Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non-muscle-invasive bladder cancer: a randomised clinical trial.
#BladderCancer
#blcsm
#uroonc
cytosine arabinoside
intravesical therapy
mitomycin C
non-muscle-invasive bladder cancer
randomised trial
urinary pH
Journal
BJU international
ISSN: 1464-410X
Titre abrégé: BJU Int
Pays: England
ID NLM: 100886721
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
revised:
29
07
2021
received:
18
06
2021
accepted:
07
08
2021
pubmed:
13
8
2021
medline:
16
4
2022
entrez:
12
8
2021
Statut:
ppublish
Résumé
To compare the urinary pH, recurrence-free survival (RFS), and safety of adjuvant intravesical therapy in patients with non-muscle-invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara-C) therapy. A total of 165 patients with NMIBC from six hospitals were randomly allocated to two groups: weekly instillation of MMC + Ara-C (30 mg/30 mL + 200 mg/10 mL) for 6 weeks and the same instillation schedule of MMC (30 mg/40 mL). The primary outcome was RFS, and secondary outcomes were urinary pH and toxicity in the two groups. A total of 81 and 87 patients were randomised into the MMC and MMC + Ara-C groups, respectively. Overall, the RFS in the MMC + Ara-C group was significantly longer (P = 0.018) than that in the MMC group. A similar significant difference was detected in patients with intermediate-risk NMIBC, but not in those with high-risk NMIBC. The mean (SD) urinary pH was significantly higher in the MMC + Ara-C group than in the MMC group, at 6.56 (0.61) vs 5.78 (0.64) (P < 0.001), and the frequency of a urinary pH of >7.0 in the MMC and MMC + Ara-C groups was 6.3% and 26.7%, respectively (P < 0.001). Multivariate analysis models including clinicopathological features and second transurethral resection demonstrated that increased urinary pH was associated with better outcomes (hazard ratio 0.18, 95% confidential interval 0.18-0.038; P < 0.001). In all, there were 14 and 10 adverse events in the MMC and MMC + Ara-C groups, respectively, without a significant difference (P = 0.113). Our randomised clinical trial suggested that intravesical therapy with MMC and Ara-C is useful and safe for patients with intermediate-risk NMIBC. Increase in urinary pH with Ara-C is speculated as a mechanism for increased anti-cancer effects.
Identifiants
pubmed: 34383381
doi: 10.1111/bju.15571
pmc: PMC9290455
doi:
Substances chimiques
Antibiotics, Antineoplastic
0
Cytarabine
04079A1RDZ
Mitomycin
50SG953SK6
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
534-541Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2021 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.
Références
Can J Urol. 2018 Aug;25(4):9407-9412
pubmed: 30125520
J Urol. 2020 May;203(5):902-909
pubmed: 31821066
Urol Oncol. 2021 Aug;39(8):498.e13-498.e20
pubmed: 33485761
Cancer Res. 1991 Oct 1;51(19):5144-52
pubmed: 1913640
PLoS One. 2018 Dec 14;13(12):e0209101
pubmed: 30550547
Cancer. 1986 Sep 15;58(6):1199-203
pubmed: 3091241
Oncotarget. 2017 Oct 09;8(56):96117-96125
pubmed: 29221191
Urol Oncol. 2009 Mar-Apr;27(2):155-9
pubmed: 18367117
Transl Androl Urol. 2019 Feb;8(1):94-100
pubmed: 30976573
Urol Clin North Am. 2020 Feb;47(1):103-110
pubmed: 31757293
World J Urol. 2019 Oct;37(10):2017-2029
pubmed: 30535583
Eur Urol. 2019 Nov;76(5):639-657
pubmed: 31443960
BJU Int. 2020 Feb;125(2):197-205
pubmed: 31597003
J Urol. 2011 Mar;185(3):802-6
pubmed: 21239010
J Natl Cancer Inst. 2001 Apr 18;93(8):597-604
pubmed: 11309436
BJU Int. 2013 Oct;112(6):742-50
pubmed: 23452187
Cancer Chemother Pharmacol. 1993;32(4):255-62
pubmed: 8324866
J Urol. 2016 Oct;196(4):1021-9
pubmed: 27317986
BJU Int. 2021 Nov;128(5):634-641
pubmed: 33783950
Urology. 2021 Mar;149:11-20
pubmed: 33181123
Ann Card Anaesth. 2016 Jul-Sep;19(3):454-62
pubmed: 27397449
Int J Urol. 2001 May;8(5):212-6
pubmed: 11328420
Clin Cancer Res. 2015 Jan 15;21(2):303-11
pubmed: 25424854
Eur Urol Focus. 2021 May;7(3):566-573
pubmed: 32532704
Cancer Med. 2020 Nov;9(21):7800-7809
pubmed: 33040478
Urology. 1982 Nov;20(5):510-4
pubmed: 6815854
Pediatr Cardiol. 2017 Jan;38(1):149-154
pubmed: 27826706