A pilot clinical trial of intravesical mitomycin-C and external deep pelvic hyperthermia for non-muscle-invasive bladder cancer

Figures & data

Table I. Baseline clinical characteristics of the study population.

Gender
Male	13	87%
Female	2	13%
Age (median)	66	IQR: 56.5–75.0
ECOG performance status
0	10	67%
1	5	33%
Charlson score (median)	3	IQR: 2–3.5
Smoking history
Current or former smoker	11	73%
Pack-years exposure^1 (median number)	34	IQR: 3–60
Urothelial carcinoma history
Prior recurrences (median number)	3	IQR: 3–5
Prior CIS	11	73%
Prior T1 tumour	4	27%
Prior high grade tumour	8	53%
Prior urethral tumour	1	7%
Prior upper tract tumour	1	7%
EORTC recurrence score
Median	6	IQR: 5–8
0 (low risk)	0	0%
1–4 (intermediate risk)	2	13%
5–9 (high risk)	11	73%
10–17 (very high risk)	2	13%
EORTC progression score
Median	8	IQR: 7–14
0–1 (low risk)	0	0%
2–6 (intermediate risk)	3	20%
7–13 (high risk)	8	53%
14–23 (very high risk)	4	27%
Prior intravesical therapy
BCG doses (median number)	9	IQR: 6–12
Mitomycin C	1	7%
Vicinium (VB4-845) clinical trial	1	7%

IQR, interquartile range.

¹Only subjects with a smoking history are included in this calculation.

Table II. Treatment-associated adverse events.

Adverse event category	Grade 1	Grade 2	Total
General
Abdominal pain	3 (20%)	2 (13%)	5 (33%)
Fatigue	2 (13%)	–	2 (13%)
Heat intolerance	–	1 (7%)	1 (7%)
Myalgia	1 (7%)	–	1 (7%)
Genitourinary
Urethral pain	6 (40%)	–	6 (40%)
Chemical cystitis	1 (7%)	3 (20%)	4 (27%)
Haematuria	3 (20%)	–	3 (20%)
Bladder spasm	1 (7%)	1 (7%)	2 (13%)
Weak urinary stream	1 (7%)	–	1 (7%)
Vaginitis	–	1 (7%)	1 (7%)
Gastrointestinal
Nausea or vomiting	1 (7%)	1 (7%)	2 (13%)
Constipation	1 (7%)	–	1 (7%)
Dermatologic
Induration/swelling	2 (7%)	2 (13%)	4 (27%)
Pruritis	3 (20%)	–	3 (20%)
Rash	2 (13%)	–	2 (13%)
Bruising	–	1 (7%)	1 (7%)
Flushing	1 (7%)	–	1 (7%)
Neurologic
Dizziness	2 (13%)	–	2 (13%)
Confusion	–	1 (7%)	1 (7%)
Anxiety	1 (7%)	–	1 (7%)
Extrapyramidal symptoms	1 (7%)	–	1 (7%)
Infectious
Urinary tract infection	–	2 (13%)	2 (13%)
Cardiovascular
Hypertension	3 (20%)	–	3 (20%)

No grade 3 or higher complications were observed.

Figure 1. (A) Cumulative incidence of recurrent bladder cancer and (B) cumulative incidence of radical cystectomy in patients with BCG-refractory NMIBC undergoing intravesical mitomycin C chemotherapy combined with deep regional pelvic hyperthermia.