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1

2 (423) 1 (4), (6) C55H84ClN17O21S3 HCl (BLM-A2)

3 [ ] ( ) ( ) 1. 15mg 30mg( ) 5 20mL 1 5mg( ) 2. 3

4 15mg 30mg( ) 5mL 1mg( ) 1mL 3. 5mg 15mg( ) ( ) mg( ) 360mg 6. 10mg 20mg /m mg 4

5 mg 15mg 30mg 15mg 30mg 5 20mL 1 5mg 15mg 30mg 5mL 1mg /1mL 5mg 15mg mg 5

6 Streptomyces verticillus PVB Ann Intern Med 87: , 1977 D VAB-6 Ann Intern Med 95: 59-61, 1981 BEP Br J Cancer 47: , 1983 BEP Int. J. Cancer 53: ,

7 SuSa GH 833K 1618K GCT27 IC ng/ml 2.4 ng/ml IC ng/ml 0.15 ng/ml ng/ml 29.0 ng/ml ng/ml 21.5 ng/ml Investigational New Drugs 8: S19-S24, 1990 line H 12.1 line H line H mg/kg mg/kg mg/kg mg/kg 600mg/kg mg/kg mg/kg mg/kg mg/kg line H , : 1983 JTG-1 4mg/kg 5 0.5mg/kg 2 0.1mg/kg % 4mg/kg % 44(4), , 1990 YST-1 YST-2 YST-3 T/C YST-1 YST-2 YST-3 90mg/kg 4 3 T/C % 30mg/kg 0.6mg/kg 2mg/kg 4 3 T/C % DNA J. Med. 7, , 1976 DNA XRCC X-ray repair cross-complementing 1 XRCC Cancer Res. 58, , 1998 DNA DNA 7

8 XRCC1 XRCC1 Carcinogenesis 23, , J. Antibiot. 25, , (1) -1 Cancer 31: , mg/kg 2 400mg VBL VBL mg / /20 VBL % 22% 17% 14% 13% 10% 10% 8% (2) BEP PVB -2 N Engl J Med 316: ,

9 Indiana 261 PVB CDDP VBL BEP ETP CDDP CR PVB 61 74/121 BEP 60 74/123 PVB 12 BEP 23 PVB 74 BEP 83 M.D.Anderson Indiana Advanced BEP PVB M.D.Anderson :p 0.05 Indiana p= % BEP PVB M.D.Anderson :p=0.048 Indiana p=0.017 log-rank 59% 500/mm 3 BEP PVB p ,000/mm 3 PVB 5 BEP 14 PVB 2 BEP 6 PVB 38%:23, p 0.02 PVB 20%:5, p= PVB 19 BEP 1 p= PVB 4 BEP 2 PVB 2 BEP 3 PVB 1 BEP PVB (3) PVB PV -3 J Clin Oncol 11: , PVB PV PV 108 PVB 110 CR PV 82 PVB 87 PV 89 PVB 94 p= PV 7 PVB 5 PV PVB (p=0.70 log-rank ) PV PVB 6 5 PV p=0.02 9

10 PVB PV PVB CDDP PV (4) BEP 4 EP 4-4 J Clin Oncol 15: , 1997 EORTC(European Organization for Research and Treatment of Cancer) 419 BEP 4 EP BEP 200 EP 195 CR BEP 92 EP 85% (p=0.0276) BEP 95% EP 87% (p=0.0075) 7.3 4% 10 BEP : EP : p log-rank ; BEP EP HR : CR p 0.83, HR 1.1; 95 ; p 0.262, HR 1.67; 95 ; , CR p 0.702, HR 1.24; 95 ; BEP :3, EP :1 BEP EP 1 7 BEP BEP (p<0.001) BEP 2 BEP (5) BEP 3 BEP 4-5 J Clin Oncol16: , 1998 Indiana BEP BEP 3 56 BEP p 0.80, p=0.93 log-rank Cox HCG HCG 1,000 miu/ml HCG>1,000 10

11 miu/ml 14 5 p<0.001 BEP 3 4 (6) BEP 3 EP 3-6 J Clin Oncol 13: , 1995 ECOG(the Eastern Cooperative Oncology Group) 178 BEP 3 EP BEP 86 EP 85 CR BEP 77 EP 71 BEP 94 EP 88 p=0.20 BEP 3 3/86 EP 11 9/85 BEP 2 2/86 EP 9 8/85 EP BEP 10 8/81 EP 23 17/75 EP EP 38 32/85 BEP 17 15/86 p BEP 95 EP 86 BEP p=0.01 log-rank 3 BEP (7) BEP 4 VIP 4-7 J Clin Oncol 16: , 1998 ECOG SWOG(the Southwestern Oncology Group) CALGB(the Cancer and Leukemia Study Group B) 304 BEP VIP (ETP CDDP) CR BEP 31 43/141 VIP 37 54/145 p=0.26 FR (favorable response) CR 2 PR BEP 60 83/139 VIP 63 89/142 2 BEP 71 VIP 74 p=0.78 log-rank 2 failure-free BEP 60 VIP 64 p=0.29 log-rank 299 Grade 3 VIP BEP p<0.001 VIP BEP 11

