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01. 항암제 임상시험 승인 현황 02. General aspect of evaluation in cancer

 CONTENTS. 01. 항암제 임상시험 승인 현황 02. General aspect of evaluation in cancer 03. Endpoint in Cancer Clinical Trial 04. Response Criteria 05. Conclusions. 식약처 신규 승인 임상시험. 식약처 신규 승인 임상시험. 2010 112 건 /439 건. 2011 112 건 /503 건. 2012 184 건 /670 건. 2013 157 건 /607 건. 25.5 %.

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01. 항암제 임상시험 승인 현황 02. General aspect of evaluation in cancer

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  1.  CONTENTS 01. 항암제 임상시험 승인 현황 02. General aspect of evaluation in cancer 03. Endpoint in Cancer Clinical Trial 04. Response Criteria 05. Conclusions

  2. 식약처 신규 승인 임상시험

  3. 식약처 신규 승인 임상시험 2010 112건/439건 2011 112건/503건 2012 184건/670건 2013 157건/607건 25.5% 22.3% 27.5% 25.9%

  4. 1. Patient evaluation 2. Tumor evaluation by staging 3. Treatment response evaluation

  5.  평가기준 - ECOG(Eastern Cooperative Oncology Group) PS - KPS (Karnofsky Performance Status) • 항암치료의 원칙 • ECOG 0, 1, 2 • KPS≧70 1. Patient evaluation 환자의 일반적 건강상태 및 운동능력평가

  6. TNM법 • Tumor_ 원발종양의 크기, 침윤 정도 • Node_ 주변 림프절 침범 정도 • Metastasis_ 다른 장기로 전이 여부 • ▷ TNM법이 가장 많이 사용되나, • 암의 종류에 따라세부적인 차이 있으며 • 독립적인 분류법에따라 진행단계를 • 결정하는 경우도 있음 .M N T 2. Tumor evaluation by staging 병기 결정을 통해 치료 방침 결정, 환자 예후 예측, 치료 결과분석 및 상호 정보교환

  7. After anti-cancer therapy • Response after variable agents • Selection of proper agent • Residual disease status • Toxicities • ETC 3. Treatment response evaluation

  8.  Time-to-Event outcomes Time between the day of registration/randomization to the date of a event Includes overall survival(OS), progression-free survival(PFS) or time-to-progression(TTP), disease-free survival(DFS) or relapse-free survival(RFS), or other event-free survivals  Tumor shrinkage or stabilization Response rate Clinical benefit  Safety 1) Toxicity (adverse events) √ OS(Overall survival, 전체생존): 무작위배정~사망 √ PFS(Progression free survival, 무진행생존): 무작위배정~종양진행 or 사망 √ TTP(Time to tumor progression, 종양 진행까지의 시간): 무작위배정~종양진행 ※ PFS와 TTP의 차이; TTP는 종양진행 없는 사망은 제외

  9.  Time-to-Event outcomes Time between the day of registration/randomization to the date of a event Includes overall survival(OS), progression-free survival(PFS) or time-to-progression(TTP), disease-free survival(DFS) or relapse-free survival(RFS), or other event-free survivals  Tumor shrinkage or stabilization Response rate Clinical benefit  Safety 1) Toxicity (adverse events)

  10. WHOResponse Criteria 1979년 RECISTResponse Criteria 2000년 Issue in WHO response criteria 1) Complexity - Needs bi-dimensional measurements - No minimum lesion size & number - Results may vary among research groups 2) New technologies 3) No longer regarded

  11. Measurability of lesion at baseline

  12. Measurable Target lesion Non-target lesion Baseline에 선정된 Target lesion은 연구 종료시점까지 동일하게 유지

  13. Objective response Measurable disease / Target lesions

  14. Objective response Measurable disease / Target lesions • { Lymph nodes } • Measuring short axis • ≥15mm: target node • <10mm: normal node

  15. Objective response Non-measurable disease / Non-target lesions

  16. Target lesion 반응 평가의 예 치료제 변경 시점

  17. Overall Response Time point response: A response assessment occurs at each protocol specified time point. Target, Non-target, New lesion의 모두 합한 반응 평가

  18. Overall Response

  19. BEST Overall Response The best overall response is the best response recorded from the start of treatment until disease progression/recurrence(taking as reference for progressive disease the smallest measurements recorded since the treatment started).

  20. Best overall response • For CR and PR criteria must be met again 4 weeks after initial documentation(this requirement ONLY for non-randomized trials with primary endpoint of response) • When SD is believed to be best response, it must also meet the protocol specified minimum time from baseline. If the minimum time is not met when SD is otherwise the best time point response, the patient’s best response depends on the subsequent assessments.

  21. Best overall response For example, A patient who has "SD" at first assessment, "PR" at second assessment, and "PD" on last assessment has a best overall response of "PR". A patient who has “SD” at first assessment, “PD” at second and does not meet minimum duration for SD, will have a best response of “PD”. The same patient lost to follow-up after the first SD assessment would be considered inevaluable.

  22. 반응 평가는 치료제의 변경 결정 및 효과 판정 근거가 되므로 중요 • 반응 평가를 위한 영상검사는 반드시 계획된 일정한 시기에시행 • Baseline시 영상검사는 follow-up 때 동일한 방법으로 시행 • RECIST 1.1에도 남아 있는 문제점이 있으므로 개정을 통해 보완

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