What s New in Radiotherapy For STS of The Extremity? Kaled M. Alektiar, MD, FASTRO Dept of Rad Onc Memorial Sloan Kettering Cancer Center

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1 What s New in Radiotherapy For STS of The Extremity? Kaled M. Alektiar, MD, FASTRO Dept of Rad Onc Memorial Sloan Kettering Cancer Center

2 Topics Predictive tools for risk assessment Reassessment of dose/volume of RT Role of IMRT/IGRT in primary disease Emerging role of SBRT in metastatic STS Biology of STS

3 Predictive Tools For better patients selection Histology specific outcome Site specific morbidity profiles

4 Better Patient Selection: Randomized Trials in Extremity STS Amputation is equivalent to WLE and RT Rosenberg et al (NCI): Ann Surg 1982 WLE + RT provides better LC than WLE alone BRT: Pisters et al (MSKCC); JCO, 1996 EBRT: Yang et al (NCI); JCO, 1998 Pre-op RT vs. Pos-op RT (NCIC): Early vs late complications. O Sullivan et al Lancet 2002

5 Who Needs Adjuvant RT? Two Examples #1 # 2 40 yo s/p WLE of STS of the thigh: 20 cm Positive margin Low grade Well diff liposarcoma 60 yo s/p WLE of STS of the forearm 2cm Negative but close margin High grade Leiomyosarcoma

6 Surgery Alone: Nomogram 684 pts Primary extremity STS Non-metastatic Treated with WLE No adjuvant RT or CT Median F/U: 58 mo 3-yr LR: 11% 5-yr LR: 13% 10 yr LR: 19% Cahlon O et al. Annl of Surg 2012.

7 Nomogram: 3 & 5 year Local Control: Concordance Probability Estimate (CPE): 0.74 Points Age <=50 >50 Size <=5cm >5cm Margin Negative Close or Positive Grade Low High Histology Atypical Lipoma or Well Diff Others Total Points Predicted LR rate at year Predicted LR rate at year

8 Case 1 40 yo s/p WLE of STS of the thigh 20 cm Positive margin Low grade Well diff liposarcoma

9 Points Age <=50 >50 Size <=5cm >5cm Margin Negative Close or Positive Grade Histology Low Atypical Lipoma or Well Diff High Recommend: No RT Others Total Points Predicted LR rate at year Predicted LR rate at year

10 Case 2 60 yo s/p WLE of STS of the forearm 2cm Negative but close margin High grade Leiomyosarcoma

11 Points Age <=50 >50 Size <=5cm >5cm Margin Negative Close or Positive Grade Histology Low Atypical Lipoma or Well Diff High Recommend: RT Others Total Points Predicted LR rate at year Predicted LR rate at year

12 Cumulative incidence of LR Histology-Specific LR UPS Myxofibrosarcoma Synovial Other Liposarcoma

13 The Enigma of Myxofibrosarcoma (MFS) 114 Myxofibrosarcoma 88 Leiomyosarcoma All primary HG p = 0.5 Out of field LR: 47% MFS vs. 8% for LMS, p = 0.04 Repetitive LR: 35% in MFS vs. 0% in LMS, p = 0.05 Mutter R et al. Cancer 2011

14 Impact of Histology on LR in STS Before IMRT 50 Gy 6 wks post-imrt

15 Myxoid Liposarcoma vs. Other Histologies: 691 pts with extremity STS (88 myxoid lipo vs. 603 other) 5-y LC: 97.7% vs. 89.6%, respectively; p = p = p = Chung PW et al. Cancer 2009

16 Question # 1 Which of the following sarcoma histologies is considered radiosensitive? A. Myxofibrosarcoma B. Myxoid chondrosarcoma C. Leiomyosarcoma D. Myxoid liposarcoma

17 Site-Specific Complications 369 pts Primary HG Extremity STS WLE and RT at MSKCC 103 pts Upper Extremity Wound re-op 1% 266 pts Lower Extremity Wound re-op 11% p = Two groups were comparable Size: < vs. 5 cm Prior excision RT type: BRT vs. EBRT Depth: deep vs. superficial Alektiar K et al. IJROBP 2005

