Skip to main content

Table 1 Pediatric Malignancy Cases Observed in the Worldwide Safety Database from 1998 to August 13, 2009

From: Summary of worldwide pediatric malignancies reported after exposure to etanercept

Case Age at malignancy diagnosis/Sex Preferred term Country Length of exposure to ETN Indication Confounding medications Additional comments
1 10 M Leukemia US 4 months Polyarthritis Methylprednisolone Malignancy unconfirmed
2 7 M Acute lymphocytic leukemia DE "a few months" Polyarthritis MTX - 1 yr History of splenomegaly prior to starting etanercept
3 4 M Acute lymphocytic leukemia DE 8 doses over 3 mos JIA (Still's) MTX - 6 mos
Prednisolone
Family history of cancer
4 19 M Acute myeloid leukemia, lymphoma US 1.5 years Ankylosing spondylitis Prednisone Lymphoma remains unconfirmed
Family history of cancer
5 9 M Hodgkin's lymphoma, Stage IV B US ETN for 1 yr; D/C'd JIA diagnosed at 11 mo of age MTX - 4 yrs, Cyclosporine - 6 mo, Mycophenolate mofetil - 7 mo, Infliximab - 3.5 yrs Reported in [1]
6 10 F Hodgkin's lymphoma stage2a US ETN for 1 yr at age 2 JIA diagnosed at 19 mo old MTX - 3.7 yrs, Infliximab - 2 doses, Leflunomide - 18 mo, Kineret - 1 mo, IV cyclophosphamide - 5 mos, Thalidomide - 7 mo, Rituximab - 2 doses, Adalimumab - 2.4 yrs Reported in [1]
7 14 M Diffuse large Bcell lymphoma DE 7 years JIA MTX  
8 15 F Hodgkin's lymphoma, stage 2 US 4 years JIA MTX Reported in [1]
9 18 F Bcell lymphoma GB 3 years JIA MTX, azathioprine, cyclosporine  
10 16 F Lymphomatoid papulosis (lymphoma) DE 20 months from 7/2004 to 3/2006 Vasculitis diagnosed in 3/94 at age 1.5 yr MTX 7/98-12/04, Cyclophosphamide 6/07 - 7/07, Azathioprine 9/07 - 11/07, Adalimumab 3/06 - 5/07, Infliximab 5/07 - 7/07, Rituximab 2/08- 3/08, Abatacept 10/08 - 11/08, Prednisolone Lymphomatoid papulosis by biopsy in 2002; confirmed in 12/08
Lymphoma diagnosed 2/09, unknown type secondary to steroid therapy
Off label use for "vasculitis"
11 21 F Hodgkin's lymphoma, stage 2a US 3.5 years JIA diagnosed at age 14 MTX - 6 yrs up to 25 mg/wk Reported in [2]
12 16 M Yolk sac tumor DE 29 days JIA MTX - 5 mo Prednisone  
13 17 Bladder cancer US NR NR No medical information Malignancy unconfirmed
14 18 F Papillary thyroid cancer US 4 years JIA diagnosed at age 10   
15 18 M Thyroid cancer DE 11 months Spondylo-arthropathy MTX Reported in [3].
16 18 F Thyroid nodule (thyroid neoplasm) GB 6 months NR but subject in JIA registry MTX Thyroid nodule, malignancy unconfirmed
17 19 F Malignant melanoma GB 11 months Psoriatic arthritis diagnosed age 10 MTX  
18 18 F Malignant melanoma GB 11 months Psoriatic arthritis, JIA   Pregnant; pre-existing pigmented nevus with change noted during first trimester of pregnancy
  1. DE = Germany; GB = Great Britain; JIA = Juvenile idiopathic arthritis; MTX = methotrexate NR = Not Reported; US = United States