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FOLFOX4 outperformed doxorubicin in advanced hepatocellular carcinoma
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FOLFOX4 yielded an OS rate that was nearly 2 months longer than the rate associated with doxorubicin in a cohort of patients in Asia, according to data presented at the 2011 Gastrointestinal Cancers Symposium.
The findings of the EACH trial were presented by Sumitra Thongprasert, MD, of Chiang Mai University in Thailand.
The trial involved 371 patients from Asia with locally advanced or metastatic hepatocellular carcinoma. Eligible participants were ineligible for resection, had at least one measurable lesion, were chemotherapy-naive and had adequate bone marrow function. Exclusion criteria included previous liver transplant and central nervous system metastasis.
The two treatment regimens were FOLFOX4 — IV oxaliplatin (Eloxatin, Sanofi-Aventis) at 85 mg/m2 on day 1; IV leucovorin at 200 mg/m2 on days 1 and 2; IV 5-FU at 400 mg/m2, then 600 mg/m2 over 22 hours on days 1 and 2 every 2 weeks — or IV doxorubicin (50 mg/m2 every 3 weeks).
There were 184 patients in the FOLFOX4 group and 187 patients in the doxorubicin group.
“FOLFOX4 showed an overall survival benefit in the [intention-to-treat] population,” Thongprasert said, noting that the median OS was 6.4 months (95% CI, 5.30-7.03) with FOLFOX4 and 4.97 months (95% CI, 4.23-6.03) with doxorubicin (P=.0695 using a stratified log-rank test); statistical significance (P=.0425) was achieved at the post hoc follow-up analysis conducted 7 months later.
Median PFS was also statistically superior in the FOLFOX4 arm, 2.93 months (95% CI, 2.43-3.53) vs. 1.77 months (95% CI, 1.63-2.30).
The response rate was 8.2% in the FOLFOX4 arm and 2.7% in the doxorubicin arm (P=.0233). The disease control rate also was higher among patients receiving FOLFOX4, 52.2% vs. 31.6% (P<.0001).
FOLFOX4 yielded significantly better outcomes with regard to OS, PFS, response rate and disease control rate in final and follow-up analyses of a Chinese subpopulation.
“The overall survival benefit of FOLFOX4 was consistent in all subgroup populations except those with high-grade [hepatocellular carcinoma],” Thongprasert said. “FOLFOX4 is the first chemotherapy regimen to demonstrate prolonged survival in advanced [hepatocellular carcinoma].”
The primary endpoint was OS. PFS, response rate (by RECIST) and safety were secondary endpoints. The current findings are from final and follow-up analyses of the intention-to-treat population and selected subgroup.
The study was conducted to evaluate the efficacy and safety of FOLFOX4 compared with doxorubicin in advanced hepatocellular carcinoma. Thongprasert said prognoses are often poor among Asian patients with locally advanced or metastatic hepatocellular carcinoma due to the prevalence of hepatitis B virus.
For more information:
- Thongprasert S. #160. Presented at: the 2011 Gastrointestinal Cancers Symposium; Jan. 20-22, 2011; San Francisco.
Disclosure: Dr. Thongprasert reported no relevant financial disclosures.