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Japanese Journal of Clinical Oncology Advance Access published online on April 23, 2007
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym011
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© 2007 Foundation for Promotion of Cancer Research

Efficacy and Safety of Gemcitabine Monotherapy in Patients with Transitional Cell Carcinoma after Cisplatin-Containing Therapy: A Japanese Experience

Hideyuki Akaza1,, Seiji Naito2, Michiyuki Usami3, Tsuneharu Miki4, Naoto Miyanaga1, Hisashi Taniai and the Japanese Gemcitabine Study Group5

1 Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Ibaraki
2 Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka
3 Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
4 Department of Urology, Kyoto Prefectural University of Medicine, Kyoto
5 Eli Lilly Japan K.K., Kobe, Japan

For reprints and all correspondence: Hideyuki Akaza, Department of Urology, Institute of Clinical Medicine, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba-city, Ibaraki, 305-0006, Japan. E-mail: akazah{at}md.tsukuba.ac.jp

Received September 30, 2006; accepted November 8, 2006

Background: In Japan, the standard chemotherapy for advanced transitional cell carcinoma (TCC) of the urothelium is MVAC (methotrexate, vinblastine, adriamycin, cisplatin). However, a second-line therapy is still required for patients with recurrent TCC who discontinued MVAC because of toxicity or have MVAC refractory tumors.

Methods: We evaluated gemcitabine monotherapy in patients with advanced TCC who were previously treated with a platinum-based regimen. Gemcitabine (1000 mg/m2) was given once a week for three consecutive weeks followed by a week of rest. This cycle was repeated at least three times, or until disease progression or intolerable adverse events were observed.

Results: Of the 46 patients entered into this study, 44 received gemcitabine. Performance status (PS) at study entry was: PS 0 (30 patients), PS 1 (12 patients) and PS 2 (2 patients). Stages III/IV were observed in 1/9 patients; the other 34 patients had relapsed after surgery. All 44 patients had been previously treated with a platinum-based regimen. The overall response rate was 25%, 1-year survival rate 52.3%, median survival time 12.6 months and median progression free survival 3.1 months. The major grade 3/4 hematological toxicity was neutropenia (47.7%), and the major grade 3/4 non-hematological toxicity was anorexia (9.1%). All adverse drug reactions seen in the study were manageable.

Conclusion: Gemcitabine monotherapy is a sufficiently active and well-tolerated therapy for patients who have previously undergone chemotherapy with a platinum-based regimen.

Key Words: gemcitabine • bladder cancer • second-line chemotherapy • transitional cell carcinoma • cisplatin resistance


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