Abstract
BACKGROUND
Currently, there is no standard treatment for patients with advanced renal cell carcinoma (RCC) who do not experience a response to firstโline immunotherapy. In the current Phase II study, the authors explored the antitumor activity of a combination of gemcitabine and oxaliplatin (LโOHP) in this setting.
METHODS
Fortyโtwo patients with RCC who had progressive disease following immunotherapy received gemcitabine (1000 mg/m^2^ intravenously on Days 1 and 8 every 21 days) and LโOHP (90 mg/m^2^ intravenously on Day 1 every 21 days) for a minimum of 2 cycles before responses were evaluated. Responses to treatment and toxicity were recorded according to the Response Evaluation Criteria in Solid Tumors and the National Cancer Institute Common Toxicity Criteria, respectively.
RESULTS
No complete responses were recorded; however, 6 patients experienced a partial response (14.28%; 95% confidence interval, 5.43โ28.5%), 11 patients (26.19%) had temporary stable disease as a best response, and the remaining 25 patients (59.52%) experienced progression despite receiving treatment. The median time to disease progression was 2.5 months (mean, 3.86 months; range, 1.5โ11.0 months), whereas the median overall survival was 9.5 months (mean, 10.46 months; range, 4.0โ22.5 months). With regard to toxicity, treatment generally was well tolerated, with only one episode of Grade 4 toxicity and expected episodes of Grade 3 toxicity, including myelosuppression and neuropathy.
CONCLUSIONS
The current results suggest that the combination of gemcitabine and LโOHP possesses a certain level of activity and an acceptable toxicity profile in patients with immunotherapyโresistant advanced RCC. Cancer 2004. ยฉ 2004 American Cancer Society.