Session 5: Isotope therapies and palliative radiotherapy

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1 Session 5: Isotope therapies and palliative radiotherapy Jeffrey Tuan, FRCR Radiation Oncology National Cancer Centre Singapore 15 Dec 2016

2 Bone metastases SREs are clinically important endpoints The burden of bone metastases Pain Disability Hospitalizations Cost Orthopaedic Surgery Radiation to Bone Pathologic Fracture Spinal Cord compression 15/12/ ESMO Prostate Cancer Preceptorship 2

3 RT for management of painful bone mets Goals of palliative Rx: 1. pain relief, 2. preservation of function, 3. maintain skeletal integrity If bone pain limited to single/limited no: local field RT can provide pain relief in ~60-85% If widespread; 1. Radiopharmaceuticals 2. or hemi-body are useful alternatives 15/12/ ESMO Prostate Cancer Preceptorship 3

4 Introduction Morbidity and mortality of bone metastases can be significant due to skeletal-related events 1 Management requires a multidisciplinary approach 2 Radiotherapy should be considered in metastatic prostate cancer patients for the treatment of bone metastases 3 1. Coleman RE Cancer 1997;80: NICE guidelines. Improving outcomes in urological cancer BAUS Metastatic prostate cancer guidelines /12/ ESMO Prostate Cancer Preceptorship 4

5 Pathological Fracture 1,2 Between 10 and 30% of lesions in long bones will develop into a pathological fracture requiring surgical intervention 2 Post operative radiotherapy May reduce risk of disease progression 1 Associated with fewer secondary surgical interventions 1 1. Townsend PW, Smalley SR, Cozard SC et al. Int Radiation Biol Phys 1995;31: Janian NA Cancer 1997;80: /12/ ESMO Prostate Cancer Preceptorship 5

6 Spinal cord compression Radiotherapy is given for spinal compression if surgical decompression is not appropriate or following surgery 1 Wide rage of dosing schedules 2 Patchell et al 3 indicates that radiotherapy following direct surgical decompression is the most effective treatment for spinal cord compression 1. British Association of Surgical Oncology. Eur J Surg Oncol 1999;25: Kwok Y, Regine WF. J Clin Oncol 2005;23: Patchell RA, Tibbs PA, Regine WF et al. Lancet 2005;366: /12/ ESMO Prostate Cancer Preceptorship 6

7 Radiotherapy for pain Radiotherapy is likely to be effective for bone pain from bone metastases 1 Mechanical pain will not be alleviated by radiotherapy 2. E.g.. In spinal instability Mechanical pain is a strong indicator for surgery 1. Janjan NA Cancer 1997;80: Coleman RE. Cancer 1997;80: /12/ ESMO Prostate Cancer Preceptorship 7

8 EBRT RT is effective in partially or completely relieving pain in majority, although transient worsening may occur. Typically first few days after RT, last 1-2 days Surgical fixation mat be indicated to decrease pain and facilitate rehabilitation in symptomatic bone mets/path# in weight bearing bone; prophylactic fixation to prevent path # 15/12/ ESMO Prostate Cancer Preceptorship 8

9 Single dose vs fractionated treatment ASTRO guidelines support single # using a dose of 8Gy; approach more convenient and cost effective; retreatment necessary in 20% of patients in single # (vs 8% in fractionated RT). No evidence of increased acute of late toxicity 15/12/ ESMO Prostate Cancer Preceptorship 9

10 Effectiveness of single 8Gy 3 RCTs Dutch multicenter trial, 1171 patients randomly assigned to 8Gy vs 24Gy/6#. Palliative benefit similar (overall pain relief 72 vs 69%); time to response (median 3 weeks). No difference in toxicity. Retreatment required by sig more patients in single #(25 vs 7%) RTOG 9714, 949 patients (breast, prostate) randomized 8Gy vs 30/10#. Excluded cauda equina/cord compression). No diff in rates for complete and partial relief (overall 66%), use of narcotics, incidence of subsequent path #. Single # 2x more likely to require irradiation (18vs9%) British trial randomly assigned 765 patients painful bone mets (8Gy vs 20/5# vs 30/10#) Median 12 mo fu; no differences in pain end points (78% overall response) no difference in time to response (median <1 mo); single # 2x as likely to require rert, but majority could be treated with single # 15/12/ ESMO Prostate Cancer Preceptorship 10

