In a Chinese single-center phase II trial reported in JAMA Surgery, Wu et al found neoadjuvant intensity-modulated radiotherapy (IMRT) followed by hepatectomy could be an effective treatment option in patients with centrally located hepatocellular carcinoma.
Study Details
In the study, 38 patients enrolled between December 2014 and January 2019 at the Cancer Institute and Hospital of the Chinese Academy of Medical Sciences, Beijing, were treated with IMRT at a prescribed dose of 50 Gy in 25 fractions prior to hepatectomy. The primary outcome measure was 5-year overall survival.
Key Findings
Radiographic tumor response to IMRT assessed prior to surgery included partial response in 16 patients (42.1%) and stable disease in 22 (57.9%). Major pathologic response was achieved in 13 patients (34.2%), including pathologic complete response in 5 (13.2%).
The median follow-up was 45.8 months (range = 6.2–80.2 months). Median overall survival was not reached; 1-, 3-, and 5-year rates were 94.6%, 75.4%, and 69.1%, respectively. Median disease-free survival was 45.8 months (range = 1.9–77.5 months); 1-, 3-, and 5-year rates were 70.3%, 54.1%, and 41.0%, respectively.
Acute radiotherapy-related adverse events were observed in 33 patients (86.8%), with grade 3 events observed in 3 patients (7.9%; thrombocytopenia, increased alanine aminotransferase, and increased aspartate aminotransferase in 1 patient each). No grade ≥ 4 acute toxicity and no late radiotherapy-related toxicity were observed.
Operative complications occurred in 13 patients (34.2%), including Clavien-Dindo grade I to II complications in 12 patients (31.6%) and a grade IIIa complication (pleural effusion) in 1 (2.6%).
The investigators concluded, “Results of this trial suggest that neoadjuvant IMRT plus surgery is effective and well-tolerated in patients with centrally located hepatocellular carcinoma. These data may inform a future randomized clinical trial of this new treatment strategy.”
Jianxiong Wu, MD, of the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Weihu Wang, MD, of the Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, are the corresponding authors for the JAMA Surgery article.
Disclosure: The study was supported by grants from the National Natural Science Foundation of China, Beijing Municipal Science & Technology Commission, and others. For full disclosures of the study authors, visit jamanetwork.com.
