An Observational Study to Identify Various Prognostic Factors in Spinal Metastatic Disease in Northern India

Abstract

Background

Spinal metastatic disease is a common complication in cancer patients, leading to significant morbidity and mortality. These metastases are more frequently found in the bones and may present with symptoms of spinal canal invasion and cord compression. Understanding the prognostic factors influencing outcomes in spinal metastatic disease is crucial for optimizing treatment strategies and improving patient quality of life.

Objective

This study aims to identify and analyze various prognostic factors, including treatment modality (surgical vs. conservative), affecting the clinical outcomes in patients with spinal metastatic disease.

Materials and Methods

A prospective observational study was conducted at a tertiary care center on 50 patients diagnosed with spinal metastatic disease for a year. Data collected included demographic information, primary cancer type, site of primary cancer, neurological status at presentation, treatment modalities employed, and overall survival. Prognostic factors were evaluated using appropriate tests, and data analysis was performed using SPSS software.

Results

The mean age of the patients was 60.7 years, with a male-to-female ratio of 1.4:1. The most common primary cancers were breast (21), lung (17), liver (8), and prostate (4). Key prognostic factors identified included sex (females having a good outcome), number of visceral metastases ≤ 1, hemoglobin, albumin, Karnofsky Performance Status score, pretreatment Klekamp score, and management (surgery).

Conclusion

This study identifies several critical prognostic factors in spinal metastatic disease, including neurological status at presentation, primary tumor type, and treatment modality. These factors should be considered when developing individualized treatment plans for patients with spinal metastatic disease to improve survival and quality of life.

Keywords

histopathology - Klekamp score - prognosis - solid tumor - spinal metastases

Introduction

Spinal metastases are the most common tumors of the spine. They are primarily found as bone metastases and can present with symptoms of spinal canal invasion and cord compression. Within the spinal column, metastasis is most commonly located in the thoracic region, followed by the lumbar region, while the cervical region is the least likely site. The most common primary malignancies that predominantly metastasize to the spine include the following tumors in descending order: breast (21%), lung (19%), prostate (7.5%), renal (5%), gastrointestinal (4.5%), and thyroid (2.5%).[1] Metastatic lesions may cause considerable morbidity, including pain, impaired mobility, pathological fractures, spinal cord and nerve root compression, and metastatic bone marrow infiltration. These lesions decrease the patient's quality of life. Pain is the most common presenting complaint in patients with spinal metastasis. If nerve involvement has occurred, the pain is sharp and shooting in a specific dermatomal distribution. When the tumor has extended inside the spinal canal, motor and sensory weakness may become permanent. The treatment of spinal metastasis depends on the degree of weakness and extension of the deficit. The more severe the deficit is upon presentation, the worse the chances are for recovery. Magnetic resonance imaging (MRI) is the investigation of choice for spinal metastases.[2] The indications for spinal metastases surgery are intractable pain, the onset of neurological deficit, and instability of the spine.[3]

The identification of good prognostic factors can aid clinicians in predicting outcomes, optimizing treatment plans, and counseling patients and their families. Known prognostic factors of spinal metastases are performance status before and after treatment, age, sex, primary neoplasm pathology, and proper treatment selection.[4] In addition to tumor biology and systemic disease burden, the choice of treatment modality—whether surgical decompression and fixation or conservative management with or without radiotherapy—has been shown to significantly influence patient outcomes. That is why, in addition to the characteristics studied in the revised Tokuhashi score,[5] we assessed potential predictive factors such as performance status, presence of organ metastases, laboratory parameters, and ongoing treatment.[6] The Klekamp score, a validated tool for assessing functional outcomes in patients with spinal metastasis, provides a measurable endpoint for determining clinical success.

Objectives

Evaluate the impact of various prognostic factors involved in metastatic spinal disease and compare the early outcome and improvement of quality of life of patients with metastatic spinal disease who will be managed conservatively versus surgically.

