Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2011-5-20
pubmed:abstractText
There is no standard second-line chemotherapy treatment for recurrent or metastatic urothelial cancer (MUC). The purpose of this phase II study was to evaluate the efficacy and toxicity of the three-drug combination of paclitaxel, ifosfamide, and nedaplatin (TIN). Patients with MUC were eligible after treatment failure with methotrexate, vinblastine, doxorubicin, and cisplatin, or gemcitabine and cisplatin. Doses for TIN therapy were paclitaxel 175?mg/m2 on day 1, ifosfamide 1500?mg/m2 on days 1-3, and nedaplatin 70?mg/m2 on day 1, every 4?weeks. Tumor response, the primary efficacy parameter, was assessed according to unidimensional measurements (Response Evaluation Criteria in Solid Tumors criteria, version 1.0). Secondary efficacy parameters were overall survival (OS) and progression-free survival (PFS). Toxicity was assessed according to the National Cancer Institute Common Toxicity Criteria, version 3.0. A total of 45 patients (13 females and 32 males) with MUC were evaluable for response and toxicity. The overall response rate was 40.0%. Median PFS time was 4.0?months (95% confidence interval [CI], 4.6-11.6). Median OS time was 8.9?months (95% CI, 10.5-18.9). Grade 3 or 4 hematologic adverse events were neutropenia (95.6%), anemia (15.6%), and thrombocytopenia (17.8%). The most common grade 3 or 4 non-hematologic adverse events were anorexia (4.4%) and elevated aspartate transaminase/alanine transaminase (2.2%). No toxic death was observed. The main limitation of this study is that only 10 patients (22.2%) who were previously treated with gemcitabine and cisplatin were included. In conclusion, TIN as second-line treatment for MUC is an active regimen with a manageable toxicity profile.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
1349-7006
pubmed:author
pubmed:copyrightInfo
© 2011 Japanese Cancer Association.
pubmed:issnType
Electronic
pubmed:volume
102
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1171-5
pubmed:meshHeading
pubmed-meshheading:21323791-Adult, pubmed-meshheading:21323791-Aged, pubmed-meshheading:21323791-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:21323791-Carcinoma, Transitional Cell, pubmed-meshheading:21323791-Disease-Free Survival, pubmed-meshheading:21323791-Drug Administration Schedule, pubmed-meshheading:21323791-Female, pubmed-meshheading:21323791-Humans, pubmed-meshheading:21323791-Ifosfamide, pubmed-meshheading:21323791-Kidney Neoplasms, pubmed-meshheading:21323791-Kidney Pelvis, pubmed-meshheading:21323791-Male, pubmed-meshheading:21323791-Middle Aged, pubmed-meshheading:21323791-Organoplatinum Compounds, pubmed-meshheading:21323791-Paclitaxel, pubmed-meshheading:21323791-Treatment Outcome, pubmed-meshheading:21323791-Ureteral Neoplasms, pubmed-meshheading:21323791-Urinary Bladder Neoplasms
pubmed:year
2011
pubmed:articleTitle
Paclitaxel, ifosfamide, and nedaplatin as second-line treatment for patients with metastatic urothelial carcinoma: a phase II study of the SUOC group.
pubmed:affiliation
Department of Urology, School of Medicine, Sapporo Medical University, Sapporo Sapporo Medical University Urologic Oncology Consortium, Sapporo, Japan. hkitamu@sapmed.ac.jp
pubmed:publicationType
Journal Article, Clinical Trial, Phase II