Thromboembolic Events Associated with Thalidomide and Multimodality Therapy for Soft Tissue Sarcomas : Results of RTOG 0330

Abstract EN

Introduction.

RTOG 0330 was developed to address the toxicity of RTOG 9514 and to add thalidomide (THAL) to MAID chemoradiation for intermediate/high grade soft tissue sarcomas (STSs) and to preoperative radiation (XRT) for low-grade STS.

Methods.

Primary/locally recurrent extremity/trunk STS: ≥8 cm, intermediate/high grade (cohort A): >5 cm, low grade (cohort B).

Cohort A: 3 cycles of neoadjuvant MAID, 2 cycles of interdigitated THAL (200 mg/day)/concurrent 22 Gy XRT, resection, 12 months of adjuvant THAL.

Cohort B: neoadjuvant THAL/concurrent 50 Gy XRT, resection, 6 months of adjuvant THAL.

Planned accrual 44 patients.

Results.

22 primary STS patients (cohort A/B 15/7).

Cohort A/B: median age of 49/47 years; median tumor size 12.8/10 cm.

100% preoperative THAL/XRT and surgical resection.

Three cycles of MAID were delivered in 93% cohort A.

Positive margins: 27% cohort A/29% cohort B.

Adjuvant THAL: 60% cohort A/57% cohort B.

Grade 3/4 venous thromboembolic (VTE) events: 40% cohort A (1 catheter thrombus and 5 DVT or PE) versus 0% cohort B.

RTOG 0330 closed early due to cohort A VTE risk and cohort B poor accrual.

Conclusion.

Neoadjuvant MAID with THAL/XRT was associated with increased VTE events not seen with THAL/XRT alone or in RTOG 9514 with neoadjuvant MAID/XRT.