1Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea
2Department of Medical Oncology and Hematology, Kyung Hee University Hospital, Seoul, Korea
3Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
4Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
5Division of Internal Medicine, Center for Breast Cancer, National Cancer Center, Goyang, Korea
6Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
7Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
8Division of Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
9Department of Medical Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
10Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea
11HERINGS, The Institute of Advanced Clinical & Biomedical Research, Seoul, Korea
Copyright © 2025 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.
Ethical Statement
Our study utilized secondary data from previously published literature, hence, the process of obtaining Institutional Review Board approval was omitted. Approval for the secondary use of data was obtained from the principal investigators included in the analysis.
Author Contributions
Conceived and designed the analysis: Zang DY, Keam B.
Collected the data: Keam B, Kim BJ, Maeng CH.
Contributed data or analysis tools: Keam B, Kim BJ, Maeng CH, Im YH, Ro J, Jung KH, Im SA, Kim TW, Lee JL, Heo DS, Kim SW, Park K, Ahn MJ, Cho BC, Kim HK, Kang YK, Cho JY, Yun HJ, Nam BH.
Performed the analysis: Kim BJ, Keam B, Maeng CH.
Wrote the paper: Kim BJ, Keam B.
Conflicts of Interest
Keam B received research funding from MSD, Bayer, AstraZeneca and Ono Pharmaceutical Co., Ltd., outside of the current work, and has served as an advisor for Handok, NeoImmuneTec, Trialinformatics and ImmuneOncia.
Im SA reports advisory role for AstraZeneca, Novartis, Roche/Genentech, Eisai, Pfizer, Amgen, Hanmi, Lilly, MSD, Daiichi Sankyo, and received research grants through institution from AstraZeneca (Inst), Pfizer (Inst), Roche/Genentech (Inst), Daewoong Pharmaceutical (Inst), Eisai (Inst), Boryung Pharmaceuticals (Inst). Jung KH reports advisory role for AstraZeneca, BIXINK, Takeda Pharmaceuticals, Novartis, Roche, Gilead, Eisai, Pfizer, MSD, Daiichi-Sankyo, Everest Medicine.
Cho BC reports advisory role for KANAPH Therapeutic Inc, Bridgebio therapeutics, Cyrus therapeutics, Guardant Health, Oscotec Inc, J INTS Bio, Therapex Co., Gilead, Amgen, AstraZeneca, Regeneron, Seagen, Samsung Bioepis, and received research grants from MOGAM Institute, LG Chem, Oscotec, Interpark Bio Convergence Corp, Gradiant Bioconvergence, Therapex, GIInnovation, GI-Cell, Abion, Abbvie, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Champions Onoclogy, CJ bioscience, CJ Blossom Park, Cyrus, Dizal Pharma, Genexine, Janssen, Lilly, MSD, Novartis, Nuvalent, Oncternal, Ono, Regeneron, Dong-A ST, Bridgebio therapeutics, Yuhan, ImmuneOncia, Illumina, Kanaph therapeutics, JINTSbio, Hanmi, CHA Bundang Medical Center, Daewoong Pharmaceutical Co., Vertical Bio AG, Korea Institute of Oriental Medicine, National Research Foundation of Korea, KHIDI.
Study code | Phase | Patients | Setting | No. of patients (intervention group) | PFS gain (mo)a) | Sum of PFS gain (mo)b) | OS gain (mo)a) | Sum of OS gain (mo)b) |
---|---|---|---|---|---|---|---|---|
1. BR07-02 [10] | Phase III | Breast cancer | 1st-line | 116 | +3.7c) | +429.2 | +8.8c) | +1,020.8 |
2. BR11-01 [11] | Phase III | Breast cancer | ≥ 1st-line | 114 | +1.7 | +193.8 | –3.6 | –410.4 |
3. BR11-16 [12] | Phase II | Breast cancer | ≥ 2nd-line | 75 | +0.9 | +67.5 | –3.9 | –292.5 |
