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The most recent version of the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of hepatocellular carcinoma (HCC) was published in 2018, and covered the diagnosis, management, treatment and follow-up of early, intermediate and advanced disease. At the ESMO Asia Meeting in November 2018 it was decided by both the ESMO and the Taiwan Oncology Society (TOS) to convene a special guidelines meeting immediately after the Taiwan Joint Cancer Conference (TJCC) in May 2019 in Taipei. The aim was to adapt the ESMO 2018 guidelines to take into account both the ethnic and the geographic differences in practice associated with the treatment of HCC in Asian patients. These guidelines represent the consensus opinions reached by experts in the treatment of patients with intermediate and advanced/relapsed HCC representing the oncology societies of Taiwan (TOS), China (CSCO), India (ISMPO) Japan (JSMO), Korea (KSMO), Malaysia (MOS) and Singapore (SSO). The voting was based on scientific evidence, and was independent of the current treatment practices, the drug availability and reimbursement situations in the individual participating Asian countries., Competing Interests: Disclosure GSB has received fees for consultancy/advisory roles from VICUS Therapeutics, Mylan, Biocon, Cipla, Boehringer Ingelheim, Novartis, GlaxoSmithKline and MSD, and research funding from VICUS Therapeutics and Cipla. AC has received fees for consultancy/advisory roles from Merck Serono, Roche, Beigene, Bayer, Servier, Eli Lilly, Novartis, Takeda, Astelas and Pierre Fabre, and research funding from Genentech, Merck Serono, Roche, Beigene, Bayer, Servier, Eli Lilly, Novartis, Takeda, Astelas, Fibrogen, Amcure, Sierra Oncology, AstraZeneca, Medimmune, Bristol-Myers Squibb and MSD. A-LC has received fees for consultancy/advisory roles from Bayer Schering Pharma, Bristol-Myers Squibb, Eisai, Merck Serono, Novartis, Ono Pharmaceutical, Exelixis, Nucleix Ltd., Roche/Genentech and IQVIA. L-TC has received research funding from Novartis, Merck Serono, TTY, Polaris, SyncorePharm, Pfizer and Bristol-Myers Squibb, honoraria from ONO, Eli Lilly, MSD, PharmaEngine, TTY, SyncorePharm, Novartis, AstraZeneca and Ipsen, patents and royalties for ENO-1 mAb from HuniLife, and is a Scientific Advisory Board member at PharmaEngine and a board member at SinoPharm Taiwan, Ltd. SPC has received fees for consultancy/advisory roles from Sirtex, Bristol-Myers Squibb, Bayer, Eisai, Ipsen, Celgene and Eli Lilly, and research funding from Sirtex and Bristol-Myers Squibb. CHH has received fees for consultancy/advisory roles from Ono Pharmaceutical, Bristol-Myers Squibb, Merck Sharp & Dohme and Merck Serono, and research funding from AstraZeneca, Genentech and Merck Sharp & Dohme. MI has received research funding from Eli Lilly Japan, Bayer, Eisai, Bristol-Myers Squibb, Ono Pharmaceutical, AstraZeneca and Merck Serono. H-YL has received fees for consultancy/advisory roles from Bayer, Bristol-Myers Squibb and Eisai. EM has received fees for consultancy/advisory roles from Amgen, Bayer, Merck Serono, Roche, Servier, AstraZeneca and Pierre Fabre. HM has received fees for consultancy/advisory roles from Mylan, Cipla, Pfizer, Eli Lilly, Novartis and AstraZeneca, and research funding from Novartis. GP has received fees for consultancy/advisory roles from Roche, Amgen, MSD, Boehringer and Bristol-Myers Squibb, and research funding from Roche, Amgen, Astellas, Pfizer and Novartis. DT has received fees for consultancy/advisory roles from Novartis, Celgene and MSD, and research funding from Novartis, Sirtex and Bristol-Myers Squibb. JT has received fees for consultancy/advisory roles from Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Infection Biosciences Limited, Ipsen, Kura Oncology, Eli Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F. Hoffmann-La Roche Ltd., Sanofi, SeaGen, Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, Biocartis, Foundation Medicine, HalioDX SAS and Roche Diagnostics. MU has received research funding from Taiho Pharmaceutical, Shire, Daiichi Sankyo, Eisai, AstraZeneca, Ono Pharmaceutical, MSD, Merck Serono, NanoCarrier, Dainippon Sumitomo Pharma, Incyte, ASLAN Pharmaceuticals and Yakult Honsha. AV has received fees for consultancy/advisory roles from Bayer, Merck Serono, Roche, Servier, AstraZeneca, Pierre Fabre, Bristol-Myers Squibb, MSD, Celgene, Beigene, EISAI, INCYTE, Eli Lilly and BTG, and research funding from INCYTE. TY has received research funding from Novartis Pharma K.K., MSD K.K., Sumitomo Dainippon Pharma Co., Ltd., Chugai Pharmaceutical Co., Ltd., Sanofi K.K., Daiichi Sankyo Co., Ltd., Parexel International Inc., Ono Pharmaceutical Co., Ltd., GlaxoSmithKline K.K. and Boehringer Ingelheim Japan, Inc. S-CC, J-YD, CH, GFH, Y-HH, TCK, S-NL, SQ, B-YR, ZR, Y-CS, C-JY and YY have declared no conflicts of interest., (Copyright © 2020 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.)

