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 . A method of determining the amount of ferumoxytol deposited in a tumor lesion, the method comprising:
a. administering to a patient having one or more tumor lesions a composition comprising ferumoxytol and a pharmaceutically acceptable carrier; and
b. detecting the amount of ferumoxytol in the tumor lesion.
2 . The method of claim 1 , wherein the ferumoxytol is administered intravenously.
3 . The method of claim 1 or claim 2 , wherein the ferumoxytol is administered at a dose of 5 mg/kg, based on the weight of the patient.
4 . The method of any one of claims 1 - 3 , wherein the amount of ferumoxytol is detected using magnetic resonance imaging (MRI).
5 . The method of claim 4 , wherein the amount of ferumoxytol is further detected by determining the change in diameter and/or volume and/or density of the tumor lesion before and after administration of ferumoxytol.
6 . The method of claim 5 , wherein the change in diameter and/or volume and/or density of the tumor lesion is determined using computed tomography.
7 . The method of claim 6 , wherein the computed tomography is used with 3- to 5-mm slice thickness.
8 . The method of claim 1 , wherein the amount of ferumoxytol is detected by:
a. removing a sample of the tumor lesion;
b. staining the sample with a dye specific for iron; and
c. examining the sample for iron content.
9 . The method of claim 8 , wherein the dye is Prussian Blue.
10 . The method of claim 8 , wherein the sample is a tumor biopsy.
11 . The method of any one of claims 1 - 8 , wherein the amount of ferumoxytol is detected from about 1 to about 72 hours after administration.
12 . The method of any one of claims 1 - 8 , wherein the amount of ferumoxytol is detected at about 1 hour after administration.
13 . The method of any one of claims 1 - 8 , wherein the amount of ferumoxytol is detected at about 24 hours after administration.
14 . The method of any one of claims 1 - 8 , wherein the amount of ferumoxytol is detected at about 48 hours after administration.
15 . The method of any one of claims 1 - 8 , wherein the amount of ferumoxytol is detected at about 72 hours after administration.
16 . A method of predicting the uptake of nal-IRI by a tumor lesion, the method comprising:
a. administering to a patient having one or more tumor lesions a composition comprising ferumoxytol and a pharmaceutically acceptable carrier; and
b. detecting the amount of ferumoxytol in the tumor lesion;
wherein, the amount of ferumoxytol deposited in the tumor is proportional to the predicted uptake of nal-IRI.
17 . The method of claim 16 , wherein the ferumoxytol is administered intravenously.
18 . The method of claim 16 or claim 17 , wherein the ferumoxytol is administered at a dose of 5 mg/kg, based on the weight of the patient.
19 . The method of any one of claims 16 - 18 , wherein the amount of ferumoxytol is detected using magnetic resonance imaging (MRI).
20 . The method of claim 19 , wherein the amount of ferumoxytol is further detected by determining the change in diameter and/or volume and/or density of the tumor lesion before and after administration of ferumoxytol.
21 . The method of claim 20 , wherein the change in diameter and/or volume and/or density of the tumor lesion is determined using computed tomography.
22 . The method of claim 21 , wherein the computed tomography is used with 3- to 5-mm slice thickness.
23 . The method of claim 16 , wherein the amount of ferumoxytol is detected by:
a. removing a sample of the tumor lesion;
b. staining the sample with a dye specific for iron; and
c. examining the sample for iron content.
24 . The method of claim 23 , wherein the dye is Prussian Blue.
25 . The method of claim 23 , wherein the sample is a tumor biopsy.
26 . The method of any one of claims 16 - 25 , wherein the amount of ferumoxytol is detected from about 1 to about 72 hours after administration.
27 . The method of any one of claims 16 - 26 , wherein the amount of ferumoxytol is detected at about 1 hour after administration.
28 . The method of any one of claims 16 - 27 , wherein the amount of ferumoxytol is detected at about 24 hours after administration.
29 . The method of any one of claims 16 - 28 , wherein the amount of ferumoxytol is detected at about 48 hours after administration.
30 . The method of any one of claims 16 - 29 , wherein the amount of ferumoxytol is detected at about 72 hours after administration.
31 . A method of treating or reducing the size of a tumor lesion, the method comprising performing the method according to any one of claims 16 - 30 on a patient having one or more tumor lesions; and administering nal-IRI to the patient.
32 . A method of determining whether treatment with nal-IRI is advisable for a patient having one or more tumor lesions, the method comprising performing the method according to any one of claims 16 - 30 on the patient; and deciding if the amount of ferumoxytol deposited in the tumor lesion is at a high enough level to suggest that treatment would be successful.
33 . A method of treating triple negative breast cancer in a patient, comprising administering to the patient an effective amount of nanoliposomal irinotecan.
34 . The method of claim 33 , wherein the nanoliposomal irinotecan is MM-398.
35 . The method of claim 34 , wherein the MM-398 is administered intravenously in an amount effective to administer the amount of irinotecan present in an 80 mg/m2 dose of irinotecan hydrochloride trihydrate.