The use of surgery in the elderly. for management of metastatic epidural spinal cord compression

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1 The use of surgery in the elderly Bone Tumor Simulators for management of metastatic epidural spinal cord compression Justin E. Bird, M.D. Assistant Professor Orthopaedic Oncology and Spine Surgery

2 Epidemiology of Spine Metastases Spine = most common site of metastatic disease to bone 5-10% of cancer pts (autopsy up to 70%) breast ca: 22% lung ca: 15% prostate ca: 10% Schaberg & Gainor, Spine % rate of cord compression Approximately 20,000 cases of MESCC in the US

3 **Bilsky et al, J Neurosurg Spine 2010;13: **

4 Presentation Unrelenting back pain Motor weakness or paralysis Bowel or bladder dysfunction Treatment Goals Pain control Durable local tumor control Maintain or improve neurologic function Maintain or obtain spinal stability

5 Treating MESCC Make the diagnosis with imaging/biopsy Then What??? Steroids? XRT? Surgery?

6 Steroids Randomized Controlled Study - 57 pts Radiation ± High dose Dexamethasone Steroids: 81% Ambulatory Post Tx No Steroids: 63% Ambulatory Post Tx Steroid Group: 11% complication Sorenson, Eur. J. Cancer, 1994

7 Steroid Toxicity with prolonged duration of use > 2-3 weeks - 51% complication Infections GI perforations Weissman, J. Neuro-Oncology, 1987 Steroid Dose 28 patients High dose (96 mg) + Radiation 8 side effects, 4 serious, 1 death 38 patients low dose (16 mg) + Radiation no serious side effects Hemidal, J. Neuro-Oncology, 1992

8 Radiation Therapy 71% relief of pain 94% preservation of ambulation 60% improvement in paresis 11% improvement in plegia 44% recovery of sphincter control Maranzano, Int. J. Rad. Onc., pts., with MSCC Prospective Radiation + Steroids

9 Radiosensitivity of Common Mets High Myeloma Lymphoma Moderate Colon Breast Prostate Lung Squamous Cell Low Renal Thyroid Melanoma Sarcoma +/-

10 Surgery Majority of patients with spinal metastasis can be managed non-operatively

11 Surgical Indications 1. Tissue for diagnosis 2. Radioresistant tumors 3. Spinal instability or bony cord compression 4. Deterioration after RT 5. Tumor recurrence 6. Persistent symptomatic disease despite medical treatments 7. Intractable pain

12 Surgical Approach Prospective study - 86 patients 25 Laminectomy 61 Vertebral body resection (VBR) Siegal, Neurosurgery, 1985

13 Surgical Approach Laminectomy Pre-op 8% ambulatory 84% paretic 8% plegic 76% sphincter dysfunction Laminectomy Post-op 39% ambulatory 35% paretic 26% plegic 57% sphincter control 20% neurologic worsening 8% Mortality Siegal, Neurosurgery, 1985

14 Surgical Approach VBR Pre-op 28% ambulatory 51% paretic 21% plegic 49% sphincter dysfunction VBR Post-op 80% ambulatory 18% paretic 2% plegic 93% sphincter control 2% neurologic worsening 7% Mortality Siegal, Neurosurgery, 1985

15 Surgical Approach Laminectomy Post-op 39% ambulatory 35% paretic 26% plegic 57% sphincter control 20% neurologic worsening 8% Mortality VBR Post-op 80% ambulatory 18% paretic 2% plegic 93% sphincter control 2% neurologic worsening 7% Mortality Siegal, Neurosurgery, 1985

16 Laminectomy Circumferential tumor is poor predictor Laminectomy + RT worse results than with RT alone Does not address anterior tumor Introduces more instability

17 Structural Stability Six Column System for stability Less than 3 columns: Stable consider XRT 3-5 columns: unstable surgery 6 columns: requires anterior and posterior reconstruction

18 Outcomes Most series - most important prognostic factor is pretreatment neurological status Mortality from surgery: 6-30% Byrne, NEJM 1992 Clinical trial comparing outcomes of surgery vs nonsurgical treatment???

19 Who should we be operating on? Tokuhashi Y et al Spine 2005;30: N - neurology O oncology (radioresistant?) M mechanical instability S systemic indications Bilksy & Smith; Hematol Oncol Clin North Am 2006; 20(6):

20 Who should we be operating on? Walker MP, Yaszemski MJ, Kim CW, Talac R, Currier BL: Clin Orthop Relat Res 2003;[415S]:S165-S175.)

