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Ovarian Cancer Clinical Trials Planning Meeting

Ovarian Cancer Clinical Trials Planning Meeting. Unanswered Questions in Upfront Therapy IP Therapy Issue Keiichi Fujiwara, MD, PhD Saitama Medical University. IP Therapy in Ovarian Cancer. Three large scale randomized trials demonstrated survival benefit on IP cisplatin-based chemotherapy.

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Ovarian Cancer Clinical Trials Planning Meeting

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  1. Ovarian Cancer Clinical Trials Planning Meeting Unanswered Questions in Upfront Therapy IP Therapy Issue Keiichi Fujiwara, MD, PhD Saitama Medical University

  2. IP Therapy in Ovarian Cancer • Three large scale randomized trials demonstrated survival benefit on IP cisplatin-based chemotherapy. • Meta-analysis indicated IP therapy reduced HR of 0.78 comparing with IV chemotherapy. • Controversial Issue • Toxicity • IP Therapy itself • Drug-related • Efficacy • Trial Design

  3. IP Therapy in Ovarian CancerControversial Issue • Toxicity • Catheter problems • CV Port Catheter is better than IP Port? • Use of IP therapy should be avoided in patients underwent left colon resection and anastomosis? • Use of paclitaxel compromise the IP catheter? • Drug related • Cisplatin? • IP Paclitaxel?

  4. IP Therapy in Ovarian CancerControversial Issue • Efficacy • Trial Design of GOG172

  5. GOG172 Trial Epithelial Ovarian Cancer Optimal Stages III Randomization Paclitaxel 135 mg/m2/24h IV D1 Cisplatin 75 mg/m2 IV D2 Q21, 6 Cycles Paclitaxel 135 mg/m2/24h IV D1 Cisplatin 100 mg/m2 IP D2 Paclitaxel 60 mg/m2 IP D8 Q21, 6 Cycles

  6. IP Therapy in Ovarian CancerControversial Issue • Efficacy • Trial Design of GOG172 • Survival Benefit was obtained because of • IP Cisplatin? • More Cisplatin Dose? --------Probably Not • IP Paclitaxel? • Day 8 Paclitaxel? • Role of Targeted Agents with IP Chemotherapy Impact of JGOG3016 Trial

  7. IP Chemotherapy in Ovarian Cancer • Trial Endpoints to be Answered • Less Toxic Combination • Can Carboplatin be replaceable to Cisplatin? • Is Day 8 IP Paclitaxel required? • Efficacy Assessment • Is IP Carboplatin better than IV Carboplatin? • Dose Day 8 IP Paclitaxel matter or Only Day 8 Paclitaxel (IV) matter? • New Approach • Combination of Targeted Agents • Bevacizumab

  8. GCIG Trial (Phase II/III Study) Pick the winner strategy Paclitaxel 175 mg/m2 IV Carboplatin AUC 6 IV Paclitaxel 60 mg/m2 IV D8 Q21, 6-8 Cycles Neoadjuvant Chemotherapyfor Stage III Epithelial Ovarian Cancer Followed by Interval Debulking Surgery Resulting Residual Disease < 1 cm Paclitaxel 175 mg/m2 IV Carboplatin AUC 6 IP Paclitaxel 60 mg/m2 IV D8 Q21, 6-8 Cycles R A N D O M Z E Paclitaxel 135 mg/m2 IV Cisplatin 75 mg/m2 6 IP Paclitaxel 60 mg/m2 IP D8 Bevacizumab Q21, 6-8 Cycles

  9. Planned Japanese IP Trial Epithelial Ovarian Cancer Stages II-IV Excluding Clear Cell Carcinoma Randomization Paclitaxel 80 mg/m2 IV Weekly Carboplatin AUC 6 IV Q21, 6-8 Cycles Paclitaxel 80 mg/m2 IV Weekly Carboplatin AUC 6 IP Q21, 6-8 Cycles Primary Endpoint: PFS Secondary Endpoint: OS, Toxicity, QOL

  10. Planned GOG Trial Paclitaxel 175 mg/m2 IV Carboplatin AUC 6 IV Bevacizumab Q21, 6-8 Cycles Paclitaxel 175 mg/m2 IV Carboplatin AUC 6 IP Bevacizumab Q21, 6-8 Cycles Optimal Debulked Stage III Epithelial Ovarian Cancer R A N D O M Z E Paclitaxel 135 mg/m2 IV Cisplatin 75 mg/m2 6 IP Paclitaxel 60 mg/m2 IP D8 Bevacizumab Q21, 6-8 Cycles

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