1 / 12

Presented by Celine BOUTROS Hotel- Dieu de France

Phase II trial of sequential gemcitabine and carboplatin followed by paclitaxel as first-line treatment of advanced urothelial carcinoma. Presented by Celine BOUTROS Hotel- Dieu de France. Background. Bladder cancer is the 4 th cancer in men, the 9 th in women

kert
Download Presentation

Presented by Celine BOUTROS Hotel- Dieu de France

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. Phase II trial of sequential gemcitabine and carboplatin followed by paclitaxel as first-line treatment of advanced urothelial carcinoma Presented by Celine BOUTROS Hotel-Dieu de France

  2. Background • Bladder cancer is the 4th cancer in men, the 9th in women • 69,000 new cases diagnosed in the US in 2008 • Transitional Cell Carcinoma (TCC): most frequent histological subtype • The standard first-line regimen in advanced TCC: - 1989-2000: Methotrexate, Vinblastine, Doxorubicin, Cisplatin (MVAC)1 - > 2000: Gemcitabine plus Cisplatin2 : similar activity, less toxicity • 1 Sternberg CN et al. Cancer 1989;64:2448-2458.2 Von der Maase H et al. J Clin Oncol 2000;18:3068-3077.

  3. Objectives of the study Primary objective • Explore the activity of Gemcitabine plus Carboplatin (GC) followed sequentially with Paclitaxel in advanced TCC Secondary objective • Assess the toxicity profile of the regimen

  4. Materials and Methodseligibility Single-Arm, Multicenter, Phase II trial, from September 2004 to September 2007 • Eligibility Criteria: • At least one dimensionally measurable disease • Locally advanced or metastatic disease • Histological infiltrative urothelial cancer • No prior chemotherapy unless given in more than one year free-interval • No prior radiation therapy • Performance status (PS) ≤ 2 • Adequate blood counts and chemistries • Normal organ function

  5. Materials and Methodstreatmentschedule Gemcitabine 800mg/m2 (D1, D8) + Carboplatin AUC 2 (D1, D8) Every 3 weeks for 4 cycles Paclitaxel 60 mg/m2 weekly for 12 weeks Evaluation (RECIST) Evaluation (RECIST)

  6. ResultsPatient Characteristics

  7. ResultsDrug delivery Assessment of drug delivery for GC and Paclitaxel sequences

  8. ResultsTreatment efficacy Response Assessment to GC and Paclitaxel sequences • 8 responses of 11 achieved in locally advanced TCC without distant metastases • Responses achieved in locally advanced TCC without distant metastases (same patients)

  9. Resultsfollow-up • Median response duration: 6 months • Median follow-up: 7 months - 21 patients died - 6 remained alive ---> 2 CR ---> 1 PR

  10. Resultstreatment-relatedtoxicities (grade 3/4)

  11. ResultsMyelosuppression-related complications

  12. Conclusion • Well tolerated regimen • ORR is in agreement with the results of previous regimens • Limited number of patients • Relatively short follow-up (7 months)

More Related