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Nicolas PENEL Andrew KRAMAR Centre Oscar Lambret , Lille, France

Activity endpoints in soft tissue sarcoma phase II trials Quality and correlations with overall survival. Nicolas PENEL Andrew KRAMAR Centre Oscar Lambret , Lille, France . Primary endpoints. Critical choice Few promising drugs Promising drugs failed to improve overall survival

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Nicolas PENEL Andrew KRAMAR Centre Oscar Lambret , Lille, France

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  1. Activityendpoints in soft tissue sarcoma phase II trialsQuality and correlationswithoverallsurvival Nicolas PENEL Andrew KRAMAR Centre Oscar Lambret, Lille, France

  2. Primaryendpoints • Criticalchoice • Few promising drugs • Promisingdrugsfailed to improveoverallsurvival • Q1: Whatis the quality of reportedprimaryendpoints ? • Q2: What are the correlationbetweenactivityendpoints and overallsurvival ? • Q3: What are the distribution of activityendpoints in positive and negative trials ?

  3. Method - General • Criteria of selection of trials: • Phase II trials • Chemotherapy (single agents or combination) or molecularytargeted agents • Afterfailure/intolerance to doxorubicin • Full reports issuedbetweenJanuary 1999 and August 2011 • English-written reports • Systematicanalysis of • 53 trials • 77 strata

  4. Q 1: Whatis the quality of reportedprimaryendpoints ?

  5. Nature of primaryendpoint

  6. Precisedefinition of primaryendpoint

  7. Design/Methodology

  8. interpretation of the results

  9. Q 2: What are the correlationbetweenactivityendpoints and overallsurvival ?

  10. PoorcorrelationbetweenmOS and BORR: p=0.058

  11. Good correlationbetween 6-monthPFR and OS (p=0.005)

  12. Q 3: Distributions of endpoints in cases of active or inactive drugs?

  13. Q1: Key-findings

  14. Q2: Endpointspossiblycorrelatedwith OS

  15. Q3: Currentdefinition of active drugs Usingcurrentdefinitions of active/inactive drugs: All primaryendpoints are statisticallyhigherwith « active drugs » But OS was not statisticallydifferent in active compared to inactive drugs

  16. Conclusion • Betterdefinition the primaryendpoint • Role of the central radiologicalreview • Statisticalhypothesisbased on primaryendpoint • Endpointscorrelatedwith OS (PFR3 , PFR6 and PFS) • But • Currentdefinitions of active drugfailed to identifydrugs able to improve the OS • We have to refine the thresholds of PFR3 and PFR6defining active drugs

  17. Thankyour for your attention

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