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A 1‐year maintenance after early adjuvant intravesical chemotherapy has a limited efficacy in preventing recurrence of intermediate risk non‐muscle‐invasive bladder cancer
Author(s) -
Serretta Vincenzo,
Morgia Giuseppe,
Altieri Vincenzo,
Di Lallo Alessandra,
Ruggiero Giovanni,
Salzano Luigi,
Battaglia Michele,
Falsaperla Mario,
Zito Aniello,
Sblendorio Domenico,
Melloni Darvinio,
Allegro Rosalinda
Publication year - 2010
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2009.09153.x
Subject(s) - medicine , epirubicin , bladder cancer , chemotherapy , regimen , surgery , cystoscopy , urology , maintenance therapy , randomized controlled trial , toxicity , cancer , urinary system , cyclophosphamide
Study Type – Therapy (RCT)
Level of Evidence 1b OBJECTIVE To evaluate the efficacy of 1‐year maintenance after a 6‐week cycle of early intravesical chemotherapy, as the role of maintenance in intravesical chemotherapy is debated. PATIENTS AND METHODS Between May 2002 and August 2003, 577 patients with non‐muscle‐invasive bladder cancer (NMI‐BC) underwent transurethral resection (TUR) and early intravesical chemotherapy (epirubicin, 80 mg/50 mL). They were randomized between a 6‐week induction cycle and the induction cycle plus maintenance with 10 monthly instillations. In all, 95 patients with T1G3, Tis or single and primary Ta–T1 G1–G2 tumours were excluded; 482 patients at intermediate risk of recurrence continued the study. All patients had cytology and cystoscopy at 3‐monthly intervals for the first 2‐years and 6‐monthly thereafter. RESULTS The tumours’ characteristics were equally distributed between the two arms. Treatment interruption for toxicity was required in 39 patients. One death due to toxicity of early instillation occurred. The median follow‐up was 48 months. Ten patients (2.5%) progressed and 117 patients (29.6%) recurred. No statistically significant difference in the recurrence‐free rate (RFS) was detected between the two arms ( P = 0.43). An advantage in favour of the maintenance arm was evident only at 18 months after TUR ( P = 0.03). A trend for a higher benefit from maintenance in primary and multiple tumours was detected. CONCLUSIONS In patients with intermediate risk NMI‐BC treated by TUR and early adjuvant chemotherapy, adding a maintenance regimen with monthly instillations for 1 year is of limited efficacy in preventing recurrence.