Antitumoral use of cabazitaxel
The invention relates to a compound of formula: which may be in base form or in the form of a hydrate or a solvate, in combination with prednisone or prednisolone, for its use as a medicament in the treatment of prostate cancer, particularly metastatic prostate cancer, especially for patients who are not catered for by a taxane-based treatment.
1. A method for treating a patient with prostate cancer that has progressed during or after treatment with docetaxel, comprising administering to said patient a dose of 20 to 25 mg/m 2 of cabazitaxel, or a hydrate or solvate thereof, in combination with a corticoid.
2. The method according to claim 1 , where the prostate cancer is an advanced metastatic disease.
3. The method according to claim 1 , where the cabazitaxel is in the form of an acetone solvate.
4. The method according to claim 3 , in which the acetone solvate contains between 5% and 8% by weight of acetone.
5. The method according to claim 1 , comprising repeating the administration of cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.
6. The method according to claim 1 , wherein the cabazitaxel is in base form.
7. The method according to claim 1 , wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide an AUC of about 991 ng·h/mL (CV 34%).
8. The method according to claim 1 , wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide an C max of about 226 ng·h/mL (CV 107%).
9. The method according to claim 1 wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide a plasma clearance of 48.5 L/h (CV 39%).
10. The method according to claim 1 , further comprising monitoring blood counts and measuring neutrophil levels in the patient.
11. The method according to claim 10 , further comprising discontinuing cabazitaxel treatment in a patient with a neutrophil count of ≦1,500 cells/mm 3 .
12. The method according to claim 1 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m 2 .
13. The method according to claim 1 , wherein the corticoid is selected from the group consisting of prednisone and prednisolone.
14. The method according to claim 13 , where the prednisone or prednisolone is administered at a dose of 10 mg/day.
15. The method according to claim 14 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m 2 .
16. The method according to claim 14 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m 2 .
17. The method according to claim 1 , where the prostate cancer is a castration resistant or hormone-refractory prostate cancer.
18. The method according to claim 17 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m 2 .
19. The method according to claim 17 , comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.
20. The method according to claim 1 , wherein the prostate cancer is a castration resistant or hormone-refractory, metastatic prostate cancer.
21. The method according to claim 20 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m 2 .
22. The method according to claim 20 , where cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m 2 .
23. The method according to claim 20 , comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.
24. The method according to claim 1 , wherein the prostate cancer is a castration resistant or hormone-refractory, metastatic prostate cancer, and wherein the corticoid is selected from the group consisting of prednisone and prednisolone, and wherein the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m 2 .
25. The method according to claim 24 , comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.
26. The method according to claim 1 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m 2 .
27. A method of increasing the survival of a patient with a castration resistant or hormone refractory, metastatic prostate cancer that has progressed during or after treatment with docetaxel, comprising administering a dose of 20 to 25 mg/m 2 of cabazitaxel, or hydrate or solvate thereof, to the patient in combination with prednisone or prednisolone.
28. The method according to claim 27 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m 2 .
29. The method according to claim 27 , comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.
30. The method according to claim 27 , where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m 2 .