Materials and Methods

• Study design: Prospective observational study

• Study duration: 1 year, August 2023 to August 2024

• Study site: A tertiary care center in the state of Rajasthan, India

• Study population: Adult patients (≥ 18 years old) diagnosed with spinal metastasis based on clinical symptoms, radiographic examinations, and/or histopathology

• Sample size: 50

• Follow-up period: 6 months

Inclusion Criteria

• Signs and symptoms of spinal metastasis

• Histologically confirmed cancer diagnosis and radiologically confirmed spinal metastases

• Patients who give consent to participate in the study

Exclusion Criteria

• History of trauma

• Previous spinal surgery

• Patients who have already received radiotherapy in the past

• Patient with other neurological conditions that might cause symptoms similar to those of spinal metastasis

• Nonconsenting and uncooperative patients

Methodology

Data Collection

All patients will be examined before treatment and will be followed up till hospital discharge and for at least 6 months postoperatively by clinical assessment. The information obtained from the medical records included age, gender, primary cancer diagnosis, laboratory parameters, ongoing treatment, and the number of visceral metastases. Performance status will be assessed using the Karnofsky Performance Status (KPS). The MRIs of the entire spine will be performed at our institution or local hospitals using similar protocols. High-resolution computed tomography (CT) chest and contrast-enhanced CT abdomen will be done to diagnose the primary tumor.

The following potential predictive factors for survival will be evaluated:

• Primary cancer site

• Age

• Gender

• Albumin

• Hemoglobin levels

• KPS score

• Number and location of visceral metastases

• Site of metastasis—cervical/thoracic/lumbar

• Type of treatment received

Patients were categorized based on management: surgical (all underwent decompression with fixation) or conservative (medical management with steroids, analgesics, supportive care, with radiotherapy given as per institutional protocol where indicated). The Klekamp and Samii[7] score ([Table 1]) will be used to assess the patient's condition preoperatively and during follow-up at 1 and 6 months. Improvement in the Klekamp score will be used to measure the degree of improvement. Improved scores at 1 and 6 months posttreatment reflect favorable outcomes, whereas declining scores indicate poor outcomes. Patient comorbidities (such as hypertension, diabetes, and other systemic illnesses) were recorded; however, these did not demonstrate a significant impact on clinical outcomes and hence were not included in the final analysis. Patients with prior spinal radiotherapy were excluded, as this group demonstrates distinct biological behavior and treatment response, potentially confounding analysis. Data was collected, analyzed, and submitted for statistical analysis using the Statistical Package for Social Science (SPSS). A p-value will be set to < 0.05 for significant results

Table 1 Klekamp score

Score	Sensory disturbance	Motor weakness	Gait	Sphincter function
5	No symptom	Full power	Normal	Normal
4	Present, not significant	Movement against resistance	Unsteady, no aid	Slight disturbance, no catheter
3	Significant, function not restricted	Movement against gravity	Mobile with aid	Residual, no catheter
2	Some restriction of function	Movement without gravity	Few steps with aid	Rarely incontinent
1	Severe restriction of function	Contraction without movement	Standing with aid	Often catheter
0	Incapacitated function	Plegia	Plegia	Permanent catheter

Results

The mean age of the patient was 60.7 years (age range: 34–73 years). The mean age of male patients was 59.4 years with a standard deviation (SD) of 9.7 years, and that of female patients was 61.9 years with an SD of 9 years. Out of the 50 patients, 29 were males and 21 were females, with a sex ratio of 1.4. The age and gender distribution of patients is shown in [Fig. 1]. The most common primary diagnoses were breast (21), lung (17), liver (8), and prostate (4) cancers ([Fig. 2]). Among the 50 patients, the dorsal (thoracic) spine showed the highest frequency of metastases with 27 patients (54%), followed by the lumbar spine with 19 patients (38%) and the cervical spine with 4 patients (8%). Of the patients with cervical spine metastases, 75% (3 out of 4) had poor outcomes. Conversely, involvement of the lumbar spine was associated with better results; 63.2% (12 out of 19) had a positive clinical outcome. Results for dorsal spine metastases were moderate, with 55.6% (15 out of 27) of patients experiencing excellent outcomes. These findings suggest that while lumbar involvement tends to be more favorable, cervical spine involvement may indicate a worse prognosis, possibly due to the higher risk of spinal cord damage in this region.

Fig. 1 Age and gender distribution.

Fig. 2 Primary tumor type.

