Baseline and pathologic characteristics of study patients
Characteristic | Placebo | Rapamycin (0.5 mg) | Rapamycin (2.0 mg) |
Number of patients | 11 | 12 | 8 |
Mean (range) age, years | 71 (39–87) | 71 (56–90) | 73 (62–86) |
Sex | |||
Male | 8 | 11 | 8 |
Female | 3 | 1 | 0 |
Race | |||
Asian | 1 | 0 | 0 |
Black or African American | 0 | 0 | 0 |
White | 10 | 12 | 8 |
Other | 0 | 0 | 0 |
Ethnicity | |||
Non-Spanish | 8 | 8 | 7 |
Spanish/Hispanic/Latino | 3 | 4 | 1 |
Pathologic stage | |||
CIS | 2 | 3 | 0 |
Ta | 7 | 5 | 4 |
T1 | 0 | 3 | 1 |
CIS+Ta | 0 | 1 | 2 |
CIS+T1 | 1 | 0 | 0 |
Ta+T1 | 1 | 0 | 1 |
Grade | |||
Low | 1 | 2 | 0 |
High | 8 | 9 | 4 |
Low+high | 2 | 1 | 4 |
Bladder cancer history | |||
Mean (range) time (months) from TURBT | 19 (3–49) | 15 (3–36) | 18 (3–45) |
Mean (range) time (months) from last pre-enrolment BCG | 4 (1–9) | 6 (1–42) | 7 (1–20) |
Prior non-BCG intravesical therapy | 2 | 4 | 3 |
Prior BCG failure* | 5 | 7 | 3 |
Disease status | |||
Primary | 6 | 3 | 3 |
Recurrent | 5 | 9 | 5 |
*Using FDA classification as described here: US Food and Drug Administration. BCG-unresponsive non-muscle invasive bladder cancer: developing drugs and biologics for treatment guidance for industry. Office of Communications, Division of Drug Information, Silver Spring, MD. 2018:1-0.
CIS, carcinoma in situ; TURBT, transurethral resection of bladder tumor.