Solid malignancies among patients in the Wegener's granulomatosis etanercept trial
dc.contributor.author | Stone, John H. | en_US |
dc.contributor.author | Holbrook, Janet T. | en_US |
dc.contributor.author | Marriott, Matthew A. | en_US |
dc.contributor.author | Tibbs, Andrea K. | en_US |
dc.contributor.author | Sejismundo, Lourdes P. | en_US |
dc.contributor.author | Min, Y. -I. | en_US |
dc.contributor.author | Specks, Ulrich | en_US |
dc.contributor.author | Merkel, Peter A. | en_US |
dc.contributor.author | Spiera, Robert F. | en_US |
dc.contributor.author | Davis, John C. | en_US |
dc.contributor.author | St. Clair, E. William | en_US |
dc.contributor.author | McCune, William Joseph | en_US |
dc.contributor.author | Ytterberg, Steven R. | en_US |
dc.contributor.author | Allen, Nancy B. | en_US |
dc.contributor.author | Hoffman, Gary S. | en_US |
dc.date.accessioned | 2007-05-02T14:14:19Z | |
dc.date.available | 2007-05-02T14:14:19Z | |
dc.date.issued | 2006-05 | en_US |
dc.identifier.citation | Stone, John H.; Holbrook, Janet T.; Marriott, Matthew A.; Tibbs, Andrea K.; Sejismundo, Lourdes P.; Min, Y.-I.; Specks, Ulrich; Merkel, Peter A.; Spiera, Robert; Davis, John C.; St.Clair, E. William; McCune, W. Joseph; Ytterberg, Steven R.; Allen, Nancy B.; Hoffman, Gary S. (2006). "Solid malignancies among patients in the Wegener's granulomatosis etanercept trial." Arthritis & Rheumatism 54(5): 1608-1618. <http://hdl.handle.net/2027.42/50634> | en_US |
dc.identifier.issn | 0004-3591 | en_US |
dc.identifier.issn | 1529-0131 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/50634 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16646004&dopt=citation | en_US |
dc.description.abstract | 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. | en_US |
dc.format.extent | 247544 bytes | |
dc.format.extent | 3118 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.publisher | Wiley Subscription Services, Inc., A Wiley Company | en_US |
dc.subject.other | Life and Medical Sciences | en_US |
dc.title | Solid malignancies among patients in the Wegener's granulomatosis etanercept trial | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Geriatrics | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | University of Michigan, Ann Arbor | en_US |
dc.contributor.affiliationother | Johns Hopkins University, Baltimore, Maryland ; Dr. Stone is a Hugh and Renna Cosner Scholar in the Johns Hopkins Bayview Center for Innovative Medicine. ; The Johns Hopkins Vasculitis Center, 5501 Hopkins Bayview Circle, JHAAC 1B.23, Baltimore, MD 21224 | en_US |
dc.contributor.affiliationother | Johns Hopkins University, Baltimore, Maryland | en_US |
dc.contributor.affiliationother | Johns Hopkins University, Baltimore, Maryland | en_US |
dc.contributor.affiliationother | Johns Hopkins University, Baltimore, Maryland | en_US |
dc.contributor.affiliationother | Johns Hopkins University, Baltimore, Maryland | en_US |
dc.contributor.affiliationother | Johns Hopkins University, Baltimore, Maryland | en_US |
dc.contributor.affiliationother | Mayo Clinic, Rochester, Minnesota | en_US |
dc.contributor.affiliationother | Boston University, Boston, Massachusetts | en_US |
dc.contributor.affiliationother | Beth Israel Medical Center, New York, New York | en_US |
dc.contributor.affiliationother | University of California, San Francisco | en_US |
dc.contributor.affiliationother | Duke University, Durham, North Carolina ; Dr. St.Clair has received consulting fees or honoraria (less than $10,000 per year) from Centocor, Human Genome Sciences, and Genentech and consulting fees or honoraria (more than $10,000 per year) from Cellective Therapeutics. | en_US |
dc.contributor.affiliationother | Mayo Clinic, Rochester, Minnesota | en_US |
dc.contributor.affiliationother | Duke University, Durham, North Carolina | en_US |
dc.contributor.affiliationother | Cleveland Clinic Foundation, Cleveland, Ohio | en_US |
dc.identifier.pmid | 16646004 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/50634/1/21869_ftp.pdf | en_US |
dc.identifier.doi | http://dx.doi.org/10.1002/art.21869 | en_US |
dc.identifier.source | Arthritis & Rheumatism | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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