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4 NOMS
45
tumors with low-grade ESCC and no neurologic decits can be treated with SRS and do
not require surgery. A recent large, single-institution study from MSKCC evaluated 657
patients receiving SRS as rst-line therapy,
which was decided using the NOMS criteria
and a multidisciplinary team [26]. Of 811 total
lesions, 665 (82%) were radioresistant histologies, most commonly RCC (170), sarcoma
(113), and NSCLC (102). A total of 28 cases
progressed with mean time to failure of
26months, and interestingly the dose of radiation given, rather than histology, was the most
predictive factor of local failure. The authors
concluded that high-dose, single-session SRS
provided durable long-term control for radioresistant tumors and that lesions irradiated to
higher doses had improved local control. Tumor
control through SRS can be effectively achieved
without the need to reduce tumor volume [27–
29]. Based on the excellent local control pro-
vided by SRS, the Spine Oncology Study Group
(SOSG) recommended for radioresistant tumors
to undergo radiosurgery in the absence of ESCC
with neurologic decit [30].
However, in the case of high-grade ESCC,
by radioresistant tumors, surgical decompression and stabilization followed by radiation often
lead to a better functional outcome. Treatment is
dictated by a landmark prospective randomized
controlled study by Patchell and co-authors [9],
where 101 patients with metastatic spine disease
were randomized to surgery and radiotherapy
versus radiotherapy alone. The study was ended
early due to the superior outcomes in the surgery
group, where those patients had over six times
the odds of ambulating after treatment compared
to the radiation alone group. The surgery group
also saw improved outcomes in days of ambulation and opioid/corticosteroid use. The conclusion of the seminal article was that surgery,
in the form of decompression and stabilization,
improved neurologic outcomes in patients with
spinal metastases. The current recommendations for patients with high-grade MESCC by
the Spine Oncology Study Group (SOSG) are
to undergo surgical decompression followed by
radiation [30].
Furthermore, while SRS provides outstanding
local tumor control, it must be delivered without
injuring the critical structures surrounding the
tumor, such as the spinal cord. Initial experience
with single-fraction SRS showed that a minimal
dose of 15 Gy must be delivered to the entire
tumor volume in order to avoid local recurrences.
However, this cannot be safely done when the
tumor abuts the spinal cord without risking spinal cord toxicity. Due to the high spatial precision of SRS, a separation of 2–3mm between the
tumor and the spinal cord is adequate in order to
provide the necessary safety margin for spinal
SRS.Therefore, in the era of spinal SRS, decompressive surgery is required for patients with
high-grade ESCC in order to provide a separation between the tumor and the spinal cord and to
provide favorable conditions for SRS.
Chemotherapy andImmunotherapy
Novel chemotherapy and immunotherapy options
have signicantly altered the landscape of all cancer treatment. From the perspective of the NOMS
framework and the treatment of spinal metastases, immunotherapy plays an important role in
conjunction with radiation when considering the
oncologic assessment. Here, we briey mention
common examples. For melanoma, cells with
BRAF mutations have a worse prognosis, and
targeted antibody therapy has been developed to
inhibit the proliferation of BRAF-mutated cells.
Cytokine-based therapies such as interferon and
IL-2 and checkpoint blockade therapies that
blunt the immune response have had good success. Common agents include ipilimumab, vemurafenib, dabrafenib, and trametinib, as seen in
melanoma spine metastasis treatment algorithm
[31]. Thyroid cancer has been treated with lenvatinib, an antibody that induces a multi-targeted
tyrosine kinase inhibition, and its broad antitumor
activity has led to promising results [32]. NSCLC
has seen improved outcomes with epidermal
growth factor receptor (EGFR)-targeted agents,
such as erlotinib, getinib, and afatinib. These
targeted agents have shown superior results to
cytotoxic chemotherapy alone [33]. Lastly, cabozantinib is an oral tyrosine kinase inhibitor used
in renal cell carcinoma and has shown improved
46
S. L. Zuckerman et al.
survival benets compared to mTOR inhibitor
everolimus [34]. Historically the response of
osseous metastases to systemic therapy has been
very limited, requiring local therapy with surgery
and/or radiation. However, the new systemic therapies are showing remarkable responses even in
bone, emphasizing the importance of close collaboration between the surgeons, radiation oncologists, and medical oncologists when deciding the
need for surgery or radiotherapy.
