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The upward trend in the immunotherapy utilization for hepatobiliary cancers.

| https://dx.doi.org/10.21037/hbsn-21-342 Hepatobiliary cancers (HBCs) include those of the liver [mainly hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma] and biliary tract (extrahepatic cholangiocarcinoma and gallbladder cancer). Based on the 2020 global cancer statistics, liver cancer ranks seventh in incidence and third in mortality among all malignant tumors, while gallbladder cancer ranks 25 in incidence and 21 in mortality (1). Due to the lack of typical symptoms and signs at the early stages, HBCs are often diagnosed at intermediate or advanced stages, and thus the opportunity of curative surgical interventions is missed (2). Therefore, most patients with HBC can only be treated with noncurative treatments, including immunotherapy. Several immunotherapeutic approaches have been attempted for HBCs, including oncolytic viruses, tumor vaccines, adoptive immunotherapy, and immune checkpoint inhibitors (ICIs; Figure 1). Of them, only ICIs, a promising group of agents that have been used in several malignancies in the past decade, have been used in clinical practice to prolong survival, and thus represent a new era in the treatment of HBCs. ICIs disrupt the tumor’s immune tolerance, causing reactivation of the host’s immune system against the cancer cells. Common ICIs include inhibitors of programmed cell death protein-1 (PD-1), programmed cell death ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated antigen-4 (CTLA-4). The use of immunotherapy may vary widely among different parts of the world and even among patient subgroups in the same country or area. In one study, Sahara et al. (3) used the National Cancer Database to investigate the use of immunotherapy for HBC as well as factors affecting such use in USA. The most important finding was that the overall use of immunotherapy in US patients with HBCs was rather low but increased over time, while HCC, especially at the advanced stage, was the most frequent indication for the use of immunotherapy (3). These findings reflect the recent developments in immunotherapy for the management of HBCs. In 2017, based on the results of the CheckMate040 trial, the US Food and Drug Administration (FDA) approved the first ICI, nivolumab, as a second-line treatment option for patients with advanced or metastatic HCC (4). Following this, several trials were conducted that assessed the safety and efficacy of ICIs, given with or without tyrosine kinase inhibitors, as firstline (e.g., lenvatinib plus pembrolizumab, atezolizumab plus bevacizumab, sintilimab plus bevacizumab) or second-line therapy (e.g., pembrolizumab, nivolumab plus ipilimumab) in patients with advanced HCC (Table 1) (5-8). Further trials and retrospective studies have evaluated the efficacy of ICIs in patients with advanced HCC (9,10). Currently, several ICIs have been approved by the FDA and included in the scientific guidelines, and their clinical use is being expanded to patients with HCC. The more frequent use of immunotherapy in patients Editorial