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Authors: de Wit R. et al, ASCO 2011 Abstract: 4509 Reviewed by: Dr. Lori Wood

A randomized phase III study comparing paclitaxel-BEP (T-BEP) to standard BEP in patients with intermediate prognosis germ cell cancer (GCC): An intergroup study of EORTC, German TCSG/AUO, MRC, and Spanish GCC group (EORTC 30983). Authors: de Wit R. et al, ASCO 2011 Abstract: 4509

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Authors: de Wit R. et al, ASCO 2011 Abstract: 4509 Reviewed by: Dr. Lori Wood

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  1. A randomized phase III study comparing paclitaxel-BEP (T-BEP) to standard BEP in patients with intermediate prognosis germ cell cancer (GCC): An intergroup study of EORTC, German TCSG/AUO, MRC, and Spanish GCC group (EORTC 30983). Authors: de Wit R. et al, ASCO 2011 Abstract: 4509 Reviewed by: Dr. Lori Wood Date posted: June 2011

  2. Thank you for downloading this update. Please feel free to use it for educational purposes. Please acknowledge OncologyEducation.ca and Dr. Lori Wood when using these slides.

  3. Since 1985, BEP chemotherapy is the gold standard treatment for all patients with metastatic GCTs Cisplatin 20 mg/m2 d1-5 Etoposide 100 mg/m2 d1-5 Bleomycin 30 iu d2, d9, d16 There are patients with intermediate and poor risk disease who still die of metastatic GCTs despite BEP There is a need to improve on standard BEP Paclitaxel has shown activity in first-line and relapsed GCTs The idea was to bring Paclitaxel into the first-line setting 175 mg/m2 d1 STUDY RATIONALE

  4. STUDY DESIGN Treatment A: BEP + Paclitaxel x 4 T-175 mg/m2 d1 n=168 GCSF R Treatment B: BEP x 4 n=169 • IGCCC • Intermediate prognosis • metastatic GCTs • Statistics: • - 10%  in 3-y PFS from • 75%  85% • - planned n=498 • - closed with n=337 due • to slow/poor accrual

  5. RESULTS - Phase II accrual from November 1999 – March 2004. - Phase III accrual from March 2004 – August 2009 and then closed early. - Median follow-up = 5.3 years.

  6. RESULTS

  7. STUDY COMMENTARY • Primary endpoint of 3-y PFS was not met • But ineligible patients unbalanced between the two arms • Primary endpoint of eligible patients only – T-BEP better • 82.7% vs. 70.1% 3-y PFS • Speculated that this was due to imbalance of ineligible patients between the two arms • Two toxic deaths associated with T-BEP (1.3%)

  8. Intriguing results but a positive trial only when data looked at eligible patients and not intention to treat analysis Given the great research question, it is hard to believe this study could not accrue and this fact really hurt this study I do not think we can incorporate these results into every day practice at this time BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS

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