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First results: September 2008

TAGAS T amoxifen or A nastrozole G ynaecological A ssessment S tudy -A RC Double Blind VWOG Study-. P Neven on behalf of TAGAS-TEAM. Johan Van Ginderachter: Maria Middelares Gent Jos Vlasselaer: ZOL- Genk Patrick Berteloot: St.-Maarten Duffel Herman Depypere: UZ-Gent

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First results: September 2008

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  1. TAGASTamoxifen or Anastrozole Gynaecological Assessment Study-A RC Double Blind VWOG Study- P Neven on behalf of TAGAS-TEAM Johan Van Ginderachter: Maria Middelares Gent Jos Vlasselaer: ZOL- Genk Patrick Berteloot: St.-Maarten Duffel Herman Depypere: UZ-Gent Patrick Neven: UZ- Leuven Dirk Timmerman: Ultrasound Reader Leilani Morales: Quality of Life Chantal Blomme: Data Manager Lieven De Clercq: Statistics & Ben Van Calster First results: September 2008 Herstsymposium VVOG: 27/09/2008

  2. Inclusion Criteria of TAGASDouble Blind RCT: Randomisation 1:1Continuing Tamoxifen vs Anastrozole Duration: Remaining 5 years Postmenopausal ER+ breast cancer Between 2-3 years on adjuvant tamoxifen No Relapse & Asymptomatic (no vaginal bleeding) TVU: Easy measurable uterus and DET ≥ 7mm Able to fill in QoL questionnaire Herstsymposium VVOG: 27/09/2008

  3. Change in DET / UV AE / SAE (menopausal symptoms) Statistics: I. Adjudication Process: Blind prediction A/T 5 investigators and the 2 TVU & MSQ readers II. Differences between Tam/Anastrozole for endpoints Objectives of TAGAS Herstsymposium VVOG: 27/09/2008

  4. TAGAS: Demographics

  5. Adverse Events (n = 39/73) …More than 1X reported (n) *Same patient **All stopped

  6. Other AE only 1X reported

  7. Serious Adverse Events (n = 8/73) …More than 1X reported (n)

  8. Withdrawn after randomisation=13 Time to withdrawal (months) A: 3,4,8,10,14,18,21,22, 25 T: 4,13,15,16 *Arthralgia

  9. Blinded AdjudicationAdjudication Process 1. ‘Therapy-blinded’ CRA e-mailed excel file with consecutive uterine (UV, DET) and QoL data of 73 patients to 7 ‘therapy-blinded adjudicators’ (5 investigators and 2 independent persons) for drug estimate Anastrozole, Tamoxifen, Undetermined. 2. Each patient was assigned A or T by majority of votes (7/7: 6/7; 5/7; 4/7 and U). Those with no majority or 4/7 one drug and other drug names, were assigned as “impossible” to adjudicate

  10. Adjudication Process65 / 73 cases: ‘majority of vote’ Unblinded drug P-value =

  11. Conclusion adjudication process • Able to adjudicate 65/73 (89%) • 8 unable: missing data for TVU, early withdrawal • 52/65 were correctly adjudicated (80%) • 13 incorrect mainly because of arthralgia • A patient who developped stiff hands was on tamoxifen • A patient who developed vaginal dryness on tamoxifen • Based on TVU and QoL and AE/SAE • 91% on anastrozole correctly assigned • 70% on tamoxifen correctly assigned Switch to A or T…and based on TVU, QoL, AE/SAE Anastrozole users are more often correctly assigned than tamoxifen users ‘Anastrozole’ side effects not unfrequent in tamoxifen users

  12. Pt 004: Joint pain (A) and same DET and UV: A>T Pt 014: Stiff hands +++ (A), same DET (T): A>T Pt 015: Less hot flashes (A), less ET (A), less vaginal dryness (T), less joint pain T>A Pt 018: Endometrial thinning, more emotional unwell, dry vagina, sexual dysfunction Pt 019: Endometrial thinning, hypercholesterolemie and all other parameters the same

  13. Visual change in DETAnastrozole versus Tamoxifen

  14. Visual change in UVAnastrozole versus Tamoxifen

  15. Visual change in vaginal dryness

  16. Visual change in arthralgia

  17. Vaginale Droogte Herstsymposium VVOG: 27/09/2008

  18. Arthralgia Herstsymposium VVOG: 27/09/2008

  19. Discussion • Expected but never as such presented! • How correct are these data? • Low numbers but clear findings • What should we have done differently? • Central reading of TVU? • Are we the first to report this? • Some exemestane data but only poster SABCS • Will this change our practice? • Arthralgia also appears in tamoxifen users • Vaginal bleeding also appears on AIs (after tam primed endometrium

  20. Conclusion • In the vast majority (80%) of patients the treatment could be correctly predicted • In comparison with tamoxifen endometrial thickness and uterine volume clearly decrease under anastrazole treatment • No difference in complaints of arthralgia and only a trend of increased vaginal dryness

  21. Acknowledgements • Patients • Investigators • J Van Ginderachter (MMG) • J Vlasselaer en G Vandeputte (ZOL) • P Berteloot (Duffel) • H Depypere (UZ Gent) • Independent readers • Leilani Morales, Dirk Timmerman • CRA and statisticians • Chantal, Lieven & Ben

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