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Overzicht activiteiten werkgroep medicamenteuze therapie

This trial compares adjuvant chemotherapy vs. no chemotherapy for serous or clear cell endometrial cancer patients. Study investigates disease-free and overall survival. Includes eligibility criteria and statistical analysis details.

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Overzicht activiteiten werkgroep medicamenteuze therapie

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  1. Overzicht activiteiten werkgroep medicamenteuze therapie Patrick Berteloot

  2. Caelyx-Gemcitabine (ovariumca): afgesloten • Tagas (borstca): afgesloten • Chirurgisch stadium I-II sereus/ clear cell endometriumca en rol van adjuvant chemo: studie is open voor inclusie • S51257-CYP-TAMBRUT: nieuw voostel

  3. Randomized trial UPSC/CC/mixed Surgical staging: HT, BSO, Cytology, Omentectomy, Pelvic lymph node dissection, peritoneal biopsies No further treatment Adjuvant chemotherapy

  4. End-points • Primary end-point: disease free survival after three years • Secondary end-point: overall survival after three years

  5. Inclusion criteria • Patients must meet all of the following inclusion criteria: • Histological proven serous or clear cell endometrial cancer (mixed endometrial carcinomas with serous or clear cell component, irrespective of percentage of serous or clear cells are allowed) • Adequate staging procedure including hysterectomy, bilateral salpingo-oophorectomy, cytology, adequate pelvic lymphadenectomy, omentectomy, peritoneal biopsies • FIGO surgical stage I-IIa • Patients must be fit to receive combination chemotherapy and optimal surgical staging (see below) • Patients must have adequate bone marrow, renal, hepatic and pulmonary function • WHO performance status 0 or 1 • > 18 years of age

  6. Exclusion criteria - Endometrial cancer of the following subtype: uterine leiomyosarcoma, endometrial stromal sarcoma, carcinosarcoma, undifferentiated endometrial cancer, endometrioid endometrial cancer (any grade) • Endometrial carcinoma with positive pelvic nodes (Stage IIIc) or evidence for transperitoneal spread (Stage IV).

  7. Statistical analysis • A randomized Phase III trial is set up to directly compare the two treatment arms. Patients will be randomized to receive either adjuvant chemo or no chemotherapy. The design will test for superiority of the chemotherapy arm over the no chemo arm. • Design: Randomized Phase III. • Primary endpoint: PFS rate at 3 years. • Statistical test: Fisher exact test (2-sided) • Parameters: • alpha error = 0.05 • beta error = 0.20 • Expected rate in the control arm (no chemo) = 69% PFS at 3 yrs • Expected rate in the experimental arm (chemo) = 95% PFS at 3 yrs • Sample size: 2 x 38 patients = 76 patients in total.

  8. Current status • Approved by ethical committee in Leuven and 9 Flemish centers (01-2008) • Trial is open for inclusion • Two patients included

  9. Caelyx-Gemcitabine (ovariumca): afgesloten • Tagas (borstca): afgesloten • Chirurgisch stadium I-II sereus/ clear cell endometriumca en rol van adjuvant chemo: studie is open voor inclusie • S51257-CYP-TAMBRUT: nieuw voostel

  10. Endoxifen Tamoxifen metabolism Gjerde, et al. Ann Oncol 2003; 19:56-61

  11. 1. Retrospective study • Objective: To study the relation between CYP 450 polymorphisms and endometrial changes under tamoxifen. • Study population: 50 postmenopausal women with ER+ breast cancer and no endometrial changes due to tamoxifen • Reference populations • 50 postmenopausal women with ER+ breast cancer and endometrial changes due to tamoxifen • 500 women with breast cancer and 500 women without breast cancer • Retrospective, monocentric study Functional polymorphisms of cytochrome P450 in women without the tamoxifen induced endometrial changes and a reference population.

  12. 2. Prospectivestudy • Objective: To study the relation between the efficacy of tamoxifen in terms of progression free survival and the ‘tamoxifen activity score’. • Study populations: two groups of postmenopausal women with ER+ metastatic breast cancer (N=140) • Low ‘tamoxifen activity score’ • High ‘tamoxifen activity score’ • Prospective, multicentric study Response to tamoxifen in metastatic ER+ breast cancer in women with a low and high ‘tamoxifen activity score’ based on CYP 450 polymorphisms and drug interaction.

  13. 3. Prospective study • Objective: To study the relation between endometrial changes under tamoxifen and the ‘tamoxifen activity score’. • Study population: two groups of postmenopausal women with ER+ breast cancer who will start on tamoxifen (N=500) • Low ‘tamoxifen activity score’ • High ‘tamoxifen activity score’ • Prospective, multicentric study Tamoxifen related endometrial changes in ER+ breast cancer in women with a low and high ‘tamoxifen activity score’ based on CYP 450 polymorphisms and drug interaction.

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