Purpose Trifluridine/tipiracil (TAS-102) was effective in patients with metastatic colorectal cancer (mCRC) in a phase II Japanese trial. This regional trial evaluated the efficacy and safety of trifluridine/tipiracil in Asian patients with mCRC with or without exposure to biologic therapy. Patients and Methods This randomized, double-blind, placebo-controlled, phase III trial was conducted at 30 sites in China, the Republic of Korea, and Thailand. Patients ≥ 18 years old with histologically or cytologically confirmed adenocarcinoma of the colon or rectum and known KRAS status who were refractory or intolerant to two or more prior chemotherapy regimens were enrolled. Eligible patients were randomly assigned (2:1 ratio; minimization method) to receive trifluridine/tipiracil (twice per day orally; 5 days on and 2 days off for 2 weeks, followed by 14 days off per cycle) or placebo. The primary end point was overall survival (intent-to-treat population). Results Between October 16, 2013, and June 15, 2015, 406 patients were randomly assigned to receive trifluridine/tipiracil (n = 271) or placebo (n = 135). Risk of death was significantly lower in the trifluridine/tipiracil arm than in the placebo arm (hazard ratio for death, 0.79; 95% CI, 0.62 to 0.99; log-rank P = .035). Median overall survival was significantly longer in the trifluridine/tipiracil than in the placebo arm (7.8 months [95% CI, 7.1 to 8.8 months] v 7.1 months [95% CI, 5.9 to 8.2 months], respectively), for a median survival follow-up time of 13.8 months (95% CI, 13.1 to 15.3 months) compared with 13.4 months (95% CI, 11.6 to 17.3 months), respectively. The incidence of serious adverse events was similar between the arms (trifluridine/tipiracil, n = 63 [23.2%]; placebo, n = 32 [23.7%]). No treatment-related deaths were reported. Conclusion Trifluridine/tipiracil has a statistically significant survival benefit compared with placebo in Asian patients with mCRC refractory or intolerant to standard chemotherapies, regardless of exposure to biologic therapy. The safety profile is similar to previous reports.

The largest burden of hepatocellular carcinoma (HCC) lies in Asia, secondary to hepatitis B virus (HBV) infection. Improved survival with sorafenib has fostered new research but many challenges remain in designing clinical trials. The disease, its management, and populations affected by it are heterogeneous worldwide and within Asia. An expert conference of Eastern Asian oncologists and hepatologists was convened to foster consensus in clinical trial design. The panel identified key areas that need to be addressed to facilitate clinical trials in Asia. Stratification by viral etiology is desirable within Asia and by region in global trials. Antiviral therapy should also be considered as a stratification factor and incorporated into HCC management in trials. The panel agreed that histological diagnosis is not required for trial entry and that Barcelona-Clinic Liver Cancer (BCLC) staging is acceptable for trials as long as portal hypertension can be better defined with standardized methodology. Consensus in treatment must be sought to allow multi-national trials and it must be recognized that first-line sorafenib is not largely feasible in Asia. Finally, Asian nations must be urged to participate in clinical trials, many of which are ongoing, to advance new treatment options in this challenging disease.