Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol

Purpose: Radiation-induced fibrosis (RIF) remains the most morbid complicat ion of radiotherapy because of the absence of spontaneous regression and th e difficulty of patient management. RIF treatment with combined pentoxifyll ine (PTX) and tocopherol (Vit E) was prompted by recent advances in cellula r and molecular biology that have improved researchers' understanding of ra diation-induced late-injury mechanisms and by the excellent results from ou r previous human and animal studies. Patients and Methods: Forty-three patients (mean [+/- SD] age, 59 +/- 10 ye ars) presenting with 50 symptomatic RIF areas involving the skin and underl ying tissues were treated from April 1995 to September 1997, patients had h ad radiotherapy for head and neck or breast cancer a mean period of 8.5 +/- 6.5 years previously. RIF developed in the first year after irradiation an d gradually worsened, without spontaneous regression, The mean measurable s urface area of RIF ([S]) at the time of this study ([S-0]) was 42 +/- 34 cm (2). The initial Subjective Objective Medical management and Analytic (SOMA ) injury evaluation score wets 13.2 +/- 5.9 and included evidence of edema, plexitis, restricted movement, and local inflammatory signs. A combination of PTX (800 mg/d) and Vit E (1,000 IU/d) was administered orally for at le ast 6 months. Results: Treatment was well tolerated, All assessable injuries exhibited co ntinuous clinical regression and functional improvement. Mean RIF surface a rea and SOMA scores improved significantly (P < .0001) at 3 months ([S-3], -39%; [SOMA(3)], -22%), 6 months ([S-6], -53%; [SOMA(6)], -35%), and 12 mon ths ([S-12], -66%; [SOMA(12)], -48%), and mean linear dimensions ([D]) dimi nished from the start of the study ([D-0], 6.5 +/- 2.5 cm) to the end of tr eatment 12 months later ([D-12], 4 +/- 2 cm), At the time of the treatment, we did not attempt to achieve the maximum effect, and the study was contin ued. Conclusion: The PTX-Vit E combination reversed human chronic radiotherapy d amage and, because no other treatment is presently available for RIF, shoul d be considered as a therapeutic measure. (C) 1999 by American Society of C linical Oncology.