12 p= BEP (8) PVB VAB-6 BVP PEB -8 82(6); , PVB CDDP VBL VAB-6 -D ACT-D VBL CDDP) ETP (A ) ETP PEB BEP (B ) A CR PR A 20 B 14 CR A 35% B 43% PR A 45% B 50% 3 A 74 B 100 B A PVB VAB-6 BVP PEB (9) PVeBV -9 87(1): 35-41, 1996 retrospective 8 PVeBV CDDP ETP VBL PVeBV 3 PVeBV 4 CR 46 PVeBV CR PVeBV CR PVeBV (10) -10 Med Pediatr Oncol 23(5): , 1994 GPO(German Society of Pediatric Oncology) PVB PVB PVB PVB VIP A 1 12

13 3 1 PVB (11) BEP -11 J Clin Oncol 12(4): , 1994 GOG Gynecologic Oncology Group BEP (12) ACT-D CDDP 3 BAP -12 Oncology Reports 7: , BEP ETP ACT-D BAP BEP BAP 6 BEP BAP BEP 83.3 p= log-rank 3 BEP BAP BAP (13) -13 Cancer 71(8): , 1993 SWOG BEP ADR EBAP PVB PVB-EBAP / / /41 Nadir 800/ L : / L

14 PVB-EBAP (14) -14 Int J Clin Oncol1: 51-56, PVB PVcBA CDDP VCR ACT-D PVB VAB-6 High-dose BEP 9 6 CR 1 CR 2 PR CR Grade3 high-dose BEP VAB PVcBA PVB 1 VAB-6 BEP 1 2. BEP (Cancer-Principles&Practice of Oncology 6 th ed, Holland-Frei Cancer Medicine ) EP BEP (National Cancer Institute) PDQ Treatment Health Professionals BEP 2(2) 14

15 B III III BEP PVB VAB-6 +VBL+ACT-D+CDDP+CPM PDQ II III BEP 3 CAMPBELL S UROLOGY AJCC III IIA IIB BEP 2-3 C BEP 3 IFM Cancer-Principles&Practice of Oncology AJCC C BEP 3 EP 4 BEP 4 C Holland-Frei Cancer Medicine 5 10cm 10cm CDDP B1,B2 B2 BEP 2 B3 BEP 4 EP

16 BEP 90% BEP yolk sac tumor CR 90 CR PVB BEP (PVB, BEP ) 16

17 VAB-6 20mg/m 2 3 / Z.Kinderchir,44(4): , Br.J.Cancer,62: , 1990 Med.Pediatr.Oncol23(5): , 1994 Pediatr.Hematol.Oncol., 15(3), , 1998 Pediatr. Hematol.Oncol., 17(1), , mg/m Cancer-Principles&Practice of Oncology -3 6 PVB BEP PVB BEP NCI-PDQ BEP BEP 17

18 ABVD ABVD 10mg/m 2 day1 day15 28 ABVD NCI-PCQ: http: // cancernet. nci. nih. gov) 2 15: ,2001 J Clin Oncol16: , 1998 N Eng J Med327: ,1992 BEP PVB 10 20mg/m BEP 15 20mg/m 2 10mg/m mg :/body mg/m mg/m mg/m mg/m VAB-6 modified PVB BEP Proceedings of the American Society of Clinical Oncology, 16, A1840, 511a,1997 Proceedings of the American Society of Clinical Oncology, 17, A2016, 525a, 1998 Proceedings of the American Society of Clinical Oncology, 17, A2017, 525a, 1998 BEP

19 30mg U /body mg 30mg U /body BEP PVB J.Clin.Oncol., 1, ,

20 GCP

21 BEP BEP

22 300mg/body BEP mg(U)/body mg/body 300mg/body mg mg( mg mg / mg / mg /69 451mg / mg 301mg mg mg mg mg BEP 360mg mg / mg / mg / mg mg 360mg 3 pp , 2003 ( ). 29 6, , 2002 BEP BEP NCI PDQ Bosl GJ. et al.:cancer of the testis. In: DeVita VT Jr., Hellman S, Rosenberg SA(Hrsg) : Cancer-Principles & Practice of Oncology 6 th Ed, pp , Lippincott Williams&Wilkins, Philadelphia, 2001 BEP 360mg mg mg mg 300mg 330mg 22

23 BEP BEP 360mg BEP 4 300mg. BEP 300mg BEP J Clin Oncol 7:387-91, 1989 BEP 4 Cancer-Principles & Practice Onclogy 2 7 Br J Cancer 71: , 1995 Cancer 97: , 2003, Jpn J Cancer Chemother 29: , BEP 4 89 Cancer 97: , U 360mg Cancer 97: , 2003 BEP 57% 49% 300mg 360mg 300mg 360mg 150mg( ) mg( ) mg( ) mg/m

24 1.5 m mg/body 1 (30mg) ( ) ( ) 24

25 1. 15mg 30mg( ) 5 20mL 1 5mg( ) 2. 15mg 30mg( ) 5mL 1mg( ) 1mL 3. 5mg 15mg( ) ( ) mg( ) 360mg 6. 10mg 20mg /m mg 25

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