MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03046nam a22003737a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
201229s20202020 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
|---|
| International Standard Serial Number |
0362-2436 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
|---|
| PMID |
33038190 |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Denosumab Treatment for Giant Cell Tumor of the Spine Including the Sacrum. |
| 251 ## - Source |
|---|
| Source |
Spine. 2020 Oct 08 |
| 252 ## - Abbreviated Source |
|---|
| Abbreviated source |
Spine. 2020 Oct 08 |
| 253 ## - Journal Name |
|---|
| Journal name |
Spine |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Year |
2020 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Manufacturer |
FY2021 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
|---|
| Publication status |
aheadofprint |
| 266 ## - Date added to catalog |
|---|
| Date added to catalog |
2020-12-29 |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
CONCLUSIONS: Results from the analysis suggest that denosumab is potentially effective treatment for patients with GCTB of the spine including the sacrum. The adverse event profile was consistent with the full study population. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
LEVEL OF EVIDENCE: 2. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
METHODS: Adults or skeletally mature adolescents with pathologically confirmed GCTB of the spine including the sacrum, and radiologically measurable evidence of active disease, were included. Patients received denosumab (120 mg subcutaneously) once every 4 weeks during the treatment phase, with loading doses on days 8 and 15 of the first cycle. Patients had surgically unsalvageable GCTB (Cohort 1), had planned surgery expected to result in severe morbidity (Cohort 2), or were enrolled from a previous GCTB study (Cohort 3). |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
OBJECTIVE: To assess the efficacy and safety of denosumab in a subset of patients with giant cell tumors of bone (GCTB) of the spine including the sacrum from an international, open-label, single-arm, phase 2 study (ClinicalTrials.gov: NCT00680992). |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
RESULTS: Overall, 132 patients were included in the safety analysis (103 in Cohort 1, 24 in Cohort 2, and 5 in Cohort 3); 131 patients were included in the efficacy analysis. Kaplan-Meier estimated probabilities of disease progression or recurrence were 3% (95% CI, 0.0-6.2) at year 1 and 7.4% (95% CI, 2.1-12.7) at years 3 and 5 in Cohort 1, and not estimable in Cohorts 2 and 3. Of 23 patients (Cohort 2) with surgery planned at baseline, 10 (43%) had on-study surgery; of these one patient had reported disease progression or recurrence after the on-study surgery. Clinical benefit was reported in 83% of patients overall (all cohorts). |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
STUDY DESIGN: This was a subanalysis of an international, multicenter, open-label study. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
SUMMARY OF BACKGROUND DATA: Standard GCTB treatment is surgical removal, either by curettage or resection, combined with intraoperative adjuvant therapy; however, some sites may not be amenable to resection (eg, skull, spine). |
| 546 ## - LANGUAGE NOTE |
|---|
| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Institution |
MedStar Washington Hospital Center |
| 656 ## - INDEX TERM--OCCUPATION |
|---|
| Department |
Orthopedic Oncology |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Henshaw, Robert M |
| 790 ## - Authors |
|---|
| All authors |
Blay JY, Bukata SV, Chawla S, Dai T, Henshaw R, Jandial D, Rutkowski P, Seeger L, Skubitz K |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| DOI |
<a href="https://dx.doi.org/10.1097/BRS.0000000000003728">https://dx.doi.org/10.1097/BRS.0000000000003728</a> |
| Public note |
https://dx.doi.org/10.1097/BRS.0000000000003728 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