Mechanical
Mechanical instability is an independent indication for surgical stabilization. Though radiation is
a powerful means of tumor control, it provides no
structural integrity—unstable fractures cannot be
made stable with radiation. No matter the tumor
histology or radiosensitivity, an unstable spine
requires surgical intervention to provide stability.
Determination of mechanical integrity is a clinical and radiographic decision.
The mainstay of mechanical determination is
the spinal instability neoplastic score (SINS) developed by the Spinal Oncology Study Group (SOSG)
(Table4.2) [36]. The grading scheme uses a combination of clinical and radiographic parameters,
each with varying degrees of severity, to determine
the ultimate stability of the spine. The nal score
allocates the patient into a stable (0–6), unstable
(13–18), or intermediate (7–12) group. More
points are given to junctional lesions compared to
rigid or semirigid areas, as are those with mechanical pain. The quality of the bony lesion—whether
it is lytic, mixed, or blastic—is also weighed and
is best determined by x-ray or CT. The involvement of the posterolateral elements is also factored.
Perhaps the greatest value in the SINS is that it can
be interpreted by many different specialties and
not just surgeons. Where previously the oncologist
may have had to rely on a radiology report alone
to determine stability, the SINS fosters improved
multidisciplinary understanding of spinal stability.
The role of pain in determining spinal stability
warrants further discussion. Three different
categories of pain represent distinct clinical
processes—biologic, neurologic, and mechanical
pain. Biologic pain is unrelated to movement or
Table 4.2 SINS [35]
SINS component Score
Location Junctional (occiput–C2,
Pain Yes 3
Bone lesion Lytic 2
Radiographic spinal
alignment
Vertebral body
collapse
Posterolateral
involvement of
spinal elements
Total score Stable 0–6
C7–T2, T11–L1, L5–
S1)
Mobile spine (C3–C6,
L2–L4)
Semirigid (T3–T10) 1
Rigid (S2–S5) 0
Occasional pain but not
mechanical
Pain-free lesion 0
Mixed (lytic/blastic) 1
Blastic 0
Subluxation/translation
present
De novo deformity
(kyphosis/scoliosis)
Normal alignment 0
>50% collapse 3
<50% collapse 2
No collapse with >50%
body involved
None of the above 0
Bilateral 3
Unilateral 1
None of the above 0
Indeterminate 7–12
Unstable 13–18
3
2
1
4
2
1
axial loading, often constant or worse at night,
and responds to steroids and radiation [25]. The
pathophysiology of biologic pain is secondary to
inammatory mediators secreted by the tumor
that becomes manifest at night or early morning
due to reduced endogenous, nocturnal steroids
levels and can typically be treated with exogenous
steroids and radiation therapy. Neurologic pain is
the result of spinal cord, cauda equina, or nerve
root compression and can present with numbness
or weakness. Mechanical pain is a sign of instability and occurs with axial loading or movement.
One important clinical encounter is the evaluation
of the inpatient with painful spinal metastases.
When taking a history, the patient has been lying
in bed for several days, and it should be no surprise they deny pain at the time of interview.
However, it is imperative to walk each patient and
to observe transitions from sitting to supine and
standing, especially hospital inpatients, and ask
4 NOMS
47
them about their pain when they were at home or
when ambulating; otherwise, an unstable lesion
requiring stabilization may be missed.
Stabilization is principally achieved through
cement augmentation or lateral mass/pedicle
screw xation. While a review of stabilization
techniques is outside the scope of this chapter, a
brief discussion of percutaneous xation is mentioned later. However, it is worth noting which
lesions can be treated with simple cement augmentation, as considerable evidence reports
decreased mechanical pain, improved mobility,
and restoration of anterior column height [37–41].
