Sarcoma Studies

NCI (Rosenberg 82, Potter 86)

Eligibility

  • Prospective Randomized Trial
  • Amputation vs. limb sparing + XRT
  • High-grade soft-tissue sarcomas of extremities

Treatment

  • 50 Gy to entire anatomic area at risk.
  • boost to 60-70 Gy.

Results

~ # pts. 5-LC 5-OS 5-DFS
NCI (Rosenberg 82 Potter 86) 16 pts Amputation 100% 88 78
27 pts WLE + 50Gy + 10Gy boost to tumor bed 90% 83 71

Conclusions

  • No difference in amputation vs. LS + XRT in DFS or AS
  • Increased size of tumor predicted poor outcome (DFS, AS) did not affect + LC

NCI Potter 1986 – Within limb sparing trial

  • randomized to receive chemotherapy or observation
  • chemotherapy: doxorubicin, cyclophosphamide, high-dose methotrexate.
Chemotherapy # pts. 3-DFS 3-OS
Dox/cyclo Mtx 37 92% 95%
observation 28 60% 94%
p-value 65 < 0.01 0.04
  • Adria based chemotherapy improves 3-OS

NCI (Yang, JCO 1998)

Eligibility

  • 140 patients with extremity sarcoma

Treatment

  • WLE +/- EBRT
  • RT: 45 Gy boost to 63 Gy.
  • Low-grade had chemo radomization as well

Low-Grade Results

Groups # pts. 10-Local Failure 10-OS
Post-op RT 26 4% ~ 80%
No RT 24 31% ~ 80%
p-value 50 < 0.01 N.S.

High-Grade Results

Groups # pts. 10-Local Failure 10-DFS 10-OS
Post-op RT+Chemo 47 0% ~ 75% 75%
No RT + chemo 44 22% ~ 75 74%
p-value 91 < 0.01 N.S. N.S.

Conclusion

  • RT improve local control for both low-grade and high-grade soft-tissue extremity sarcoma
  • RT does not impact OS.

MSKCC (Pisters JCO 96)[2]

  • Extremity and superficial trunk sarcoma

Treatment

  • WLE randomized to brachytherapy vs observation
  • brachytherapy to tumor + 2 cm

Brachtherapy Technique

  • Afterloading catheters 1 cm apart
  • The catheters were sutured to the skin at the catheter exit site with buttons and nonabsorbable sutures.
  • drain over the tumor bed
  • wound was closed in layers.
  • 42 to 45 Gy over 4 to 6 days with iridium 192.
  • loaded no sooner than the 6th postoperative day.
  • No special effort was made to treat the surgical scar, the drain site, or the wide margins that are typically

included in an external-beam radiation plan.

Overall Results

Groups # of patients 5-Freedome from local recurrence disease specific survival
brachytherapy 86 82% 84%
observation 74 69% 81%
p-value 164 .04 N.S.

High-grade Lesion Results

Groups # of patients 5-Freedome from local recurrence disease specific survival
brachytherapy 63 89% 80%
observation 56 66% 80%
p-value 119 <.01 N.S.

Low-grade Lesion Results

Groups # of patients 5-Freedome from local recurrence
brachytherapy 23 74%
observation 22 64%
p-value 45 N.S.
  • DFS not significantly different in any of the groups
  • overall local control benefit primary due to the high-grade lesions

Princess Margaret Hospital (O'Sullivan)[1]

  • Pre-op vs. Post-op Trial
  • 190 Patients

Treatment

  • 50 Gy Pre-op RT + WLE vs WLE + 66-70 Gy Post-op RT
  • 50 Gy to 5 cm proximal and distal to tumor bed
  • 16-20 Gy boost in post-op arm
  • 2 Gy per fraction
Groups 5-Local Control 5-cause specific survival 5-OS
pre-op RT 93% 78% 73%
post-op RT 92% 73% 67%

Conclusion

  • Wound complications were 2 x more with pre-op RT (35% vs 17%)
  • Greater fibrosis with post-op RT.
  • early improvement in OS was not substantiated at 5-years
  • only resection margins significant for local control
  • tumor size and grade significat for metastatic relapse, OS, and cause-specific survival
  • Grade predictor of recurence-free survival
Bibliography
1. O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. PMID: 12103287
2. Pisters PW, Harrison LB, Leung DH, Woodruff JM, Casper ES, Brennan MF. Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma. J Clin Oncol. 1996 Mar;14(3):859-68. PMID: 8622034
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