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ASCO 2010 Phase III Trial of Bevacizumab in the Primary Treatment of Advanced Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer: A Gynecologic Oncology Group (GOG) Study.

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  1. ASCO 2010Phase III Trial of Bevacizumab in the Primary Treatment of Advanced Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer: A Gynecologic Oncology Group (GOG) Study R.A. Burger, F. Brady, M.A. Bookman, J.L. Walker, H.D. Homesley, J. Fowler, B.J. Monk, B.E. Greer, M. Boente, S.X. Liang Reviewed by: Dr. Daniel Heng Abstract: LBA1 Date posted: Jun 18 2010

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

  3. Paclitaxel 175 mg/m2 + Carboplatin AUC 6 x 6 Placebo x 6 Maintenance Placebo x 16 N=625 R Paclitaxel 175 mg/m2 + Carboplatin AUC 6 x 6 Bevacizumab 15mg/kg x 6 Maintenance Placebo x 16 N=625 Paclitaxel 175 mg/m2 + Carboplatin AUC 6 x 6 Bevacizumab 15mg/kg x 6 Maintenance Bevacizumab 15mg/kg x 16 N=623 First-line advanced epithelial ovarian fallopian tube primary peritoneal cancer Stage III w/macroscopic dz or suboptimal or Stage IV PS 0-2 Median f/u = 17.4 months

  4. PATIENT CHARACTERISTICS

  5. RESULTS

  6. STUDY COMMENTARY • Subgroups including stage (III macroscopic, III suboptimal, IV), performance status (0 vs 1/2), age (<60-, 60-70, >70) all had PFS benefit when comparing PC+B B vs PC alone. • Numerically more hypertension (up to 10%) and GI perforation, hemorrhage, or fistulization (up to 2.6%) was seen in the bevacizumab arms as expected • Independent radiologic assessment has not been reported. Although this trial was blinded, there may be investigator assessment bias as patients receiving bevacizumab will likely have hypertension.

  7. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Although there is a PFS benefit, there was no overall survival benefit. • Although second- and third-line therapies in ovarian cancer are available, dilution of overall survival benefit due to these is likely not significant and cross-over or contamination of targeted therapies did not appear to occur. • Hazard ratio for PFS was 0.717 which is not as substantial as hazard ratios seen for other targeted therapies in other disease sites (such as renal cell carcinoma) that led to regulatory approval. • 15mg/kg of bevacizumab is triple the dose and triple the cost of bevacizumab used for advanced colorectal cancer. • Longer follow-up and cost-effectiveness data will be required but these results are interesting in that targeted therapy may show some benefit in ovarian cancers.

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