Gemcitabine and paclitaxel every 2 weeks in patients with previously untreated urothelial carcinoma

BACKGROUND: Patients with urothelial carcinoma are not always amenable to cisplatin‐based chemotherapy. The authors previously reported that they achieved a 60% response rate in patients who failed on cisplatin‐based combination chemotherapy (methotrexate, vinblastine, doxorubicin, and cisplatin) by...

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Bibliographic Details
Published in:Cancer 2009-06, Vol.115 (12), p.2652-2659
Main Authors: Calabrò, Fabio, Lorusso, Vito, Rosati, Gerardo, Manzione, Luigi, Frassineti, Luca, Sava, Teodoro, Di Paula, Eugenio Donato, Alonso, Silvia, Sternberg, Cora N.
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Deoxycytidine - administration & dosage
Deoxycytidine - adverse effects
Deoxycytidine - analogs & derivatives
Disease-Free Survival
Drug Administration Schedule
Female
gemcitabine
Humans
Infusions, Intravenous
Injections, Intravenous
Male
Medical sciences
Middle Aged
Neutropenia - chemically induced
outpatient regimen
paclitaxel
Paclitaxel - administration & dosage
Paclitaxel - adverse effects
Tumors
Urinary Bladder Neoplasms - drug therapy
Urinary Bladder Neoplasms - mortality
Urinary Bladder Neoplasms - pathology
urothelial carcinoma
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Summary:BACKGROUND: Patients with urothelial carcinoma are not always amenable to cisplatin‐based chemotherapy. The authors previously reported that they achieved a 60% response rate in patients who failed on cisplatin‐based combination chemotherapy (methotrexate, vinblastine, doxorubicin, and cisplatin) by using a convenient outpatient regimen of gemcitabine (G) and paclitaxel (P) every 2 weeks. A multicenter trial was initiated in 5 Italian centers to evaluate this regimen as first‐line chemotherapy. METHODS: From January 2003 to April 2005, 54 patients who had histologically proven, measurable disease (according to Response Evaluation Criteria in Solid Tumors) with a World Health Organization (WHO) performance status (PS) from 0 to 2, metastatic or inoperable urothelial carcinoma, no prior systemic cytotoxic or biologic treatment, a creatinine clearance ≥40 mL per minute, and bilirubin 1 site of disease, and 13% of patients had ≥3 sites of disease. In total, 343 cycles were administered. Five patients achieved a complete response, and 15 patients achieved a partial response; thus, the overall response rate was 37% in an intent‐to‐treat analysis. Hematologic toxicity was predominant but manageable. G‐CSF was used in only 6% of cycles. The median survival was 13.2 months, and the median time to disease progression was 5.8 months. CONCLUSIONS: In a multicenter study, G and P was found to be a well–tolerated outpatient regimen. This regimen demonstrated promise and may be considered in patients who are unable to receive cisplatin. Cancer 2009. © 2009 American Cancer Society. In this multicenter trial, a convenient outpatient regimen of gemcitabine and paclitaxel given e
ISSN:0008-543X
1097-0142
DOI:10.1002/cncr.24313