Table 1

Treatment responses of bortezomib on human patients

Patient numberTrial startTrial stopcGVHD organsImmunosuppression before trialImmunosuppression at conclusion of the studycGVHD score before start of the trialcGVHD score at conclusion of the studyComments
1 10/16/12 4/10/13 Steroid refractory ophthalmic GVHD, mouth Cyclosporine ophthalmic drop Cyclosporine ophthalmic drop Eyes 3 Eyes 1 Restarted on bortezomib 6 mo after the completion of the study due to relapse of cGVHD. 
Mouth 1 Mouth 0 
2 11/20/12 1/15/13 Eyes, mouth, skin Mycophenolate 100 mg twice daily, tacrolimus 1 mg daily, sirolimus 1 mg twice daily, prednisone 20 mg alternating with 40 mg Mycophenolate 100 mg twice daily, tacrolimus 1 mg daily, sirolimus 1 mg twice daily, prednisone 20 mg alternating with 40 mg Mouth 3 Mouth 3 Early withdrawal due to mouth sores. 
Joints 3 Joints 3 
Skin 2 Skin 2 
3 01/14/13 05/07/13 Skin, mouth, eyes, GI, lungs, joints, and fascia Mycophenolate 1000 mg twice daily and prednisone 40 mg qod Mycophenolate 1000 mg twice daily and prednisone 40 mg qod 2 for all organs involved 2 for all organs involved No significant response was observed 
4 03/18/13 08/27/13 Skin, GI, mouth, and joint Tacrolimus 1.5 mg twice daily, mycophenolate 1 g twice daily, prednisone 40 mg/day Tacrolimus 1.5 mg twice daily, Mycophenolate 1 g twice daily, prednisone 30 mg/day Skin 3 Skin 2 Significant healing of the ulcerated skin and mild softening/ decrease in pigmentation. Improved swallowing 
GI 2 GI 1 
Mouth 3 Mouth 2 
Joint 3 Joint 2 
5 06/25/13 12/10/13 Steroid-dependent hemolytic anemia, mouth, and eye Prednisone 60 mg/day and tacrolimus 1 mg a day alternating with 0.5 mg/day Prednisone 0.5 mg 3 times a week Anemia: severe Anemia: mild Restarted on bortezomib, 4 mo after the completion of the study to maintain the response 
Mouth 1 Mouth 0 
Eye 1 Eye 0 
6 08/02/13 09/03/13 Steroid-refractory skin Tacrolimus 1.5 mg twice daily Tacrolimus 1.5 mg twice daily Skin 3 Skin 3 Withdrawn from the study after one month due to relapse of the chronic myelomonocytic leukemia 
7 08/13/13 01/07/14 Skin, eyes, and mouth Tacrolimus 0.5 mg thrice daily, Sirolimus 1 mg daily, prednisone 30 mg daily Tacrolimus 0.5 mg twice daily, prednisone 15 mg alternating with 5 mg daily Skin 2 Skin 1 Responding but withdrawn early from the study due to neuropathy 
Eyes 2 Eyes 1 
Mouth 0 Mouth 0 
8 09/17/13 11/05/13 Skin, mouth, and lung Prednisone 30 mg daily, sirolimus 1 mg three times a week Prednisone 15 mg daily alternating with 10 mg a day; tacrolimus 0.5 mg twice a day Skin 3 Skin 2 Withdrawn early from the study due to symptomatic respiratory infections and hospital admissions 
Mouth 2 Mouth 1 
Lung 3 Lung 3 
9 09/20/13 03/14/14 Skin, mouth, eyes, and liver Cyclosporine 25 mg 3 times a week and prednisone 30 mg daily None Mouth 2 Mouth 0 Relapse of GVHD 4 mo after the last dose of the study drug 
Eye 2 Eye 1 
Skin 1 Skin 0 
10 12/6/13 1/24/14 Steroid-intolerant and -dependent skin, mouth, and eyes Prednisone 20 mg qod and cyclosporine 25 mg daily. Prednisone 20mg qod and cyclosporine 25 mg daily. Skin 3 Skin 3 Withdrawn early from the study due to low platelets 
Mouth 2 Mouth 2 
