A 3-arm randomized control trial to compare the efficacy of re-circulant hyperthermic intravesical chemotherapy versus conventional intravesical mitomycin C and BCG therapy for intermediate-risk non-muscle invasive bladder cancer.
Humans
Urinary Bladder Neoplasms
/ pathology
Mitomycin
/ administration & dosage
Male
Female
BCG Vaccine
/ administration & dosage
Administration, Intravesical
Middle Aged
Aged
Hyperthermia, Induced
/ methods
Antibiotics, Antineoplastic
/ administration & dosage
Neoplasm Invasiveness
Treatment Outcome
Adjuvants, Immunologic
/ administration & dosage
Combined Modality Therapy
Non-Muscle Invasive Bladder Neoplasms
BCG
Bladder cancer
Chemohyperthermia
HIVEC
Intermediate risk
Intravesical therapy
Low-grade
Mitomycin C
NMIBC
Journal
World journal of urology
ISSN: 1433-8726
Titre abrégé: World J Urol
Pays: Germany
ID NLM: 8307716
Informations de publication
Date de publication:
31 Oct 2024
31 Oct 2024
Historique:
received:
09
06
2024
accepted:
22
10
2024
medline:
1
11
2024
pubmed:
1
11
2024
entrez:
31
10
2024
Statut:
epublish
Résumé
To evaluate the efficacy and side effects of re-circulant hyperthermic intravesical chemotherapy versus conventional treatments for intermediate risk non-muscle invasive bladder cancer (NMIBC). A randomized 3-arm, parallel group trial was conducted at a single tertiary care centre. 135 patients with low-grade intermediate-risk cancer, having undergone complete resection of bladder tumor were included. Patients were assigned 1:1:1, to receive intra-vesical chemo-hyperthermia (C-HT), mitomycin-C (MMC) or BCG therapy. There was no treatment crossover. Patients were followed up with check cystoscopy every 3 months for histopathological recurrence. The three arms were comparable in terms of age, gender, tumor size, number of tumors and clinical stage or grade of tumors. Mean tumor size was 2.58 (± 0.88) cm and the mean number of tumors resected was 2.04 (± 1.02) (Range 1-5). There was no significant difference between the various groups for tumor recurrence (χ2 = 1.96, p = 0.375) or time to recurrence (13.6 vs. 10.8 vs. 9.8 months, p = 0.844) though incidence of non-healing necrotic area was higher with C-HT (22.2% vs. 11.1% and 4.8%, χ2 = 6.093, p = 0.048). Median (IQR) follow up period was 26 (12-52) months. Treatment discontinuation or drug intolerance was significantly higher in BCG arm (p = 0.03). Intravesical C-HT with MMC, conventional MMC and BCG are equally effective and comparable alternatives for intravesical therapy in low-grade intermediate-risk NMIBC. Higher incidence of non-healing resection site with C-HT and higher local symptoms with BCG are a concern.
Identifiants
pubmed: 39480527
doi: 10.1007/s00345-024-05338-x
pii: 10.1007/s00345-024-05338-x
doi:
Substances chimiques
Mitomycin
50SG953SK6
BCG Vaccine
0
Antibiotics, Antineoplastic
0
Adjuvants, Immunologic
0
Types de publication
Journal Article
Randomized Controlled Trial
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
609Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
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