Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression

Ito, Kei; Sugita, Shurei; Nakajima, Yoshiyuki; Furuya, T.; Ogawa, Hiroomi; Hayakawa, S.; Hozumi, Takeshi; Saito, Makoto; Kiura, Katsuyuki

doi:10.1016/j.ijrobp.2021.07.1690

Cited by 24 publications

(11 citation statements)

References 32 publications

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“…Surgery in conjunction with postoperative radiation is an established treatment paradigm that decreases neurological morbidity and improves LC compared with radiation alone. 1,2,9,[11][12][13][14][15][16] Currently, preoperative embolization of spine metastases is considered a surgical adjunct to mitigate blood loss in spine metastases from hypervascular primary malignancies. However, recent multivariate analysis elucidated an association between preoperative spinal embolization and enhanced LC in patients treated with surgical decompression and adjuvant SBRT.…”

Section: Discussionmentioning

confidence: 99%

Neoadjuvant Arterial Embolization of Spine Metastases Associated With Improved Local Control in Patients Receiving Surgical Decompression and Stereotactic Body Radiotherapy

et al. 2023

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BACKGROUND: Spine metastases often cause significant pain, instability, and/or neurological morbidity. Local control (LC) of spine metastases has been augmented with advances in systemic therapies, radiation, and surgical technique. Prior reports suggest an association between preoperative arterial embolization and improved LC and palliative pain control. OBJECTIVE: To further elucidate the role of neoadjuvant embolization on LC of spine metastases and the potential for improved pain control in patients receiving surgery and stereotactic body radiotherapy (SBRT). METHOD: A retrospective single-center review between 2012 and 2020 identified 117 patients with spinal metastases from various solid tumor malignancies managed with surgery and adjuvant SBRT with or without preoperative spinal arterial embolization. Demographic information, radiographic studies, treatment characteristics, Karnofsky Performance Score, Defensive Veterans Pain Rating Scale, and mean daily doses of analgesic medications were reviewed. LC was assessed using magnetic resonance imaging obtained at a median 3-month interval and defined as progression at the surgically treated vertebral level. RESULTS: Of 117 patients, 47 (40.2%) underwent preoperative embolization, followed by surgery and SBRT and 70 (59.8%) underwent surgery and SBRT alone. Within the embolization cohort, the median LC was 14.2 months compared with 6.3 months among the nonembolization cohort (P = .0434). Receiver operating characteristic analysis suggests ≥82.5% embolization predicted significantly improved LC (area under the curve = 0.808; P < .0001). Defensive Veterans Pain Rating Scale mean and maximum scores significantly decreased immediately after embolization (P < .001). CONCLUSION: Preoperative embolization was associated with improved LC and pain control suggesting a novel role for its use. Additional prospective study is warranted.

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Section: Discussionmentioning

confidence: 99%

Neoadjuvant Arterial Embolization of Spine Metastases Associated With Improved Local Control in Patients Receiving Surgical Decompression and Stereotactic Body Radiotherapy

et al. 2023

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“…When interpreting the results of the present study, these limitations need to be considered. Moreover, these results of this study cannot be generalized to the comparably novel approach of separation surgery followed by stereotactic body radiation therapy [ 18 , 19 , 20 ]. Separation surgery includes epidural decompression and spinal stabilization without gross total or en bloc-resection of the metastasis [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

“…The cumulative local progression rate at 1 year was 16.4%. Moreover, in a recent phase 2 trial of 33 patients receiving separation surgery plus SBRT with 2 × 12 Gy, the local failure rate at 12 months was 13% [ 20 ]. These rates were higher than the 12-month rate of freedom from an in-field recurrence and lower than the 12-month rate of local progression-free survival observed in the surgery plus radiotherapy group of present study.…”

Section: Discussionmentioning

confidence: 99%

Radiotherapy with or without Decompressive Surgery for Metastatic Spinal Cord Compression: A Retrospective Matched-Pair Study Including Data from Prospectively Evaluated Patients

