IPSS DCCT DCCT Provided by Dr. John Lachin 2
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1 2008Mar09 CSPOR CRC NSAS-BC02 DFS Disease Free Survival CSPOR-BC NPO NPO / Validity Time-to- Reliability Reproducibility QALY Intra-rater reliability Inter-rater reliability Sensitivity Feasibility IPSS IPSS =0.08 = ;88:
2 IPSS DCCT DCCT Provided by Dr. John Lachin 2
3 PFS Progresson Free Survival reliabile valid NSCLC * PFS QOL ALS QC *Yothers JCO 2007; 25: PFSOS OS PFS OS PFS PFS Freidlin et al. JCO 2007; 25: PFS PFS Time-to- PFS attrition PFS 2 PD QALY USA FDA. Guidance for industry clinical trial endpoints for 2! the approval of cancer drugs and biologics. 2007May Time-to-event 100 Overall survival (All randomized) OS Overall Survival TTP Time to Progression PD PD 50 PFS Progression Free Survival PD HR = 0.68 [ ] TTF Time to Treatment Failure p = (stratified log-rank test) DFS Disease Free Survival 2 RFS Recurrence Free Survival RFI Recurrence Free Interval Overall survival (%) Median follow-up : 3 yrs 3-year OS - S % - Surgery alone 70.1% (years) No. at risk S-1 Surgery alone Gastrointestinal Cancers Symposium (ASCO-GI), Jan , 2007, Orlando, FL 3
4 Time-to-event Kaplan-Meier product-limit Kaplan-Meier 5 MST Median Survival Time (2 death1 death1 censor1 death (1-1/10) 1(1-1/10)(1-1/9) 1(1-1/10)(1-1/9)(1-1/7) Hinotsu, Akaza, Ohashi and Kotake(1999), Cancer 86: Late-phase FDA Johnson et al. JCO 21: , FDA QOL 1992 RRTTP DFS TTF QOL Johnson et al. JCO 21: , Johnson et al. JCO 21: , refractory CR RR 26 DFS RR 10 CML RR+ 9 refractory RR+TTP 7 4 DFS 2 FDA TTP CCR 1 1 4
5 RR Time-to-event Johnson et al. JCO 21: , DFS: SRE 3 Pamidronate,Zoledronate Mitoxantrone* CML Busulfan Tamoxifen TTP: Paclitaxel BleomycinTalc* Tamoxifen* DCIS Tamoxifen CDDP Amifostine* OS PFS DFS Hudis et al. JCO 2007; 25: Hudis et al. JCO 2007; 25: DCIS Punt et al. JNCI 2007; 99: Punt et al. JNCI 2007; 99: OS 8 DFS 5
6 Allegra et al. JCO 2007; 25: Time to Failure of Strategy? Time-to- QALY Oxaliplatin PFS Tme to Failure of Strategy(TFS) 1 TFS FDA July 21, 2004 Three Month Change in PSA as a Surrogate Endpoint for surrogate endpoint Mortality in Advanced Hormone-Refractory Prostate Cancer: Data From Southwest Oncology Group Study QOL OS PFS * Patrick A. Burch, M.D. OS PFS 7, Graham F. Greene, M.D. 8, Mitchell C. Benson, M.D., 1 OS DFS Eric J. Small, M.D. 9, Derek Raghavan, M.D., Ph.D, 10 E. David PSA *Buyse Burzykowski et al. Evaluation of Surrogate Endpoints, Springer, Prostate cancer endpoints workshop Daniel P. Petrylak, M.D. 1, Donna Ankerst, Catherine M. Tangen, Dr.PH. 2, Maha A. Hussain, M.D. 3, Primo N. Lara Jr., M.D. 4, Jeffrey A. Jones, M.D. 5, Mary Ellen Taplin, M.D. 6, Crawford, M.D. 11 1Columbia University, New York, NY 2 Southwest Oncology Group Statistical Center, Seattle, WA 3 University of Michigan Comprehensive Cancer Center, Ann Arbor, MI 4 University of California, Davis, Sacramento, CA 5 Baylor College of Medicine, Houston, TX 6 University of Massachusetts Medical Center, Worcester, MA 7 Mayo Clinic, Rochester, MN 8 University of Arkansas for Medical Science, Little Rock, AR 9 University of California San Francisco Cancer Center, San Francisco, CA 10 Cleveland Clinic Foundation, Cleveland, OH 11 University of Colorado Health Science Center, Denver, CO Schema Criterion 1a: Survival by Treatment R D/E* Docetaxel 60 mg/m 2 IV D2 every 21 days Estramustine 280 mg po TID, D1-5 Premedication: Dexamethasone 20 mg PO TID starting evening of D1 M/P Mitoxantrone 12 mg/m 2 IV every 21 days Prednisone 5 mg po BID continuously 100% 80% 60% 40% 20% Median At Risk Deaths in Months D + E M + P P =.02 *Per protocol amendment January 15, 2001: Coumadin 2 mg PO daily + ASA 325 mg PO daily was added Docetaxel and mitoxantrone doses could be increased to 70 mg/m 2 and 14 mg/m 2, respectively, if no grade 3 or 4 toxicities were seen in cycle 1 0% Months After Registration 6
7 Criterion 1b: Survival by Surrogate Criterion 1c: Survival by Treatment and Surrogate 100% 80% 60% no 50% dec 50% dec At Risk P <.0001 Deaths Median in Months % 80% 60% D + E, no 50% dec D + E, 50% dec M + P, no 50% dec M + P, 50% dec At Risk P <.0001 Deaths Median in Months % 40% 20% 20% 0% Months After Registration 0% Months After Registration NSCLC TTP vs Johnson et al. Lancet Oncology 2006; 7: NSCLC TTP vs Johnson et al. Lancet Oncology 2006; 7: OS Tang et al. JCO 2007; 25: Buyse et al. JCO 2007; 25: OS PFS PFS 6 OS OS PFS PFS 20 OS 11% 7-15% PFSOS 6 PFS 57% 12 OS 52% 7
8 18 ) Sargent et al. JCO 2007; 25: DFS 5 Sargent et al.(jco 2005) DFS 2 DFS5 3 DFS5OS III 0.92( ), II Time-to- QALY AZTAIDS Volberding, et al. NEJM 1990;322:941-9 AZT QOL Lenderking, et al. NEJM 1994;330: QOL adjusted-life year QALY QALY AZT 8
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抗悪性腫瘍薬の開発における臨床試験エンドポイント 一般的には, 全生存期間 (OS) が真のエンドポイントとして考えられている. OS の定義 : ランダム化からあらゆる原因による死亡までの期間 OS を主要評価項目とした臨床試験を実施する場合, がん腫によっては, 非常に試験期間が長くなってしまう
抗悪性腫瘍薬の開発における臨床試験エンドポイント 一般的には, 全生存期間 (OS) が真のエンドポイントとして考えられている. OS の定義 : ランダム化からあらゆる原因による死亡までの期間 OS を主要評価項目とした臨床試験を実施する場合, がん腫によっては, 非常に試験期間が長くなってしまう. 無増悪生存期間 (PFS) や無病生存期間 (DFS), 客観的奏効率など,OS よりも短期間で評価可能なエンドポイントを主要評価項目とした臨床試験の実施が検討されることが多い.
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Title 泌尿器科領域に於ける17-Ketosteroidの研究 17-Ketosteroidの臨床的研究 第 III 篇 : 尿 Author(s) 卜部, 敏入 Citation 泌尿器科紀要 (1958), 4(1): 3-31 Issue Date 1958-01 URL http://hdl.handle.net/2433/111559 Right Type Departmental Bulletin
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