J.O. Park

The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with biliary tract cancer (BTC), published in late 2022 were adapted in December 2023, according to established standard methodology, to produce the Pan-Asian adapted (PAGA) ESMO consensus guidelines for the management of Asian patients with BTC. The adapted guidelines presented in this manuscript represent the consensus opinions reached by a panel of Asian experts in the treatment of patients with BTC representing the oncological societies of China (CSCO), Indonesia (ISHMO), India (ISMPO), Japan (JSMO), Korea (KSMO), Malaysia (MOS), the Philippines (PSMO), Singapore (SSO), Taiwan (TOS) and Thailand (TSCO), co-ordinated by ESMO and the Taiwan Oncology Society (TOS). The voting was based on scientific evidence and was independent of the current treatment practices, drug access restrictions and reimbursement decisions in the different regions of Asia. Drug access and reimbursement in the different regions of Asia are discussed separately in the manuscript. The aim is to provide guidance for the optimisation and harmonisation of the management of patients with BTC across the different countries and regions of Asia, drawing on the evidence provided by both Western and Asian trials, whilst respecting the differences in screening practices and molecular profiling, as well as age and stage at presentation. Attention is drawn to the disparity in the drug approvals and reimbursement strategies, between the different countries.

The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with oncogene-addicted metastatic non-small-cell lung cancer (mNSCLC), published in January 2023, was modified according to previously established standard methodology, to produce the Pan-Asian adapted (PAGA) ESMO consensus guidelines for the management of Asian patients with oncogene-addicted mNSCLC. The adapted guidelines presented in this manuscript represent the consensus opinions reached by a panel of Asian experts in the treatment of patients with oncogene-addicted mNSCLC representing the oncological societies of China (CSCO), Indonesia (ISHMO), India (ISMPO), Japan (JSMO), Korea (KSMO), Malaysia (MOS), the Philippines (PSMO), Singapore (SSO), Taiwan (TOS) and Thailand (TSCO), co-ordinated by ESMO and the Korean Society for Medical Oncology (KSMO). The voting was based on scientific evidence and was independent of the current treatment practices, drug access restrictions and reimbursement decisions in the different regions of Asia. The latter are discussed separately in the manuscript. The aim is to provide guidance for the optimisation and harmonisation of the management of patients with oncogene-addicted mNSCLC across the different regions of Asia, drawing on the evidence provided by both Western and Asian trials, while respecting the differences in screening practices, molecular profiling and age and stage at presentation. Attention is drawn to the disparity in the drug approvals and reimbursement strategies between the different regions of Asia.

[[abstract]]The authors report that in the original publication the ESMO-MCBS v1.1 scores for durvalumab-cisplatin-gemcitabine and pembrolizumab-cisplatin-gemcitabine are 4 and 1, respectively. The higher ESMO-MCBS v1.1 score for cisplatin-gemcitabine-durvalumab is due to the high 2-year OS gain observed with this regimen (14.2%). This was, however, based on only 9 patients (2.6% of the durvalumab-treated patients) who were still alive at that time. Thus, it should be noted that it does not currently provide evidence that durvalumab is vastly superior to pembrolizumab in combination with cisplatin-gemcitabine as both drugs incur similar clinical benefit with a HR OS of 0.75 and 0.83 and absolute median OS benefit of 1.6 and 1.8 months, respectively. Future updates to the ESMO-MCBS methodology will account for the proportion of study patients included in tail of the curve survival analyses, resulting in a lower MCBS score for durvalumab-cisplatin-gemcitabine. Recommendation 4a should read as follows: “Recommendation 4a. The combination of cisplatin-gemcitabine with durvalumab or pembrolizumab should be considered as standard of care in first-line BTC [I, A; ESMO-Magnitude of Clinical Benefit (MCBS) v1.1 score for durvalumab: 4; ESMO-MCBS v1.1 score for pembrolizumab: 1]. Cisplatin-gemcitabine-S1 is an alternative therapeutic option for fit patients [II, B].”[Figure presented] The revised Figure 1 Algorithm for the treatment of biliary tract cancer is given below. The authors would like to apologise for any inconvenience caused.