Background: Pre- surgical treatment with denosumab has been associated with downstaging in patients (pts) with resectable GCTB. Here, we report our “real world” experience with pre-operative denosumab on surgical downstaging in GCTB pts treated at our institution. Methods: We have surgically treated 91 patients with resectable GCTB between 2010 and 2014. Here, we report the outcome of 18 of these patients treated pre-operatively with denosumab 120 mg SC (day 1, 8, 15, 28 and every 4 weeks thereafter) for at least three months and then post-operatively every 4 weeks for 6 months. Timing of surgery was based on clinical and radiological findings. Histologic diagnosis was centrally reviewed by an expert pathologist. Screening for H3F3A mutation is ongoing and will be presented at the meeting. Results: Median age was 36 years (range 19-72). Seventeen pts were treated at first diagnosis and 1 at relapse. Three pts are still on pre-operative treatment. Most had the lesion in the lower limb (n = 5 distal femur, n = 2 proximal femur, n = 3 distal tibia, n = 2 proximal tibia, n = 2 proximal fibula), 3 in the upper limb (n = 1 distal humerus , n = 1 distal radio, n = 1 proximal radio) and 1 in the sacrum. Median time on pre-operative denosumab was 5.7 months (range 3-6). Toxicity was as expected. In 1 case therapy was interrupted due to dental disease found after first dose administration. Out of 14 evaluable pts treated with denosumab, 11 (78%) pts were treated with curettage, 2 (14%) with resection for GCTB of the proximal fibulae and 1 (7%) with resection and prosthetic replacement for GCTB of the proximal radio. Pts without severe morbidity at surgery was 78% and preservation rate of the joint function was 99%. At a median follow-up of 12.3 months, 2 pts are relapsed and are on treatment with denosumab at the same schedule. Conclusions: In our clinical practice experience, we confirm that the use of preoperative denosumab in pts with resectable GCTB is safe and associated with a reduction in invasive surgical procedures and a good preservation rate of joint function.
Denosumab in patients with resectable giant cell tumor of bone (GCTB): Effect on surgical downstaging in a "real world" experience
FRANCHI, ALESSANDRO;Capanna, R.
2015-01-01
Abstract
Background: Pre- surgical treatment with denosumab has been associated with downstaging in patients (pts) with resectable GCTB. Here, we report our “real world” experience with pre-operative denosumab on surgical downstaging in GCTB pts treated at our institution. Methods: We have surgically treated 91 patients with resectable GCTB between 2010 and 2014. Here, we report the outcome of 18 of these patients treated pre-operatively with denosumab 120 mg SC (day 1, 8, 15, 28 and every 4 weeks thereafter) for at least three months and then post-operatively every 4 weeks for 6 months. Timing of surgery was based on clinical and radiological findings. Histologic diagnosis was centrally reviewed by an expert pathologist. Screening for H3F3A mutation is ongoing and will be presented at the meeting. Results: Median age was 36 years (range 19-72). Seventeen pts were treated at first diagnosis and 1 at relapse. Three pts are still on pre-operative treatment. Most had the lesion in the lower limb (n = 5 distal femur, n = 2 proximal femur, n = 3 distal tibia, n = 2 proximal tibia, n = 2 proximal fibula), 3 in the upper limb (n = 1 distal humerus , n = 1 distal radio, n = 1 proximal radio) and 1 in the sacrum. Median time on pre-operative denosumab was 5.7 months (range 3-6). Toxicity was as expected. In 1 case therapy was interrupted due to dental disease found after first dose administration. Out of 14 evaluable pts treated with denosumab, 11 (78%) pts were treated with curettage, 2 (14%) with resection for GCTB of the proximal fibulae and 1 (7%) with resection and prosthetic replacement for GCTB of the proximal radio. Pts without severe morbidity at surgery was 78% and preservation rate of the joint function was 99%. At a median follow-up of 12.3 months, 2 pts are relapsed and are on treatment with denosumab at the same schedule. Conclusions: In our clinical practice experience, we confirm that the use of preoperative denosumab in pts with resectable GCTB is safe and associated with a reduction in invasive surgical procedures and a good preservation rate of joint function.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
