(P 038) TENOSYNOVIAL GIANT CELL TUMOR OBSERVATIONAL PLATFORM PROJECT (TOPP): 2-YEAR OBSERVATIONAL SUB-ANALYSIS OF AGE AND PATIENT-REPORTED OUTCOMES FROM AN EU/US PROSPECTIVE REGISTRY

Objective: Diffuse-type tenosynovial giant cell tumor (dt-TGCT) is a rare, locally aggressive neoplasm. The prospective international TOPP registry described the impact of dt-TGCT on patient-reported outcomes (PRO) from a baseline (BL) snapshot, and more recently as a 2-year follow-up based on treatment strategies. As TGCT mainly affects a younger working population, this analysis assesses how quality of life (QoL) can be affected by age.

Methods: TOPP is an observational prospective study conducted at 12 sites (7 European countries [10 sites]; 2 US sites). For patients (pts) with histologically confirmed dt-TGCT, tumor status and treatment strategy were calculated during the 2-year observation period. Captured PRO measurements were assessed at BL (at the time of enrollment into the registry), 6 months, Year 1 (Y1), 18 months, and Year 2 (Y2). Only pts with post BL data were included in the analysis. PRO endpoints (EuroQol-5 Dimension visual analog scale [EQ-5D VAS], EQ-5D, Brief Pain Inventory [BPI] Pain Severity, Worst Pain, Worst Stiffness, Patient-Reported Outcomes Measurement Information System-Physical Function [PROMIS-PF]) were calculated as medians in pts for whom scores were collected at each time point. Pts who did not complete the questionnaire were excluded from PRO analysis at the specific time point. Pts were categorized based on their age: < 40 years, 40–59 years, or ≥60 years.

Results: At time of enrollment (BL), 176 pts (108 female, 61.4%) were included in the Full Analysis Set (FAS), and the mean age was 43.5 ±14.3 years (range 18–77). Most pts were aged < 40 years (78/176, 44.3%), followed by 69/176 pts (39.2%) at ages 40–59 years, and 29/176 pts (16.5%) aged ≥60 years. The most common tumor status was recurrent disease and ≥1 prior treatment in pts < 40 years (Y1, 47.4%; Y2; 48%). Primary diagnosis and ≥1 prior treatment was most common in pts ≥60 years (44.8%) (Table 1). At Y1 and Y2, the highest percentage of wait-and-see treatment strategy was seen in the oldest group (51.7%), as opposed to pts < 40 years (Y1, 37.2%; Y2, 33.3%) and 40–59 years (Y1, 34.8%; Y2, 31.9%) (Table 2). Over the 2-year observation period, Pain Intensity scores noticeably improved in pts < 40 years of age (BL, n=71, 3.00; Y2, n=51, 1.00), whereas Pain Intensity scores were higher in pts aged ≥60 years from BL (n=27, 1.86) to Y2 (n=24, 2.65) (Table 3, Figure 1A). Similarly, Pain Severity scores numerically improved in the youngest group from BL (n=71, 3.00) through Y2 (n=52, 1.50) and in the group ages 40–59 (BL, n=67, 3.25); Y2, n=56, 2.38) as opposed to the group ≥60 years for whom Pain Severity scores did not improve from BL (n=28, 2.38) through Y2 (n=24, 2.50) (Table 3, Figure 1B). Numerical improvement was observed in Worst Stiffness scores in pts aged < 40 years from BL (n=71, 5.00) through Y2 (n=52, 3.00), while Worst Stiffness scores increased from 3.00 (n=27) at BL to 4.00 (n=25) at Y2 in pts aged ≥60 years (Table 3, Figure 1C). EQ5D VAS scores deteriorated over time in the older population (≥60 years: at BL [n=29, 80.00], at Y2 [n=25, 65.00]), compared to an increase in the younger populations (< 40 years: at BL [n=71, 70.00], at Y2 [n=52, 75.00]; 40–59 years: at BL [n=68, 70.00] at Y2 [n=58, 80.00]) (Table 3). No numerical differences were observed in EQ5D and PROMIS-PF scores among the age groups over the 2-year observational period.

Conclusion: This is the first analysis to describe the impact of age on QoL as a 2-year follow-up in pts with D-TGCT. The youngest group (aged < 40 years) showed the most improvement in PRO over the 2-year observational period, potentially due to a higher percentage of these pts being actively treated compared to the oldest group (aged ≥60 years) who were predominantly wait-and-see, had a decrease in EQ5DVAS scores over time, and resulted in more complaints. As TGCT is most present in a younger working population, these findings could be considered in future studies.

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