Radiation Oncology/Palliation/Spinal Cord Compression/Randomized

Spinal Cord Compression Randomized Evidence Steroids Copenhagen -- 96 mg dexamethasone vs. control Randomized. 57 patients with spinal cord compression. Arm 1) high-dose dexamethasone (IV bolus 96mg, then 96 mg x3 days, then 10 day taper) vs. Arm 2) no steroids 1994 8142159 -- "Effect of high-dose dexamethasone in carcinomatous metastatic spinal cord compression treated with radiotherapy: a randomised trial." (Sorensen S, Eur J Cancer. 1994;30A(1):22-7.) Outcome: Gait function dexamethasone 81% vs. control 63%, 6-months later 59% vs. 33%. Median OS no difference Toxicity: Significant side effects 11% Conclusion: High-dose glucocorticoid therapy should be given as adjunct Rotterdam -- bolus 10 mg IV vs. bolus 100 mg IV Randomized. 37 patients with cord compresion. Arm 1) Dexamethasone bolus 10 mg IV vs. Arm 2) dexamethasone bolus 100 mg IV. Both followed by dexamethasone 16 mg daily 1989 2771077 -- "Initial bolus of conventional versus high-dose dexamethasone in metastatic spinal cord compression." (Vecht CJ, Neurology. 1989 Sep;39(9):1255-7.) Outcome: Improved neurologic status: moderate 8% vs. high 25% (NS). Overall no difference in pain, ambulation, or bladder function Conclusion: No difference Comment: Small trial, and clinically significant difference (8% vs. 25%) if real Surgery Bluegrass Neuro-Oncology Consortium (1992-2002) -- Surgery + RT vs. RT alone Randomized. Stopped early after meeting stopping rule. 101 patients, paraplegia <=48 hours. Spinal cord compression from mets (excluded radiosensitive histologies, CNS primary). Decadron 100 mg, then 24 mg Q6. Arm 1) Surgery + RT vs. Arm 2) RT alone. 32 unable to walk (16 vs. 16). RT 30/10, field 8cm wide and one VB above/below lesion. RT started within 14 days post-op, or within 24 hrs of randomization. Endpoint ability to walk. 2008 16112300 -- "Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial." (Patchell RA, Lancet. 2005 Aug 20-26;366(9486):643-8.) Ability to walk: surgery + RT 84% vs. RT alone 57% (SS). Length of response: 122 days vs. 13 days (SS). No improvement: surgery + RT 19% vs. RT alone 62% (SS) If ambulatory: Ability to walk 94% vs. 74% (SS); duration of response 153 days vs. 54 days (SS) If non-ambulatory: Ability to walk 62% vs. 19% (SS); duration of response 59 days vs. 0 days (SS) Cross-over: ambulatory patients treated with RT alone and failed, then treated with surgery: 30% able to walk Continence: surgery + RT 156 days vs. RT alone 17 days (SS); OS 126 days vs. 100 days (SS) Conclusion: Direct decompression + RT better than RT alone, even for patients who are ambulatory RT Dose Italy (1998-2002) -- 16/2 (over 1 week) vs. 15/3 + 15/5 (over 2 weeks) Randomized. 300 patients, short life expectancy (<=6 months), with metastatic spinal cord compression. Dexamethasone 8 mg IV BID, taper after end of RT. Arm 1) Short-course RT (8 Gy x 2 over 7 days) vs Arm 2) Split-course RT (5 Gy x 3, 4 day break, 3 Gy x 5). RT 2 VBs above and below. 2005 15738534 — "Short-Course Versus Split-Course Radiotherapy in Metastatic Spinal Cord Compression: Results of a Phase III, Randomized, Multicenter Trial." (Maranzano E et al. J Clin Oncol. 2005 May 20;23(15):3308-10.) Outcome: Pain relief short 56% vs long 59% (NS), ambulation 68% vs. 71% (NS), bladder function 90% vs. 89% (NS). Median OS 4 months. Recurrence 2%, all in short course Toxicity: Grade 1-2 dysphagia 14%, Grade 1-2 diarrhea 7% Conclusion: Both regimens effective, short-course more convenient for patients