11 Single # RT dose Single 8Gy more effective than lower dose Multicenter trial 651 pts, randomly assigned 8Gy vs 4Gy as single dose; breast lung prostate; overall response rate higher at 4; 8; 52 weeks with 8Gy (83% vs 71%; 91% vs 83%; 93% vs 82%) retreatment rate significantly lower for 8Gy (14 vs 22%) 15/12/ ESMO Prostate Cancer Preceptorship 11

12 Re-irradiation May be useful option if initial treatment fails to adequately relieve pain or subsequent relapse Meta-analysis; 7 studies; 2694 patients initially treated with RT found re RT subsequently used in 527 (20%), re RT produced some benefit; pain relief in 58% 850 patients; 8Gy vs 20/8#; 521 patients received assigned treatment; no diff in pain response (28 vs32); no stats difference in incidence of path # or spinal cord compression. Acute toxicity higher in 20/8# (LOA, vomit, diarrhea, skin reddening), no diff in patient reported global QoL 15/12/ ESMO Prostate Cancer Preceptorship 12

13 Stereotactic RT Gy, median 20Gy used to treat 393 patients (renal melanoma mets) 69% prior RT. Long term pain improvement 86% (94% RCC 96% melanoma). Long term tumor control achieved in 90% of lesions treated with SRS as primary treatment modality (87 RCC 75 melanoma). Of 32 patients with progressive neurological deficit prior to Rx, 27 (84%) improved clinically 15/12/ ESMO Prostate Cancer Preceptorship 13

14 Rational for bone seeking isotope therapies >90% of patients with advanced prostate cancer have bone mets which can be the cause of debilitating pain Skeletal-related events include spinal cord compression, fracture, need for sx or RT Many patients have relatively little extraosseous disease 15/12/ ESMO Prostate Cancer Preceptorship 14

15 Systemic isotope therapy Technetium-99 Rhenium-186 Type of isotope 15/12/ ESMO Prostate Cancer Preceptorship 15

16 Bone targeted radiopharmaceuticals Radium 223 dicloride Alpha particle emitting agent; mimics Ca++ and forms hydroxyapatite at areas of increased bone turnover Indicated for treatment of CRPC, symptomatic bone mets, no known visceral mets Pre-requisite is presence of uptake on bone scan that correlate with pain 15/12/ ESMO Prostate Cancer Preceptorship 16

17 Original Article Alpha Emitter Radium-223 and Survival in Metastatic Prostate C. Parker, S. Nilsson, D. Heinrich, S.I. Helle, J.M. O'Sullivan, S.D. Fosså, A. Chodacki, P. Wiechno, J. Logue, M. Seke, A. Widmark, D.C. Johannessen, P. Hoskin, D. Bottomley, N.D. James, A. Solberg, I. Syndikus, J. Kliment, S. Wedel, S. Boehmer, M. Dall'Oglio, L. Franzén, R. Coleman, N.J. Vogelzang, C.G. O'Bryan-Tear, K. Staudacher, J. Garcia-Vargas, M. Shan, Ø.S. Bruland, O. Sartor, for the ALSYMPCA Investigators N Engl J Med Volume 369(3): July 18, 2013 Radium 223 increased OS and time to first symptomatic skeletal related event Symptomatic skeletal events defined as 1. EBRT to relieve skeletal symptoms, 2. new symptomatic path #, 3. occurrence of spinal cord compression, 4. tumor related surgical intervention 15/12/ ESMO Prostate Cancer Preceptorship 17

18 ALSYMPCA trial Parker C et al. N Engl J Med 2013;369: CRPC; multiple bone mets; either progressed on docetaxel or not candidates for docetaxel 2 or more bone mets; no visceral mets 921 patients; 2:1 ratio BSC vs 6# radium 223 every 4 weeks BSC included second line hormonal or bisphosphonates ~80% had 6 or > lesions and 40% had 20 or more lesions 15/12/ ESMO Prostate Cancer Preceptorship 18

19 ALSYMPCA trial: Key results Primary endpoint: OS sig prolonged, median 149 vs 11.3 HR %CI ; benefit consistent across all patient subgroups, -/+docetaxel Time to first symptomatic skeletal event sig increased (15.6 vs 9.8 mo HR % CI routine XR not used SSE detected clinically Favorable safety profile; lower freq adverse event compared to placebo, no clinical meaningful differences in G3/4 adverse events Similar efficacy received prior docetaxel or docetaxel naïve; well tolerated irrespective of docetaxel use Better QoL Kaplan-Meier Estimates of Overall Survival and the time to the first symptomatic skeletal event Parker C et al. N Engl J Med 2013;369: /12/ ESMO Prostate Cancer Preceptorship 19

