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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. - PowerPoint PPT Presentation
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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 2010Abstract: LBA4519Reviewed by: Dr. Lori WoodDate posted: Jun 18 2010
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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.
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STUDY RATIONALE
• 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
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R
Treatment A: M-CAVI:Methotrexate 30 mg/m2 d1, d15, d22Carboplatin AUC 4.5 d1Vinblastine 3 mg/m2 d1, d15, d22q4wksN=119
Treatment B: GC:Gemcitabine 1000 mg/m2 d1 and d8Carboplatin AUC 4.5 d1q3wksN=119
STUDY DESIGN
- 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
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RESULTS
GC MCAVI HR P valuePS 0
1
2
16.8%
38.7%
44.5%
16%
38.7%
45.4%
Visceral Metastases 46.2% 55.5% SS
GFR 60 ml/min 55% 55%
RECIST RR 41.2% 30.3% p=0.01
PFS 5.8m 4.2m p=0.78
OS 9.3m 8.1m 0.94 p=0.64
Median follow-up = 4.5 years
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RESULTS: TOXICITY
GC MCAVI P value
Grade 3/4 Thrombocytopenia 48.3% 19.4% SS
Febrile Neutropenia 4.2% 14.4% SS
Severe/Acute Toxicity
(predefined definition)9.3% 21.2% SS
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STUDY COMMENTARY
• Gemcitabine/Carboplatin did not increase overall survival compared to Methotrexate, Carboplatin, Vinblastine
• It was somewhat more tolerable
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BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS
• 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
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