Randomized Phase III Trial on Gemcitabine Versus Mytomicin in Recurrent Superficial Bladder Cancer: Evaluation of Efficacy and Tolerance
| Autor: | Salvatore Del Prete, Sergio Bellini, Rosario Guarrasi, Vincenzo Faiola, Antonio Miragliuolo, Michele Lanna, Liliana Montella, Gregorio Cennamo, Alberto Abbruzzese, Raffaele Addeo, Bruno Vincenzi, Michele Caraglia |
|---|---|
| Přispěvatelé: | Addeo, R, Caraglia, Michele, Bellini, S, Abbruzzese, A, Vincenzi, B, Montella, L, Miragliuolo, A, Guarrasi, R, Lanna, M, Cennamo, G, Faiola, V, DEL PRETE, S. |
| Rok vydání: | 2010 |
| Předmět: |
Male
Antimetabolites Antineoplastic Cancer Research medicine.medical_specialty Maximum Tolerated Dose endocrine system diseases Mitomycin medicine.medical_treatment Urology Deoxycytidine Maintenance therapy medicine Carcinoma Humans Survival rate Aged Neoplasm Staging Carcinoma Transitional Cell Chemotherapy Antibiotics Antineoplastic business.industry Cancer Prognosis medicine.disease Gemcitabine Surgery Survival Rate Treatment Outcome Urinary Bladder Neoplasms Oncology Female Neoplasm Recurrence Local business Progressive disease medicine.drug Epirubicin |
| Zdroj: | Journal of Clinical Oncology. 28:543-548 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2008.20.8199 |
| Popis: | Purpose Approximately 30% to 40% patients with a superficial bladder cancer treated with Bacille Calmette-Guerin (BCG) or epirubicin do not respond; of the initial responders, 35% have a relapse within 5 years. We compare the therapeutic efficacy and toxicity of intravescical infusions of gemcitabine (GEM) with mitomycin (MMC) in patients with a recurrent superficial bladder cancer. Patients and Methods Patients with a history of a previously treated, recurrent Ta-T1, G1-G3 bladder transitional cell carcinoma were enrolled in the study. The patients received a 6-week course of GEM infusions or 4-week course of MMC. In both arms, for the initial responders who remained free of recurrences, maintenance therapy consisted of 10 monthly treatments during the first year. Results A total of 120 patients were enrolled and randomly assigned to either the MMC or GEM treatment arm. At the end of the study, 109 patients (55 in MMC and 54 in GEM) were assessable. The median duration of follow-up was 36 months for either arm. In the GEM arm, 39 (72%) of 54 patients remained free of recurrence versus 33 (61%) of 55 in MMC arm. Among patients with recurrences, 10 in the MMC arm and six in the GEM arm also had a progressive disease by stage. The incidence of chemical cystitis in the MMC arm was statistically higher than in the GEM arm (P = .012). Conclusion This study demonstrates that GEM has better efficacy and lower toxicity than MMC; therefore, GEM appears as a logical candidate for intrabladder therapy in patients with refractory transitional cancer. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|