Effects of denosumab on pain and analgesic use in giant cell tumor of bone: Interim results from a phase II study

Figures & data

Table I. Demographic and disease characteristics and pain and analgesic use scores at baseline.*

Characteristic	Cohort 1^† (N = 170)	Cohort 2^‡ (N = 101)
Demographic and disease characteristics
Female, n (%)	102 (60.0)	57 (56.4)
Location of target lesion, n (%)
Lower extremity (tibia, femur, fibula, or patella/knee)	14 (8.2)	57 (56.4)
Sacrum	42 (24.7)	4 (4.0)
Lung	42 (24.7)	2 (2.0)
Pelvic bone	23 (13.5)	12 (11.9)
Upper extremity (radius, humerus, or metacarpus)	11 (6.5)	17 (16.8)
Vertebrae (cervical, thoracic, or lumbar)	21 (12.4)	3 (3.0)
Skull	7 (4.1)	0
Pelvis (soft tissue only)	2 (1.2)	0
Other	8 (4.7)	6 (5.9)
GCTB disease type, n (%)
Primary resectable	0	63 (62.4)
Primary unresectable	48 (28.2)	0
Recurrent resectable	0	38 (37.6)
Recurrent unresectable	122 (71.8)	0
Prior GCTB therapies, n (%)
Surgery	130 (76.5)	44 (43.6)
Radiation	42 (24.7)	6 (5.9)
Intravenous bisphosphonates	32 (18.8)	10 (9.9)
Chemotherapy	24 (14.1)	2 (2.0)
Oral bisphosphonates	7 (4.1)	1 (1.0)
BPI-SF worst pain score,^§ n (%)
No/mild pain (0–4)	86 (50.6)	45 (44.6)
Moderate pain (5–6)	26 (15.3)	20 (19.8)
Severe pain (7–10)	50 (29.4)	29 (28.7)
Missing	8 (4.7)	7 (6.9)
AQA score,^¶ n (%)
No/low analgesic use (AQA score ≤ 2)	114 (67.1)	87 (86.1)
Strong opioid use (AQA score ≥ 3)	56 (32.9)	14 (13.9)

AQA, Analgesic Quantification Algorithm; BPI-SF, Brief Pain Inventory-Short Form.

*Demographic characteristics of patients in Cohorts 1 and 2 have been reported [13]; ^†Cohort 1 comprised patients with surgically unsalvageable disease; ^‡Cohort 2 comprised patients with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity; ^§BPI-SF: 0 = no pain, 1–4 = mild pain requiring mild analgesics (e.g. acetaminophen or NSAID), 5–6 = moderate pain requiring aggressive analgesic intervention, and 7–10 = severe pain requiring aggressive analgesic intervention [14,15]; ^¶AQA: 0 = no analgesic use, 1 = non-opioid analgesics, 2 = weak opioids only, 3 = strong opioids ≤ 75 mg oral morphine equivalents/day (OME/day), 4 = strong opioids > 75–150 mg OME/day, 5 = strong opioids 150–300 mg OME/day, 6 = strong opioids > 300–600 mg OME/day, and 7 = strong opioids > 600 mg OME/day [19].

Figure 1. Proportion of patients who experienced a clinically relevant improvement in pain among patients with baseline pain scores ≥ 2. Time points with ≥ 10 patients are shown. n = number of patients with data at the visit.

Figure 2. Time to clinically relevant improvement in baseline pain in patients with baseline BPI-SF pain score ≥ 2. Data shown through 9 months.

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