Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis

Journal of Clinical Oncology

Volumn 21, Issue 13, 2003, Pages 2545-2550

  Delanian, Sylvie ^a   Porcher, Raphael ^b   Balla Mekias, Saida ^b   Lefaix, Jean Louis ^b  

^a SAINT LOUIS HOSPITAL   (France)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TOCOPHEROL; PENTOXIFYLLINE; PLACEBO; ANTIOXIDANT; RADIOPROTECTIVE AGENT; TOCOPHEROL;

ARTICLE; BREAST CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG POTENTIATION; DRUG TOLERABILITY; FEMALE; HUMAN; MONOTHERAPY; PRIORITY JOURNAL; RADIATION INJURY; RANDOMIZED CONTROLLED TRIAL; SKIN FIBROSIS; TREATMENT OUTCOME; AGED; BREAST TUMOR; MIDDLE AGED; PATHOLOGY; RADIATION PNEUMONIA;

AGED; ANTIOXIDANTS; BREAST NEOPLASMS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MIDDLE AGED; PENTOXIFYLLINE; PLACEBOS; RADIATION PNEUMONITIS; RADIATION-PROTECTIVE AGENTS; TOCOPHEROLS; TREATMENT OUTCOME;

EID: 0038352140     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.06.064     Document Type: Article

References (29)

1. Delanian S, Lefaix J-L: Reversibility of radiation-induced fibroatrophy (in French). Rev Med Interne 23:164-174, 2002
2. Lefaix J-L, Daburon F: Diagnosis of acute localized irradiation lesions: A review of the French experimental experience. Health Phys 75:375-384, 1998
3. Delanian S, Martin M, Bravard A, et al: Cu/Zn superoxide dismutase modulates phenotypic changes in cultured fibroblasts from human skin with chronic radiotherapy damage. Radiother Oncol 58:325-331, 2001
4. Fajardo L: Pathology of radiation injury, in Masson Monographics in Diagnostic Pathology New York, NY, Sternberg ed. 1982, p 285
5. Lefaix J-L, Delanian S, Leplat J-J, et al: Successful treatment of radiation-induced fibrosis using Cu/Zn-SOD and Mn-SOD: An experimental study. Int J Radiat Oncol Biol Phys 35:305-312, 1996
6. Delanian S, Baillet F, Huart J, et al: Successful treatment of radiation-induced fibrosis using liposomal Cu/Zn superoxide dismutase: Clinical trial. Radiother Oncol 32:12-20, 1994
7. Dion M, Hussey D, Doornbos J, et al: Preliminary results of a pilot study of pentoxifylline in the treatment of late radiation soft tissue necrosis. Int J Radiat Oncol Biol Phys 19:401-407, 1990
8. Werner-Wasik M, Madoc-Jones H: Trental relieves pain from postradiation fibrosis. Int J Radiat Oncol Biol Phys 25:757-758, 1993
9. Cornelison T, Okunieff P, Naydich B, et al: Trial of Pentoxifylline in patients with functional disability caused by radiation-induced advanced regional fibrosis: Preliminary report. Proc Am Assoc Cancer Res 37:615, 1996 (abstr 4185)
10. Futran N, Trotti A, Gwede C: Pentoxifylline in the treatment of radiation-related soft tissue injury: Preliminary observations. Laryngoscope 107:391-395, 1997
11. Baillet F: Alpha-tocopherol treatment of radio-fibrosis post-brachytherapy for breast cancer. Radiother Oncol 43:S3, 1997 (abstr 9)
12. Delanian S, Balla-Mekias S, Lefaix J-L: Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol 17:3283-3290, 1999
13. Lefaix J-L, Delanian S, Vozenin M-C, et al: Striking regression of subcutaneous fibrosis induced by high-doses of gamma rays using a combination of pentoxifylline and alpha-tocopherol: An experimental study. Int J Radiat Oncol Biol Phys 43:839-847, 1999
14. Machin D, Campbell M. Statistical tables for the design of clinical trials. Oxford/Blackwell Scientific Publications. 1987
15. Rodeman H, Bamberg M: Cellular basis of radiation induced fibrosis. Radiother Oncol 35:83-90, 1995
16. Rubin P, Johnston C, Williams J, et al: A perpetual cascade of cytokines post-irradiation leads to pulmonary fibrosis. Int J Radiat Oncol Biol Phys 33:99-109, 1995
17. Martin M, Lefaix J-L, Crechet F, et al: Temporal modulation of TGF-beta1 and b-actin gene expression in pig skin and muscular fibrosis after ionizing radiation. Radiat Res 134:63-70, 1993
18. Rudolph R, Vandeberg J, Schneider J, et al: Slowed growth of cultured fibroblasts from human radiation wounds. Plast Reconstr Surg 82:669-675, 1988
19. Remacle J, Raes M, Toussaint O, et al: Low levels of reactive oxygen species as modulators of cell function. Mutation Res 316:103-122, 1995
20. Martin M, Lefaix J-L, Delanian S: TGF-beta1 and radiation fibrosis: A master switch and a specific therapeutic target? Int J Radiat Oncol Biol Phys 47:277-290, 2000
21. Border W, Noble N: Transforming growth factor beta in tissue fibrosis. N Engl J Med 331:1286-1292, 1994
22. Delanian S, Lefaix J-L: Refractory osteoradionecrosis: Striking healing with combination of pentoxifylline-tocopherol: Proceedings of ESTRO. Radiother Oncol 56:S129, 2000 (abstr 474)
23. Delanian S, Lefaix J-L: Complete healing of severe osteoradionecrosis by treatment combining pentoxifylline, tocopherol and clodronate. Br J Radiol 75:467-469, 2002
24. Letur-Konirsch H, Guis F, Delanian S: Major uterine restoration by radiation sequelae regression with a combination of pentoxifylline-tocopherol: A phase II study. Fertil Steril 77:1219-1226, 2002
25. Ledee-Bataille N, Olivennes F, Lefaix J-L, et al: Combined treatment by pentoxifylline and tocopherol for recipient women with a thin endometrium enrolled in an oocyte donation program. Hum Reprod 17:1249-1253, 2002
26. Berman B, Duncan M: Pentoxifylline inhibits normal human dermal fibroblast in vitro proliferation, collagen, glycosaminoglycan, and fibronectin production, and increases collagenase activity. J Invest Dermatol 92:605-610, 1989
27. Berman B, Duncan M: Pentoxifylline inhibits the proliferation of human fibroblasts derived from keloid, scleroderma and morphoea skin and their production of collagen, glycosaminoglycans and fibronectin. Br J Dermatol 123:339-346, 1990
28. Duncan M, Berger R, Berman B: Pentoxifylline and interferon regulated mechanisms in inhibition of dermal fibroblast collagen synthesis. J Invest Dermatol 100:549, 1993 (abstr)
29. Duncan M, Hasan A, Berman B: Pentoxifylline and interferons decrease type I and III procollagen mRNA levels in dermal fibroblasts: Evidence for mediation by nuclear factor 1 down-regulation. J Invest Dermatol 104:282-286, 1995