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Two regimens active when cisplatin therapy not advised
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Two chemotherapy regimens showed activity in patients with advanced urothelial cancer who are ineligible for cisplatin therapy, according to data presented by Maria De Santis, MD, a medical oncologist at Kaiser Franz Josef-Spital in Vienna.
The results were from the phase-2 EORTC study 30986. The researchers from various institutions throughout Europe randomly assigned 178 patients to gemcitabine (Gemzar, Lilly) with carboplatin or methotrexate, carboplatin and vinblastine (M-CAVI).
The overall response rate was 42% in the gemcitabine plus carboplatin group, and the complete response rate was 3.4%. In the M-CAVI group, the overall response rate was 31%, and the complete response rate was 4.6%.
In the gemcitabine plus carboplatin group, the most common toxicity was grade-4 thrombocytopenia with hemorrhage. In the M-CAVI group, the most common toxicities were grade-3 mucositis, grade-3/4 neutropenic fever and grade-3/4 renal toxicity. In the M-CAVI group, 4.6% died as a result of treatment. – by Emily Shafer
For more information:
- De Santis M, Bellmunt J, Mead B, et al. #288. Presented at: 2008 Genitourinary Cancers Symposium; Feb. 14-16, 2008; San Francisco.
Cisplatin is one of the key agents of many drug regimens that are considered the standard of care for these patients. However, patients with comorbidities or impaired renal function are not good candidates for this treatment. In the past few decades, there have been efforts to develop effective combinations of drugs to treat these patients effectively. The two regimens in this trial are more friendly to the kidneys. However, there was a fair amount of controversy related to the toxicity, and there was a relatively high death rate for the regimens that were hopefully going to be kinder and gentler. So, there is no direct effect on clinical practice today. This trial will continue, the data will mature, and perhaps then there will be information.
– Robert Dreicer, MD
Chair of Solid Tumor Oncology
Taussig Cancer Institute, Cleveland Clinic