20 Kaplan-Meier Estimates of Overall Survival and the time to the first symptomatic skeletal event Parker C et al. N Engl J Med 2013;369: /12/ ESMO Prostate Cancer Preceptorship 20

21 Main secondary efficacy end points in the intention-to-treat population Parker C et al. N Engl J Med 2013;369: /12/ ESMO Prostate Cancer Preceptorship 21

22 Adverse events that occurred in at least 5% of patients in either study group in the safety population Parker C et al. N Engl J Med 2013;369: /12/ ESMO Prostate Cancer Preceptorship 22

23 Subgroup analysis of hazard ratios for death in the two study groups Parker C et al. N Engl J Med 2013;369: /12/ ESMO Prostate Cancer Preceptorship 23

24 Combination Radium 223 being studied in combination with other agents, role not established Radium 223 combined with Abiraterone and Enzalutamide in 189 patients, multicenter phase IIIb trial No new safety issues, potential benefits need confirmation in prospective trials 15/12/ ESMO Prostate Cancer Preceptorship 24

25 Beta emitting radiopharmaceuticals Strontium 89 Samarium 153 Largest study N=757, treatment of strontium-89 integrated with Docetaxel chemotherapy. No statistical sig difference in OS or clinical progression free survival Myelosuppression is predominant toxicity; more prominent with strontium than samarium 15/12/ ESMO Prostate Cancer Preceptorship 25

26 Strontium-89 Pure b-emitter, t1/2 50 days High uptake in osteoblastic metastases Remains in tumor site for up to 100 days Pain relief in 80%^, 10% pain free Mean response duration 3-6 mo 1. Dafermou A, Colamussi P, Griganti M, Cittanti C, Bestagno M, Piffanelli A. A multicenter observational study if radionuclide therapy in patients with painful bone metastases of prostate cancer. European Journal of Nuclear medicine 2001;28: /12/ ESMO Prostate Cancer Preceptorship 26

27 Strontium-89: Toxicity Significant and prolonged bone marrow toxicity 1 Red blood cell transfusion may be needed 1 Prolonged thrombocytopenia and leucopenia 1 1. Gunawardana D, Lichetenstein HM, Better N et al. Clin Nucl Med 2004;29: /12/ ESMO Prostate Cancer Preceptorship 27

28 Strontium-89 vs External Beam RT Quilty et al 1994 Radioth. Oncol 31; pts with painful bone metastases 3 way randomization Response 200MBq Strontium-89 65% 20Gy/ 5# local EBRT 68% 6Gy x 1# hemi-body EBRT 67% At 12 weeks freedom from new painful metastases was 63.9% for SR-89 (p<0.05) vs. 41.7% after local RT and 51.1% after hemi-body No sig OS difference 15/12/ ESMO Prostate Cancer Preceptorship 28

29 Samarium-153 Reported to provide effective and well-tolerated pain relief for bone metastases from prostate cancer, reducing the need for opioid use 1,2 Improvement in bone pain observed within 1-2 weeks of treatment2 Not widely used 1. Resche I, Chatal JF, Pecking A et al. Eur J Cancer 1997;33: Sator O, Reid RH. Hoskin PJ et al. Urology 2004;63: /12/ ESMO Prostate Cancer Preceptorship 29

30 Summary for Strontium and Samarium For strontium and Samarium, there can be good relief of pain for several months, but there is no evidence of a survival benefit There is mild bone marrow toxicity 15/12/ ESMO Prostate Cancer Preceptorship 30

31 Conclusions RT is a useful low toxicity treatment for bone pain in patients with metastases from prostate cancer Single # EBRT are as effective as longer schedules Systemic bone-seeking isotopes in the past have shown both pain relief and a delay to next skeletal event Radium-223 is a significant advance in isotope treatment, no only causing effective pain relief and delaying further pain, but also prolonging survival 15/12/ ESMO Prostate Cancer Preceptorship 31

32 Thank you New NCCS 4 gantry PTC + 17 RT bunkers Integrated labs 2021 Jeffrey.tuan.k.l@singhealth.com.sg 15/12/ ESMO Prostate Cancer Preceptorship 32

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