4. BR13-11 [13] | Phase II | Breast cancer | 1st-line | 59 | +3.0 | +177.0 | NA | NA |
5. BR15-10 [14] | Phase II | Breast cancer | ≥ 1st-line | 92 | +5.7c) | +524.4 | NA | NA |
6. BR15-17 [15] | Phase II | Breast cancer | ≥ 1st-line | 62 | +4.2c) | +260.4 | +6.3 | +390.6 |
7. CO06-01 [16] | Phase II | Colon cancer | 1st-line | 40 | –2.2 | –88.0 | +3.2 | +128.0 |
8. GU10-16 [17] | Phase II | Urothelial carcinoma | 1st-line | 39 | +1.1 | +42.9 | –1.9 | –74.1 |
9. HN16-08 [18] | Phase II | Adenoid cystic carcinoma | ≥ 1st-line | 30 | +8.0 | +240.0 | NA | NA |
10. LU02-01 [19] | Phase III | NSCLC | 1st-line | 156 | –1.6c) | –249.6 | +1.0 | +156.0 |
11. LU Unknown [20] | Phase II | NSCLC | 1st-line | 40 | +0.0c) | +0.0 | +7.4 | +296.0 |
12. LU05-03 [21] | Phase III | NSCLC | 2nd-line | 82 | –0.1c) | –8.2 | +1.9 | +155.8 |
13. LU05-04 [22] | Phase III | NSCLC | 1st-line | 209 | +1.0 | +209.0 | +1.2 | +250.8 |
14. LU08-01 [23] | Phase III | NSCLC | 2nd-line | 68 | +6.0c) | +408.0 | +3.3 | +224.4 |
15. LU12-01 [24] | Phase II | NSCLC | 2nd-line | 80 | –0.8 | –64.0 | +1.3 | +104.0 |
16. LU12-07 [25] | Phase III | SCLC | 1st-line | 48 | +1.9c) | +91.2 | –2.3 | –110.4 |
17. LU12-13 [26] | Phase II | NSCLC | 2nd-line | 46 | –1.0 | –46.0 | +2.2 | +101.2 |
18. ST02-01 [27] | Phase III | Stomach cancer | 1st-line | 88 | +0.2 | +17.6 | –0.6 | –52.8 |
19. ST03-02 [28] | Phase III | Stomach cancer | 1st-line | 139 | +0.6c) | +83.4 | +1.2c) | +166.8 |
20. ST06-01 [29] | Phase III | Stomach cancer | 1st-line | 314 | +1.1c) | +345.4 | +1.7c) | +533.8 |
21. ST10-01 [30] | Phase III | Stomach cancer | 2nd-line | 54 | –1.4 | –75.6 | –1.6 | –86.4 |
Total sum of PFS gain | +2,558.4 mo (+213.2 yr) | Total sum of OS gain | +2,501.6 mo (+208.5 yr) |
KCSG, Korean Cancer Study Group; NA, not available; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; SCLC, small cell lung cancer.
a) PFS or OS gain is defined as the difference between median PFS or OS in the intervention and control group,
b) Sum of PFS or OS gain is defined as the difference between median PFS or OS in the intervention and control groups × the number of patients in the intervention group,
c) Difference was statistically significant.
Study code | Phase | Patients | IP provided (Cost/unit) | No. of patients (receiving IP) | Total cost provideda) |
---|---|---|---|---|---|
1. HN14-01 [31] | Phase II | Salivary gland cancer | Nintedanib (₩29,896/100 mg) | 20 | ₩542,433,024 |
2. LY14-09 (NCT02433795) | Phase II | Lymphoma | Bendamustin (₩151,971/100 mg) | 27 | ₩485,123,177 |
Rituximab (₩897,482/500 mg) | |||||
3. ST14-11 [32] | Phase II | Stomach cancer | Oxaliplatin (₩318,397/100 mg) | 45 | ₩351,507,606 |
Irinotecan (₩116,655/100 mg) | |||||
TS1 (₩3,916/25 mg) | |||||
4. HN15-16 [33] | Phase II | Head & Neck cancer | Durvalumab (₩10,041,606/1,500 mg) | 105 | ₩6,008,340,712 |
Tremelimumab (₩5,574,085/75 mg) | |||||
5. LU16-07 [34] | Phase II | Pulmonary sarcomatoid carcinoma | Durvalumab (₩10,041,606/1,500 mg) | 17 | ₩1,419,533,095 |
Tremelimumab (₩5,574,085/75mg) | |||||
6. HN17-11 [35] | Phase II | Nasopharyngeal cancer | Nivolumab (₩1,118,490/100 mg) | 38 | ₩1,593,139,680 |
Gemcitabine (₩151,164/1,000 mg) | |||||
Total cost provided in 6 studies | ₩10,400,077,294 |
Study code | Phase | Patients | Setting | No. of patients (intervention group) | PFS gain (mo) |
Sum of PFS gain (mo) |
OS gain (mo) |
Sum of OS gain (mo) |
---|---|---|---|---|---|---|---|---|
1. BR07-02 [10] | Phase III | Breast cancer | 1st-line | 116 | +3.7 |
+429.2 | +8.8 |
+1,020.8 |
2. BR11-01 [11] | Phase III | Breast cancer | ≥ 1st-line | 114 | +1.7 | +193.8 | –3.6 | –410.4 |
