Denosumab Re-Challenge and Long-Term Efficacy for Aneurysmal Bone Cyst of the Spine: Enhanced Treatment Algorithm.

Background/Objective: Surgical treatment of aneurysmal bone cysts (ABCs) can be challenging, especially in the spine. Non-surgical treatments such as with denosumab have shown promising results in different osteolytic pathologies. This retrospective observational study aimed to evaluate the long-term clinical and radiologic response of patients with ABCs of the mobile spine treated with denosumab and propose an updated treatment algorithm. Methods: Six patients with relapsed and symptomatic ABCs of the mobile spine were treated with denosumab (120 mg subcutaneously on days 1, 8, 15, 29, and every 4 weeks thereafter) between 2012 and 2023. Disease assessments were conducted using CT and MRI at 3, 6, 9, and 12 months post-treatment. Clinical data, including pain levels, symptoms, and adverse events, were documented from patients' charts. Results: Patients underwent an initial phase of treatment with denosumab, receiving a mean of 22 administrations (range 13-42) over a median follow-up period of 41 months (range 15-98 months). Clinical improvement was observed in all patients after 4 weeks of treatment, and all patients demonstrated a radiological response after 12-24 weeks on denosumab. Three patients were progression-free after discontinuing denosumab following 13, 15, and 42 administrations, respectively. At the last follow-up, after 38, 43, and 98 months, these patients remained stable without relapse of the disease. Three patients had a relapse of disease after denosumab; two of them underwent denosumab re-challenge, while one patient received one mesenchymal stem cells (MSCs) injection. All patients showed clinical and radiological improvement and were resulted to be disease-free at the last follow-up. Conclusions: This study demonstrates the long-term efficacy and safety of denosumab in treating ABCs of the mobile spine, as well as the potential of re-challenge in managing recurrence. A treatment algorithm is proposed, positioning denosumab as a viable therapeutic option after other local treatments. Careful patient selection, monitoring, and further research are necessary to optimize denosumab use for ABCs.

Factors associated with increased length of stay and risk of complications in 336 patients submitted to spine surgery. The role of a validated capture system (SAVES v2) as a first-line tool to properly face the problem.

PURPOSE: In this study, we analyzed the use of a validated capture system (Spinal Adverse Events Severity system, SAVES V2) as a first non-technical skill to properly face the relevant problem of surgical complications (SCs) and adverse events (AEs) in spinal surgery. METHODS: We retrospectively collected AEs occurring in a tertiary referral center for spine surgery from January 2017 to January 2018 and classified them according to SAVES V2 system. We compared this collection of AEs with a prospective collection performed without any classification system. Univariate and multivariate logistic regression models were used to determined odds ratio (ORs) for selected potential risk factors of AEs and prolonged length of stay. RESULTS: Overall a higher number of AEs was retrospectively recorded using SAVES system compared to the prospective recording without the use of any capture system (97/336 vs 210/336, p < 0.001). The length of stay (LOS) increased in the group of complicated patients for all the procedures examined. In the non-oncological group, LOS was significantly higher for complicated patients compared to uncomplicated patients (F = 44.11, p = 0.0000). Similar results have been obtained in the oncological group of patients. In the multivariate regression model surgical time and postoperative AEs emerged as risk factors for prolonged LOS, while only the presence of previous surgeries was confirmed as risk factor for AEs. CONCLUSION: Considering that the rate of AEs and SCs in spinal surgery is still high despite the improvement of technical skills, we suggest the use of SAVES V2 capture system as a first-line tool to face the problem.

Carbon Fiber-Reinforced PolyEtherEtherKetone (CFR-PEEK) Instrumentation in Degenerative Disease of Lumbar Spine: A Pilot Study.

