Cyclophosphamide versus placebo in scleroderma lung disease

New England Journal of Medicine

Volumn 354, Issue 25, 2006, Pages 2655-2666

  Tashkin, Donald P ^a,m   Elashoff, Robert ^a   Clements, Philip J ^a   Goldin, Jonathan ^a   Roth, Michael D ^a   Furst, Daniel E ^a   Arriola, Edgar ^a   Silver, Richard ^b   Strange, Charlie ^b   Bolster, Marcy ^b   Seibold, James R ^c   Riley, David J ^c   Hsu, Vivien M ^c   Varga, John ^d   Schraufnagel, Dean E ^d   Theodore, Arthur ^e   Simms, Robert ^e   Wise, Robert ^f   Wigley, Fredrick ^f   White, Barbara ^f   Steen, Virginia ^g   Read, Charles ^g   Mayes, Maureen ^h   Parsley, Ed ^h   Mubarak, Kamal ⁱ   Connolly, M Kari ^j   Golden, Jeffrey ^j   Olman, Mitchell ^k   Fessler, Barri ^k   Rothfield, Naomi ^l   Metersky, Mark ^l   more..

^a UNIVERSITY OF CALIFORNIA   (United States)

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^d UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^e BOSTON UNIVERSITY   (United States)

^f JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g GEORGETOWN UNIVERSITY   (United States)

^h UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

ⁱ WAYNE STATE UNIVERSITY   (United States)

^j UNIVERSITY OF CALIFORNIA   (United States)

^k UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^l UNIVERSITY OF CONNECTICUT HEALTH CENTER   (United States)

^m UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; PLACEBO;

ADULT; ANEMIA; ARTICLE; BLADDER CANCER; BODY WEIGHT; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FEMALE; FOLLOW UP; HEMATURIA; HEMORRHAGIC CYSTITIS; HIGH RESOLUTION COMPUTER TOMOGRAPHY; HUMAN; INTERSTITIAL LUNG DISEASE; LEUKOPENIA; LUNG ALVEOLITIS; LUNG DISEASE; LUNG EXAMINATION; LUNG FUNCTION; LUNG LAVAGE; MAJOR CLINICAL STUDY; NEUTROPENIA; PNEUMONIA; PREDICTION; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SYMPTOMATOLOGY; TREATMENT FAILURE; TREATMENT OUTCOME; UNITED STATES; UNSPECIFIED SIDE EFFECT; VITAL CAPACITY;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; AUTOIMMUNE DISEASES; BRONCHOALVEOLAR LAVAGE FLUID; CYCLOPHOSPHAMIDE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LEUKOPENIA; LUNG DISEASES, INTERSTITIAL; MALE; MIDDLE AGED; REGRESSION ANALYSIS; RESPIRATORY FUNCTION TESTS; SCLERODERMA, SYSTEMIC; TREATMENT OUTCOME; VITAL CAPACITY;

EID: 33745227399     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa055120     Document Type: Article

References (34)

