Method for Assessing and Predicting Efficacy of Breast Cancer Treatment with a Long-Acting Topoisomerase I Inhibitor
AssigneeNektar Therapeutics
InventorsYen Lin CHIA, Ute HOCH, Alison HANNAH, Michael A. ELDON
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Abstract
Provided is a method of treating an individual suffering from a cancer such as breast cancer by administering to the individual a long-acting topoisomerase I inhibitor such as SN-38 or irinotecan, and correlating the level of at least one tumor marker such as CA27.29 in the individual with response of the cancer to treatment with the long-acting topoisomerase I inhibitor, to thereby provide a method for predicting and assessing the therapeutic efficacy of the treatment.
Claims23
A method for assessing response to treatment with a long-acting topoisomerase-I inhibitor selected from SN-38 and irinotecan in a subject having breast cancer, the method comprising:
- (i) determining the level of a tumor marker in a bodily fluid sample of the subject to provide a reference level of the tumor marker, where the tumor marker is selected from CA27.29, CA15-3 and CEA,
- (ii) treating said subject over a duration of time of at least 2 weeks by administering a dosage amount of the long-acting topoisomerase-I inhibitor on a given dosing schedule,
- (iii) determining the level of the tumor marker in a bodily fluid sample of the subject following said treating in step (ii), wherein the bodily fluid is the same as in step (i),
- (iv) correlating the level of the tumor marker in step (iii) with response of the breast cancer to treatment with the long-acting topoisomerase-I inhibitor, wherein in the event of a level of the tumor marker in step (iii) that is either unchanged or reduced from the reference level in step (i), a positive response to treatment is determined, and in the event of a level of tumor marker in step (iii) that is increased from the reference level in step (i), a negative response to treatment is determined.
Use of the level of a tumor marker selected from CA27.29, CA15-3 and CEA in a bodily fluid selected from blood, serum, and plasma, for predicting efficacy of treatment with a long-acting topoisomerase-I inhibitor in a subject diagnosed with breast cancer, wherein the long-acting topoisomerase-I inhibitor is selected from long-acting irinotecan and long-acting SN-38.
Use of the level of a tumor marker selected from CA27.29, CA15-3 and CEA in a bodily fluid selected from blood, serum, and plasma, for predicting exposure of breast cancer to levels of SN-38 resulting from treatment of the breast cancer with a long-acting topoisomerase-I inhibitor in a subject diagnosed with breast cancer, wherein the long-acting topoisomerase-I inhibitor is selected from long-acting irinotecan and long-acting SN-38, and exposure of the breast cancer to SN-38 correlates with efficacy of treatment.
Dependencies are inferred from the claim text.