18 Subsite-Specific Complications Femoral vessels Femur Sciatic nerve Rimner A et al. Cancer 2008

19 Complications & Thigh Compartment Wound re-op Edema Neuropathy Rimner A et al. Cancer 2008

20 364 lower extremity EBRT and at PMH ( ); no chemo. Females (6% vs 2%, p = 0.02); > 55 yr (7% vs 1%, p = 0.004) Median fracture time: 44 mos (range, 12 to 153 months) Fracture rates: Crude rates 5-yr frequency Overall 6.3 % 4 % High-dose (60-66 Gy) 10 % 7 % Low-dose (50 Gy) 2 % 0.6 % Holt et al. JBJS 2005

21 205 consecutive patients with thigh STS over 15 years ( ) at MSKCC without bone invasion or bone resection 5-year actuarial fracture risk was 29% if resection included periosteum (P = ) Cox regression, entire group: Periosteal excision was the only independent factor Separate Cox model, periosteal stripping subset (n = 54): Female gender: 47% risk (P = 0.022) Chemotherapy: 45% risk (P = 0.020) Lin et al. Cancer 1998

22 56 y/o female with anterior thigh STS, measuring 10 cm, received 66 Gy: What s the risk of fracture?

23 Question # 2 Which site is associated with the highest risk of fracture after radiation in sarcoma? A. Arm B. Thigh C. Forearm D. Leg

24 Dosimetric Predictors of Fracture in Lower Extremity STS Fracture No fracture p Mean Dose 45 8 Gy Gy 0.01 Max. Dose 64 7 Gy 59 8 Gy 0.02 V % 64 22% 0.01 Dickie CI et al IJROBP 2009.

25 RT Volume: Could Be Reduced? Vortex Randomized Trial All 216 pts Stratified by: Margin, grade, and center. No adjuvant chemotherapy 108 Control 50 Gy to CTV1 16 Gy to CTV2 (GTV + 2 cm) 108 Research 66 Gy CTV2 (GTV + 2 cm) CTV 1 = GTV plus 5 cm cranio-caudally and 2 axially Robinson M et al ASTRO 2016

26 Difference in TESS at 2 Years Robinson M et al ASTRO 2016

27 Change in TESS Score Robinson M et al ASTRO 2016

28 Grade 2 Late Toxicity at 2 Years Control Research P Skin 34% 37% 0.7 Subcutaneous 47% 41% 0.3 Bone 11% 15% 0.4 Joint 18% 18% 0.9 Robinson M et al ASTRO 2016

29 Local Control Median F/U: 5 years C: 86% R: 84% Robinson M et al ASTRO 2016

30 Oncologic Outcome: Survival Robinson M et al ASTRO 2016

31 Question # 3 What impact did the volume reduction of the field of RT in the VORTEX randomized trial in extremity sarcoma, have on outcome? A. Higher rate of local recurrence B. No difference in late complications C. Better functional outcome D. Lower risk of distant relapse

32 RT Dose: Is there a need for a boost with positive margin after Pre-op RT? PMH MGH Yami A et al IJROPB, 2010 Pan E et al. J Surg Oncol 2014

33 Question # 4 What is the optimal management for patients with positive microscopic margin whose treatment consisted of preoperative RT to 50 Gy followed by an oncologic resection? A. Observation B. Re-excision C. RT boost D. Chemotherapy

34 Role of IMRT/IGRT Intensity Modulated Radiotherapy (IMRT) Rationales Outcome Volume reduction using conventional RT Image-Guided Radiotherapy

35 Rationales for IMRT in Extremity STS PTV GTV PTV GTV 3-D IMRT % Hong et al Int J Rad Oncol Biol Phys, 2004

36 Proportion Surviving Tumor Control Median Follow-up: 35 months 5-year 95% CI: LC 94% DMFS 62% LC DM OS OS 65% Months Alektiar KM et al. JCO 2008

