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Radiation Oncology: Updates, Innovations & Controversies

(P 310) PREOPERATIVE RADIOTHERAPY WITH HYPERTHERMIA IN RECURRENT AND RADIATION-INDUCED SARCOMAS: RESULTS OF A PHASE 2 CLINICAL TRIAL

Location: The Liffey, Level 1

    Author(s)

  • Piotr L. Rutkowski, MD, PhD

    Head of Department of Soft Tissue/Bone Sarcoma and Melanoma
    Maria Sklodowska-Curie National Research Institute of Oncology, Department of Soft Tissue/Bone Sarcoma and Melanoma, Warsaw Poland
    Warsaw, Mazowieckie, Poland

    • Co-Author(s)

  • Mateusz Jacek Spalek, MD, PhD (he/him/his)

    Associate Professor Deputy Head of Radiotherapy I Department
    Maria Sklodowska-Curie National Research Institute of Oncology, Department of Soft Tissue/Bone Sarcoma and Melanoma, Department of Radiotherapy I, Warsaw Poland
    Warsaw, Mazowieckie, Poland

  • AB

    Aneta Borkowska, MD, PhD

    Maria Sklodowska-Curie National Research Institute of Oncology, Department of Soft Tissue/Bone Sarcoma and Melanoma, Warsaw Poland
    Warsaw, Mazowieckie, Poland

  • MW

    Michal Wagrodzki, MD, PhD

    Maria Sklodowska-Curie National Research Institute of Pathology, Warsaw Poland
    Warsaw, Mazowieckie, Poland

  • PC

    Patricia Castaneda-Wysocka, MD

    Maria Sklodowska-Curie National Research Institute of Oncology, Department of Radiology, Warsaw Poland
    Warsaw, Mazowieckie, Poland

Objective: The role of perioperative treatment in radiation-induced and in-field recurrent sarcomas (RIS/IFRS) is unknown. Re-irradiation may be associated with a risk of significant late toxicity and is therefore rarely used. We hypothesized that the combination of preoperative or definitive 12x 3 Gy radiotherapy (RT) with or without integrated 3.5 Gy to 42 Gy boost combined with twice-weekly regional hyperthermia would not result in significant late toxicity in patients with RIS/IFRS.

Methods: We conducted a prospective, single-arm, phase 2 clinical trial NCT04398095. We enrolled patients with locally advanced or oligometastatic RIS/IFRS. Treatment consisted of three weeks of radiotherapy, four fractions per week, 3 or 3.5 Gy per fraction, combined with regional hyperthermia, followed by surgery or observation. The choice of boost or no-boost regimen was based on resectability as assessed by two oncological surgeons. The procedure would be considered tolerable if significant RT-related late adverse events (grade 3+ CTCAE 5.0) occurred in less than 20% of patients at 18 months after RT. We planned to enroll 20 patients based on Wilson's method for calculating confidence intervals.

Results: We recruited 20 patients. Eight of them had RIS while twelve were diagnosed with IFRS.
Median follow-up was 24 months. Mild or moderate radiation dermatitis was observed in 14 patients. One patient experienced grade 2 gastrointestinal toxicity. Late toxicities included limited limb mobility in two patients (grade 1 and 2), grade 1 skin fibrosis in four patients, and chronic skin ulceration (grade 2) in two patients. None of the patients available for evaluation developed grade 3 or higher late toxicity.
Seven patients who received the no-boost regimen experienced local failure. None of the patients who received the boost regimen developed local progression. Eight patients developed distant metastases. Four patients died.

Conclusion: Our results provide hypothesis-generating data suggesting that preoperative re-irradiation with hyperthermia is a safe treatment for RIS/IFRS. However, the local efficacy without dose escalation is unsatisfactory, suggesting its importance in the design of further clinical trials.