Treatment of Breast Cancer with Liposomal Irinotecan
Provided are methods for treating breast cancer in a patient by administering effective amounts of liposomal irinotecan sucrosofate (MM-398). The breast cancer may be triple negative breast cancer (TNBC), estrogen receptor/progesterone receptor (ER/PR) positive breast cancer, ER-positive breast cancer, or PR-positive breast cancer, or metastatic breast cancer.
1 .- 6 . (canceled)
7 . A method of treating a patient having metastatic breast cancer with active brain metastasis comprising intravenously administering an antineoplastic therapy to the patient once every two weeks, the antineoplastic therapy consisting of a 60 mg/m 2 dose of liposomal irinotecan based on the molecular weight of irinotecan hydrochloride trihydrate.
8 . The method of claim 7 , wherein the breast cancer is HER2 negative breast cancer.
9 . The method of claim 7 , wherein the breast cancer is triple negative breast cancer.
10 . The method of claim 7 , wherein the active brain metastasis is at least one new or progressive brain metastasis after prior radiation therapy.
11 . The method of claim 10 , wherein the at least one new or progressive brain metastasis is greater than or equal to 1 cm in longest diameter on gadolinium-enhanced magnetic resonance imaging.
12 . The method of claim 7 , wherein the patient has failed at least one prior platinum-based chemotherapy regimen.
13 . The method of claim 7 , wherein the patient has failed prior treatment with gemcitabine or has become resistant to gemcitabine.
14 . The method of claim 7 , wherein prior to each administration of the liposomal irinotecan, the patient is pre-medicated with dexamethasone, an anti-emetic, or both dexamethasone and an anti-emetic.
15 . The method of claim 14 , wherein the anti-emetic is a 5-HT3 antagonist.
16 . The method of claim 7 , wherein the liposomal irinotecan is administered intravenously over 90 minutes.
17 . The method of claim 7 , wherein prior to treatment with the liposomal irinotecan, the patient receives a ferumoxytol infusion followed by a magnetic resonance imaging scan.
18 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan sucrose octasulfate encapsulated in liposomes.
19 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan encapsulated in liposome vesicles in a gelated or precipitated state as a sucrose octasulfate salt.
20 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan encapsulated in liposome vesicles comprising 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), cholesterol, and a polyethyleneglycol-derivatized phosphatidyl-ethanolamine.
21 . The method of claim 20 , wherein the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidylethanolamine (MPEG-2000-DSPE).
22 . The method of claim 20 , wherein the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is in the amount of approximately one polyethyleneglycol (PEG) molecule for every 200 phospholipid molecules.
23 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan sucrose octasulfate encapsulated in liposomes having a unilamellar lipid bilayer vesicle comprising 6.81 mg/mL 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 2.22 mg/ml cholesterol, and 0.12 mg/ml methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidyl ethanolamine (MPEG-2000-DSPE).