TREATMENT OF LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE-INVASIVE BLADDER CANCER WITH A THERMALLY GELLING PHARMACEUTICAL COMPOSITION CONTAINING MITOMYCIN
A method of reducing risk of bladder tumor recurrence, progression or death, or a method of increasing probability of disease-free survival at 15 months post-treatment, or a method of increasing probability of maintaining an achieved complete response for at least 15 months post-treatment comprises administering to a patient in need thereof a thermally gelling pharmaceutical composition once weekly for six weeks, the patient having low-grade intermediate-risk non-muscle invasive bladder cancer, and the thermally gelling pharmaceutical composition comprising a reverse thermal gelation agent, a polymer, and mitomycin. The risk is reduced or the probability is increased in comparison to the risk or probability expected if the patient were instead to receive TURBT monotherapy as treatment.
1 . A method of reducing risk of bladder tumor recurrence, progression or death comprising the step of:
administering to a patient in need thereof a thermally gelling pharmaceutical composition once weekly for six weeks,
wherein the patient has low-grade intermediate-risk non-muscle invasive bladder cancer,
wherein the thermally gelling pharmaceutical composition comprises Poloxamer 407, hydroxypropylmethylcellulose, and mitomycin, and
wherein the risk is reduced in comparison to a risk expected if the patient were instead to receive TURBT monotherapy as treatment.
2 . The method according to claim 1 , wherein the patient has had TURBT for treatment of non-muscle invasive bladder cancer at any time prior to the administration of the gel comprising mitomycin.
3 . The method according to claim 1 , wherein the patient has not had TURBT for treatment of non-muscle invasive bladder cancer at any time prior to the administration of the gel comprising mitomycin.
4 . The method according to claim 1 , wherein the thermally gelling pharmaceutical composition comprises 75 mg of mitomycin.
5 . A method of increasing probability of disease-free survival at 15 months post-treatment comprising the step of:
administering to a patient in need thereof a thermally gelling pharmaceutical composition once weekly for six weeks,
wherein the patient has low-grade intermediate-risk non-muscle invasive bladder cancer,
wherein the thermally gelling pharmaceutical composition comprises Poloxamer 407, hydroxypropylmethylcellulose, and mitomycin, and
wherein the probability is increased in comparison to a probability expected if the patient were instead to receive TURBT monotherapy as treatment.
6 . The method according to claim 5 , wherein the patient has had TURBT for treatment of non-muscle invasive bladder cancer at any time prior to the administration of the gel comprising mitomycin.
7 . The method according to claim 5 , wherein the patient has not had TURBT for treatment of non-muscle invasive bladder cancer at any time prior to the administration of the gel comprising mitomycin.
8 . The method according to claim 5 , wherein the thermally gelling pharmaceutical composition comprises 75 mg of mitomycin.
9 . A method of increasing probability of maintaining an achieved complete response for at least 15 months post-treatment comprising the step of:
administering to a patient in need thereof a thermally gelling pharmaceutical composition once weekly for six weeks,
wherein the patient has low-grade intermediate-risk non-muscle invasive bladder cancer,
wherein the thermally gelling pharmaceutical composition comprises Poloxamer 407, hydroxypropylmethylcellulose, and mitomycin, and
wherein the probability is increased in comparison to a probability expected if the patient were instead to receive TURBT monotherapy as treatment.
10 . The method according to claim 9 , wherein the patient has had TURBT for treatment of non-muscle invasive bladder cancer at any time prior to the administration of the gel comprising mitomycin.
11 . The method according to claim 9 , wherein the patient has not had TURBT for treatment of non-muscle invasive bladder cancer at any time prior to the administration of the gel comprising mitomycin.
12 . The method according to claim 9 , wherein the thermally gelling pharmaceutical composition comprises 75 mg of mitomycin.