Health-related Quality of Life of Patients With Non-Intra-abdominal Desmoid-Type Fibromatosis During Active Surveillance: Results of a Prospective Observational Study.

"The authors report no conflict of interest."

"The HRQoL data were collected within the GRAFITI trial, a prospective, multicentre observational study performed in 7 sarcoma centers in the Netherlands. The study was approved by the Ethics Committee of the Erasmus Medical Centre (MEC-2014-124), registered in the Dutch trial register (study ID: NTR4714), and all patients provided written informed consent. The study design, details on study procedures, and objective outcome measures of the GRAFITI trial have been published previously., Briefly, AS was evaluated as an initial approach for adult patients with non–intra-abdominal sporadic DTF without previous treatment for the current lesion. Patients with severe pain or functional impairment due to the tumor at the time of inclusion (as indicated by the patient) were excluded. The follow-up protocol consisted of follow-up visits and imaging examinations (ultrasound and MRI) during an AS approach for a minimum of 3 years. In case of tumor growth or progressive symptoms, the AS management strategy was re-evaluated according to the international guidelines. For these patients, the decision to start an AT was made by both the physician and the patient and was discussed in a multidisciplinary meeting. Active treatments could include systemic therapy, surgical resection, or radiotherapy. After the start of AT, clinical follow-up no longer took place in the GRAFITI trial setting. All patients were asked to complete the HRQoL questionnaire on paper at baseline and 6, 12, and 24 months after the start of an AS approach. After a switch to AT, patients were still asked to complete the HRQoL questionnaire. As per protocol, patients did not complete a questionnaire at 36-month follow-up, clinical and HRQoL data from baseline to 24-month follow-up were reported here. Progression-free survival and the cumulative incidence of the start of an active treatment at 3 years have been reported previously. "