{Reference Type}: Clinical Trial, Phase II
{Title}: Results of a phase II pilot study of moderate dose radiotherapy for inoperable desmoid-type fibromatosis--an EORTC STBSG and ROG study (EORTC 62991-22998).
{Author}: Keus RB;Nout RA;Blay JY;de Jong JM;Hennig I;Saran F;Hartmann JT;Sunyach MP;Gwyther SJ;Ouali M;Kirkpatrick A;Poortmans PM;Hogendoorn PCW;van der Graaf WTA;
{Journal}: Ann Oncol
{Volume}: 24
{Issue}: 10
{Year}: Oct 2013
{Factor}: 51.769
{DOI}: 10.1093/annonc/mdt254
{Abstract}: <B>BACKGROUND: </B>To determine the activity of radiotherapy in patients with inoperable desmoid-type fibromatosis (DF) a multicenter prospective phase II trial was carried out.<BR><B>METHODS: </B>Patients with inoperable progressive disease of primary, recurrent or incompletely resected lesions received a dose of 56 Gy in 28 fractions. Follow-up MRI studies were carried out every 3 months for 2 years and thereafter every 6 months. The primary end point was local control rate at 3 years, estimated by a nonparametric method for interval-censored survival data. Secondary end points were objective tumor response, acute and late toxic effect.<BR><B>RESULTS: </B>Forty-four patients (27 F/17 M) were enrolled from 2001 to 2008. Median age was 39.5 years. Main tumor sites included trunk 15 (34.1%) and extremities 27 (61.3%). Median follow-up was 4.8 years. The 3-year local control rate was 81.5% (90% one-sided confidence interval 74% to 100%). Best overall response during the first 3 years was complete response (CR) 6 (13.6%), partial response (PR) 16 (36.4%), stable disease 18 (40.9%), progressive disease 3 (6.8%) and nonassessable 1 (2.3%). Five patients developed new lesions. After 3 years, the response further improved in three patients: (CR 2, PR 1). Acute grade 3 side-effects were limited to skin, mucosal membranes and pain. Late toxic effect consisted of mild edema in 10 patients.<BR><B>CONCLUSIONS: </B>Moderate dose radiotherapy is an effective treatment of patients with DF. Response after radiation therapy is slow with continuing regression seen even after 3 years.