0.001). The objective response rate was also significantly higher in the HAIC using FOLFOX group compared with the TACE group (RECIST: 45.9% versus 17.9%; p<0.001; mRECIST: 48.4% versus 32.7%; p=0.004). Subsequent surgical resection was performed in 23.8% of patients in the HAIC using FOLFOX group compared with 11.5% of patients receiving TACE (p=0.004). Serious treatment-related adverse events occurred in a greater proportion of patients receiving TACE than HAIG using FOLFOX (30% versus 19%; p=0.03).
Although delivery of this new treatment is more complex than current widely used standard-of-care therapy, the improved efficacy observed with HAIC using FOLFOX over TACE offers promise for patients with unresectable HCC. Final OS data to confirm the survival benefit are awaited.
Abstract and session details
- Shi M et al. Hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil, and leucovorin (FOLFOX) versus transarterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (HCC): A randomised phase III trial. ESMO Virtual Congress 2020, Abstract 981O
Proffered Paper – GI, non colorectal, 20.09.2020, h. 12:30 – 14.10, Channel 1