01.08.2010 | Original Article | Ausgabe 4/2010
Third-line gemcitabine monotherapy for platinum-resistant advanced urothelial cancer
International Journal of Clinical Oncology
- Norihito Soga, Hideaki Kise, Kiminobu Arima, Yoshiki Sugimura
To evaluate the efficacy and toxicity of third-line gemcitabine monotherapy (Gem) in patients with platinum-resistant advanced urothelial cancer (UC).
Patients and methods
From July 2005 to March 2009, 13 patients were enrolled. All patients had previously received methotrexate, vinblastine, doxorubicin, and cisplatin as first-line therapy. Second-line therapy consisted of paclitaxel/carboplatin (Pca) therapy: paclitaxel (175 mg/m2) followed by carboplatin (area under the curve = 5) was intravenously infused on day 1 of each 21-day cycle. Following Pca failure, Gem was given as third-line treatment: gemcitabine (1,000 mg/m2) was intravenously administered on days 1, 8, and 15 of each 28-day cycle. All patients were eligible for toxicity assessment. Survival curves were produced using the Kaplan–Meier method.
An average of 3.2 Gem cycles (range, 1–8 cycles) were given. Following Gem treatment, overall response rates were 0% CR, 7.7% PR (n = 1), 53.8% SD (n = 7), and 38.5% PD (n = 5). Grade 3–4 toxicities included anemia (31%), neutropenia (31%), and thrombocytopenia (31%). One case experienced grade 3–4 hepatic dysfunction during treatment with Gem. Low-grade alopecia was observed in all 13 patients (100%). Median time to progression and overall survival was 2 and 7.3 months, respectively, following Gem. The 1- and 2-year overall survival rate was 30.8% and 15.3%, respectively, for Gem.
Gem as third-line therapy was performed safely with good tolerability in platinum-resistant advanced UC, even though the efficacy was very limited.