Randomized phase III trial of 2nd line gemcitabine and paclitaxel chemotherapy in patients with advanced bladder cancer: short-term versus prolonged treatment [German Association of Urological Oncology (AUO) trial AB 20/99].
Ann Oncol
; 22(2): 288-94, 2011 Feb.
Article
em En
| MEDLINE
| ID: mdl-20682548
ABSTRACT
BACKGROUND:
The second-line chemotherapeutic treatment for metastatic urothelial cancer (UC) after failure of cisplatin-based first-line therapy needs to be improved. Based on encouraging phase II data of gemcitabine and paclitaxel (Taxol) (GP), this trial was designed to compare a short-term (arm A) versus a prolonged (arm B) second-line combination chemotherapy of GP. PATIENTS ANDMETHODS:
Of 102 randomized patients, 96 were eligible for analysis. Primary end point was overall survival (OS). Secondary end points were progression-free survival (PFS), objective response rates (ORR) and toxicity.RESULTS:
Neither OS [arm A 7.8 (95% CI 4.2-11.4), arm B 8.0 (95% CI 4.9-11.1) months] and PFS [arm A 4.0 (95% CI 0-8.0), arm B 3.1 (95% CI 1.9-4.2) months] nor ORR (arm A 37.5%, arm B 41.5%) were significantly different. On prolonged treatment, more patients experienced severe anemia (arm A 6.7% versus arm B 26.7% grade III/IV anemia; P = 0.011). In six patients, treatment was stopped during the first cycle due to disease progression or toxicity. Two patients died due to treatment-related toxic effects.CONCLUSION:
Due to rapid tumor progression and toxicity at this dosage and schedule in a multicenter setting, it was not feasible to deliver a prolonged regimen. However, a high response rate of â¼40% makes GP a promising second-line treatment option for patients with metastatic UC.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Bexiga Urinária
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Carcinoma de Células de Transição
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Protocolos de Quimioterapia Combinada Antineoplásica
Tipo de estudo:
Clinical_trials
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Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
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Aged
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Aged80
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Humans
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Middle aged
Idioma:
En
Revista:
Ann Oncol
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2011
Tipo de documento:
Article