Use of ketorolac for treatment of squamous cell carcinomas of the oral cavity or oropharynx

Abstract

The present invention provides novel methods for prevention or treatment of primary and recurring squamous cell carcinoma of the oral cavity or oropharynx comprising topical administration, to the oral cavity or oropharynx, of an effective amount of an NSAID, especially a composition administering from about 0.001% to about 0.2% ketorolac to the oral cavity, alone or as an adjunct to surgery and/or radiation therapy.

What is claimed is: 
     
       1. A method of treatment for primary and recurring squamous cell carcinoma of the oral cavity or oropharynx of a human or mammal having said carcinoma comprising the topical administration to the oral cavity or oropharynx of said human or lower animal, of a composition, free of hyaluronic acid, comprising an effective amount of an NSAID, alone or as an adjunct to surgery and/or radiation therapy, wherein said composition is held in the oral cavity for a period of from about 15 seconds to about 10 minutes, then largely expectorated rather than being swallowed. 
     
     
       2. A method according to claim 1 wherein the NSAID is selected from the group consisting of aspirin, ibuprofen, naproxen, indomethacin, piroxicam flurbiprofen, meclofenamate sodium, ketoprofen, tenidap, tebufelone, ketorolac, and mixtures thereof. 
     
     
       3. A method according to claim 1 wherein the NSAID is ketorolac. 
     
     
       4. A method of treatment for primary and recurring squamous cell carcinoma of the oral cavity or oropharynx of a human or mammal having said carcinoma comprising the topical administration to the oral cavity or oropharynx of said human or lower animal, of a composition, free of hyaluronic acid, providing from about 0.001% to about 0.2%, by weight of ketorolac to the oral cavity or oropharynx, alone or as an adjunct to surgery and/or radiation therapy, wherein said composition is held in the oral cavity for a period of from about 15 seconds to about 10 minutes, then largely expectorated rather than being swallowed. 
     
     
       5. A method according to claim 4 comprising topical administration of a composition providing from about 0.01% to about 0.15%, by weight of ketorolac to the oral cavity or oropharynx. 
     
     
       6. A method according to claim 5 wherein the ketorolac is ketorolac tromethamine. 
     
     
       7. A method according to claim 6 wherein the ketorolac tromethamine essentially consists of the (-)-S enantiomer. 
     
     
       8. A method according to claim 7 wherein said composition is in the form of a mouthwash, mouthspray, dental solution, or toothpaste. .Iadd.9. A method for the prophylaxis of primary and recurring squamous cell carcinoma of the oral cavity or oral pharynx of a human or mammal in need thereof, comprising the topical administration to the oral cavity or oropharynx of said human or mammal, of a composition free from hyaluronic acid, comprising an effective amount of an NSAID, alone or as an adjunct to surgery and/or radiation therapy, wherein said composition is held in the oral cavity for a period of from 15 seconds to about 10 minutes, then largely expectorated rather than being swallowed. .Iaddend..Iadd.10. A method according to claim 9 wherein the NSAID is selected from the group consisting of aspirin, ibuprofen, naproxen, indomethacin, piroxicam, flurbiprofen, meclofenamate sodium, ketoprofen, tenidap, tebufelone, ketorolac, and mixtures thereof. .Iaddend..Iadd.11. A method according to 
     
     
        claim 10 wherein the NSAID is ketorolac. .Iaddend..Iadd.12.  A method for the prophylaxis of primary and recurring squamous cell carcinoma of the oral cavity or oral pharynx of a human or mammal in need thereof comprising the topical administration to the oral cavity or oropharynx of said human or mammal, of a composition free from hyaluronic acid, providing from about 0.001% to about 0.2% by weight of ketorolac, alone or as an adjunct to surgery and/or radiation therapy, wherein said composition is held in the oral cavity for a period of from 15 seconds to about 10 minutes, then largely expectorated rather than being swallowed. .Iaddend..Iadd.13. A method according to claim 12 comprising topical administration of a composition providing from about 0.01% to about 0.15%, by weight of ketorolac to the oral cavity or oropharynx. .Iaddend..Iadd.14. A method according to claim 13 wherein the ketorolac is ketorolac tromethamine. .Iaddend..Iadd.15. A method according to claim 14 wherein the ketorolac tromethamine essentially consists of the (-)-S enantiomer. .Iaddend..Iadd.16. A method according to claim 15 wherein said composition is in the form of a mouthwash, mouthspray, dental solution, or toothpaste. .Iaddend.