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Abstrak :
Pendahuluan: World Health Organization (WHO) mendefinisikan Giant Cell-Tumour (GCT) merupakan tumor tulang yang bersifat jinak, mempunyai sifat dan kecenderungan untuk agresif lokal. Tujuan tata laksana GCT adalah menghilangkan jaringan tumor, mempertahankan fungsi tulang yang terkena, serta mencegah rekurensi. Sampai saat ini belum ada konsensus seragam untuk tata laksana GCT primer. Denosumab merupakan antibodi monoklonal yang berikatan dengan RANKL. Dengan adanya ikatan antara denosumab dengan RANKL, ikatan antara RANKL dengan RANK tidak terjadi, sehingga diharapkan tidak terjadi pertumbuhan tumor. Akan tetapi masih ada beberapa masalah yang masih menjadi pertanyaan antara lain: apakah pemakaian denosumab menurunkan angka rekurensi dibandingkan tata laksana konvensional sebelumnya, bagaimana efikasi denosumab pada tata laksana GCT, serta berapa dosis dan lama terapi denosumab diberikan. Dengan belum adanya pedoman baku penggunaan denosumab, dan belum adanya telaah sistematis serta penelitiannya di Indonesia, maka meta-analisis ini dilakukan untuk menjawab pertanyaan-pertanyaan tersebut dalam membantu menyusun pedoman penggunaannya sehingga menghasilkan kebijakan baru dalam tata laksana GCT di Indonesia. Metode: Telah dilakukan pencarian dalam lima database menggunakan kata kunci ("DENOSUMAB" AND ("GIANT CELL TUMOR" OR "GCT") AND "OUTCOME"). Penilaian risiko bias studi dengan desain randomized controlled trial dilakukan dengan Cochrane Collaboration’s tool for assessing risk of bias, sedangkan penilaian risiko bias studi dengan desain nonrandomized controlled trial dan kohort dilakukan dengan Newcastle-Ottawa Quality Assessment Form for cohort study. Hasil Setelah diseleksi, didapatkan 21 studi yang dilakukan penilaian risiko bias. Meta-analisis menemukan bahwa terdapat 85,5% (IK95%: 74,9-96,0%) pasien mendapatkan perbaikan klinis; perbaikan radiologis pada 82.4% (95% IK: 73,3-91,4%) pasien; perubahan histopatologis pada 96,5% (95% IK: 93,6-99,3%) pasien; serta rekurensi sebesar 27,2% (95% IK: 18,7-35,7%) dan rekurensi pada denosumab dibanding kontrol yakni RR: 2,6 (95% CI: 1,66-4,09); total kejadian efek samping berat pada rahang sebesar 2,7% (95% IK: 1,4-4,0%). Kesimpulan: Administrasi Denosumab pada pasien GCT sebagai terapi sistemik memiliki efikasi yang baik dalam perbaikan klinis; perbaikan radiologis; penurunan aktivitas sel GCT; potensi efek samping yang rendah; akan tetapi angka kejadian rekurensi lebih tinggi dibanding kontrol. Meski demikian, studi komparatif eksperimen acak terkontrol dirasa perlu lebih banyak untuk meningkatkan kualitas hasil studi. ......Introduction: The World Health Organization (WHO) defines GCT as a benign bone tumor, with the nature and tendency for local aggressiveness. The goal of GCT management is to remove tumor tissue, maintain the function of the affected bone, and prevent recurrence. To date there has been no uniform consensus for primary GCT management. Denosumab is a monoclonal antibody that binds to RANKL. With the bond between denosumab and RANKL, the bond between RANKL and RANK does not occur, so that no tumor growth is expected. However, there are still a number of questions that remain questionable, among others: whether the use of denosumab reduces recurrence rates compared to previous conventional management, how the efficacy of denosumab in the management of GCT, and how much dose and duration of denosumab therapy is given. With no standard guidelines for using denosumab, and no systematic study and research in Indonesia. This meta-analitic study was conducted to answer these questions in helping to develop guidelines for their use so as to produce new policies in the management of GCT in Indonesia. Methods: Five databases have been searched using keywords ("DENOSUMAB" AND ("GIANT CELL TUMOR" OR "GCT") AND "OUTCOME"). After being selected, 21 studies were carried out with a bias risk assessment with the Newcastle-Ottawa Quality Assessment Form for cohort studies for studies with cohort designs and nonrandomized controlled trials while for one study a randomized controlled trial was conducted with the Cochrane Collaboration's tool for assessing risk of bias with results 4 poor quality studies. Results: The meta-analysis found that there were 85.5% (CI 95%: 74.9-96.0%) patients received clinical improvement, there was a reduction in VAS scale pain in 98.9% (CI 95%: 96.5-101.4% ) patient; radiological improvement in 85.5% 82.4% (95% CI: 73.3-91.4%) patients; histopathological changes in 96.5% (95% CI: 93.6-99.3%) patients; and recurrence of 27.2% (95% CI: 18.7-35.7%) and recurrence in denosumab compared to controls namely RR: 2.6 (95% CI: 1.66-4.09); the total incidence of severe side effects on the jaw was 2.7% (95% CI: 1.4-4.0%). Conclusions: Denosumab administration in GCT patients as a systemic therapy has good efficacy in clinical improvement; radiological repair; decreased GCT cell activity; low potential for side effects; however the recurrence rate is higher than the control. However, comparative studies of randomized controlled trials are deemed necessary to improve the quality of study results.