Kyphoplasty is a percutaneous technique in which
a balloon is inated within the vertebral body, creating space for radiopaque polymethyl methacrylate (PMMA) to be injected into the vertebral body
[37, 42]. Vertebroplasty is a similar percutaneous
procedure without balloon ination, in which
PMMA is injected into the vertebral body under
uoroscopy [43]. The only study to provide Class
I evidence of balloon kyphoplasty compared to
non-operative management for treatment of painful metastatic fractures was the Cancer Patient
Fracture Evaluation (CAFE) study [39]. The randomized, multicenter trial evaluated 65 patients
treated with kyphoplasty compared to 52 treated
non-operatively and found a statistically signicant improvement in pain, activity, analgesic
requirement, and quality of life in the kyphoplasty
group. No signicant changes were found in the
nonsurgical group.
Radiation therapy in patients at risk of
mechanical instability generally fails to provide
symptom relief and leads to adverse events.
Huisman and co-authors [44] investigated how
mechanical back pain due to instability responded
to radiation by matching 38 patients who failed
RT and required re-treatment to 76 control
patients without failure. Their results showed that
the SINS was independently associated with RT
failure (OR 1.3, 95% CI 1.1–1.5 p=0.01), concluding that signicant spinal instability increases
the risk of RT failure independent of related variables. Lam etal. [45] studied 299 spinal metastasis patients without ESCC who received
cEBRT.Spinal adverse events were the primary
outcome and included vertebral fracture, hospitalization for pain, neurologic compromise, or
surgery. Multivariable analysis revealed that
adverse events were signicantly higher in SINS
≥11 (HR 2.5, 95% CI 1.3–4.9, p=0.007).
Systemic
Surgical decision-making must take into consideration overall patient health and prognosis. If a comprehensive assessment is overlooked, unanticipated
morbidity can ensue that could have otherwise
been avoided. The NOMS framework is predicated
on the patient’s ability to tolerate surgery, a decision based on two components: (1) acute preoperative assessment and (2) expected survival.
The acute preoperative assessment is made in
conjunction with the treating oncologists and
anesthesiologist. While survival may be promising, an acute deterioration due to side effects
from chemotherapy can defer surgical intervention. In cachectic and malnourished patient,
nutritional status should also be evaluated. In a
study of 4310 non-cancer patients undergoing
lumbar spinal fusion, hypoalbuminemia was an
independent predictor of wound dehiscence,
infection, and readmission [46]. This same trend
was seen in a study of 161 patients undergoing
surgery for spinal metastases [47]. After multivariable logistic regression, albumin <3.5g/dL
was an independent predictor of death at 1-year
post-surgery.
The expected survival is predicated on tumor
histology, extent of metastatic tumor burden,
medical comorbidities, and overall response to
systemic therapy. Several prognostic scoring systems have been developed including the
Tokuhashi [48] or Tomita [49] scores. However,
in an era of rapidly evolving systemic therapy
and continually changing survival expectations
for cancer patients, their heavy reliance on primary tumor histology to predict survival challenges their relevance. More recently, Pereira
et al. [50] developed and validated a survival
algorithm that placed less weight on primary
tumor histology. Creating a model and scoring
system from 649 patients from two tertiary centers, multivariate cox regression revealed the following factors to be predictive of survival: older
age, poor performance status, primary cancer
48
S. L. Zuckerman et al.
type, more than one spine metastasis, lung/liver
metastasis, brain metastasis, systemic therapy,
higher white blood cell count, and lower hemoglobin. Surgery for spinal metastases provides
palliation of local symptoms and may play a role
even in the setting of expected short survival if
the symptoms are severe.
Surgical Considerations
Separation Surgery
In the era of SRS, the goals of surgery for MESCC
have changed. Since SRS provides reliable tumor
control regardless of tumor volume and histology, extensive cytoreductive surgery is no longer
necessary. As discussed above, the primary goal
of surgery is to provide adequate separation
between the tumor and the spinal cord in order to
safely undergo SRS and to provide spinal column
stability. Separation surgery is a procedure that
separates tumor from the spinal cord to allow
delivery of radiation to the tumor site [12]. The
spinal uid space is reconstituted so that an adequate distance (2–3 mm) is created between
tumor and the spinal cord, and SRS can be initiated safely without fear of periprocedural cord
compression progression or overdosing the spinal cord [51]. Adequate circumferential spinal
cord decompression is vital to the success of the
operation [11, 52]. The decompression is generally achieved with laminectomy, bilateral facetectomy, and pedicle removal, providing access
to the ventral epidural space. Since the majority
of epidural metastatic tumors originate in the vertebral body, sectioning of the posterior longitudinal ligament (PLL) is of paramount importance
in order to access the epidural tumor and to
ensure adequate decompression of the spinal
cord and reconstitution of the thecal sac.
