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ESMO-Magnitude of Clinical Benefit Scale: Evaluation Forms version 1.1

The scale considers overall survival, progression-free survival, disease free survival, hazard ratio, response rate, quality of life, prognosis of the condition and toxicity. There are 5 evaluation forms which are freely accessible and downloadable:

Evaluation form 1

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For new approaches to adjuvant therapy or new potentially curative therapies

Evaluation form 2a

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For therapies that are not likely to be curative with primary endpoint of OS with separate sheets for:

  • IF median OS with the standard treatment is <12 months
  • IF median OS with the standard treatment is >12 months, <24 months
  • IF median OS with the standard treatment is >24 months

Evaluation form 2b

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For therapies that are not likely to be curative with primary endpoint PFS with separate sheets for:

  • IF median PFS with standard treatment is <6 months
  • IF median PFS with standard treatment is >6 months

Evaluation form 2c

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For therapies that are not likely to be curative with primary endpoint other than OS or PFS or equivalent (non-inferiority) studies

Evaluation form 3

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For single-arm studies in “orphan diseases” and for diseases with “high unmet need” when primary outcome is PFS or ORR.

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