Schuster, James M.

Abstract Background The treatment of oligometastatic (≤5 metastases) spinal disease has trended toward ablative therapies, yet to the authors’ knowledge little is known regarding the prognosis of patients presenting with oligometastatic spinal disease and the value of this approach. The objective of the current study was to compare the survival and clinical outcomes of patients with cancer with oligometastatic spinal disease with those of patients with polymetastatic (>5 metastases) disease. Methods The current study was an international, multicenter, prospective study. Patients who were admitted to a participating spine center with a diagnosis of spinal metastases and who underwent surgical intervention and/or radiotherapy between August 2013 and May 2017 were included. Data collected included demographics, overall survival, local control, and treatment information including surgical, radiotherapy, and systemic therapy details. Health‐related quality of life (HRQOL) measures included the EuroQOL 5 dimensions 3‐level questionnaire (EQ‐5D‐3L), the 36‐Item Short Form Health Survey (SF‐36v2), and the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ). Results Of the 393 patients included in the current study, 215 presented with oligometastatic disease and 178 presented with polymetastatic disease. A significant survival advantage of 90.1% versus 77.3% at 3 months and 77.0% versus 65.1% at 6 months from the time of treatment was found for patients presenting with oligometastatic disease compared with those with polymetastatic disease. It is important to note that both groups experienced significant improvements in multiple HRQOL measures at 6 months after treatment, with no differences in these outcome measures noted between the 2 groups. Conclusions The treatment of oligometastatic disease appears to offer a significant survival advantage compared with polymetastatic disease, regardless of treatment choice. HRQOL measures were found to improve in both groups, demonstrating a palliative benefit for all treated patients.

BACKGROUND This study was designed to identify preoperative predictors of survival in surgically treated patients with metastatic epidural spinal cord compression (MESCC), to examine how these predictors are related to 8 prognostic models, and to perform the first full external validation of these models in accordance with the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement. METHODS One hundred forty‐two surgically treated patients with MESCC were enrolled in a prospective, multicenter North American cohort study and were followed for 12 months or until death. Cox regression was used. Noncollinear predictors with < 10% missing data, with ≥ 10 events per stratum, and with P < .05 in a univariate analysis were tested through a backward stepwise selection. For the original and revised Tokuhashi prognostic scoring systems (PSSs), Tomita PSS, modified Bauer PSS, van der Linden PSS, Bartels model, Oswestry Spinal Risk Index, and Bollen PSS, this study examined calibration graphically, discrimination with Harrell c‐statistics, and survival stratified by risk groups with the Kaplan‐Meier method and log‐rank test. RESULTS The following were significant in the univariate analysis: type of primary tumor, sex, organ metastasis, body mass index, preoperative radiotherapy to MESCC, physical component (PC) of the 36‐Item Short Form Health Survey, version 2 (SF‐36v2), and EuroQol 5‐Dimension (EQ‐5D) Questionnaire. Breast, prostate and thyroid primary tumor (HR: 2.9; P =.0005), presence of organ metastasis (hazard ratio (HR): 2.0; P = .005) and SF‐36v2 PC (HR: 0.95; P < .0001) were associated with survival in multivariable analysis. Predicted prognoses poorly matched observed values on calibration plots; Bartels model calibration slope was 0.45. Bollen PSS (0.61; 95% CI: 0.58‐0.64) and Bartels model (0.68; 95% CI: 0.65‐0.71) had the lowest and highest c‐statistics, respectively. CONCLUSIONS The primary tumor type (breast, prostate, or thyroid), an absence of organ metastasis, and a lower degree of physical disability are preoperative predictors of longer survival for surgical MESCC patients. These results are in keeping with current models. This full external validation of 8 prognostic PSSs or model of survival in surgical MESCC patients has revealed that calibration is poor, especially for long‐term survivors, whereas discrimination is possibly helpful.

BACKGROUNDThe Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) was developed as the first spine oncology‐specific health‐related quality of life (HRQOL) measure. This study evaluated the psychometric properties and clinical validity of the SOSGOQ in a diverse cohort of patients with spinal metastases.METHODSAn international, multicenter, prospective observational cohort study including patients with spinal metastases who underwent surgery and/or radiotherapy was conducted by the AOSpine Knowledge Forum Tumor. Demographic, tumor, and treatment data were collected. HRQOL was evaluated using the SOSGOQ and Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF‐36) at baseline and fixed follow‐up times. Construct validity was assessed using multitrait scaling analyses, confirmatory factor analyses, and correlation with the SF‐36 and NRS pain score. Test‐retest reliability was assessed in a subgroup of patients between 12 weeks after treatment and the retest 4 to 9 days later.RESULTSA total of 238 patients were enrolled at 9 centers across North America; 153 of these patients had HRQOL data available at 12 weeks after treatment. Multitrait scaling analyses and confirmatory factor analyses resulted in a refined version of the SOSGOQ with 4 domains and 4 single items. The revised SOSGOQ (SOSGOQ2.0) demonstrated strong correlations with SF‐36 and the ability to discriminate between clinically distinct patient groups. Reliability of the SOSGOQ2.0 was demonstrated to be good, with an intraclass correlation coefficient ranging from 0.58 to 0.92 for the different domains.CONCLUSIONSThe SOSGOQ2.0 is a reliable and valid measure with which to evaluate HRQOL in patients with spinal metastases. It is recommended to use the SOSGOQ2.0 together with a generic HRQOL outcome measure to comprehensively assess HRQOL and increase sensitivity and specificity. Cancer 2018;124:1828‐38. © 2018 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

