This site is intended for Healthcare professionals only.

First new upfront treatment Unresectable Liver Cancer


First new upfront treatment Unresectable Liver Cancer

Lenvatinib capsules have been approved (Lenvima, Eisai Inc.) as first-line treatment of patients with unresectable Liver Cancer or hepatocellular carcinoma (HCC) by  Food and Drug Administration, USA.

The approval has been accorded after REFLECT study, a multicenter non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC. The subjects were randomized to either 8 mg or 12 mg oral lenvatinib (depending on the patient’s weight) versus 400 mg sorafenib twice daily until disease progression or unacceptable toxicity. The drug is approved at the 8 mg once-daily dose for patients <60 kg and at the 12 mg once-daily dose for those ≥60 kgs.

The trial showed that lenvatinib was non-inferior to sorafenib (HR 0.92, 95% CI 0.79-1.06). Though not statistically superior, median overall survival was 13.6 months in the lenvatinib-treated group versus 12.3 months in the sorafenib group. It also demonstrated a statistically significant improvement in progression-free survival (PFS) with lenvatinib as compared to sorafenib. The overall response rate was higher for the lenvatinib arm as compared to sorafenib (41% vs. 12% per mRECIST and 19% vs. 7% per RECIST 1.1).

“Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade,” said Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center in New York City, in a press release from drugmaker Eisai. “REFLECT is the first-ever positive phase III trial against an active comparator in unresectable HCC.”

The most common adverse reactions observed in the lenvatinib-treated patients with HCC (≥20%) in order of decreasing frequency were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.

The recommended lenvatinib dosages for patients with HCC are the following:

  • 12 mg orally once daily in patients 60 kg or greater actual body weight or
  • 8 mg orally once daily in patients less than 60 kg actual body weight.

Lenvatinib was previously approved for advanced thyroid cancer and renal cell carcinoma.

The following two tabs change content below.
Dr. Kamal Kant Kohli

Dr. Kamal Kant Kohli

A Medical practitioner with a flair for writing medical articles, Dr Kamal Kant Kohli joined Medical Dialogues as an Editor-in-Chief for the Speciality Medical Dialogues. Before Joining Medical Dialogues, he has served as the Hony. Secretary of the Delhi Medical Association as well as the chairman of Anti-Quackery Committee in Delhi and worked with other Medical Councils of India. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751
Source: Press Release

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted