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Two carboplatin regimens show similar efficacy in advanced urothelial cancer
De Santis M. J Clin Oncol. 2011;doi:10.1200/JCO.2011.37.3571.
Two different carboplatin-based chemotherapy regimens showed no difference in efficacy in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy, according to researchers in Europe.
“Cisplatin-containing combination therapy has been the standard of care in the treatment of advanced or metastatic urothelial cancer since the late 1980s,” the researchers wrote. “However, more than 50% of patients are ineligible for cisplatin because of poor performance status, impaired renal function or comorbidity that forbids high-volume hydration. So far, no standard chemotherapy has been established for this patient group.”
The phase 2/3 study compared the combination of gemcitabine and carboplatin with the combination of methotrexate, carboplatin and vinblastine. In the phase 2 part, which included 178 patients ineligible for cisplatin, both regimens were shown to be active and safe. The phase 3 part included 238 patients recruited between March 2001 and March 2008. They were randomly assigned to each treatment group.
Severe acute toxicity was observed in 9.3% of the gemcitabine/carboplatin group vs. 21.2% of the methotrexate/carboplatin/vinblastine group. In the gemcitabine/carboplatin group, 21% stopped treatment due to toxicity vs. 21.8% in the methotrexate/carboplatin/vinblastine group.
In the gemcitabine/carboplatin group, 41.2% had a complete or partial response vs. 30.3% in the methotrexate/carboplatin/vinblastine group. When considering only confirmed responses, the difference became significant.
The median OS was 9.3 months in the gemcitabine/carboplatin arm vs. 8.1 months in the methotrexate/carboplatin/vinblastine arm. The median PFS was 5.8 months in the gemcitabine/carboplatin arm vs. 4.2 months in the methotrexate/carboplatin/vinblastine arm. Neither difference was statistically significant.
“Although the most effective treatment for patient ineligible for cisplatin remains to be defined, the results of this randomized phase 2/3 study are still a major step forward,” the researchers wrote.
Disclosure: Some of the study researchers report receiving financial compensation from Eli Lilly.
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