1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
3Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
4Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
5Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
6Department of Genomic Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
7Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
8Department of Oncology/Hematology, Kyungpook National University Chilgok Hospital, Daegu, Korea
9Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
10Department of Medical Oncology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea
11Division of Hematology/Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
12Division of Medical Oncology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
13Center for Colorectal Cancer, National Cancer Center, Research Institute and Hospital, Goyang, Korea
14Department of Internal Medicine, Hallym University Medical Center, Hallym University, Anyang, Korea
Copyright © 2023 by the Korean Cancer Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Level | Clinical implication | Required level of evidence |
---|---|---|
1 | Treatment should be considered standard of care | MFDS, FDA, EMA or equivalent-approved drug OR |
Prospective, randomized, phase III trials showing the benefit of survival endpoints | ||
2 | Treatment would be considered | Prospective phase I/II trials show clinical benefita) |
3 | Clinical trials to be discussed with patients | A: Retrospective study or case series show potential clinical benefit in a specific tumor type |
B: Clinical studies show potential clinical benefit in other indications | ||
4 | Preclinical data only, lack of clinical data | Preclinical evidence suggests the potential benefit |
G | Suspicious germline variant on tumor tissue NGS | Suggestive actionable germline variant on tumor tissue testing |
R | Predictive biomarker of resistance | FDA-recognized predictive biomarker of resistance |
EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration; K-CAT, KPMNG scale of Clinical Actionability of molecular Targets; KPMNG, Korean Precision Medicine Networking Group; MFDS, Ministry of Food and Drug Safety; NGS, next-generation sequencing.
a) Prospective phase I/II trials supporting level 2 targets include clinical trials across tumor types such as basket trials. In this case, the clinical benefit needs to be judged by expert consensus.
Level | Clinical implication | Required level of evidence |
---|---|---|
1 | Treatment should be considered standard of care | MFDS, FDA, EMA or equivalent-approved drug OR |
Prospective, randomized, phase III trials showing the benefit of survival endpoints | ||
2 | Treatment would be considered | Prospective phase I/II trials show clinical benefit |
3 | Clinical trials to be discussed with patients | A: Retrospective study or case series show potential clinical benefit in a specific tumor type |
B: Clinical studies show potential clinical benefit in other indications | ||
4 | Preclinical data only, lack of clinical data | Preclinical evidence suggests the potential benefit |
G | Suspicious germline variant on tumor tissue NGS | Suggestive actionable germline variant on tumor tissue testing |
R | Predictive biomarker of resistance | FDA-recognized predictive biomarker of resistance |
EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration; K-CAT, KPMNG scale of Clinical Actionability of molecular Targets; KPMNG, Korean Precision Medicine Networking Group; MFDS, Ministry of Food and Drug Safety; NGS, next-generation sequencing.