In the univariate analysis, a good outcome was associated with sex (females having a good outcome), number of visceral metastases ≤ 1, primary cancer diagnosis (favorable diagnoses: breast and prostate cancer), hemoglobin, albumin, KPS ≥ 70, Klekamp score ≥ 14, and management (surgery) ([Table 1]). Patients with higher hemoglobin and higher albumin levels have better chances of having a good outcome ([Table 2]). Age and site of spinal metastasis were not associated with the outcome of the patient. [Tables 2] and [3] show patient characteristics and the association of different variables with outcome.

Table 2 Association of different variables with outcome among the participants

Variable	Outcome, n (%)		p-Value
	Poor (n = 22)	Good (n = 28)
Age group
<60	5 (33.3)	10 (66.7)	0.320
≥60	17 (48.6)	18 (51.4)
Sex
Male	17 (58.6)	12 (41.4)	0.014
Female	5 (23.8)	16 (76.2)
Number of visceral metastases
0–1	7 (24.1)	22 (75.9)	< 0.001
>1	15 (71.4)	6 (28.6)
Site of spinal metastasis
Cervical	3 (75)	1 (25)	0.376
Dorsal	12 (44.4)	15 (55.6)
Lumbar	7 (36.8)	12 (63.2)
Primary site
Breast	5 (27.8)	13 (72.2)	0.024
Kidney	3 (60.0)	2 (40.0)
Liver	4 (66.7)	2 (33.3)
Lung	8 (80.0)	2 (20.0)
Prostate	1 (11.1)	8 (88.9)
Thyroid	1 (50.0)	1 (50.0)
Management
Conservative	15 (62.5)	9 (37.5)	0.011
Surgery	7 (26.9)	19 (73.1)
Total	22 (44.0)	28 (56.0)

Table 3 Association of mean age, mean hemoglobin, mean albumin, KPS, and pretreatment Klekamp score with outcome among the participants

Variable	Outcome		p-Value
	Poor (n = 22)	Good (n = 28)
Age	60.86 ± 9.96	60.14 ± 9.47	0.795
Hemoglobin	11.68 ± 1.25	12.46 ± 0.86	0.012
Albumin	3.18 ± 0.30	3.61 ± 0.40	< 0.001
KPS score
<70	16 (66.7%)	8 (33.3%)	0.0038
≥70	6 (25.0%)	18 (75.0%)
Pretreatment Klekamp score
<14	14	8	0.028
≥14	8	20

Abbreviation: KPS, Karnofsky Performance Status.

A logistic regression analysis was performed on significant associations to test for predictors of outcome from spinal metastasis. Reference values were taken for categorical variables, and the unadjusted odds ratio (OR) was derived from the test estimates. A good outcome was associated with sex (females having a good outcome), number of visceral metastases ≤ 1, hemoglobin, albumin, KPS score, pretreatment Klekamp score, and management (surgery) ([Table 4]). Of the 50 patients in the study, 26 (52%) underwent surgical management, while 24 (48%) received conservative treatment. Outcomes varied significantly between the groups. Among those who had surgery, 19 (73.1%) had good outcomes and 7 (26.9%) had poor outcomes. Conversely, in the conservatively managed group, 15 patients (62.5%) experienced poor outcomes and only 9 (37.5%) achieved good outcomes. Univariate analysis ([Table 2]) and logistic regression analysis ([Table 4]) confirmed that surgical management was significantly associated with improved clinical outcomes, with an OR of 4.52 (95% confidence interval [CI]: 1.37–14.99, p = 0.013).

Table 4 Predictive factors for the outcome of spinal metastasis

Variable Reference: poor outcome	Unadjusted odds ratio (95% CI)	SE	p-Value
Sex Reference: female	0.22 (0.063–0.767)	0.636	0.017
Visceral metastasis Reference: 1	0.13 (0.036–0.454)	0.649	0.002
Primary site Reference: breast	0.18 (0.045–0.672)	0.65	0.007
Management Reference: conservative	4.52 (1.37–14.99)	0.611	0.013
Hemoglobin	2.51 (1.32–4.89)	0.329	0.005
Albumin	20.72 (3.35–129.26)	0.932	0.001
KPS score	1.05 (1.008–1.083)	0.018	0.017
Pretreatment Klekamp score	4.38 (1.324–14.415)	0.609	0.016

Abbreviations: CI, confidence interval; KPS, Karnofsky Performance Status; SE, standard error.

