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 journalArticle

24 Citations (Scopus)

Abstract

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
JournalOncology
Volume69
Issue number5
DOIs
Publication statusPublished - Dec 2005

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gemcitabine
Urinary Bladder Neoplasms
Cisplatin
Survival
Transitional Cell Carcinoma
Neoplasms
Appointments and Schedules
Safety
Vinblastine
Poisons

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II study of gemcitabine and cisplatin in patients with advanced or metastatic bladder cancer : Long-term follow-up of a 3-week regimen. / Adamo, V.; Magno, C.; Spitaleri, G.; Garipoli, C.; Maisano, C.; Alafaci, E.; Adamo, B.; Rossello, R.; Scandurra, G.; Scimone, A.

In: Oncology, Vol. 69, No. 5, 12.2005, p. 391-398.

Research output: Contribution to journalArticle

Adamo, V, Magno, C, Spitaleri, G, Garipoli, C, Maisano, C, Alafaci, E, Adamo, B, Rossello, R, Scandurra, G & Scimone, A 2005, 'Phase II study of gemcitabine and cisplatin in patients with advanced or metastatic bladder cancer: Long-term follow-up of a 3-week regimen', Oncology, vol. 69, no. 5, pp. 391-398. https://doi.org/10.1159/000089993
Adamo, V. ; Magno, C. ; Spitaleri, G. ; Garipoli, C. ; Maisano, C. ; Alafaci, E. ; Adamo, B. ; Rossello, R. ; Scandurra, G. ; Scimone, A. / Phase II study of gemcitabine and cisplatin in patients with advanced or metastatic bladder cancer : Long-term follow-up of a 3-week regimen. In: Oncology. 2005 ; Vol. 69, No. 5. pp. 391-398.
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title = "Phase II study of gemcitabine and cisplatin in patients with advanced or metastatic bladder cancer: Long-term follow-up of a 3-week regimen",
abstract = "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.",
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T1 - Phase II study of gemcitabine and cisplatin in patients with advanced or metastatic bladder cancer

T2 - Long-term follow-up of a 3-week regimen

AU - Adamo, V.

AU - Magno, C.

AU - Spitaleri, G.

AU - Garipoli, C.

AU - Maisano, C.

AU - Alafaci, E.

AU - Adamo, B.

AU - Rossello, R.

AU - Scandurra, G.

AU - Scimone, A.

PY - 2005/12

Y1 - 2005/12

N2 - 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.

AB - 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.

KW - Advanced/metastatic bladder cancer

KW - Cisplatin

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KW - Phase II trial

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