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Long-term follow-up of a prospective trial of pre-operative external-beam radiation and post-operative brachytherapy for retroperitoneal sarcoma. LA Mikula, PF Ridgway, CN Catton, JJ Jones, B O’Sullivan, MA Ko, CJ Swallow University of Toronto

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slide1

Long-term follow-up of a prospective trial of pre-operativeexternal-beam radiationand post-operative brachytherapyfor retroperitoneal sarcoma

LA Mikula, PF Ridgway, CN Catton,

JJ Jones, B O’Sullivan, MA Ko,

CJ Swallow

University of Toronto

Mount Sinai Hospital & Princess Margaret Hospital

Toronto, Canada

retroperitoneal sarcoma princess margaret hospital n 45 resected patients 1975 1988
Retroperitoneal SarcomaPrincess Margaret Hospitaln=45 resected patients, 1975-1988

OS

Local Relapse-Free Survival

Distant relapse-Free Survival

Catton, O’Sullivan et al, Int J Rad Oncol Biol Phys 1994; 29:1005.

treatment schema
Treatment Schema
  • Patients with RPS referred to Princess Margaret Hospital, Toronto, June 1996-April 2003
  • Inclusion criteria: resectable disease & no mestastases; signed informed consent

Pre-operative XRT: 45 Gy/5 weeks

4-6 weeks

Surgery

Post-operative brachytherapy (BT):

25 Gy (0.5Gy/hr, depth 0.5cm)

slide6

RPS

n=83

incurable

n=12

refused

therapy n=2

trial

recent

resection

n=14

n=55

mets

n=5

resection

pre-op death

n=4

n=46

BT

n=2

pre-op XRT

n=40

no RT

n=2

BT and post-op

XRT n=2

+ BT

n=19

- BT

n=21

XRT = external beam radiation therapy

BT = post-operative brachytherapy

Jones et al, Ann Surg Onc 2002,9,346

pre operative external beam radiation
Pre-operative External Beam Radiation
  • Conformal planning using 3D techniques
  • Shielding of contralateral kidney; liver
post operative brachytherapy
Post-operative Brachytherapy
  • Single plane of 3-8 afterloading BT catheters placed on the surgical bed with 1cm spacing
  • Planar implant dose of 0.5 Gy/hr, depth 0.5cm
  • Afterloading iridium-192 pulsed dose rate BT unit
  • BT initiated once GI function returned (7-14 days post-op)
outcomes follow up
Outcomes & Follow-up
  • Follow-up: clinic visit + CT scan every 6 months x5 years, then anually
    • Minimum follow-up 48 months
  • Outcomes:
    • Survival
    • Disease recurrence
    • Toxicity: Radiation Therapy Oncology Group scores
      • Pre-operative toxicity
      • Acute post-operative toxicity (within 3 months)
      • Late toxicity (3 months to 1 year post-op)

Jones et al, Ann Surg Onc 2002,9,346

pre operative toxicity 40 patients treated with pre op xrt
Pre-Operative Toxicity:40 patients treated with pre-op XRT
  • All patients had a maximum RTOG score of ≤ 2
  • Acute toxicity scores related to upper and lower GI symptoms …
    • … except for one patient who developed cystitis

Jones et al, Ann Surg Onc 2002,9,346

acute post operative toxicity 46 resected patients
Acute Post-operative Toxicity:46 resected patients

4

life-

threatening

0

none

1

mild

2

medical

therapy

3

hospital

admission

5

death

n=

15 8 5 11 6 1

4/6 had BT

Hepatic failure

Jones et al, Ann Surg Onc 2002,9,346

modified late toxicity 3 12 months post op
Modified Late Toxicity(3-12 months post-op)

0

none

1

mild

2

medical

therapy

5

death

3

hospital

admission

4

life-

threatening

36 1 1 1 1 2

n=

2 late complications

of duodenal perforation

6/6 had BT

Jones et al, Ann Surg Onc 2002,9,346

clinicopathologic features pre op xrt surgery
Clinicopathologic Features:Pre-op XRT + Surgery
  • N=40
  • Male 15, female 25
  • Median age 58 yrs (range 41-75)
  • Primary presentation of RPS = 29 (72%)
  • Referred with recurrent disease = 11 (28%)
  • Tumour characteristics:
    • Median size 19cm (range 4-40cm)
    • 55% high grade
    • 70% liposarcoma
treatment characteristics
Treatment Characteristics
  • Patients who completed pre-op XRT & surgery:
    • Median pre-op XRT dose = 45 Gy (range 45-57 Gy)
    • Median BT dose = 23 Gy (range 7.5-25 Gy)
    • All resections were grossly complete
    • 97% had resection of contiguous structures
    • No patients received adjunctive chemotherapy
status at last follow up
Status at Last Follow-Up
  • Median follow-up 89 months (7.4 years)
  • No patients lost to follow-up
  • 4 patients recurred and were re-resected
  • At last follow-up:
    • 25 alive and disease-free (62.5%)
    • 3 alive with recurrent disease (7.5%)
    • 9 dead of disease (22.5%)
    • 3 dead of other causes (7.5%)
slide18

Overall Survival (n=40)

5yr OS 10yr OS 75% 63%

median OS not reached at median 89 mos. f/u

(months)

slide19

Recurrence-Free Survival (n=40)

5yr RFS 10yr RFS 69% 52%

median RFS ≈ 120 mos. median 89 mnths f/u

slide20

OS BT (n=19) vs no BT (n=21)

5yr OS 10yr OS

80% 80%

Log Rank: p=0.27

5yr OS 10yr OS

68% 54%

Median not reached

median OS not reached

slide21

RFS BT (n=19) vs no BT (n=21)

5yr RFS: 75% 10yr RFS:--

5yr RFS 10yr RFS 61% 47%

Log Rank: p=0.58

No BT: median RFS not reached

BT: median RFS ≈ 106 mnths

slide22

OS in High-Grade Tumours (n=22)

5yr RFS 10yr RFS 68% ---

Log Rank: p=0.68

No BT, n=10

BT, n=12

5yr RFS 10yr RFS 58% 47%

No BT: median OS not reached

BT: median OS ≈ 116 mnths

historical vs current data
Historical vs. Current Data

OS

Local Relapse-Free Survival

Catton, O’Sullivan et al, Int J Rad Oncol Biol Phys 1994; 29:1005.

conclusions
Conclusions
  • Pre-operative XRT was well tolerated
  • Brachytherapy to the upper abdomen was associated with significant toxicity
  • Pre-operative XRT and aggressive surgical resection shows promise in improving local control and long-term survival in RPS
intent to treat analysis
Intent-to-treat Analysis
  • For all 55 patients entered into the trial: 2-year OS 73%
  • For 46 patients resected with curative intent: 2-year OS 88%