title: Thromboembolic Events Associated with Thalidomide and Multimodality Therapy for Soft Tissue Sarcomas: Results of RTOG 0330.
abstract: 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.
authors.affiliation: Department of Surgical Oncology, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Kane
authors.forename: J
authors.initials: J
authors.lastname: Harris
authors.forename: W G
authors.initials: WG
authors.lastname: Kraybill
authors.forename: D C
authors.initials: DC
authors.lastname: Harmon
authors.forename: D S
authors.initials: DS
authors.lastname: Ettinger
authors.forename: D R
authors.initials: DR
authors.lastname: Lucas
authors.forename: T F
authors.initials: TF
authors.lastname: Delaney
authors.forename: D
authors.initials: D
authors.lastname: Wang
authors.forename: W J
authors.initials: WJ
authors.lastname: Curran
authors.forename: B L
authors.initials: BL
authors.lastname: Eisenberg