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The ENGOT plan for rare gyn cancer S. Pignata ENGOT Chair - PowerPoint PPT Presentation

Apr 18, 2023 •288 likes •415 views

The ENGOT plan for rare gyn cancer S. Pignata ENGOT Chair National Cancer Institute of Naples Italy Rationale for ENGOT rare cancer plan Progress in gynaecologic oncology needs clinical studies, translational research and cooperation

  1. The ENGOT plan for rare gyn cancer S. Pignata ENGOT Chair National Cancer Institute of Naples Italy

  2. Rationale for ENGOT rare cancer plan • Progress in gynaecologic oncology needs clinical studies, translational research and cooperation … • In rare tumours questions are complex and definitive answers need trials within reasonable time. • Trials are unfeasible by a single National group

  3. ENGOT MAP 2017 SGCTG PGOG GROINS NCRI EORTC- GCG AGO-Germany BGOG GINECO TRSGO GEICO HeCOG MaNGO MITO ISGO

  4. October strategic meeting • Decision taken to promote a specific plan for rare cancers • Questionnaire to the groups to collect all ongoing activities • Identification of a single person per group joining this working group

  5. • 45 different projects were declared (retrospective, prospective registry, phase 2 trials) – 23 projects happy for external collaboration – 10 projects overlapping, possibly able to merge – 2 projects combine registry and tumour sample collections  Meeting in september to present the projects and to be discussed about collaboration or improvement ….

  6. Plan • Meeting in september with the rare tumour representatives • Presentation of the trials searching collaboration; discussion on possible merging of initiatives • Discussion on type of studies to be performed

  7. Type of trials • Retrospective (studies that can involve all ENGOT groups) • Registry/prospective • New drugs in specific disease (i.e. Alienor) • New drugs (umbrella trials in rare gyn disease) • «Joint-Venture» duplicating clinical trials for future meta analysis (NRG/D Gershenson Project) • Tumour banking (trial specific or connected to registries)

  8. A randomized, 3-arm phase III trial of paclitaxel/carboplatin versus paclitaxel/carboplatin/maintenance letrozole versus letrozole monotherapy in patients with stage II-IV, primary low-grade serous carcinoma of the ovary or peritoneum • CT  O arm acceptable Observation until disease progression • letrozole monotherapy or severe toxicity Paclitaxel + arm acceptable? Randomizati Carboplatin on #2 x 6 cycles • Use of bevacizumab? Letrozole until Eligib disease progression • Feasibility of parallel le or severe toxicity Randomizat Patie ion #1 trials with single data nts center  anticipated Letrozole until Letrozole x 6 disease progression Meta analysis cycles or severe toxicity • TR biomarkers Randomization #1 will be done in a 5:2 ratio (250 to CT, and 100 to L) Stratified by residual disease (< 1 cm vs > 1 cm) Randomization #2 will be done in a 1:1 ratio Stratified by no persistent vs persistent disease ENGOT network to make it a big GCIG trial

  9. ENGOT Biobanking J Sehouli; I Braicu

  10. Conclusions • A plan to improve research for rare gyn cancer in ENGOT • Close collaboration and regular update to GCIG • Thanks to Isabelle and sorry for not being with you • CIAO!!!

  11. SoA project (Lyon, Automne France 2018) • Goals – evidence base for diagnose and management of rare gynecological cancers. – multidisciplinary conference will provide comprehensive state-of-the art summaries from key note speakers, – Audience Gyn, Onco, Onco-gyn, RT, biologists – Up to date scientific reviews on • biology, • biomarkers, • preservation of fertility, • specificity by subgroups of rare cancers, • updated GCIG/ESGO guidelines, • unanswered questions and future clinical trials.

  12. SoA project (Lyon, France Automne 2018) 400 to 500 persons • Organisation – Faculties 20 to 30 speakers – 2 days meeting • General sessions • Breakout sessions • Lecture – Sponsoring • Industries • ESGO • …

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