Abstract 3206
Background
The management of marginally resectable STS is challenging. The study aim is to assess the efficacy and safety of preoperative hypofractionated RT combined with chemotherapy in primary locally advanced STS.
Methods
Single-arm clinical trial enrolls patients for one cycle of doxorubicin and ifosfamide (AI) chemotherapy followed by 5x5 Gy RT, and 2 cycles of AI in 7-8 weeks gap between RT end and surgery. Tumor response was assessed in DWI-MR imaging and pathologically by EORTC STBSG criteria. The primary endpoint is rate of limb-sparing surgeries and R0 resections.
Results
24 patients(pts) met eligibility criteria: 21 finished the whole planned protocol treatment. 3 pts underwent extremity amputation, two after 1st AI cycle due to poor tolerance, one due to extensive tumor invasion without possibility of vessels reconstruction. One toxic death occurred outside our center related to severe bone marrow suppression with septic shock after 2nd AI cycle. Early tolerance of chemotherapy was acceptable. Grade 3+ CTCAE4.03 toxicity developed in 11pts. AI dose was reduced in 8pts who completed therapy (4pts in 2 cycles; 4pts in 1 cycle). Early RT tolerance was satisfactory. EORTC grade 1 radiation dermatitis developed in 13pts and grade 2 in 2pts. Postoperative wound complications occurred in 6pts, including 2 severe wound dehiscence with hospitalization. Very good pathological response (<1% of stainable tumor cells; grade A/B) was reported in 5pts, good pathological response (<50% tumor cells; grade C/D) - in 12pts.
Conclusions
Preoperative AI chemotherapy combined with hypofractionated RT is a feasible method of the management of marginally resectable STS providing a good pathological responses and acceptable treatment toxicity.
Clinical trial identification
Legal entity responsible for the study
Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.
Funding
Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.
Editorial Acknowledgement
Disclosure
T. Switaj: Honoraria for lectures: Novartis, Roche, MSD, BMS. A.M. Czarnecka: Honoraria for lectures: Novartis, MSD, BMS. P.L. Rutkowski: Honoraria: Bristol-Myers Squibb, Roche, Novartis, Merck, Sharp & Dohme, GlaxoSmithKline; Paid consulting role: Bristol-Myers Squibb, Roche, Merck, Sharp & Dohme, Blueprint Medicines, Amgen; Speakers’ bureau: Novartis, Pfizer, Merck, Sharp & Dohme; Institutional research funding: Bristol-Myers Squibb, Novartis; Travel expenses: Novartis. All other authors have declared no conflicts of interest.
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