While corpectomies may be performed for the
purpose of anterior column stabilization, standalone posterior constructs have been shown to
provide reliable stabilization with low risk of
instrumentation failure. Amankulor and colleagues [53] reported symptomatic instrumentation failure, dened as reoperation, in a very
low percentage (2.8%) of patients undergoing
separation surgery with posterior segmental
instrumentation only. Anterior column instrumentation was utilized in a small subset of patients
(17.4%) with the most severe forms of anterior
column compromise. In a recent review of MIS
and separation surgery, three studies reported
their experience with separation surgery using an
open approach. The mean local failure rate was
17.1% with a mean time to local recurrence of
13.6 months. The single study that investigated
OS rates found a 78% 1-year survival rate in
patients with systemic therapy post-SRS compared to 56% in patients without systemic therapy
(p = 0.02). Several factors were found to offer
improved control and survival, including a higher
dose of hypofractionated SRS, concomitant systemic treatment, and lower epidural disease grade
[11, 53].
However, newer techniques are evolving.
Perhaps the most notable is the use of laser interstitial thermal therapy (LITT) to provide adequate
separation of tumor from the dura. Tatsui etal. [54]
published an exploratory analysis in 11 patients
undergoing LITT followed by SRS.Intraoperative
MRI guidance was used to place a laser probe into
the involved epidural space, and laser thermal
therapy ablates the offending tumor. MRI changes
are seen as a thermal map to allow real-time monitoring of intensity and spread of heat within the
involved tissue [54]. A second study of 19 patients
with long- term follow-up (range 10–64 weeks)
showed excellent results [55]. Systemic therapy
was continued for all patients with statistically
signicant improvement in pain and function at
3months. LITT can also be done in conjunction
with percutaneous xation, as seen in a second
report of eight patients requiring decompression
and stabilization [56].
Surgical Stabilization
Within the mechanical assessment, the primary
decision point is deciding whether the patient
needs to be stabilized or not. In fact, many forms
of stabilization exist, ranging from cement
augmentation to open instrumented stabilization.
Patients with vertebral compression fractures benet from vertebroplasty or kyphoplasty as
4 NOMS
49
evidenced by the previously cited CAFÉ study. In
instances of fracture extension into the posterior
elements, percutaneous pedicle instrumentation is
required in order to restore stability. In cases of
more extensive fractures, open surgical stabilization may be required. Open and percutaneous
instrumented stabilization provides comparable
pain relief, and stabilization and selection technique is predicated on the preference of the surgeon. However, the risk of wound complications
may be lower after percutaneous stabilization.
Wound complications after open surgery for
MESCC have been reported to range from 12 to
26% of cases [57–59], and prior conventional radiation is perhaps the strongest risk factor for wound
breakdown [59, 60]. On the other hand, decreased
invasiveness can facilitate earlier return to radiation or systemic therapy, and even conventionally
fractionated radiation can be started within 1week
of surgery and sometimes 2–3days [61].
It has been our practice to utilize cement
augmentation of the screws when performing
short- segment stabilization. Adjuvant therapy,
comorbidities, and malnourishment prevent a
biologically favorable environment for a bony
fusion, and the hardware is heavily relied upon
for the remaining years of life. Cement augmen-
tation along the pedicle screw tract can increase
pullout strength [62] and has also been shown to
decrease rates of pseudoarthroses in osteoporotic
patients [63]. Screw pullout or pedicle fracture
can be catastrophic, especially in a short-segment
fusion with adjacent sites of tumor inltration.
From 2011 to 2014, we reported 44 patients who
underwent short-segment cement-augmented
percutaneous spinal xation for unstable tumors.