Patient numberTrial startTrial stopcGVHD organsImmunosuppression before trialImmunosuppression at conclusion of the studycGVHD score before start of the trialcGVHD score at conclusion of the studyComments
1 10/16/12 4/10/13 Steroid refractory ophthalmic GVHD, mouth Cyclosporine ophthalmic drop Cyclosporine ophthalmic drop Eyes 3 Eyes 1 Restarted on bortezomib 6 mo after the completion of the study due to relapse of cGVHD. 
Mouth 1 Mouth 0 
2 11/20/12 1/15/13 Eyes, mouth, skin Mycophenolate 100 mg twice daily, tacrolimus 1 mg daily, sirolimus 1 mg twice daily, prednisone 20 mg alternating with 40 mg Mycophenolate 100 mg twice daily, tacrolimus 1 mg daily, sirolimus 1 mg twice daily, prednisone 20 mg alternating with 40 mg Mouth 3 Mouth 3 Early withdrawal due to mouth sores. 
Joints 3 Joints 3 
Skin 2 Skin 2 
3 01/14/13 05/07/13 Skin, mouth, eyes, GI, lungs, joints, and fascia Mycophenolate 1000 mg twice daily and prednisone 40 mg qod Mycophenolate 1000 mg twice daily and prednisone 40 mg qod 2 for all organs involved 2 for all organs involved No significant response was observed 
4 03/18/13 08/27/13 Skin, GI, mouth, and joint Tacrolimus 1.5 mg twice daily, mycophenolate 1 g twice daily, prednisone 40 mg/day Tacrolimus 1.5 mg twice daily, Mycophenolate 1 g twice daily, prednisone 30 mg/day Skin 3 Skin 2 Significant healing of the ulcerated skin and mild softening/ decrease in pigmentation. Improved swallowing 
GI 2 GI 1 
Mouth 3 Mouth 2 
Joint 3 Joint 2 
5 06/25/13 12/10/13 Steroid-dependent hemolytic anemia, mouth, and eye Prednisone 60 mg/day and tacrolimus 1 mg a day alternating with 0.5 mg/day Prednisone 0.5 mg 3 times a week Anemia: severe Anemia: mild Restarted on bortezomib, 4 mo after the completion of the study to maintain the response 
Mouth 1 Mouth 0 
Eye 1 Eye 0 
6 08/02/13 09/03/13 Steroid-refractory skin Tacrolimus 1.5 mg twice daily Tacrolimus 1.5 mg twice daily Skin 3 Skin 3 Withdrawn from the study after one month due to relapse of the chronic myelomonocytic leukemia 
7 08/13/13 01/07/14 Skin, eyes, and mouth Tacrolimus 0.5 mg thrice daily, Sirolimus 1 mg daily, prednisone 30 mg daily Tacrolimus 0.5 mg twice daily, prednisone 15 mg alternating with 5 mg daily Skin 2 Skin 1 Responding but withdrawn early from the study due to neuropathy 
Eyes 2 Eyes 1 
Mouth 0 Mouth 0 
8 09/17/13 11/05/13 Skin, mouth, and lung Prednisone 30 mg daily, sirolimus 1 mg three times a week Prednisone 15 mg daily alternating with 10 mg a day; tacrolimus 0.5 mg twice a day Skin 3 Skin 2 Withdrawn early from the study due to symptomatic respiratory infections and hospital admissions 
Mouth 2 Mouth 1 
Lung 3 Lung 3 
9 09/20/13 03/14/14 Skin, mouth, eyes, and liver Cyclosporine 25 mg 3 times a week and prednisone 30 mg daily None Mouth 2 Mouth 0 Relapse of GVHD 4 mo after the last dose of the study drug 
Eye 2 Eye 1 
Skin 1 Skin 0 
10 12/6/13 1/24/14 Steroid-intolerant and -dependent skin, mouth, and eyes Prednisone 20 mg qod and cyclosporine 25 mg daily. Prednisone 20mg qod and cyclosporine 25 mg daily. Skin 3 Skin 3 Withdrawn early from the study due to low platelets 
Mouth 2 Mouth 2 

qod, every other day.

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