This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Delanian, S. Articles by Lefaix, J.-L. Search for Related Content PubMed PubMed Citation Articles by Delanian, S. Articles by Lefaix, J.-L. Social Bookmarking                            What's this?

Randomized, Placebo-Controlled Trial of Combined Pentoxifylline and Tocopherol for Regression of Superficial Radiation-Induced Fibrosis

Sylvie Delanian, Raphael Porcher, Saida Balla-Mekias, Jean-Louis Lefaix

From the Service d’Oncologie-Radiothérapie and Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Paris; and Direction des Sciences du Vivant/Département de Radiobiologie et de Radiopathologie, Commissariat à l’Energie Atomique/Fontenay-aux-Roses, Fontenay-aux-Roses, France.

Address reprint requests to Sylvie Delanian, MD, Service d’Oncologie-Radiothérapie, Hôpital Saint Louis 1, Ave Claude Vellefaux, 75010 Paris, France; email: sylvie.delanian{at}sls.ap-hop-paris.fr.

Purpose: Radiation-induced fibrosis (RIF) is a rare morbid complication of radiotherapy, without an established method of management. RIF treatment with a combination of pentoxifylline (PTX) and alpha-tocopherol (vitamin E; Vit E) was recently prompted by the good results of a clinical trial and an animal study. The present double-blind, placebo-controlled, monocentric study was designed to assess the efficacy of this combination in treating RIF sequelae.

Patients and Methods: Twenty-four eligible women with 29 RIF areas involving the skin and underlying tissues were enrolled from December 1998 to April 2000. These patients, previously irradiated for breast cancer, were randomly assigned to four balanced treatment groups: (A) 800 mg/d of PTX and 1,000 U/d of Vit E; (B) PTX plus placebo; (C) placebo plus Vit E; and (D) placebo-placebo. The main end point measure was the relative regression of measurable RIF surface after 6 months of treatment. Assessment was completed by depth (with ultrasonography) and associated symptom measures.

Results: Twenty-two patients with 27 RIF areas were analyzed at 6 months. Mean RIF surface regression was significant with combined PTX/Vit E versus double placebo (60% ± 10% v 43% ± 17%; P = .038). The median slope for the speed of RIF surface area and volume regression was significantly higher for group A than groups B, C, and D. All treatments were well tolerated.

Conclusion: Six months’ treatment of combined PTX/Vit E can significantly reduce superficial RIF. Synergism between PTX and Vit E is likely, as treatment with each drug alone is ineffective, but these results require confirmation in larger series.

The study was supported by the Délégation à la Recherche Clinique of Assistance Publique des Hôpitaux de Paris, Paris, France.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				C. Bourgier, M.-C. Vozenin-Brotons, and R. Arriagada Enhanced Local Control by Radiation Boost in Breast Cancer: Back Side of the Coin? J. Clin. Oncol., December 20, 2007; 25(36): 5841 - 5843. [Full Text] [PDF]

				T Konishi, T Watanabe, and H Nagawa Treatment of local ischaemia: another promising approach for gastrointestinal complications of pelvic radiotherapy. Gut, August 1, 2006; 55(8): 1209 - 1209. [Full Text] [PDF]

				R. W. Moss Should Patients Undergoing Chemotherapy and Radiotherapy Be Prescribed Antioxidants? Integr Cancer Ther, March 1, 2006; 5(1): 63 - 82. [Abstract] [PDF]

				S. Delanian, R. Porcher, J. Rudant, and J.-L. Lefaix Kinetics of Response to Long-Term Treatment Combining Pentoxifylline and Tocopherol in Patients With Superficial Radiation-Induced Fibrosis J. Clin. Oncol., December 1, 2005; 23(34): 8570 - 8579. [Abstract] [Full Text] [PDF]

				I. Bairati, F. Meyer, M. Gelinas, A. Fortin, A. Nabid, F. Brochet, J.-P. Mercier, B. Tetu, F. Harel, B. Abdous, et al. Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients J. Clin. Oncol., August 20, 2005; 23(24): 5805 - 5813. [Abstract] [Full Text] [PDF]

				J Andreyev Gastrointestinal complications of pelvic radiotherapy: are they of any importance? Gut, August 1, 2005; 54(8): 1051 - 1054. [Abstract] [Full Text] [PDF]

				C. Chatziantoniou and J.-C. Dussaule Insights into the mechanisms of renal fibrosis: is it possible to achieve regression? Am J Physiol Renal Physiol, August 1, 2005; 289(2): F227 - F234. [Abstract] [Full Text] [PDF]

				D. Azria, A. Pelegrin, J.-B. Dubois, R.-O. Mirimanoff, and M. Ozsahin Radiation Therapy and Tamoxifen: Concurrent or Sequential? It's No Longer the Question! J. Clin. Oncol., June 20, 2005; 23(18): 4239 - 4241. [Full Text] [PDF]

				T. B Chiao and A. J Lee Role of Pentoxifylline and Vitamin E in Attenuation of Radiation-Induced Fibrosis Ann. Pharmacother., March 1, 2005; 39(3): 516 - 522. [Abstract] [Full Text] [PDF]

				C Georges, J-L Lefaix, and S Delanian Resolution of symptomatic epidural fibrosis following treatment with combined pentoxifylline-tocopherol Br. J. Radiol., October 1, 2004; 77(922): 885 - 887. [Abstract] [Full Text] [PDF]

				P. Okunieff, E. Augustine, J. E. Hicks, T. L. Cornelison, R. M. Altemus, B. G. Naydich, I. Ding, A. K. Huser, E. H. Abraham, J. J. Smith, et al. Pentoxifylline in the Treatment of Radiation-Induced Fibrosis J. Clin. Oncol., June 1, 2004; 22(11): 2207 - 2213. [Abstract] [Full Text] [PDF]