Pain was markedly decreased without perioperative morbidity, and only two patients required
subsequent decompression [64]. Three other large
studies reported similar positive results [65–67].
One study also reported percutaneous placement
of iliac screws for lumbopelvic instability [68].
Percutaneous screws can also be used in miniopen decompressions or corpectomies [69, 70].
Case Illustrations
Case #1 Fig.4.3
A 62-year-old woman with esophageal adenocarcinoma presented with lower back pain exacerbated by movement. Imaging showed an L3 lytic
metastasis with <50% loss of vertebral body
abd
ce
Fig. 4.3 (a–e) Case 1: L3 metastasis treated with kyphoplasty and radiosurgery
50
ab d
c
Fig. 4.4 (a–d) Case 2: T6 metastasis treated with separation surgery and radiosurgery
S. L. Zuckerman et al.
height (SINS 11) and low-grade epidural tumor
extension (a, b, c). Patient underwent kyphoplasty for stabilization (d) and 24 Gy singlefraction stereotactic radiosurgery treatment (e).
Case #2 Fig.4.4
A 76-year-old woman with squamous cell carcinoma of the lung presented with thoracic back
pain, with an intact neurologic examination.
Imaging showed a T6 metastasis with highgrade compression of the spinal cord (ESCC 3)
(a, b). Patient underwent separation surgery for
decompression of the spinal cord (c) and spinal
stabilization (d). She subsequently underwent
hypofractionated radiotherapy to T5 and T6.
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Spinal Instability inMetastatic
Disease
JoshuaC.Patt andDanielP.Leas
5
Introduction
The vast majority of patients presenting with
metastatic disease of the spine will not require
any intervention. The overall prognosis for these
patients is uniformly poor, and every effort must
be made to understand their burden of disease,
performance status, and life expectancy before
considering intervention. If after a thorough multidisciplinary discussion, it seems reasonable to
consider intervention, the treating physician must
determine if surgery is indicated or not.
The most quoted and evidence-based indication for surgery is based on the Patchell et al.
study which demonstrated a statistically signicant advantage for surgical intervention for
patients with acute loss of ambulatory ability or
impending loss of ambulatory status with epidural
spinal cord compression from non-highly radiosensitive tumors [1]. With a careful understanding
of this article, one will notice that this study was
specically looking at cord compression. With the
average cord terminus at approximately L1, this
study cannot routinely be used to justify interven-
tion in the lumbar spine. Acute neurologic decit
in lumbar spine metastatic disease is less common, and intervention should be considered on an
individual basis. Moreover, this study has several
limitations that are discussed in the chapter entitled “Critical evaluation of the current literature.”
A second major category for intervention in spinal metastatic disease is instability. Spinal instability was classically dened by Panjabi and White
[2] in their landmark study. Their work is helpful
in understanding the basic elements required for
spinal stability, particularly in iatrogenic instability
and trauma. A variety of systems have been developed to better understand stability, and these will be
discussed below. The most recent advance in understanding neoplastic instability comes from the Spinal
instability neoplastic score (SINS) developed by a
multi- institutional working group. We will highlight
a number of historical classication systems and end
on this comprehensive system and its ability to guide
management, particularly in the lumbar spine.
Initial Evaluation
Clinical Evaluation
J. C. Patt, MD, MPH (*)
Levine Cancer Institute, Atrium Health,
Charlotte, NC, USA
e-mail: Joshua.Patt@carolinashealthcare.org
D. P. Leas, MD
Department of Orthopaedic Surgery, Carolinas
Medical Center, Atrium Health, Charlotte, NC, USA
e-mail: Daniel.Leas@carolinashealthcare.org
© Springer International Publishing AG, part of Springer Nature 2018
R. A. W. Marco (ed.), Metastatic Spine Disease, https://doi.org/10.1007/978-3-319-76252-4_5
Clinical instability is classically considered with
one or more of the three key domains: the spinal column (intrinsic), the paraspinal musculature and tendinous attachments (dynamic), and
the central neuromotor control. Dysfunction in
any of these three categories can cause pain and
55