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Solid malignancies among patients in the Wegener's Granulomatosis Etanercept Trial.

Publication ,  Journal Article
Stone, JH; Holbrook, JT; Marriott, MA; Tibbs, AK; Sejismundo, LP; Min, Y-I; Specks, U; Merkel, PA; Spiera, R; Davis, JC; St Clair, EW ...
Published in: Arthritis Rheum
May 2006

OBJECTIVE: Etanercept is a soluble fusion protein designed to inhibit tumor necrosis factor (TNF). During the Wegener's Granulomatosis Etanercept Trial (WGET), a placebo-controlled trial of etanercept given in addition to standard therapy for remission induction and maintenance, more solid malignancies were observed in the etanercept group than in the group treated with standard therapy alone. This study was undertaken to further explore the potential association between anti-TNF therapy and the development of malignancy in these patients. METHODS: One hundred eighty patients with active WG were enrolled and followed up for a median of 27 months. At enrollment, disease characteristics, treatment history, specific medical history items, and information about previous WG treatments and risk factors for malignancy were recorded. During the trial, the occurrence of malignancies and other adverse events was recorded prospectively. RESULTS: All 6 solid malignancies observed during the WGET occurred in the etanercept group (P = 0.01 versus placebo group); based on a comparison of age- and sex-specific incidence rates, 1.92 solid malignancies would have been expected in this group. The solid malignancies included 2 cases of mucinous adenocarcinoma of the colon, 1 each of metastatic cholangiocarcinoma, renal cell carcinoma, and breast carcinoma, and 1 recurrent liposarcoma. There were no differences between the 2 treatment groups in sex distribution, disease severity, personal or family history of cancer, or tobacco and alcohol use. The etanercept group was older at baseline and less likely to be newly diagnosed with WG at the time of randomization. Patients who developed solid tumors were older than patients who did not. All etanercept-treated patients who developed solid tumors were also treated with cyclophosphamide during the trial. However, there were no differences between the groups in the amount of cyclophosphamide received during the trial or the percentage who had received cyclophosphamide before enrollment. There were also no differences in the mean duration of daily cyclophosphamide therapy or the maximum daily cyclophosphamide dosage before enrollment. CONCLUSION: Data from the WGET, the first substantial reported experience of the combined use of etanercept and cyclophosphamide in the treatment of WG, indicate that the combination of TNF inhibition and cyclophosphamide may heighten the risk of cancer beyond that observed with cyclophosphamide alone.

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Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

May 2006

Volume

54

Issue

5

Start / End Page

1608 / 1618

Location

United States

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Receptors, Tumor Necrosis Factor
  • Prospective Studies
  • Neoplasms
  • Middle Aged
  • Male
  • Immunoglobulin G
  • Humans
  • Granulomatosis with Polyangiitis
  • Female
 

Citation

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Stone, J. H., Holbrook, J. T., Marriott, M. A., Tibbs, A. K., Sejismundo, L. P., Min, Y.-I., … Wegener’s Granulomatosis Etanercept Trial Research Group, . (2006). Solid malignancies among patients in the Wegener's Granulomatosis Etanercept Trial. Arthritis Rheum, 54(5), 1608–1618. https://doi.org/10.1002/art.21869
Stone, John H., Janet T. Holbrook, Matthew A. Marriott, Andrea K. Tibbs, Lourdes P. Sejismundo, Y. -. I. Min, Ulrich Specks, et al. “Solid malignancies among patients in the Wegener's Granulomatosis Etanercept Trial.Arthritis Rheum 54, no. 5 (May 2006): 1608–18. https://doi.org/10.1002/art.21869.
Stone JH, Holbrook JT, Marriott MA, Tibbs AK, Sejismundo LP, Min Y-I, et al. Solid malignancies among patients in the Wegener's Granulomatosis Etanercept Trial. Arthritis Rheum. 2006 May;54(5):1608–18.
Stone, John H., et al. “Solid malignancies among patients in the Wegener's Granulomatosis Etanercept Trial.Arthritis Rheum, vol. 54, no. 5, May 2006, pp. 1608–18. Pubmed, doi:10.1002/art.21869.
Stone JH, Holbrook JT, Marriott MA, Tibbs AK, Sejismundo LP, Min Y-I, Specks U, Merkel PA, Spiera R, Davis JC, St Clair EW, McCune WJ, Ytterberg SR, Allen NB, Hoffman GS, Wegener’s Granulomatosis Etanercept Trial Research Group. Solid malignancies among patients in the Wegener's Granulomatosis Etanercept Trial. Arthritis Rheum. 2006 May;54(5):1608–1618.
Journal cover image

Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

May 2006

Volume

54

Issue

5

Start / End Page

1608 / 1618

Location

United States

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Receptors, Tumor Necrosis Factor
  • Prospective Studies
  • Neoplasms
  • Middle Aged
  • Male
  • Immunoglobulin G
  • Humans
  • Granulomatosis with Polyangiitis
  • Female