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 | Â |
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 | Â |
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 | Â |
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 | Â | Â |
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 | Â |
18 | 18 F | Malignant melanoma | GB | 11 months | Psoriatic arthritis, JIA | Â | Pregnant; pre-existing pigmented nevus with change noted during first trimester of pregnancy |