Phase II trial of sequential Phase II trial of sequential gemcitabine and carboplatin gemcitabine and carboplatin followed by paclitaxel as followed by paclitaxel as first-line treatment of first-line treatment of advanced urothelial carcinoma advanced urothelial carcinoma Presented by Celine BOUTROS Presented by Celine BOUTROS Hotel-Dieu de France Hotel-Dieu de France
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1 Phase II trial of sequential gemcitabine and carboplatin followed by paclitaxel as first-line treatment of advanced urothelial carcinoma Presented by.
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Phase II trial of sequential gemcitabine Phase II trial of sequential gemcitabine and carboplatin followed by paclitaxel and carboplatin followed by paclitaxel
as first-line treatment of advanced as first-line treatment of advanced urothelial carcinomaurothelial carcinoma
Presented by Celine BOUTROSPresented by Celine BOUTROS
Hotel-Dieu de FranceHotel-Dieu de France
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BackgroundBackground
• Bladder cancer is the 4Bladder cancer is the 4thth cancer in men, the 9 cancer in men, the 9thth in women in women
• 69,000 new cases diagnosed in the US in 200869,000 new cases diagnosed in the US in 2008
• Transitional Cell Carcinoma (TCC): most frequent histological subtypeTransitional Cell Carcinoma (TCC): most frequent histological subtype
• The standard first-line regimen in advanced TCC:The standard first-line regimen in advanced TCC:
- > 2000: Gemcitabine plus Cisplatin- > 2000: Gemcitabine plus Cisplatin22 : similar activity, less toxicity : 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.
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Objectives of the studyObjectives of the study
• Explore the activity of Explore the activity of Gemcitabine plus Carboplatin Gemcitabine plus Carboplatin (GC) followed sequentially with (GC) followed sequentially with Paclitaxel in advanced TCC Paclitaxel in advanced TCC
Secondary Secondary objectiveobjective
Secondary Secondary objectiveobjective • Assess the toxicity profile of the Assess the toxicity profile of the
Materials and MethodsMaterials and Methodseligibilityeligibility
Eligibility Criteria:Eligibility Criteria:
• At least one dimensionally measurable diseaseAt least one dimensionally measurable disease• Locally advanced or metastatic diseaseLocally advanced or metastatic disease• Histological infiltrative urothelial cancerHistological infiltrative urothelial cancer• No prior chemotherapy No prior chemotherapy unless given in more than one year free-unless given in more than one year free-intervalinterval• No prior radiation therapyNo prior radiation therapy• Performance status (PS) ≤ 2Performance status (PS) ≤ 2• Adequate blood counts and chemistriesAdequate blood counts and chemistries• Normal organ functionNormal organ function
Eligibility Criteria:Eligibility Criteria:
• At least one dimensionally measurable diseaseAt least one dimensionally measurable disease• Locally advanced or metastatic diseaseLocally advanced or metastatic disease• Histological infiltrative urothelial cancerHistological infiltrative urothelial cancer• No prior chemotherapy No prior chemotherapy unless given in more than one year free-unless given in more than one year free-intervalinterval• No prior radiation therapyNo prior radiation therapy• Performance status (PS) ≤ 2Performance status (PS) ≤ 2• Adequate blood counts and chemistriesAdequate blood counts and chemistries• Normal organ functionNormal organ function
Single-Arm, Multicenter, Phase II trial , from September 2004 to September 2007
Single-Arm, Multicenter, Phase II trial , from September 2004 to September 2007
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Materials and MethodsMaterials and Methodstreatmenttreatment scheduleschedule
Response Assessment to GC and Paclitaxel Response Assessment to GC and Paclitaxel sequences sequences
(1) 8 responses of 11 achieved in locally advanced TCC without distant metastases(2) Responses achieved in locally advanced TCC without distant metastases (same patients)
ResultsResultsfollow-upfollow-up
• Median response duration: 6 monthsMedian response duration: 6 months
• Median follow-up: 7 monthsMedian follow-up: 7 months
- 21 patients died- 21 patients died
- 6 remained alive ---> 2 CR- 6 remained alive ---> 2 CR