21 **Patchell study Lancet 2005**

22 **Patchell study Lancet 2005** Randomized Prospective Multi-institutional Non-Blinded XRT (+ high dose steroids) 30 Gy (3 Gy per fraction) Surgery + XRT (+ high dose steroids) Circumferential decompression and stabilization

23 **Patchell study Lancet 2005** Powered for 200 pts Primary endpoint: Ability to walk s/p treatment Median follow-up 102 (s) versus 93 d (xrt) Stopped at interim analysis after 100 pts Percentage of pts who were able to walk after surgery + xrt was significantly higher than the xrt group alone 84% versus 57%

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26 Length of time all study patients remained ambulatory after treatment Median 122 d vs 13 d

27 Length of time patients who were ambulatory at study entry remained ambulatory after treatment Amb pts maintaining ambulation: 94% vs 74% Median LOA: 153d vs 53d

28 32 pts entered study non-ambulatory (16 each group) Surgery + XRT: 10/16 regained ambulation XRT alone: 3/16 62% vs 19% p=0.012

29 10 pts in XRT group crossed over to receive surgery

30 Results cannot be used to justify surgery in all patients with MESCC. Use reasonable clinical judgement. Surgery is an effective treatment for MESCC, but should surgery be the initial treatment? The best treatment for spinal cord compression caused by metastatic disease is surgery as initial treatment followed by radiotherapy. - Patchell et all Lancet 2005

31 First-line therapy is corticosteroids, and radiotherapy is the mainstay of treatment for most patients; however, a recent randomised trial has shown that, for selected patients, the combination of radical surgery and radiation is superior to radiation only. - Cole & Patchell Lancet 2008

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33 Objective To determine effectiveness and adverse effects of radiotherapy, surgery and corticosteroids in MESCC. Selection criteria Randomized controlled trials (RCTs) of radiotherapy, surgery and corticosteroids in adults with MESCC.

34 Radiosensitive histologies were excluded however radio-insensitive histologies were included

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37 Authors conclusions 1) Patients with stable spines retaining the ability to walk may be treated with radiotherapy. 2) There is some evidence of benefit from decompressive surgery in ambulant patients with poor prognostic factors for radiotherapy; and in non-ambulant patients with a single area of compression, paraplegia < 48 hours, nonradiosensitive tumours and a predicted survival of more than three months.

38 People with MESCC are not a homogeneous population Surgery is effective in select patients Patient selection is critical!!!

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40 The Patchell Progression Surgery is beneficial for the treatment of MESCC Select group Radio-insensitive tumor Single site of compression No paraplegia for >48 hours Benefit of surgery is limited to the population <65 years of age

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42 Complication rates increased! Cost increased!

43 Are we over-utilizing surgery???

44 Research Questions What is the utilization of surgery in the >= 65 yo population? Was surgery the first line of treatment or used after failure of XRT? Does hospital volume or hospital type influence the use of surgery for MESCC?

45 Cohort Selection SEER-Medicare TCR-Medicare Inclusion criteria Cancer diagnosis between Myeloma, lymphoma, renal, prostate, lung, breast, colorectal, thyroid Age >= 65 years Alive at cancer diagnosis Diagnosis of secondary malignancy of spine All cases of metastatic spinal cord compression Treated with a surgical decompression or xrt (30 days before and 1 year after a code) Continuously enrolled with Part A & B, but no HMO between cancer diagnosis and 12 months after the MESCC diagnosis, or between cancer diagnosis and death if patients died within 1 year of the MESCC diagnosis Exclusion Primary tumors of spine/spinal cord Age < 65 No treatment delivered (hospice care)

46 Cohort Selection Identifying patients with cancer Cancer Registry Site Identify all cases of metastatic spinal cord compression ICD 9 coding = malignant neoplasm of vertebral column OR = secondary malignant neoplasm of brain and spinal cord AND = unspecified disease of spinal cord (spinal cord compression)

47 Cohort Selection CPT codes for surgery Cervical or thoracic decompression and instrumentation 63020, 63040, 63045, 63081, 63046, 63055, 63085, 63101, 25548, 22554, 22590, 22600, 22556, 22610, 22532, 22840, 22842, 22843, 22845, 22846, 22847, and CPT codes for XRT , 77280, 77285, 77290, 77299, 63620, 63621, G0173, G0174, G0178, G0251, G0338, G0339, and G0340

48 Treatment Surgery Yes or no Primary or secondary intervention? XRT Yes or no Primary or secondary intervention?

49 Potential Related Factors Hospital size Options Number of beds Number of cases of metastatic disease admissions Number of cases of MESCC Institution characteristics Teaching Community

50 Potential Related Factors Cofounding variables Age Sex Comorbidities Socioeconomic status Marital status

51 Outcomes LOS hospital Complications ICD 9 Neuro = ; Pulmonary = 518.5, , , 997.3, 481, 482, 486 ; VTE = , , ; Cardiac = and 410 ; urinary = , ; GI = , 560.1, ; Wound = 998.3, , , 998.6, 998.8, ; UTI = 595.0, 595.9, ; Meningitis = 320, ; Sepsis = 038 ; Decubitis ulcer = Re-operations Mortality Median survival Cost Discharge home versus SNF versus rehab

52 Preliminary Results SEER Medicare Dataset N=1548

53 Time between cancer diagnosis and MESCC diagnosis

54 Treatments delivered

55 Age at MESCC diagnosis

56 Demographics

57 Cancer Site

58 Use of surgery

59 Use of surgery

60 Use of surgery relative to the use of radiation

61 Next steps Evaluate Outcomes: LOS hospital Complications Re-operations Mortality Median survival Cost Discharge home versus SNF versus rehab Evaluate influence of hospital volume on Use of surgery Outcomes Analyze TCR-Medicare dataset

62 Acknowledgments Maria Suarez-Almazor M.D., Research Mentor Ying Xu, Analyst Dr. Elting Ashleigh Guadagnolo, M.D. Jinhai Huo CERCIT #RP140020