Question: In patients with metastatic epidural spinal cord
compression (MESCC), is direct decompressive surgery and radiation therapy
more effective than radiation therapy alone?
Design: Randomized (allocation
concealed)*,
unblinded, controlled trial with a median follow-up of 93 to 102 days.
Information provided by author.
Setting: 7 centers in the United States.
Patients: 101 patients with cancer who were =18 years of age
(median age, 60 y; 70% men) and had magnetic resonance imaging evidence of
MESCC (true displacement of the spinal cord by an epidural mass), =1
neurological sign or symptom (including pain), and were not totally paraplegic
for =48 hours before study entry. Exclusion criteria were compression of
only the cauda equina or spinal roots; multiple discrete compressive lesions;
radiosensitive tumors such as lymphomas, leukemia, multiple myeloma, and
germ-cell tumors; preexisting or concomitant neurological problems not related
to MESCC; previous MESCC; previous spinal radiation precluding receipt of the
study dose; poor medical status precluding surgery; or expected survival of
<3 months. Follow-up was 100%.
Intervention: Patients were allocated to radiation therapy alone (n
= 51) or direct decompressive surgery and radiation therapy (n = 50). At the
time of diagnosis, all patients received pretreatment dexamethasone, unless it
was contraindicated. Steroids were then reduced and continued until the
completion of radiation therapy. Patients in the radiation therapy group
received radiation therapy at a dose of 30 Gy in 10 fractions within 24 hours
after randomization. Treatments were delivered to a port encompassing one
vertebral body above and one below the lesion. Surgery was done within 24
hours after randomization and was tailored for each patient depending on the
level of the spine involved and the patient's circumstances. The aim was to
provide immediate direct circumferential decompression of the spinal cord. If
spinal instability was present, cement, metallic rods, bone-grafting, or other
fixation devices were used to stabilize the spine. Patients in the surgery
group received the same dose of radiation therapy within 14 days after
surgery. All patients received dexamethasone until the end of radiation
therapy.
Main outcome measures: Ability to walk (=2 steps with each foot
unassisted). Secondary outcomes were urinary continence, change in functional
scores (Frankel functional scale scores), and muscle strength (American Spinal
Injury Association motor scores), and use of corticosteroids and opioid
analgesics.
Main results: Analysis was by intention to treat. More patients in
the surgery group than in the radiation therapy group were able to walk after
treatment (Table). Patients in
the surgery group also retained the ability to walk for a longer period than
those in the radiation therapy group (mean, 122 vs 13 d; p = 0.003). Among the
patients who could walk and those who could not walk at study entry, more
patients who received surgery retained or regained the ability to walk after
treatment than those who received radiation therapy alone. Patients who
received surgery had better maintenance of urinary continence, muscle
strength, functional ability, and longer survival time
(Table). The surgery group also
had greater reductions in corticosteroid use (mean dexamethasone dose, 1.6 vs
4.2 mg/d; p = 0.0093) and opioid use (mean morphine dose, 0.4 vs 4.8 mg/d; p =
0.002).
Conclusion: In patients with metastatic epidural spinal cord
compression (MESCC), direct decompressive surgery and radiation therapy was
more effective than radiation therapy alone for improving the ability to
walk.
Sources of funding: National Cancer Institute and National Institute of
Neurological Disorders and Stroke.
While many argue about the role and timing of surgery and radiation therapy
in MESCC, the goals of treatment remain the maintenance and improvement of
function and quality of life in these patients undergoing palliative
therapy.
With the strong biases of the surgical community ultimately proved correct
with the early termination of this study, it is no wonder only 123 patients
were deemed eligible and ultimately only 101 patients were enrolled in this
multicenter trial spanning more than 10 years. Even with the wide variability
of surgical technique (anterior vs posterior decompression alone vs
decompression with stabilization), which was not well described in the study,
there was overwhelming proof that immediate surgery followed by radiation
therapy maximized the ability to walk, continence, and survival time.
The nonsurgical treatment of spinal metastases is best for radiosensitive
tumors in the absence of epidural disease and neurological
dysfunction1,2.
In nonsurgically treated patients, the response rate to
treatment1 and
survival2 is
decreased in the presence of neurological dysfunction. Vertebroplasty and
kyphoplasty have a role in the relief of metastatic back pain in the absence
of epidural
disease3.
The surgical treatment of metastatic spine disease has been associated with
improved quality of life in terms of pain, tiredness, nausea, anxiety,
drowsiness, appetite, and
well-being4. The
cost-effectiveness of providing and maintaining the ability of patients to get
to the bathroom independently, sit for meals with their family, and play with
their grand-children is difficult to quantify. This study clearly sends the
message to both radiation oncologists and spinal surgeons that properly
selected patients with metastatic spinal cord compression benefit maximally
from surgical treatment followed by radiation therapy.
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