Discussion

Spinal metastasis poses a significant clinical challenge due to the complex interplay of oncological, neurological, and functional considerations. Understanding prognostic factors is crucial for achieving favorable outcomes and mitigating adverse effects. This study analyzed the prognostic factors for improvement in the Klekamp score in patients with spinal metastases with a known primary tumor. Considering the poor overall survival in patients with spinal metastases, especially with known primaries, we limited follow-up to 6 months to focus on early functional outcomes and quality of life improvements during this high-impact period. Predicting outcome is important when selecting the appropriate treatment schedule in cancer patients.[8] Several previous investigations have analyzed various potential prognostic factors.[6] [8] [9] [10] [11] In a study done by Switlyk et al[6] in Norway, prolonged survival was associated with the primary tumor site (breast, prostate), albumin level (≥ 30 g/L), KPS (good), number of visceral metastases (0–1 locations), and analgesic use (none, nonopioid, analgesics, or weak opioids). Improvement in Klekamp score is known to be associated with the histology of the primary tumor, good performance status, and the absence of visceral metastases.[8] [9] [10] [12] Our results are consistent with the findings in previous reports. The following discussion highlights the relevance of the selected prognostic indicators:

• Age and sex: Younger patients generally show better resilience and functional recovery compared with older individuals. However, our study did not find a significant difference in outcome among different age groups. Our study also revealed that female patients were significantly more likely to have a good outcome compared with males. An OR of 0.22 indicates that males had 78% higher odds of a poor outcome. Additionally, sex-specific differences in tumor biology may influence prognosis.

• Serum albumin and hemoglobin: Hypoalbuminemia and anemia serve as indicators of systemic disease burden and poor nutritional status, correlating with worse outcomes. Higher levels of these markers may suggest better systemic health and a more favorable prognosis. To our knowledge, this factor, although important, has not previously been included in a prognostic score for patients with spinal metastases. A 0.1 unit increase in albumin corresponds to an adjusted OR of approximately 1.39 (95% CI: 1.13–1.71). A 0.1 g/dL increase in serum albumin is linked to a 39% higher chance of a positive outcome. Each unit increase in hemoglobin corresponds to a 2.5-fold increase in the odds of a good outcome. Higher hemoglobin levels likely indicate better physiological reserve, lower tumor burden, and enhanced oxygen-carrying capacity. This underscores the importance of nutritional support and systemic optimization in the care of patients with spinal metastasis.

• Primary tumor site: Univariate analysis showed that tumors with inherently better biological behavior (e.g., breast or prostate cancer) tend to have better outcomes compared with those with aggressive histologies like lung or liver cancer. However, logistic regression analysis showed that patients with breast tumors are significantly less likely to experience a poor outcome. The OR of 0.18 indicates 82% lower odds of poor outcome compared with patients with nonbreast primaries. This may reflect the relative responsiveness of breast cancer to treatment and its slower progression in spinal metastasis. On the other hand, lung tumors were significantly associated with higher odds of poor outcome (OR = 7.43, p = 0.014).

• Visceral metastasis: The presence and number of visceral metastases often indicate advanced disease and a worse prognosis. Patients with ≤ 1 visceral metastasis had a significantly better outcome than those with multiple metastases. An OR of 0.13 implies an 87% reduction in the odds of a poor outcome, indicating that limited systemic disease burden is a strong protective factor.

• Site of spinal metastasis: Although cervical spine involvement was observed in only 4 patients (8%), it was associated with the highest rate of poor outcomes—75% (3 out of 4) had poor recovery. This may be due to the high functional importance of the cervical spinal cord, where even minor compression can lead to severe neurological deficits. In contrast, lumbar spine metastasis, noted in 19 patients (38%), had the best prognosis, with 63.2% (12 out of 19) experiencing good outcomes. The dorsal (thoracic) spine was the most commonly involved region, affecting 27 patients (54%), with 55.6% (15 out of 27) achieving good outcomes. These findings suggest that cervical involvement may be a negative prognostic factor, while lumbar involvement tends to have a more favorable clinical course; however, no statistical significance was observed.