3. BR11-16 [12] | Phase II | Breast cancer | ≥ 2nd-line | 75 | +0.9 | +67.5 | –3.9 | –292.5 |
4. BR13-11 [13] | Phase II | Breast cancer | 1st-line | 59 | +3.0 | +177.0 | NA | NA |
5. BR15-10 [14] | Phase II | Breast cancer | ≥ 1st-line | 92 | +5.7 |
+524.4 | NA | NA |
6. BR15-17 [15] | Phase II | Breast cancer | ≥ 1st-line | 62 | +4.2 |
+260.4 | +6.3 | +390.6 |
7. CO06-01 [16] | Phase II | Colon cancer | 1st-line | 40 | –2.2 | –88.0 | +3.2 | +128.0 |
8. GU10-16 [17] | Phase II | Urothelial carcinoma | 1st-line | 39 | +1.1 | +42.9 | –1.9 | –74.1 |
9. HN16-08 [18] | Phase II | Adenoid cystic carcinoma | ≥ 1st-line | 30 | +8.0 | +240.0 | NA | NA |
10. LU02-01 [19] | Phase III | NSCLC | 1st-line | 156 | –1.6 |
–249.6 | +1.0 | +156.0 |
11. LU Unknown [20] | Phase II | NSCLC | 1st-line | 40 | +0.0 |
+0.0 | +7.4 | +296.0 |
12. LU05-03 [21] | Phase III | NSCLC | 2nd-line | 82 | –0.1 |
–8.2 | +1.9 | +155.8 |
13. LU05-04 [22] | Phase III | NSCLC | 1st-line | 209 | +1.0 | +209.0 | +1.2 | +250.8 |
14. LU08-01 [23] | Phase III | NSCLC | 2nd-line | 68 | +6.0 |
+408.0 | +3.3 | +224.4 |
15. LU12-01 [24] | Phase II | NSCLC | 2nd-line | 80 | –0.8 | –64.0 | +1.3 | +104.0 |
16. LU12-07 [25] | Phase III | SCLC | 1st-line | 48 | +1.9 |
+91.2 | –2.3 | –110.4 |
17. LU12-13 [26] | Phase II | NSCLC | 2nd-line | 46 | –1.0 | –46.0 | +2.2 | +101.2 |
18. ST02-01 [27] | Phase III | Stomach cancer | 1st-line | 88 | +0.2 | +17.6 | –0.6 | –52.8 |
19. ST03-02 [28] | Phase III | Stomach cancer | 1st-line | 139 | +0.6 |
+83.4 | +1.2 |
+166.8 |
20. ST06-01 [29] | Phase III | Stomach cancer | 1st-line | 314 | +1.1 |
+345.4 | +1.7 |
+533.8 |
21. ST10-01 [30] | Phase III | Stomach cancer | 2nd-line | 54 | –1.4 | –75.6 | –1.6 | –86.4 |
Total sum of PFS gain | +2,558.4 mo (+213.2 yr) | Total sum of OS gain | +2,501.6 mo (+208.5 yr) |
Study code | Phase | Patients | IP provided (Cost/unit) | No. of patients (receiving IP) | Total cost provided |
---|---|---|---|---|---|
1. HN14-01 [31] | Phase II | Salivary gland cancer | Nintedanib (₩29,896/100 mg) | 20 | ₩542,433,024 |
2. LY14-09 (NCT02433795) | Phase II | Lymphoma | Bendamustin (₩151,971/100 mg) | 27 | ₩485,123,177 |
Rituximab (₩897,482/500 mg) | |||||
3. ST14-11 [32] | Phase II | Stomach cancer | Oxaliplatin (₩318,397/100 mg) | 45 | ₩351,507,606 |
Irinotecan (₩116,655/100 mg) | |||||
TS1 (₩3,916/25 mg) | |||||
4. HN15-16 [33] | Phase II | Head & Neck cancer | Durvalumab (₩10,041,606/1,500 mg) | 105 | ₩6,008,340,712 |
Tremelimumab (₩5,574,085/75 mg) | |||||
5. LU16-07 [34] | Phase II | Pulmonary sarcomatoid carcinoma | Durvalumab (₩10,041,606/1,500 mg) | 17 | ₩1,419,533,095 |
Tremelimumab (₩5,574,085/75mg) | |||||
6. HN17-11 [35] | Phase II | Nasopharyngeal cancer | Nivolumab (₩1,118,490/100 mg) | 38 | ₩1,593,139,680 |
Gemcitabine (₩151,164/1,000 mg) | |||||
Total cost provided in 6 studies | ₩10,400,077,294 |
KCSG, Korean Cancer Study Group; NA, not available; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; SCLC, small cell lung cancer. PFS or OS gain is defined as the difference between median PFS or OS in the intervention and control group, Sum of PFS or OS gain is defined as the difference between median PFS or OS in the intervention and control groups × the number of patients in the intervention group, Difference was statistically significant.
IP, investigational product; KCSG, Korean Cancer Study Group. Total cost was calculated using individual patient data, including the number and dose of IP treatments for each patient, obtained through KCSG data warehouse (Trialinformatics).