Claims for Patent: 9,345,767

Summary for Patent: 9,345,767

Title:	Method for selecting chemotherapy for gastric cancer patient using combination drug of tegafur, gimeracil and oteracil potassium and EGFR inhibitor
Abstract:	A method for predicting a therapeutic effect of chemotherapy with a combination drug containing tegafur, gimeracil, and oteracil potassium in a gastric cancer patient by: (1) measuring an expression level of epidermal growth factor receptor (EGFR) in a biological sample obtained from the patient; (2) comparing the expression level of EGFR obtained in step (1) with a corresponding predetermined cut-off point; and (3) predicting that the patient is likely to sufficiently respond to chemotherapy when a tegafur, gimeracil, and oteracil potassium combination drug is used with an EGFR inhibitor, when the step (2) comparison reveals that the expression level of EGFR is greater than the cut-off point, or predicting that the patient is likely to sufficiently respond to chemotherapy when a tegafur, gimeracil, and oteracil potassium combination drug is used alone, when the step (2) comparison reveals that the expression level of EGFR is not greater than the cut-off point.
Inventor(s):	Kobunai; Takashi (Tokyo, JP), Saito; Hitoshi (Tokushima, JP), Takechi; Teiji (Tokyo, JP)
Assignee:	TAIHO PHARMACEUTICAL CO., LTD. (Tokyo, JP)
Application Number:	14/117,426
Patent Claims:	1. A method for treating gastric cancer in a patient in need of such treatment, comprising: (1) measuring an expression level of EGFR contained in a biological sample obtained from the patient with an immunohistochemical staining method (IHC method); (2) comparing the expression level of EGFR obtained in step (1) with a corresponding predetermined cut-off point, wherein the corresponding predetermined cut-off point of the expression level of EGFR protein is 1+; and (3) thereafter performing chemotherapy by administering a combination drug containing tegafur, gimeracil, and oteracil potassium in combination with an EGFR inhibitor to said patient when the comparison in step (2) reveals that the expression level of EGFR is greater than the cut-off point. 2. A method for treating gastric cancer in a patient in need of such treatment, comprising: (1) measuring an expression level of EGFR contained in a biological sample obtained from the patient with an immunohistochemical staining method (IHC method); (2) comparing the expression level of EGFR obtained in step (1) with a corresponding predetermined cut-off point, wherein the corresponding predetermined cut-off point of the expression level of EGFR protein is 1+; and (3) thereafter performing chemotherapy by administering a combination drug containing tegafur, gimeracil, and oteracil potassium alone to said patient when the comparison in step (2) reveals that the expression level of EGFR is not greater than the cut-off point. 3. The method according to claim 1, wherein the combination drug containing tegafur, gimeracil, and oteracil potassium has a molar ratio for tegafur:gimeracil:oteracil potassium=1:0.4:1. 4. The method according to claim 1, wherein the EGFR inhibitor is cetuximab. 5. The method according to claim 1, wherein the chemotherapy is postoperative adjuvant chemotherapy. 6. The method according to claim 2, wherein the combination drug containing tegafur, gimeracil, and oteracil potassium has a molar ratio for tegafur:gimeracil:oteracil potassium=1:0.4:1. 7. The method according to claim 2, wherein the chemotherapy is postoperative adjuvant chemotherapy. 8. The method according to claim 1, wherein the combination drug containing tegafur, gimeracil, and oteracil potassium, and the EGFR inhibitor used in combination are administered according to an administration schedule of one or more 6 week courses, the 6 week course comprising: administering the combination drug every day for 4 weeks in an amount of 80 mg/m.sup.2, in terms of tegafur per body surface area, per day, followed by 2-week withdrawal, and administering the EGFR inhibitor weekly in an amount of 400 mg/m.sup.2 per body surface area on the first day of each course and 250 mg/m.sup.2 per body surface area on the remaining days. 9. The method according to claim 2, wherein the combination drug containing tegafur, gimeracil, and oteracil potassium is administered according to an administration schedule of one or more 6 week courses, the 6 week course comprising: administering the combination drug every day for 4 weeks in an amount of 80 mg/m.sup.2, in terms of tegafur per body surface area, per day, followed by 2-week withdrawal.

Details for Patent 9,345,767

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2031-05-16
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2031-05-16