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EORTC 30986: Gemcitabine/carboplatin did not improve survival in advanced urothelial cancer
The combination of gemcitabine and carboplatin produced OS equivalent to a regimen of methotrexate, carboplatin and vinblastine in patients with advanced urothelial cancer deemed unfit for cisplatin-based chemotherapy, phase 3 results from the EORTC 30986 trial showed.
Maria De Santis, MD, with Kaiser Franz Josef-Spital der Stadt Wien in Vienna, Austria, said researchers hypothesized that gemcitabine and carboplatin would improve OS to 13.5 months compared with 9 months for methotrexate, carboplatin and vinblastine (M-CAVI).
However, at a median follow-up of 4.5 years, OS was only 9.3 months for gemcitabine and carboplatin vs. 8.1 months for M-CAVI (HR=0.94; 95% CI, 0.72-1.22).
“The intent-to-treat analysis of the primary endpoint of overall survival shows no statistically significant difference between the two treatment arms,” De Santis said. “The hypothesized increase to 13.5 months was not reached.”
De Santis presented updated results from EORTC 30986 at the 2010 ASCO Annual Meeting. Phase 2 results were published last year in the Journal of Clinical Oncology.
From January 2001 to March 2008, 238 chemotherapy-naive patients were enrolled and randomly assigned 1,000 mg/m2 gemcitabine and 4.5 area under the curve carboplatin every 3 weeks for at least two cycles or 30 mg/m2 methotrexate, 4.5 area under the curve carboplatin and 3 mg/m2 vinblastine every 4 weeks for at least two cycles. There were 119 patients in both arms.
There was no statistical difference for PFS between the two arms (P=.78), but gemcitabine and carboplatin produced superior results for overall response and toxicity. Best overall response was 41.2% with gemcitabine and carboplatin, and 43 patients had confirmed response compared with 30.3% for M-CAVI. Twenty-five patients in that group had confirmed response.
Fewer patients in the gemcitabine and carboplatin group experienced grade-3/grade-4 toxicities (9.3% vs. 21.2%). There were four toxic deaths in the M-CAVI group.
For more information:
- De Santis M. #LBA4519.