Milea Timbergen

169 Clinical characteristics and outcomes of active surveillance The clinical characteristics and outcomes of patients treated with AS of the included studies are shown in Table 2. Most studies only included sporadic DTF, whilst seven studies also included FAP-related DTF. It was mostly unclear whether these FAP-patients were included in the AS groups, and no study published separate results for the AS approach in FAP-related DTF patients. Treatment strategy comparisons included surgery with or without adjuvant radiotherapy, isolated limb perfusion, cryotherapy, radiotherapy, and systemic treatments including chemotherapy, tyrosine kinase inhibitors, and hormonal treatment. One study compared three groups categorised by surgical margins 28 , another study categorised groups based on their pregnancy status 2 . From the later, only groups A, B and C (representing patients with diagnosed during pregnancy [A], diagnosed within 6 months after delivery [B], and previously diagnosed and still in situ at the time of pregnancy [C]) were included in the analysis. Group D (resected before pregnancy without clinical evidence of residual or recurrent disease), was excluded from the results owing to lack of reporting of clinical outcome and shift to active treatment. One study only reported the outcome of 37 patients with RECIST whilst they had 72 patients undergoing AS (Table 2) 31 . Furthermore, one study also described a group of patients with resected tumours (group B). This group was excluded from analysis and only groups A and C from this study were included 29 . Few studies solely included patients receiving AS 26, 27, 36, 37 . Ten studies provided the type and interval of imaging during the AS approach. Most studies used intervals of two to six months after the first evaluation with either computed tomography (CT) 25 or magnetic resonance imaging 8, 10, 23, 27, 37 , or a combination. Few studies used additional ultrasound 9, 36, 37 . Two studies stated to ‘change to annual visits’ after tumour stabilisation or after two years of follow-up 30, 36 . Active surveillance as a single treatment The total number of patients was 3527, of which 1480 (42%) received AS. Three studies allowed the use of non-steroidal anti-inflammatory drugs (NSAIDs) in symptomatic patients during the AS approach or did not consider shift to hormonal therapy as a “failure of AS” (Table 2) 6, 8, 38 . As the use of NSAIDs could be under reported by both patients and researchers, the results of these studies were included in the analysis of this paper. The number of patients receiving AS approach ranged from 3 to 388 per included study. The total group receiving AS consisted of 205 males and 526 females (reported in fifteen studies), for the remaining patients (n = 749), the sex was not further specified. The median percentage of females in each reported study was 72% (IQR: 67-78%). The reported median 6

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