USE OF ANAMORELIN TO TREAT CANCER-RELATED FATIGUE
Methods of using anamorelin to treat fatigue and increasing physical activity in defined cancerous patient populations.
1 . A method of treating cancer-related fatigue in a patient in need thereof comprising orally administering to the patient a therapeutically effective amount of anamorelin, wherein the patient has:
a) a fatigue score on the FACIT-F subscale of ≤34;
b) a C-reactive protein concentration of ≥3 mg/L; and
c) cancer.
2 . A method of increasing subjective perception of physical activity in a cancer patient in need thereof comprising orally administering to the patient a therapeutically effective amount of anamorelin.
3 . The method of claim 2 , comprising an increase of physical activity on the Godin-Shephard Leisure-Time Physical Activity Questionnaire.
4 . A method of treating cancer-related fatigue in a patient in need thereof comprising orally administering to the patient a therapeutically effective amount of anamorelin.
5 . The method of claim 4 , comprising treatment of cancer-related fatigue on the FACIT-F subscale.
6 . The method of claim 1 , wherein the patient has:
a) a fatigue score on the FACIT-F subscale of ≤34; or
b) a C-reactive protein concentration of ≥3 mg/L.
7 . (canceled)
8 . The method of claim 1 , wherein the patient has:
a) a fatigue score on the FACIT-F subscale of ≤34;
b) a C-reactive protein concentration of ≥3 mg/L;
c) cancer;
d) no evidence of depression; and
e) a hemoglobin level ≥9 g/dL.
9 . The method of claim 1 , wherein the patient has:
a) a fatigue score on the FACIT-F subscale of ≤30, 26, 22, or 18; or
b) a C-reactive protein concentration of ≥5 mg/L; 10 mg/L, 15 mg/L, or 20 mg/L.
10 . The method of claim 1 , wherein the patient has:
a) a fatigue score on the FACIT-F subscale of ≤30, 26, 22, or 18; and
b) a C-reactive protein concentration of ≥5 mg/L; 10 mg/L, 15 mg/L, or 20 mg/L.
11 . The method of claim 1 , wherein the patient has a C-reactive protein concentration of ≥10 mg/L.
12 . (canceled)
13 . (canceled)
14 . (canceled)
15 . (canceled)
16 . The method of claim 1 , wherein the patient has a hemoglobin level of greater than 9, 10, 11, or 12 g/dL.
17 . The method of claim 1 , wherein the method achieves a clinically meaningful improvement on the FACIT-F subscale.
18 . The method of claim 1 , wherein the method achieves a clinically meaningful improvement on the Godin-Shephard Leisure-Time Physical Activity Questionnaire.
19 . The method of claim 1 , wherein the method achieves a clinically meaningful improvement on a scale selected from PROMIS-fatigue, MF SI-SF-general, and FAACT-anorexia.
20 . (canceled)
21 . (canceled)
22 . The method of claim 1 , wherein the patient has an unintentional weight loss of from 2% to 15% within the previous 12 months.
23 . The method of claim 1 , wherein the patient has an unintentional body weight loss of less than 5%, 4%, or 3% in the previous 12 months.
24 . The method of claim 1 , wherein the patient has a BMI greater than 20 kg/m 2 ,
22 . 5 kg/m 2 , or 25 kg/m 2 .
25 . (canceled)
26 . The method of claim 1 , wherein the patient has:
a) an albumin concentration in the normal range of from 3.4 to 5.4 g/dL,
b) a fasting plasma glucose concentration of from 70 to 140 mg/dL; and/or
c) an IGF-1 concentration of from 75 to 150 ng/mL.
27 . The method of claim 1 , wherein the patient lacks a cause of increased CRP selected from an infection or an autoimmune disorder.