1 / 9

Adjuvant therapy: LMS

Adjuvant therapy: LMS. High activity of gemcitabine/docetaxel in advance disease suggests potential role as adjuvant therapy Adjuvant phase II study of dose-rated based gemcitabine/docetaxel followed by doxorubicin Endpoints: DFS at year 2 If DFS at year 2 is promising, would propose RCT.

watson
Download Presentation

Adjuvant therapy: LMS

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Adjuvant therapy: LMS • High activity of gemcitabine/docetaxel in advance disease suggests potential role as adjuvant therapy • Adjuvant phase II study of dose-rated based gemcitabine/docetaxel followed by doxorubicin • Endpoints: • DFS at year 2 • If DFS at year 2 is promising, would propose RCT

  2. Schema Gem 900 d 1, 8 + doce 75 d 8; q 3 wk x 4 cycles Repeat CT scan Doxorubicin 60 mg/m2 q 3 w x 4 Repeat CT scan 6 weeks after CT c/a/p every 3 mo for 2 y, then every 6 mo

  3. Objectives • PRIMARY: -two-year PFS (target > 50% PFS at 2 years) • SECONDARY: -safety, tolerability as adjuvant therapy -explore impact of age, “STS stage”, mitotic rate, ER and PR, menopausal status on PFS

  4. Should we stage like STS? • FIGO stage I and II -Indifferent to size, grade, depth • High grade LMS -would be STS stage IIB or III

  5. STS v. FIGO staging • FIGO I (uterus) or II (uterus and cervix) • grade 2, 3, or 4 • T1b or T2b • By definition all uterine sarcs are “deep” • Explore whether STS staging is superior to FIGO in terms of ability to predict PFS

  6. Statistical approach • Target accrual 45 patients • Bayesian model for continuous assessment of PFS and safety • Accrue at least 15 patients per year • Stop early if data suggest 2 year PFS will be no better that 30%

  7. Data management • On line SARC registration • On line data entry • Data monitored by SARC • Real-time assessment of endpoints by statistical office

  8. Milestones • Full protocol written, reviewed, approved by SARC, industry sponsors, MSKCC IRB • Contracts between SARC and Lilly, SARC and Sanofi-Aventis are completed • Gemcitabine and docetaxel both supplied • Drug distribution from SARC to institutions

More Related