Abstrak :
Pendahuluan : Giant Cell Tumor tulang (GCT) merupakan tumor tulang jinak yang dapat secara lokal bersifat agresif dengan tingkat rekurensi mencapai 20%. Antigen Ki-67 dan p53 adalah penanda imunohistokimia pada GCT yang menandakan proliferasi sel dan supresi tumor. Penelitian ini menganalisis hubungan antara penanda Ki-67 dan p53 dengan rekurensi pada kasus GCT. Metode : Penelitian adalah suatu studi Cross-sectional kategorikal. Data yang dikumpulkan adalah data demografis pasien, keterangan terkait diagnosis dan tindakan serta hasil pemeriksaan Ki-67 dan p53. Data pasien Ekspresi Ki-67 dan p53 dievaluasi dengan teknik pewarnaan imunohistokimia menggunakan metode avidin-biotin complex perioxidase dengan menggunakan kit LSAB2. Hasil : Terdapat 26 laki-laki dan 37 perempuan dengan usia rata-rata adalah 34,77 tahun berkisar antara 16 sampai 61 tahun. 13 kasus dengan rekurensi lokal. Tidak terdapat hubungan antara rekurensi dengan karakteristik tumor (jenis kelamin, usia, ukuran tumor, lokasi tumor, stadium tumor dan tindakan operasi). Tidak ada hubungan antara Ki-67 (p=0.524) dan rekurensi lokal serta terdapat hubungan yang signifikan antara p53 dengan rekurensi lokal (p=0.048). Kesimpulan : Ekspresi Ki-67 tidak berhubungan dengan rekurensi, sedangkan ekspresi p53 berhubungan dengan rekurensi giant cell tumor tulang. Tidak terdapat hubungan antara rekurensi lokal dengan karakteristik tumor (jenis kelamin, usia, lokasi tumor, ukuran tumor, stadium tumor dan tindakan operasi).

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Introduction : Giant cell tumor of bone (GCTB) is a benign neoplasm that may be locally aggressive with recurrence rate reaching 20%. Ki-67 and p53 are immunochemistry markers that marked cell proliferations and tumor suppression. This research analyze the association between Ki-67 and p53 with recurrence of GCT. Method :This study is a Cross-sectional categorical study. Demography of the patients, diagnosis and treatment related to the GCT, and Ki-67 and p53 results were taken. The expression of Ki-67 and p53 were evaluated using a immunochemistry staining with avidin-biotin complex peroxidase by using KSAB2 kit. Result : There are 26 men and 37 women with an average age is 34.77 years ranged from 16 to 61 years. 13 cases with local recurrence. There is no association between recurrence and tumor characteristics (sex, age, tumor size, tumor location, stage and operation). There is no association between Ki-67 with local recurrence (p=0,524) and a significant association between p53 and local recurrence (p=0,048). Conclusion : Ki-67 was not associated with recurrence, mean while p53 was associated with recurrence of GCT. There is no association between recurrence and tumor characteristics (sex, age, tumor size, tumor location, stage, and operation).