Introduction Symptomatic Metastatic Epidural Spinal Cord Compression (MESCC) afflicts up to 10% of all cancer patients and is associated with shortened survival and worsened quality of life. This study aims to identify the key survival prognostic factors in MESCC patients who were surgically treated for a single symptomatic lesion. Material and Methods 142 MESCC patients were enrolled in a prospective North American multi-center study and followed postoperatively for 12 months. Using univariate analyses, Kaplan-Meier methods, and log-rank tests the prognostic value of various clinical predictors were assessed. Non-collinear predictors with p < 0.05 in univariate analyses were included in the final Cox proportional hazards model. Results The overall median survival was 7.7 months (range: 3 days – 35.6 months); breast cancer had the longest median survival (12.1 months). Ten patients (7%), whose primary cancer were lung (3), kidney (3), sarcoma (2), prostate (1), and breast (1), died within 30-days postoperatively and 88 had died at 12 months (62%). Univariate analyses yielded eight significant predictors for survival: the growth of primary tumor (Tomita Grade 1 vs Grade 2 and 3), BMI, gender, preoperative SF-36 physical component, EQ-5D, and ODI scores as well as the presence of either visceral or extraspinal bony metastasis. The multiple regression analysis revealed that the Tomita grade (Grade 1 vs Grade 2 and 3; HR: 2.81, p = 0.007), the absence of visceral metastasis (HR: 2.01; p = 0.0044), and higher score on SF-36 physical component (HR: 0.95, p < 0.0001) were independent predictors for longer survival regardless of the selection method used (backward, forward, or stepwise). Conclusion Slow growing tumor (Tomita Grade 1), absence of visceral metastasis, and lower degree of preoperative physical disability, as reflected by a higher score on the SF-36 physical component questionnaire, are good prognostic factors for survival in selected patients who underwent surgical treatment for a focal symptomatic MESCC lesion.

Introduction Although surgery is being increasingly used in patients with Metastatic Epidural Spinal Cord Compression (MESCC) as a complementary strategy to radiation and chemotherapy, the impact of surgery on quality of life (QoL) is not well established. This study aimed to prospectively evaluate survival, neurological, functional, and QoL outcomes in MESCC patients undergoing operative management. Material and Methods A total of 142 surgically treated patients with a single symptomatic MESCC lesion enrolled in a prospective North American multi-center study were followed for 12 months. Clinical data, such as Brief Pain Inventory (BPI), ASIA, SF-36, Oswestry Disability Index (ODI), and EQ-5D scores, were obtained both pre- and post-operatively. Results The median survival was 7.7 months. The 30-day and 12-month mortality rates were 9% and 62%, respectively. Six weeks post-operatively, ambulatory status ( p = 0.02) and bladder control ( p = 0.03) were significantly improved. Overall, 67.5% of ASIA B, C, or D patients gained at least 1 grade after surgery, 25% remained stable, and 7.5% deteriorated. ODI, EQ-5D, BPI scores were significantly improved at each follow-up (p ≤ 0.01). SF-36 scores were generally higher after surgery for mental and physical components, and for all domains except energy/fatigue. The incidence of wound complications was 10% and 2 patients required a second surgery (screw malposition and epidural hematoma). Conclusion Surgical intervention, as a complementary adjunct to radiation and chemotherapy, provides immediate and sustained improvement in pain, neurological, functional, and QoL outcomes with acceptable risks in patients with a focal symptomatic MESCC lesion.

Introduction Symptomatic metastatic epidural spinal cord compression (MESCC) afflicts up to 10% of all cancer patients. MESCC is associated with shortened survival and worsened quality of life; thus, early diagnosis and management is crucial. In a multidisciplinary setting, life expectancy must be considered along with other factors, such as patient's symptoms and overall medical condition, to select the optimal patient-specific treatment plan. This study aims to identify and compare key survival prognostic factors in surgically treated symptomatic MESCC patients with a 12-month postoperative follow-up. Materials and Methods Over a 5-year period, 145 patients surgically treated for a single symptomatic MESCC lesion were enrolled in a prospective North American multicenter study. Univariate analyses, Kaplan–Meier methods, and log-rank tests were used to evaluate the prognostic value of various clinical predictors. Preoperative prognostic factors evaluated: age, gender, comorbidities, history of smoking, metastases outside the spine, site of primary tumor, previous systemic treatment for the primary tumor, MESCC location, number of vertebral body involved, previous MESCC treatment, ASIA score, motor deficits, bladder dysfunction, Oswestry Disability Index (ODI), EQ-5D, SF-36v2 mental and physical components, and ability to walk four steps. Predictors with p < 0.2 in univariate analyses were included into the final Cox proportional hazards model. Results The overall median survival was 7.7 months (235 days). Lung and breast cancer had the shortest and longest median survival, respectively (4.5 vs. 12.1 months). Nine patients (6%), whose primary cancer were lung (3), kidney (3), melanoma (1), prostate (1), and breast (1), died within 30 days after surgery; 46 (32%), 61 (42%), 74 (51%), and 86 (59%) patients died at 3, 6, 9, and 12 months, respectively. The site of primary tumor, number of vertebrae involved, ODI, EQ-5D, ASIA score, metastases outside the spine, bladder dysfunction, and ability to walk four steps were significant predictors on the univariate analyses. However, the multivariate Cox-regression analysis demonstrated that only spinal metastasis involving four or more vertebral bodies had a negative impact on survival ( p = 0.002, HR: 25). Conclusion The extent of spinal metastasis, which is regarded as an indicator of the severity of patient's metastasis burden, and the site of the primary tumor, although not statistically significant in our regression model but well recognized in the literature as an important clinical predictor, are considered as independent predictors of poor prognosis in patients with a single-level symptomatic MESCC lesion. MESCC patients are a challenging and vulnerable heterogenous population. It is essential to identify factors predicting survival, functional and clinical outcomes in this population to guide patient-centered management to optimize quality of life.