Rades

Küchler

Graumüller

et al. 2022

Cancers

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In 2005, a randomized trial showed that addition of surgery to radiotherapy improved outcomes in patients with metastatic spinal cord compression (MSCC). Since then, only a few studies compared radiotherapy plus surgery to radiotherapy alone. We performed a retrospective matched-pair study including data from prospective cohorts treated after 2005. Seventy-nine patients receiving radiotherapy alone were matched to 79 patients assigned to surgery plus radiotherapy (propensity score method) for age, gender, performance score, tumor type, affected vertebrae, other bone or visceral metastases, interval tumor diagnosis to MSCC, time developing motor deficits, and ambulatory status. Improvement of motor function by ≥1 Frankel grade occurred more often after surgery plus radiotherapy (39.2% vs. 21.5%, p = 0.015). No significant differences were found for post-treatment ambulatory rates (59.5% vs. 67.1%, p = 0.32), local progression-free survival (p = 0.47), overall survival (p = 0.51), and freedom from in-field recurrence of MSCC (90.1% vs. 76.2% at 12 months, p = 0.58). Ten patients (12.7%) died within 30 days following radiotherapy alone and 12 patients (15.2%) died within 30 days following surgery (p = 0.65); 36.7% of surgically treated patients did not complete radiotherapy as planned. Surgery led to significant early improvement of motor function and non-significantly better long-term control. Patients scheduled for surgery must be carefully selected considering potential benefits and risk of perioperative complications.

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“…Additionally, stereotactic body radiation therapy has become a fundamental tool for the treatment of spine metastasis that provided good local control, especially in radioresistant tumor [ 23 , 24 ]. The separation surgery followed by stereotactic radiation therapy was effective in decompression and long-term local control [ 25 ]. Compared with conventional radiotherapy, stereotactic body radiotherapy at a dose of 24 Gy in 2 daily fractions was superior to conventional external beam radiotherapy at a dose of 20 Gy in 5 daily fractions in improving the complete response rate for pain [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

Cost-Utility Analysis Compared Between Radiotherapy Alone and Combined Surgery and Radiotherapy for Symptomatic Spinal Metastases in Thailand

et al. 2022

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Objective: To investigate the patient quality of life and cost-utility compared between radiotherapy alone and combined surgery and radiotherapy for spinal metastasis (SM) in Thailand.Methods: Patients with SM with an indication for surgery during 2018–2020 were prospectively recruited. Patients were assigned to either the combination surgery and radiotherapy group or the radiotherapy alone group. Quality of life was assessed by EuroQol-5D-5L (EQ-5D-5L) questionnaire, and relevant healthcare costs were collected pretreatment, and at 3-month and 6-month posttreatment. Total lifetime cost and quality-adjusted life-years (QALYs) were estimated for each group.Results: Twenty-four SM patients (18 females, 6 males) were included. Of those, 12 patients underwent combination treatment, and 12 underwent radiotherapy alone. At 6-month posttreatment, 10 patients in the surgery group, and 11 patients in the nonsurgery group remained alive for a survival rate of 83.3% and 91.7%, retrospectively. At 6-month posttreatment, the mean utility in the combination treatment group was significantly better than in the radiotherapy alone group (0.804 ± 0.264 vs. 0.518 ± 0.282, respectively; p = 0.011). Total lifetime costs were 59,863.14 United States dollar (USD) in the combination treatment group and 24,526.97 USD in the radiation-only group. The incremental cost-effectiveness ratio using 6-month follow-up data was 57,074.01 USD per QALY gained.Conclusion: Surgical treatment combined with radiotherapy to treat SM significantly improved patient quality of life compared to radiotherapy alone during the 6-month posttreatment period. However, combination treatment was found not to be cost-effective compared to radiotherapy alone for SM at the Thailand willingness-to-pay threshold of 5,113 USD/QALY.

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Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression

Cited by 24 publications

References 32 publications

Neoadjuvant Arterial Embolization of Spine Metastases Associated With Improved Local Control in Patients Receiving Surgical Decompression and Stereotactic Body Radiotherapy

Neoadjuvant Arterial Embolization of Spine Metastases Associated With Improved Local Control in Patients Receiving Surgical Decompression and Stereotactic Body Radiotherapy

Radiotherapy with or without Decompressive Surgery for Metastatic Spinal Cord Compression: A Retrospective Matched-Pair Study Including Data from Prospectively Evaluated Patients

Cost-Utility Analysis Compared Between Radiotherapy Alone and Combined Surgery and Radiotherapy for Symptomatic Spinal Metastases in Thailand

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