CFR-PEEK is gaining popularity in spinal oncological applications due to its reduction of imaging artifacts and radiation scattering compared with titanium, which allows for better oncological follow-up and efficacy of radiotherapy. We evaluated the use of these materials for the treatment of lumbar degenerative diseases (DDs) and considered the biomechanical potential of the carbon fiber in relation to its modulus of elasticity being similar to that of bone. Twenty-eight patients with DDs were treated using CRF-PEEK instrumentation. The clinical and radiographic outcomes were collected at a 12-month FU. Spinal fusion was evaluated in the CT scans using Brantigan scores, while the clinical outcomes were evaluated using VAS, SF-12, and EQ-5D scores. Out of the patients evaluated at the 12-month FU, 89% showed complete or almost certain fusion (Brantigan score D and E) and presented a significant improvement in all clinical parameters; the patients also presented VAS scores ranging from 6.81 ± 2.01 to 0.85 ± 1.32, EQ-5D scores ranging from 53.4 ± 19.3 to 85.0 ± 13.7, SF-12 physical component scores (PCSs) ranging from 29.35 ± 7.04 to 51.36 ± 9.75, and SF-12 mental component scores (MCSs) ranging from 39.89 ± 11.70 to 53.24 ± 9.24. No mechanical complications related to the implant were detected, and the patients reported a better tolerance of the instrumentation compared with titanium. No other series of patients affected by DD that was stabilized using carbon fiber implants have been reported in the literature. The results of this pilot study indicate the efficacy and safety of these implants and support their use also for spinal degenerative diseases.

Indications and Limits of Surgery for Spinal Metastases Derived from Lung Cancer: A Single-Center Experience.

Lung cancer is the second most frequently diagnosed cancer in the world, and surgery is an integral part of the treatment for spinal metastases. The aims of this retrospective study were to assess the overall survival of surgically treated patients affected by lung cancer spinal metastases and identify any factors related to a better survival rate. We recruited 56 consecutive patients (34 male and 22 female) surgically treated for metastatic lung cancer in the spine from 2009 to 2019. Surgical indications were based on a previously published and validated flow chart following a multidisciplinary evaluation. We assessed the localization of vertebral metastases, the presence of other bone or visceral metastases, neurological status according to the Frankel score, ambulatory autonomy, and general status, measured with the Karnofsky performance scale. The expected prognosis was retrospectively assessed according to the revised Tokuhashi score. The median survival was 8.1 months, with over a third of patients surviving more than 1 year. We observed a global improvement in all clinical parameters after surgical treatment. The Tokuhashi predictive score did not correlate with survival after surgery. The results of this study suggest that the surgical treatment of symptomatic spinal metastases from lung cancer can improve quality of life, even in patients with a shorter life expectancy, by controlling pain and improving autonomy.

Clear Cell Renal Cell Carcinoma Spinal Metastases: Which Factors Matter to the Overall Survival? A 10-Year Experience of a High-Volume Tumor Spine Center.

Clear cell renal cell carcinoma (ccRCC) usually spreads in the spinal region causing instability or spinal cord compression leading to neurological deficits. Therefore, surgical treatment is required for improving the outcome of patients. The aim of this study is to identify which prognostic factors could affect overall survival in patients affected by ccRCC. Methods: Retrospective cohort study of patients with ccRCC spinal metastases, surgically treated from November 2009 to April 2019. Demographic and clinical data were collected. The Kaplan−Meier method was used to estimate overall survival, and the log-rank test was used to evaluate differences in survival among potentially prognostic factors. Results: A total of 69 patients were surgically treated and followed up for a median period of 65 months. The average age at the time of surgery was 62.6 years old. The median overall survival (OS) was 34.7 months (95% CI 20.8−51.9) and 5-year OS was 31.2% (95% CI 19.2−44.1). A high Tokuhashi score (p = 0.0217), the presence of visceral metastases (p < 0.001), other bone metastases (p = 0.02012) and the kind of surgical treatment (p = 0.0395) are the main prognostic factors that influence the OS. Moreover, 3-year progression-free survival (PFS) was analyzed: the median PFS was 53.1 months and the % 3-year PFS was 62.9% (45.2−76.3). In the multivariate analysis, only pre-operative radiation therapy had a significant impact on 3-year PFS (95% CI 0.929−12.994, p = 0.0643). Conclusion: The results of this study suggest that the absence of visceral metastases and an aggressive surgery as en-bloc, when feasible, could prolong the survival rate and improve quality of life for patients.