• KPS score: Baseline functional status is a strong predictor of treatment tolerance and recovery potential. Higher pretreatment KPS scores are associated with better posttreatment functional outcomes. We found that patients having a KPS score ≥ 70 were significantly associated with a good outcome (p-value < 0.05). For a 10-point increase in KPS score, the adjusted OR is approximately 1.63 (95% CI: 1.08–2.20). Patients with a 10-point higher KPS score at presentation had 63% higher odds of a good outcome.

• Conservative versus surgical management: The choice of treatment modality depends on factors like spinal stability, neurological status, and patient preferences. Surgical intervention is often indicated for mechanical instability or progressive neurological deficits. Out of 50 patients, 26 (52%) underwent surgical intervention, while 24 (48%) were managed conservatively. Surgical management was significantly associated with a better prognosis. Among the surgical group, 19 patients (73.1%) had good outcomes, compared with only 9 patients (37.5%) in the conservative group. Conversely, 62.5% (15/24) of conservatively treated patients had poor outcomes, compared with only 26.9% (7/26) in the surgical group. The logistic regression analysis revealed that surgery was associated with a 4.5-fold increase in the odds of a good outcome (OR: 4.52, 95% CI: 1.37–14.99, p = 0.013). These results support the role of surgical decompression and fixation in improving functional and neurological outcomes, especially in patients with potentially reversible deficits.

• Neurological status at presentation: The degree of neurological compromise at diagnosis is a crucial factor. Patients presenting with mild deficits or early intervention have a greater likelihood of functional recovery compared with those with severe, prolonged deficits. We found that patients having a Klekamp score ≥ 14 had higher chances of having a good outcome, as seen by improvement in Klekamp score in these patients after treatment. An OR of 4.38 means they were more than four times as likely to achieve a good outcome, likely due to preserved neurological function before intervention.

Although radiological scoring systems such as the Spinal Instability Neoplastic Score (SINS) or Tokuhashi score are valuable for guiding treatment decisions, they were not applied in this study as all surgical patients underwent posterior decompression with fixation. We did not apply these scores, as our study's objective was to evaluate prognostic determinants rather than guide treatment decisions. Radiotherapy was administered to selected conservatively managed patients as per institutional protocol; however, treatment protocols and dose–response relationships were beyond the scope of this study. The findings of this research underscore the importance of a multidimensional approach to the management of spinal metastasis. A better understanding of the prognostic factors can help refine clinical decision-making and improve patient outcomes.

Limitations

This study has a few limitations that should be considered when interpreting the results. The small sample size and single-center design may limit statistical power and generalizability. Follow-up was restricted to 6 months, appropriate for this cohort with limited survival, but longer studies could provide insights into late outcomes. Logistic regression was used without interaction terms or survival models such as Cox regression, as the sample size was insufficient for more complex analyses. All surgical patients underwent decompression with fixation, but treatment protocol details such as radiotherapy dosing were not assessed, since the focus was prognostic factors rather than protocol efficacy. Tumor burden scores such as SINS or Tokuhashi were not included, as they were beyond the study's objective, though future multicenter studies integrating radiological assessments and advanced modeling may improve prognostic accuracy.

Conclusion

The management of cancer patients with spinal metastasis requires an integrated approach, incorporating oncological, nutritional, and functional assessments. This study highlights the significance of prognostic factors such as age, sex, serum albumin, hemoglobin levels, primary tumor site, visceral metastases, site of spinal involvement, KPS score, Klekamp score, and type of management in predicting outcomes. Improved Klekamp scores at 1- and 6-month posttreatment serve as a reliable indicator of favorable prognosis. This underscores the importance of timely and personalized treatment strategies. We need to prioritize early detection and timely initiation of treatments to optimize functional recovery and survival. Although comorbidities were evaluated in our cohort, they were not found to significantly influence outcomes. Nonetheless, systemic factors may contribute to prognosis in larger multicenter cohorts and should be explored further in future studies.

Future research should focus on validating these findings in larger cohorts and exploring the interplay between these factors. Incorporating advanced diagnostic tools and precision medicine approaches could further enhance patient care. A comprehensive and proactive approach remains essential to improving survival and quality of life in this challenging clinical setting.

Conflict of Interest

None declared.

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Publication History

Article published online:
05 December 2025