Yoon, Kim, Hong, Kim, Kim, Kim, Yun, Yoo, Ahn, Kim, Lee, Kim, Park, Jeong, Cheon, Kim, Yun, Lim, Cha, Jang, Zang, Kim, Kang, and Kim: ERRATUM: Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group
ERRATUM: Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group
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
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For the data represented in Table 2, we have corrected the level of evidence of K-CAT level 2 and 3. As the table shown, prospective phase I/II trials required for K-CAT level 2 include clinical trials across tumor types, such as basket trials. For the clinical benefit of specific cancer types, expert consensus is needed. K-CAT level 3A requires a retrospective study or case series with potential clinical benefit in s specific tumor types. K-CAT level 3B is revised from a retrospective study as clinical studies show potential clinical benefits in other indications. The corrected version of the table is below.
Table 2.
KPMNG scale of clinical actionability of molecular target (K-CAT)
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.