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Authors: De Santis M et al, ASCO 2010 Abstract: LBA4519 Reviewed by: Dr. Lori Wood

Randomized phase II/III trial comparing gemcitabine/ carboplatin (GC) and methotrexate/carboplatin/ vinblastine (M-CAVI) in patients (pts) with advanced urothelial cancer (UC) unfit for cisplatin-based chemotherapy (CHT): Phase III results of EORTC study 30986.

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Authors: De Santis M et al, ASCO 2010 Abstract: LBA4519 Reviewed by: Dr. Lori Wood

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  1. Randomized phase II/III trial comparing gemcitabine/ carboplatin (GC) and methotrexate/carboplatin/ vinblastine (M-CAVI) in patients (pts) with advanced urothelial cancer (UC) unfit for cisplatin-based chemotherapy (CHT): Phase III results of EORTC study 30986 Authors: De Santis M et al, ASCO 2010 Abstract: LBA4519 Reviewed by: Dr. Lori Wood 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. Wood when using these slides.

  3. Up to 50% of pateints with metastatic urothelial cancer are not eligible for standard dose cisplatin due to creatinine clearance, performance status, and co-morbidities Difficult to know how to treat unfit patients with metastatic urothelial cancer Also, there is no clear consensus on how to define “unfit” For this study: based on ECOG PS and GFR STUDY RATIONALE

  4. STUDY DESIGN Treatment A: M-CAVI: Methotrexate 30 mg/m2 d1, d15, d22 Carboplatin AUC 4.5 d1 Vinblastine 3 mg/m2 d1, d15, d22 q4wks N=119 R Treatment B: GC: Gemcitabine 1000 mg/m2 d1 and d8 Carboplatin AUC 4.5 d1 q3wks N=119 • Metastatic TCC • Unfit patients: • - PS 2 and/or • - GFR 30-60 ml/min • Primary outcome: • - overall survival • - Statistics: • - median OS 9.0m •  13.5m with GC

  5. RESULTS Median follow-up = 4.5 years

  6. RESULTS: TOXICITY

  7. STUDY COMMENTARY • Gemcitabine/Carboplatin did not increase overall survival compared to Methotrexate, Carboplatin, Vinblastine • It was somewhat more tolerable

  8. Most Canadian medical oncologists would not be using Methotrexate, Carboplatin and Vinblastine as their standard therapy for unfit patients Most would be using: Gemcitabine alone Gemcitabine/Carboplatin This trial supports the use of Gem/Carbo given that it does not have a worse outcome and does have a better tolerability This trial also gives a modern day median survival for unfit bladder cancer patients based on the Bajorin (MSKCC) risk factors (poor PS and presence of visceral metastases) 0 factors = 12m 1 factor = 9.3m 2 factors = 5.5m BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS

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