Adjuvant radioimmunotherapy may boost survival after liver-cancer surgery

Last Updated: 2020-03-19

By Reuters Staff

NEW YORK (Reuters Health) - Adjuvant treatment with radioactive iodine (131-I)-labeled metuximab prolongs survival after resection of hepatocellular carcinoma (HCC) expressing CD147, according to results of an open-label, phase-2 trial from China.

"This treatment was particularly effective in patients with HCC tumors that were larger than 5 cm in diameter, had microvascular invasion, were not completely encapsulated, and were poorly differentiated," histopathological features that are closely associated with a high risk of early recurrence, the researchers report in The Lancet Gastroenterology & Hepatology.

For the study, 156 patients aged 18 to 75 years who underwent curative-intent resection of histologically confirmed HCC expressing CD147 were randomly allocated to adjuvant 131-I-metuximab (one transarterial injection given four to six weeks after surgery) or no adjuvant treatment. There were 78 patients in each group. Median follow-up was 55.9 months.

Five-year recurrence-free survival, the primary outcome, was significantly higher in the metuximab group than the control group (43.4% vs. 21.7%; hazard ratio, 0.49; 95% confidence interval, 0.34 to 0.72), report Dr. Feng Shen of Second Military Medical University, in Shanghai, and colleagues.

The study also confirmed CD147 not only as a negative prognostic marker, but also as a positive predictor of successful adjuvant 131-I-metuximab therapy, note the authors of a comment published with the study.

"This result is important because, with the exception of high blood alpha-fetoprotein concentrations as a positive predictor of response to ramucirumab, there are currently no established biomarkers that can predict response to HCC therapies," write Dr. Arndt Vogel and Dr. Anna Saborowski of Hannover Medical School in Germany.

Adverse events associated with adjuvant 131-I-metuximab occurred in 45% of patients. These events were grade 3 or 4 in 21% of patients. "These adverse events were all resolved with appropriate treatment within 2 weeks of being identified," the study team reports.

"Overall, the study provides convincing evidence supporting the antitumor activity of adjuvant 131-I-metuximab in a selected high-risk patient population with CD147-positive tumors," write Drs. Vogel and Saborowski, "and the authors have a strong rationale to verify these data in a phase 3 trial. A follow-up study should preferably be done in a global setting and should include a larger proportion of non-HBV-infected patients with an age-range similar to that in other clinical trials involving patients with HCC."

Dr. Shen did not respond to a request for comment by press time.

The study was funded by the State Key Project on Infectious Diseases of China. The authors declared no conflicts of interest.

SOURCE: http://bit.ly/391fY4g and http://bit.ly/2w9Qg0t Lancet Gastroenterology & Hepatology, online March 9, 2020.