Phase II study of gemcitabine and cisplatin in patients with advanced or metastatic bladder cancer: Long-term follow-up of a 3-week regimen

V. Adamo, C. Magno, G. Spitaleri, C. Garipoli, C. Maisano, E. Alafaci, B. Adamo, R. Rossello, G. Scandurra, A. Scimone

Research output: Contribution to journalArticlepeer-review


Background: Bladder cancer is the fifth most common cancer among men and the seventh among women. At diagnosis, at least 25% of bladder cancer tumors are locally or systemically advanced. Systemic chemotherapy is the only current modality for advanced or metastatic transitional cell carcinoma of the bladder. Recently, a phase III randomized study has demonstrated that the regimen with gemcitabine (GMC) and cisplatin (CDDP) had a survival advantage similar to the standard M-VAC (methotrexate, vinblastine, doxorubicin and cisplatin), with a better safety profile. Aim: It was the aim of this study to evaluate the tumor response rate, the median time to progression, the median survival and toxicity in a 21-day schedule with GMC and CDDP in patients with advanced/metastatic bladder cancer. Patients and Methods: From September 1998 to December 2000, 27 patients with advanced/metastatic transitional cell carcinoma were enrolled. All patients received 1,200 mg/m2 GMC administered as a 30-min intravenous infusion on days 1 and 8, and 75 mg/m2 CDDP as a 1-hour infusion on day 2. Cycles were repeated every 21 days. The patients had a median age of 59.8 years (range 39-75) and an Eastern Cooperative Oncology Group performance status of 0-2. Results: Twenty-five patients were valuable for toxic effects, length of survival and tumor response. The statistical analysis was performed in May 2004. Mean and median follow-up were 20.23 and 13.2 months (range 2-68), respectively. The overall remission rate (complete response + partial response) was 48% (95% CI 28.4-67.6%). The median time to progression was 9 months (range 2-56). The median duration of survival for all patients was 13.2 months (range 2-68+), with 1-year and 23-month survival rates of 60 and 20%, respectively. There was no grade 4 toxicity or treatment-related death. Grade 3 anemia was observed in 4 patients (16%) and grade 3 thrombocytopenia occurred in 6 patients (24%). No grade 3-4 nausea/vomiting or neutropenia was observed. Conclusion: GMC and CDDP is an active schedule with a good safety profile in a 21-day regimen. It may be a valid alternative to the standard 28-day regimen due to its high tumor response and survival with a low incidence of toxicity, especially in pretreated and metastatic patients.

Original languageEnglish
Pages (from-to)391-398
Number of pages8
Issue number5
Publication statusPublished - Dec 2005


  • Advanced/metastatic bladder cancer
  • Cisplatin
  • Gemcitabine
  • Phase II trial

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Fingerprint Dive into the research topics of 'Phase II study of gemcitabine and cisplatin in patients with advanced or metastatic bladder cancer: Long-term follow-up of a 3-week regimen'. Together they form a unique fingerprint.

Cite this