Frontline Lenvima Provided Survival Benefit for Patients With Liver Cancer

In a trial of patients with hepatocellular carcinoma (HCC) — the most common type of liver cancer — a survival benefit was seen when Lenvima (lenvatinib) was given as initial treatment as opposed to trans-arterial chemoembolization (TACE), which is the standard treatment.

The researchers conducted an observational study of 31 eligible patients across multiple cancer centers, seeking to determine whether treatment with Lenvima was effective for patients with stage B2 HCC who had not previously had TACE and systemic chemotherapy, and had preserved organ function.

All the patients in the trial had HCC that was stage B2, as defined by the Barcelona Clinic Liver Cancer (BCLC) staging system, which is a set of criteria for the management of HCC based on performance status, tumor extent and Child-Pugh score (an assessment of prognosis of liver disease).

Results were presented at the 2022 ASCO Gastrointestinal Cancers Symposium.

The study’s main goal of overall survival was met, with 71% of patients being alive after one year of treatment. The median overall survival — or amount of time that a patient survives starting from the time of treatment — was 17 months.

The median progression-free survival, or time from treatment until the disease progresses, was 10.4 months. The objective response rate (ORR), which shows the percentage of patients who responded to treatment, was measured by two different models —RECIST 1.1 and mRECIST — with the difference being that mRECIST criteria only measures the enhanced or viable portion of lesions. For RECIST 1.1, overall response rate was 22.6%, and 70.0% for mRECIST.

Given that the standard treatment for these patients is TACE — a way of localizing chemotherapy and synthetic materials into a blood vessel to cut off the tumor’s blood supply and force chemotherapy within the tumor — researchers stressed Lenvima may not be suitable for some patients.

If a patient’s disease does not meet the up-to-7 criteria, which is devised by adding the number of tumors plus the diameter (in centimeters) of the largest tumors. If that number is greater than seven, the person may have a decline in their liver function, and Lenvima treatment may not be as beneficial.

Most of the patients were men (94%), with causes of chronic liver disease being hepatitis B virus (three patients), hepatitis C virus (six), alcohol abuse (nine) or other (10).

The most common side effects of any severity patients experienced were fatigue (68%) hypertension (65%) and anorexia (61%). Common serious or severe side effects were: increased aspartate aminotransferase (23%), which is a blood test that identifies liver damage; increased alanine aminotransferase (16%), which also indicates liver damage; and severe or worse proteinuria, which is increased levels of protein in urine (13%).

Treatment interruption was required in 61% of patients, and dose reduction in 81%. Out of 24 patients at the time of researcher analysis, 17 (55%) discontinued because of disease progression, nine (29%) due to side effects, and two (6%) to switch to curative treatments. There was one patient death of unknown causes, though the patient’s disease had partially responded to the treatment prior to their death.

For post-study treatment, 11 patients were treated with systemic chemotherapy, six were given TACE and one was given trans-arterial infusion.

Looking ahead, the researchers wrote that randomized trials comparing Lenvima and TACE for these patients are warranted, and systemic chemotherapy before TACE will be a standard treatment strategy.

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