37 IMRT vs. BRT For Primary HG STS of the Extremity All 134 pts Received RT at MSKCC 1/1/95-12/31/06 63 IMRT 2/02-12/06 50 Gy pre-op (10 pts) 63 Gy post-op (53 pts) 71 BRT 1/95-11/03 45 Gy LDR cgy/day Alektiar KM et al. Cancer 2011

38 Distribution of Variables IMRT BRT p Size (cm) 10 >10 Margin Negative Positive/close 30 (48%) 33 (52%) 32 (51%) 31 (49%) 50(70%) 21 (30%) 57 (80%) 14 (20%) No significant difference based on age, sex, depth, site, and CT

39 Significant Wound Complications: i.e. IV Antibiotics or Re-operation All: 20/134 pts (15%) 5/20 re-operation IMRT: 12/63 (19%) 1/12 re-operation BRT: 8/71 (11%) 4/8 re-operation : p = 0.6

40 Proportion Local Control Local Control and RT Type IMRT = 63 BRT = p = IMRT retained its significance as the only independent predictor of improved LC on multivariate analysis, p = Months Alektiar KM et al. Cancer 2011

41 IMRT vs Conventional EBRT: Median F/U 49 months 320 pts with primary extremity STS WLE and adjuvant RT 165 pts IMRT 155 pts Conventional EBRT Folkert M et al JCO 2014

42 Distribution of Variables EBRT IMRT p High Grade 120 (78%) 21 (87%) 0.05 Positive/close Margin 61 (40%) 85 (52%) 0.04 Pre-op RT 5 (3%) 35 (21%) No significant difference based on age, sex, depth, site, and CT

43 IMRT vs Conventional EBRT: Median F/U: 49 mo IMRT retained its significance as an independent predictor of improved LC: HR 0.45 ((% CI: ); p = 0.02 Folkert M et al JCO 2014

44 Who is Getting RT at MSKCC? Factor/year P > 50 yr 46% 56% 65% <.001 Lower Extremity 76% 72% 75%.6 High Grade 84% 85% 86%.8 Deep 82% 92% 92%.003 > 10cm 30% 37% 43% <.001 +/Close Margins 27% 32% 47% <.001 Histology UPS/MFS 20% 39% 44% <.001 Liposarcoma 42% 21% 27% <.001 Synovial 16% 16% 10%.15 Other 22% 25% 18%.2

45 Question # 5 Based on Memorial Sloan Kettering data, which type of radiation was associated with improved local control in extremity soft tissue sarcoma? A. 3-D radiation B. Interstitial brachytherapy C. IMRT D. Intraoperative radiation

46 LR STS Extremity IMRT: Long Term F/U Median F/U: 69 mo Median F/U alive pts: 91 mo 5-y LR 9% (95% CI: )

47 IMRT For STS Extremity: Large # of pts Median F/U: 4.3 years 5-y LR 6.2 (95% CI: ) 317 pts with primary extremity STS Median F/U: 4.7 years 5 yr LC 6.2% (95% CI: %)

48 Bone Fractures with IMRT G1 G2 G3 G3

49 Femoral Fracture with IMRT: 88 Thigh/groin STS. Median F/U: 67 mo. Crude rate: 6.8 (6/88). Median time to fracture: 23 mo (range 7-88). 5-yr cumulative risk: 8.8% (95% CI: %). Folkert et al. CTOS 2013

50 Observed vs. Expected Femoral Fracture Risk With IMRT PMH femur fracture nomogram was predictive in the IMRT cohort. Crude risk of fracture Observed : 6.8% Expected: 26.4% Postop IMRT to 84% Dose 63 Gy Folkert et al. CTOS 2016

51 PMH Phase II Trial: Wound avoidance # of pts: 59 Med size: 9.5 cm High grade: 93% Deep: 98% Wound comp: 30.5% O Sullivan B et al Cancer 2013

52 IMRT Results: PMH # of pts: 59 Tumor size > 10 cm: 44% High grade: 93% Deep: 98% Median F/U: 49 months Local recurrence: 4/59 (6.8%) 5-year LR-free survival: 88.2% O Sullivan B et al Cancer 2013

53 Immobilization & Set-up Errors # of pts: 31 LE STS Tx: Preop IMRT Inter/intrafractional motion: CBCT & optical loc system CTV PTV expansion: 5 mm Dickie C I et al IJROBP. 2010

