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Phase II study of a cremophor-free, polymeric micelle formulation of paclitaxel for patients with advanced urothelial cancer previously treated with gemcitabine and platinum

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Summary

Introduction Genexol-PM is a novel Cremophor® EL (CrEL)-free polymeric micelle formulation of paclitaxel. This multicenter phase II study was designed to evaluate the efficacy and safety of Genexol-PM monotherapy in patients with advanced urothelial carcinoma who developed disease progression after gemcitabine and cisplatin combination chemotherapy. Patients and Methods Patients received Genexol-PM 240 mg/m2 intravenously over 3 h every 3 weeks without premedication. Intra-patient dose escalation to 300 mg/m2 was allowed during the second and subsequent cycles if pre-specified toxicities were not observed during the first cycle. The primary endpoint was response. Results Thirty-seven patients were enrolled in this study. Platinum-free interval was less than 6 months in 27 (73%) patients, and 24 (64%) were categorized as having intermediate or poor prognosis according to Bajorin’s criteria. Of 34 evaluable patients, there were 7 responses (21%; 95% CI, 7–34%), including one complete response (CR), with a median response duration of 6.5 months (95% CI, 3.5–9.6 months). The median time to progression was 2.7 months (95% CI, 0.9–4.6 months) with a median overall survival of 6.5 months (95% CI, 5.0–8.0 months). The most common grade 3/4 non-hematologic toxicities were peripheral neuropathy (sensory type 5.9%; motor type 8.8%) and infection (5.9%). Grade ≥3 hematologic toxicities occurred in only one patient. Conclusion Genexol-PM was generally well tolerated and demonstrated sufficient antitumor activity to warrant further development when used as second-line chemotherapy after gemcitabine-cisplatin failure in patients with urothelial carcinoma (NCT01426126).

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Acknowledgments

Genexol-PM was provided by Samyang Co. Seoul, Korea. This study was presented in part at the 2011 ASCO Genitourinary Cancer Symposium, Orlando, FL, USA, February 17–19, 2011.

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Nothing special to be declared.

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Correspondence to Jin-Hee Ahn.

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Lee, JL., Ahn, JH., Park, S.H. et al. Phase II study of a cremophor-free, polymeric micelle formulation of paclitaxel for patients with advanced urothelial cancer previously treated with gemcitabine and platinum. Invest New Drugs 30, 1984–1990 (2012). https://doi.org/10.1007/s10637-011-9757-7

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