Long-Term Outcome of Radiotherapy for Primary and Recurrent Ledderhose Disease

Purpose: Use of radiotherapy (RT) for treating primary and recurrent plantar fibromatosis (Ledderhose disease, LD) has been reported in a few clinical studies. This chapter presents and analyzes for the first time the results of a long-term study. Initial results of our pilot study on a smaller number of patients with shorter follow-up have already been published (Seegenschmiedt 2007; Seegenschmiedt and Attassi 2003). Patients & Methods: From 01/1997 to 12/2009, 158 consecutive patients (91 males, 67 females; mean age 49, median 52, range 9–81 years) were referred for treatment. Ninety-four feet were unaffected and 222 feet affected (84 bilateral, 29 right, 25 left). Ninety-one patients (47 males, 44 females) received RT on 136 feet; 67 patients with 134 feet served as control w/o RT: prior to first contact all patients had growth or an increasing number of nodules (N) and cords (C); moreover, 88 (97%) had symptoms (S) within 6–12 months including pain (P), numbness (N), or other symptoms (O); 86 (95%) had walking difficulties (W) due to pain and/or used orthotics. Thirty-five feet (26%) had recurrent or progressive LD after one or more surgical procedures before RT. Orthovoltage RT (125–150 kV X-rays) was used in all cases with the exception of two adolescents (3 feet) who had megavolt electron beam RT due to more complex target volumes. RT was applied in 5 weekly fractions of 3 Gy repeated after a mean of 12 (range 10–15) weeks up to 30 Gy total dose; three patients (5 feet) received only one RT series. Primary endpoints were (a) prevention of progression (PP) and avoidance of surgery (AS). Secondary endpoints were number or size of nodules or cords, symptom relief including pain relief, function, subjective satisfaction using a linear analogue scale (LAS), and radiogenic side effects scored according to the Common Toxicity Criteria (CTC) and Late Effects Normal Tissue (LENT) scales. Results: In 01/2011, all patients (feet) with a minimum follow-up (FU) of 24 months were evaluated; mean FU was 68 (range 24–144) months. Six (7%) patients (11 (8%) feet) had progression and of those 5 (6%) patients (7 (5%) feet) had salvage surgery, one with longer healing period. Sixty feet (44%) remained stable and 65 (48%) feet regressed with regard to nodules, cords, or symptoms; of those, 35 feet achieved complete remission (CR) with freedom of all nodules, cords, and symptoms; 30 feet had partial remission (PR). Previous symptoms and dysfunction improved in up to 90% of all sites. Patients’ satisfaction improved by 3.2 points on the subjective symptom score in 81 (89%) patients. Acute side effects (CTC 1° or 2°) occurred in 29 (21%) or 7 (5%) feet. Chronic sequelae (LENT 1°: dryness or fibrosis of skin) occurred in 22 (16%) feet. No grade 3 acute or late side effects occurred. The control group without RT had significantly higher progression and surgical intervention rates. Multivariate analysis found recurrent LD, nicotine abuse, advanced and symptomatic disease as poor prognostic parameters. Conclusions: External beam RT is the most effective treatment both for primary and recurrent LD as compared to all published surgical results. After long-term follow-up (FU) of at least 2 years, only 6 (7%) patients (with 11 (8%) feet) had recurrent or progressive disease with only 5 (6%) patients (7 (5%) feet) requiring salvage surgery. As compared to the known outcome after surgery, RT reaches a high and long-term remission rate, causes much less side effects, is less impaired by relapses, and thus is highly cost-effective in the long-term management of LD. Although so far no cure is available for LD, the application of RT appears to be “best care” for primary early stage LD, while the potential role of RT for recurrent or progressive LD after completion of surgery has still to be defined in conjunction with foot surgeons in future prospective clinical trials.