54 Immobilization

55 CTV: GTV + 4 cm in long axis Volume Expansion: Preop IMRT CTV: GTV cm in radial axis PTV: CTV plus 1 cm margin in all directions

56 CTV : Tumor bed + 4 cm in long axis Volume Expansion: Postop IMRT CTV: Tumor bed cm in radial axis PTV: CTV plus 1 cm margin in all directions

57 Image-Guided RT (IGRT) Larrier et al. Surg Oncol Clin N Am, 2016

58 IGRT Phase II Trial: RTOG 0630 To determine the effect of reduced RT volume through IGRT on late radiation morbidity at 2 years Late morbidity defined as grade 2 in terms of edema, subcutaneous fibrosis, or joint stiffness.

59 RTOG 0630 Grade 2 n % Fibrosis 3/ Stiffness 2/ Edema 3/ Wang D et al JCO 2015

60 Emerging Role of SBRT in Metastatic STS

61 Chemotherapy for Metastatic STS: EORTC Judson et al. Lancet Oncol 2014

62 Adjuvant Chemotherapy: EORTC Trial 351 pts High risk STS Surgery+/- post-op RT 176 pts No further therapy 175 pts 5 cycles Adriamycin/ifosfamide Woll PJ et al Lancet 2012

63 Adjuvant Chemotherapy: EORTC Trial OS Distant relapse 35% 35% Woll PJ et al Lancet 2012

64 Neoadjuvant Chemotherapy: Italian & Spanish Sarcoma Group Trial 328 pts High risk extremity/trunk 3 cycles of epirubicin+ifosfamide Surgery+/- RT 164 pts No further therapy 164 pts 2 more cycles of CT Gronchi A et al JCO 2012

65 Neoadjuvant Chemotherapy: Italian & Spanish Sarcoma Group Trial OS Distant relapse 33% 32% Gronchi A et al JCO 2012

66 SBRT For Spinal Metastasis in STS Spinal mets: T12 Preop IGRT: 24 Gy Resection: 6 weeks Tumor necrosis: 95% Histology: myxoid lipo.

67 SBRT For Spinal Metastasis 88 pts with spinal metastasis from sarcoma Median F/U: 14.4 mo Leeman J et al J Neurosurgery Spine 2016

68 Hypofractionated vs Single Fraction SBRT For Spinal Metastasis in STS Folket M et al. IJROBP 2014

69 SBRT For Lung Metastasis in STS Frakulli et al Anticancer Research 2015 # of pts # of lesions Dose/fraction 2-y LC Dhakal et al Gy/10 88% Mehta et al Gy/3-4 94% Navarria et al Gy/1-8 96% Frakulli et al Gy/3-8 86% Baumann et al Gy/4-5 86%

70 Classifications of STS Taylor B et al. Nature Rev Ca 2011

71 Molecular Biology of STS

72 Translocations in STS Taylor B et al. Nature Rev Ca 2011

73 Genes Alterations in STS Histology Alteration Involved gene(s) % Synovial t(x;18) (p11;q11) SYT-SSX1, SYT-SSX2 90% DSRCT t(11;22) (p13;q12) EWS-WT1 90% Alveolar RMS t(2;13) PAX3-FKHR 85% Myxoid liposarcoma t(12;16) (q13;p11) TLS (FUS)-CHOP 75% Myxoid chondrosarcoma t(9;22) (q22;q12) EWS-CHN (TEC) 75% Clear cell sarcoma t(12;22) (q13;q12) EWS-ATF1 75%

74 Genomic Landscape of STS TCGA, Cell 2018

75 Genomic Landscape of STS TCGA, Cell 2018

76 Genomic Landscape of STS TCGA, Cell 2018

77 Radiation & Immunotherapy in Extremity STS:

78

79 Type of RT and Time Period: Primary Extremity STS 100% 80% 60% 40% IMRT 3-D BRT 20% 0%

80 Nomogram For RT-associated Femoral Fractures Gortzak Y et al. Cancer 2010

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