1. Steen VD, Conte C, Owens GR, Medsger TA Jr. Severe restrictive lung disease in systemic sclerosis. Arthritis Rheum 1994; 37:1283-9.
2. White B, Moore WC, Wigley FM, Xiao HQ, Wise RA. Cyclophosphamide is associated with pulmonary function and survival benefit in patients with scleroderma and alveolitis. Ann Intern Med 2000;132:947-54.
3. Latsi PI, Wells AU. Evaluation and management of alveolitis and interstitial lung disease in scleroderma. Curr Opin Rheumatol 2003;15:748-55.
4. Silver RM, Warrick JH, Kinsella MB, Staudt LS, Baumann MH, Strange C. Cyclophosphamide and low-dose prednisone therapy in patients with systemic sclerosis (scleroderma) with interstitial lung disease. J Rheumatol 1993;20:834-44.
5. Akesson A, Scheja A, Lundin A, Wollheim F. Improved pulmonary function in systemic sclerosis after treatment with cyclophosphamide. Arthritis Rheum 1994;37:729-35.
6. Steen VD, Lanz JK Jr, Conte C, Owens GR, Medsger TA Jr. Therapy for severe interstitial lung disease in systemic sclerosis: a retrospective study. Arthritis Rheum 1994;37:1290-6.
7. Davas EM, Peppas C, Maragou M, Alvanou E, Hondros D, Dantis PC. Intravenous cyclophosphamide pulse therapy for the treatment of lung disease associated with scleroderma. Clin Rheumatol 1999;18:455-61.
8. Behr J, Vogelmeier C, Beinert T, et al. Bronchoalveolar lavage for evaluation and management of scleroderma disease of the lung. Am J Respir Crit Care Med 1996;154:400-6.
9. Varai G, Earle L, Jimenez SA, Steinert RM, Varga J. A pilot study of intermittent intravenous cyclophosphamide for the treatment of systemic associated lung disease. J Rheumatol 1998;25:1325-9.
10. Pakas I, Ioannidis JP, Malagari K, Skopouli FN, Moutsopoulos HM, Vlachoyiannopoulos PG. Cyclophosphamide with low or high dose prednisolone for systemic sclerosis lung disease. J Rheumatol 2002;29:298-304.
11. Giacomelli R, Valentin G, Slasano F, et al. Cyclophosphamide pulse regimen in the treatment of alveolitis in systemic sclerosis. J Rheumatol 2002;29:731-6.
12. Preliminary criteria for the classification of systemic sclerosis (scleroderma). Arthritis Rheum 1980;23:581-90.
13. Medsger TA Jr. Classification, prognosis. In: Clements PJ, Furst DE, eds. Systemic sclerosis. 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 2004:17-28.
14. BAL Cooperative Group Steering Committee. Bronchoalveolar lavage constituents in healthy individuals, idiopathic pulmonary fibrosis, and selected comparison groups. Am Rev Respir Dis 1990;141:S169-S202.
15. Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Respir Dis 1981;123:659-64.
16. Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea: contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest 1984;85:751-8.
17. Crapo RO, Morris AH. Standardized single breath normal values of carbon monoxide diffusing capacity. Am Rev Respir Dis 1981;123:185-9.
18. American Thoracic Society. Standardization of spirometry, 1994 update. Am J Respir Crit Care Med 1995;152:1107-36.
19. American Association for Respiratory Care. AARC clinical practice guideline: body plethysmography. Respir Care 1994;39:1184-90.
20. Guidelines for the measurement of respiratory function: recommendations of the British Thoracic Society and the Association of Respiratory Technicians and Physiologists. Respir Med 1994;88:165-94.
21. American Thoracic Society. Single-breath carbon monoxide diffusing capacity (transfer factor): recommendations for a standard technique - 1995 update. Am J Respir Crit Care Med 1995;152:2185-98.
22. Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis 1969;99:696-702.
23. Clements PJ, Lachenbruch PA, Seibold JR, et al. Inter and intraobserver variability of total skin thickness score (modified Rodnan TSS) in systemic sclerosis. J Rheumatol 1995;22:1281-5.
24. Petty TL. The National Mucolytic Study: results of a randomized, doubleblind, placebo-controlled study of iodinated glycerol in chronic obstructive bronchitis. Chest 1990;98:75-83.
25. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
26. Steen VD, Medsger TA Jr. The value of the Health Assessment Questionnaire and special patient-generated scales to demonstrate change in systemic sclerosis patients over time. Arthritis Rheum 1997;40:1984-91.
27. Clements PJ, Wong WK, Hurwitz EL, et al. The disability index of the Health Assessment Questionnaire is a predictor and correlate of outcome in the high-dose versus low-dose penicillamine in systemic sclerosis trial. Arthritis Rheum 2001;44:653-61.
28. Ferris BG. Epidemiology Standardization Project (American Thoracis Society). Am Rev Respir Dis 1978;118:1-120.
29. Huber PJ. Robust regression: asymptotics, conjectures, and Monte Carlo. Ann Statist 1973;1:799-821.
30. Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med 1999;18:1341-54.
31. Witek TJ Jr, Mahler DA. Minimal important difference of the transition dyspnoea index in multinational clinical trial. Eur Respir J 2003;21:267-72.
32. Talar-Williams C, Hijazi YM, Walther MM, et al. Cyclophosphamide-induced cystitis and bladder cancer in patients with Wegener granulomatosis. Ann Intern Med 1996;124:477-84.
33. Baltus JA, Boersma JW, Hartman AP, Vandenbroucke JP. The occurrence of malignancies in patients with rheumatoid arthritis treated with cyclophosphamide: a controlled retrospective follow-up. Ann Rheum Dis 1983;42:368-73.
34. Radis CD, Kahl LE, Baker GL, et al. Effects of cyclophosphamide on the development of malignancy and on longterm survival of patients with rheumatoid arthritis: a 20-year followup study. Arthritis Rheum 1995;38:1120-7.