Abstrak :
[ABSTRAK
Pendahuluan: GCT tulang merupakan lesi jinak tetapi secara lokal dapat bersifat agresif pada daerah epifisis. Angka rekurensi yang tinggi, dilaporkan mencapai 75%. Tumor dapat bermetastasis ke paru (2-9%) dan tercatat 0-37% angka mortalitas akibat metastasis. Beberapa penelitian menghasilkan variasi berbeda penanganan tumor ini terhadap luaran onkologi dan fungsional serta angka kematian paska pembedahan. Penelitian ini bertujuan melaporkan pengalaman dalam penatalaksanaan pembedahan tumor ini dan untuk melihat adanya hubungan antara tatalaksana pembedahan dengan dampak klinis. Metode: Penelitian ini merupakan kohort retrospektif, sebanyak 99 pasien GCT tulang menjalani tindakan kuretase ataupun wide resection di Rumah Sakit Cipto Mangunkusumo pada 1995 - 2014. Luaran onkologi berdasarkan angka rekurensi lokal, metastasis tumor serta mortalitas dan luaran fungsional berdasarkan sistem penilaian Musculoskeletal Tumor Society (MSTS). Hasil: Lokasi tumor terutama di distal femur (25,2%). Rekurensi lokal terjadi pada 4 pasien, terutama di distal femur (50%). Rekurensi lokal terjadi seimbang pada wide resection dan kuretase dan secara statistik tidak bermakna (p 0.578, uji eksak Fischer). Tidak dijumpai kejadian rekurensi lokal pada seluruh pasien yang mengalami metastasis. Metastasis terjadi pada kelompok wide resection. Kematian terjadi pada 4 pasien yang mengalami metastasis. Sebagian besar pasien (51,1%) menunjukkan luaran fungsional kategori sangat baik (skor MSTS di atas 75%). Analisis kesintasan bebas rekurensi lokal secara statistik tidak bermakna (p 0.564). Analisis multivariat (regresi Cox) hanya faktor metastasis yang berpengaruh pada mortalitas (p. 0.001) Kesimpulan: Terdapat hubungan yang bermakna antara stadium tumor dengan metastasis dan jenis tindakan operasi. Tidak terdapat perbedaan bermakna antara kejadian rekurensi lokal dan metastasis serta luaran fungsional dengan jenis tindakan operasi.

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ABSTRACT
Introduction: Giant cell tumor of bone is benign lesion with ability to be locally aggressive in epiphysis. Its recurrence rate was reported as high as 75%. Tumor can metastasize to lungs (2-9%) and up to 37% mortality rate due to metastasis. Several studies have reported different rates of local recurrence, lung metastasis, mortality rate, and functional outcome. This study aims to report our experience and analyze the correlation between surgery and clinical findings. Methods: In this retrospective cohort, 99 patients GCT of bone undergone curettage or wide resection in Cipto Mangunkusumo Hospital during 1995-2014. Oncological outcome were analyzed according to local recurrence rate, metastasis, and mortality rate, while functional outcome were measured according to Musculoskeletal Tumor Society Score (MSTS). Results: Tumor location were predominantly in distal femur (25.2%). Local recurrence were observed in 4 patient and mainly in distal femur (50%). Local recurrence were evenly balanced between surgical curettage and wide resection (50% each) and thus not statistically significant (Exact Fischer, p=0.578). Metastasis were observed in patients who undergone wide resection, however, no significant correlation were found between metastasis incidence and types of surgical intervention (Exact Fischer, p=0.318). Four have died related to metastasis. No local recurrence were observed in patients suffering from metastasis. In more than half of patients (51.5%), the functional status were very good (MSTS >75. Recurrence-free survival analysis not significant statistically (p 0.564).Multivariate analysis (Cox regression) showed that only metastasis was found to be significantly correlated to mortality (p. 0.001). Conclusion: Tumor stage was correlated to metastasis, and type of surgical intervention. No significant correlation were found between local recurrence, metastasis, and functional outcome to types of surgical intervention., Introduction: Giant cell tumor of bone is benign lesion with ability to be locally aggressive in epiphysis. Its recurrence rate was reported as high as 75%. Tumor can metastasize to lungs (2-9%) and up to 37% mortality rate due to metastasis. Several studies have reported different rates of local recurrence, lung metastasis, mortality rate, and functional outcome. This study aims to report our experience and analyze the correlation between surgery and clinical findings. Methods: In this retrospective cohort, 99 patients GCT of bone undergone curettage or wide resection in Cipto Mangunkusumo Hospital during 1995-2014. Oncological outcome were analyzed according to local recurrence rate, metastasis, and mortality rate, while functional outcome were measured according to Musculoskeletal Tumor Society Score (MSTS). Results: Tumor location were predominantly in distal femur (25.2%). Local recurrence were observed in 4 patient and mainly in distal femur (50%). Local recurrence were evenly balanced between surgical curettage and wide resection (50% each) and thus not statistically significant (Exact Fischer, p=0.578). Metastasis were observed in patients who undergone wide resection, however, no significant correlation were found between metastasis incidence and types of surgical intervention (Exact Fischer, p=0.318). Four have died related to metastasis. No local recurrence were observed in patients suffering from metastasis. In more than half of patients (51.5%), the functional status were very good (MSTS >75. Recurrence-free survival analysis not significant statistically (p 0.564).Multivariate analysis (Cox regression) showed that only metastasis was found to be significantly correlated to mortality (p. 0.001). Conclusion: Tumor stage was correlated to metastasis, and type of surgical intervention. No significant correlation were found between local recurrence, metastasis, and functional outcome to types of surgical intervention.]

