Abstract | BACKGROUND: METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P < .008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS:
Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients.
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Authors | Giuseppe Di Lorenzo, Sisto Perdonà, Rocco Damiano, Adriana Faiella, Francesco Cantiello, Sandro Pignata, Paolo Ascierto, Ester Simeone, Marco De Sio, Riccardo Autorino |
Journal | Cancer
(Cancer)
Vol. 116
Issue 8
Pg. 1893-900
(Apr 15 2010)
ISSN: 0008-543X [Print] United States |
PMID | 20162706
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | (c) 2010 American Cancer Society. |
Chemical References |
- Antimetabolites, Antineoplastic
- BCG Vaccine
- Deoxycytidine
- Gemcitabine
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Topics |
- Administration, Intravesical
- Aged
- Antimetabolites, Antineoplastic
(administration & dosage)
- BCG Vaccine
(administration & dosage, adverse effects, therapeutic use)
- Deoxycytidine
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Female
- Humans
- Male
- Retreatment
- Treatment Failure
- Urinary Bladder Neoplasms
(pathology, therapy)
- Gemcitabine
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