Abstract
Background
The objective of this study was to evaluate the efficacy and toxicity of combination chemotherapy with gemcitabine and paclitaxel as a second-line regimen in patients with advanced urothelial carcinoma.
Methods
Twenty patients with advanced urothelial carcinoma who were resistant to an M-VAC (methotrexate, vinblastine, doxorubicin, and cisplatin) chemotherapy regimen were administered chemotherapy consisting of intravenous gemcitabine 2500 mg/m2 and paclitaxel 150 mg/m2 (GP) every 2 or 3 weeks.
Results
The patients received a median of 7.7 cycles of treatment (range, 2–20 cycles). Six of the 20 patients (30%; 95% confidence interval [CI], 10%–50%) had a major response to treatment (a complete response [CR] in 5% and a partial response [PR] in 25%). Seven patients (35%) had stable disease (SD). The median duration of response was 4.5 months (range, 1–9 months) and the disease control rate (CR + PR + SD) was 65%. The median survival was 11.5 months (range, 2–22 months) and the 1-year survival rate was 35%. The patients tolerated this regimen well, with only grade 3–4 neutropenia being observed in 6 patients (30%), anemia in 3 (15%), and thrombocytopenia in 1 (5%). The response rate to M-VAC in the first-line chemotherapy was significantly associated with the response to GP as the second-line chemotherapy.
Conclusion
The combination of gemcitabine and paclitaxel is active and well tolerated as a second-line treatment in patients with advanced urothelial carcinoma.
Similar content being viewed by others
References
Sternberg CN, Yagoda A, Scher HI, et al. (1988) M-VAC (methotrexate, vinblastine, doxorubicin and cisplatin) for advanced transitional cell carcinoma of the urothelium. J Urol 139:461–469
Logothetis CJ, Dexeus FH, Finn L, et al. (1990) A prospective randomized trial comparing MVAC and CISCA chemotherapy for patients with metastatic urothelial tumors. J Clin Oncol 8:1050–1055
Saxman SB, Propert KJ, Einhorn LH, et al. (1997) Long-term follow-up of a phase III Intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a Cooperative Group study. J Clin Oncol 15:2564–2569
Tannock I, Gospodarowicz M, Connolly J, et al. (1989) M-VAC (methotrexate, vinblastine, doxorubicin and cisplatin) chemotherapy for transitional cell carcinoma: the Princess Margaret Hospital experience. J Urol 142:289–292
Connor JP, Olsson CA, Benson MC, et al. (1989) Long-term follow-up in patients treated with methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) for transitional cell carcinoma of urinary bladder: cause for concern. Urology 34:353–356
Lorusso V, Pollera CF, Antimi M, et al. (1998) A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Italian Co-operative Group on Bladder Cancer. Eur J Cancer 34:1208–1212
Stadler WM, Kuzel T, Roth B, et al. (1997) Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol 15:3394–3398
Moore MJ, Tannock IF, Ernst DS, et al. (1997) Gemcitabine: a promising new agent in the treatment of advanced urothelial cancer. J Clin Oncol 15:3441–3445
Roth BJ, Dreicer R, Einhorn LH, et al. (1994) Significant activity of paclitaxel in advanced transitional-cell carcinoma of the urothelium: a phase II trial of the Eastern Cooperative Oncology Group. J Clin Oncol 12:2264–2270
Papamichael D, Gallagher CJ, Oliver RT, et al. (1997) Phase II study of paclitaxel in pretreated patients with locally advanced/metastatic cancer of the bladder and ureter. Br J Cancer 75:606–607
Rothenberg ML, Sharma A, Weiss GR, et al. (1998) Phase I trial of paclitaxel and gemcitabine administered every 2 weeks in patients with refractory solid tumors. Ann Oncol 9:733–738
Sternberg CN, Calabro F, Pizzocaro G, et al. (2001) Chemotherapy with an every-2-week regimen of gemcitabine and paclitaxel in patients with transitional cell carcinoma who have received prior cisplatin-based therapy. Cancer 92:2993–2998
Meluch AA, Greco FA, Burris HA, et al. (2001) Paclitaxel and gemcitabine chemotherapy for advanced transitional-cell carcinoma of the urothelial tract: a phase II trial of the Minnie Pearl Cancer Research Network. J Clin Oncol 19:3018–3024
Takahashi T, Higashi S, Nishiyama H, et al. (2006) Biweekly paclitaxel and gemcitabine for patients with advanced urothelial cancer ineligible for cisplatin-based regimen. Jpn J Clin Oncol 36:104–108
Kaufman DS, Carducci MA, Kuzel TM, et al. (2004) A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer. Urol Oncol 22:393–397
Li J, Juliar B, Yiannoutsos C, et al. (2005) Weekly paclitaxel and gemcitabine in advanced transitional-cell carcinoma of the urothelium: a phase II Hoosier Oncology Group study. J Clin Oncol 23:1185–1191
von der Maase H, Hansen SW, Roberts JT, et al. (2000) Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 18:3068–3077
Hainsworth JD, Meluch AA, Litchy S, et al. (2005) Paclitaxel, carboplatin, and gemcitabine in the treatment of patients with advanced transitional cell carcinoma of the urothelium. Cancer 103:2298–2303
Author information
Authors and Affiliations
Corresponding author
About this article
Cite this article
Kanai, K., Kikuchi, E., Ohigashi, T. et al. Gemcitabine and paclitaxel chemotherapy for advanced urothelial carcinoma in patients who have received prior cisplatin-based chemotherapy. Int J Clin Oncol 13, 510–514 (2008). https://doi.org/10.1007/s10147-008-0779-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10147-008-0779-x