Abstrak :
Latar Belakang: Giant Cell Tumor (GCT) adalah tumor yang sering mengenai individu berusia 20-45 tahun. Penatalaksanaan GCT radius distal adalah untuk menghilangkan massa tumor sepenuhnya dan mempertahankan pergelangan tangan. Beberapa metode rekonstruksi dapat dilakukan seperti arthrodesis total, Free Vascularized Fibular Graft (FVFG) atau Non-Vascularized Fibular Graft (NVFG), dengan prosedur rekonstruksi terutama melibatkan artroplasti atau arthrodesis pergelangan tangan parsial. Penelitian ini disusun untuk mengetahui perbandingan luaran fungsional pasien rekonstruksi GCT radius distal menggunakan teknik FVFG, NVFG, dan arthrodesis. Metode: Penelitian ini merupakan penelitian analitik dengan desain studi potong lintang yang menilai keluaran. post operasi dan tidak pada subjek tidak terdapat perlakuan khusus pada pasien. Pengambilan data akan dilakukan di RSUPN Cipto Mangunkusumo, Jakara, dan dilaksanakan pada bulan Juli 2020 – Juli 2021. Populasi target pada penelitian ini yaitu pasien yang telah didiagnosis dengan GCT tulang distal radius dan telah dilakukan operasi penyelamatan ekstrimitas beserta prosedur rekonstruksi berupa NVFG atau FVFG atau arthrodesis. Hasil : Terdapat 21 pasien GCT radius distal di RSCM pada penelitian ini yang termasuk kriteria inklusi dan di ikutkan dalam proses analisis data. Jumlah subjek laki-laki adalah 12 orang dan perempuan 9 orang (rasio 4:3). Golongan usia yang paling banyak adalah 21-30 tahun (33,3%). Tidak didapatkan hubungan yang bermakna di antara ketiga prosedur tersebut dengan luaran fungsional pasien (p = 0,49). Namun apabila dilihat dari rerata skor MSTS yang terbaik adalah metode FVFG dengan skor 24,4. Rerata FVFG lebih baik bila dibandingkan dengan arthrodesis 23,2 dan NVFG 23,18. Kesimpulan: Tidak terdapat perbedaan luaran fungsional dari tatalaksana operasi penyelamatan ekstremitas pada pasien dengan GCT tulang distal radius yang dilakukan prosedur NVFG, FVFG, dan arthrodesis. ......Background: Giant Cell Tumor (GCT) is a tumor that often affects individuals aged 20- 45 years. Management of the distal radius GCT is to completely remove the tumor mass and preserve the wrist. Several reconstruction methods can be performed such as total arthrodesis, Free Vascularized Fibular Graft (FVFG) or Non-Vascularized Fibular Graft (NVFG), with the reconstructive procedure primarily involving arthroplasty or partial wrist arthrodesis. This study was structured to compare the functional outcomes of patients with distal radius GCT reconstruction using FVFG, NVFG, and arthrodesis techniques. Method: This study is an analytic study with a cross-sectional design that assesses outcomes. postoperatively and not on the subject there is no special treatment for the patient. Data collection will be carried out at Cipto Mangunkusumo General Hospital, Jakarta, and will be held in July 2020 – July 2021. The target population in this study are patients who have been diagnosed with GCT of the distal radius and have undergone extremity rescue surgery along with reconstruction procedures in the form of NVFG or FVFG or arthrodesis. Result: There were 21 distal radius GCT patients at the RSCM in this study which included the inclusion criteria and were included in the data analysis process. The number of male subjects was 12 people and 9 female subjects (4:3). The most common age group is 21-30 years (33.3%). There was no significant relationship between the three procedures and the patient's functional outcome (p = 0.49). However, when viewed from the average MSTS score, the best is the FVFG method with a score of 24.4. The mean FVFG was better when compared to arthrodesis 23.2 and NVFG 23.18. Conclusion: There was no difference in the functional outcome of limb salvage surgical management in patients with GCT of the distal radius who underwent NVFG, FVFG, and arthrodesis procedures.