Carole Mercier1, Michaël Claessens2, Andy Buys MSc3, Sergii Gryshkevych4, Charlotte Billiet2, Ines Joye2, Steven Van Laere3, Peter Vermeulen3, Paul Meijnders2, Fredrik Löfman4, Philip Poortmans5, Luc Dirix6, Dirk Verellen2, Piet Dirix2. 1. Department of Radiation Oncology, Iridium Netwerk, Wilrijk (Antwerp), Belgium; Translational Cancer Research Unit (TCRU), Center for Oncological Research (CORE), University of Antwerp, Edegem (Antwerp), Belgium. Electronic address: carole.mercier@gza.be. 2. Department of Radiation Oncology, Iridium Netwerk, Wilrijk (Antwerp), Belgium; Translational Cancer Research Unit (TCRU), Center for Oncological Research (CORE), University of Antwerp, Edegem (Antwerp), Belgium. 3. Translational Cancer Research Unit (TCRU), Center for Oncological Research (CORE), University of Antwerp, Edegem (Antwerp), Belgium. 4. Department of Machine Learning, RaySearch Laboratories AB, Stockholm, Sweden. 5. Department of Radiation Oncology, Iridium Netwerk, Wilrijk (Antwerp), Belgium. 6. Translational Cancer Research Unit (TCRU), Center for Oncological Research (CORE), University of Antwerp, Edegem (Antwerp), Belgium; Department of Medical Oncology, GZA Sint-Augustinus, Wilrijk (Antwerp), Belgium.
Abstract
PURPOSE: Increasing evidence suggests that patients with a limited number of metastases benefit from SABR to all lesions. However, the optimal dose and fractionation remain unknown. This is particularly true for bone and lymph node metastases. Therefore, a prospective, single-center, dose-escalation trial was initiated. METHODS: Dose-Escalation trial of STereotactic ablative body RadiOtherapY for non-spine bone and lymph node metastases (DESTROY) was an open-label phase 1 trial evaluating SABR to nonspine bone and lymph node lesions in patients with up to 3 metastases. Patients with European Cooperative Oncology Group performance status ≤1, an estimated life expectancy of at least 6 months, and histologically confirmed nonhematological malignancy were eligible. Three SABR fractionation regimens, ie, 5 fractions of 7.0 Gy versus 3 fractions of 10.0 Gy versus a single fraction of 20.0 Gy, were applied in 3 consecutive patient cohorts. The rate of ≥grade 3 toxicity, scored according to the Common Toxicity Criteria for Adverse Events v. 4.03, up to 6 months after SABR, was the primary endpoint. The trial was registered on clinicaltrials.gov (NCT03486431). RESULTS: Between July 2017 and December 2018, 90 patients were enrolled. In total 101 metastases were treated. No ≥grade 3 toxicity was observed in any of the enrolled patients (95% CI 0.0%-12.3% for the first cohort with 28 analyzable patients; 95% CI 0.0%-11.6% for the second and third cohort with 30 analyzable patients each). Treatment-related grade 2 toxicities occurred in 4 out of 30 versus 2 out of 30 versus 2 out of 30 patients for the 5, 3 and 1 fraction schedule, respectively. Actuarial local control rate at 12 months was 94.5%. CONCLUSION: All 3 treatment schedules were feasible and effective with remarkably low toxicity rates and high local control rates. From a patient and resource point of view, the single-fraction schedule is undoubtedly most convenient.
PURPOSE: Increasing evidence suggests that patients with a limited number of metastases benefit from SABR to all lesions. However, the optimal dose and fractionation remain unknown. This is particularly true for bone and lymph node metastases. Therefore, a prospective, single-center, dose-escalation trial was initiated. METHODS: Dose-Escalation trial of STereotactic ablative body RadiOtherapY for non-spine bone and lymph node metastases (DESTROY) was an open-label phase 1 trial evaluating SABR to nonspine bone and lymph node lesions in patients with up to 3 metastases. Patients with European Cooperative Oncology Group performance status ≤1, an estimated life expectancy of at least 6 months, and histologically confirmed nonhematological malignancy were eligible. Three SABR fractionation regimens, ie, 5 fractions of 7.0 Gy versus 3 fractions of 10.0 Gy versus a single fraction of 20.0 Gy, were applied in 3 consecutive patient cohorts. The rate of ≥grade 3 toxicity, scored according to the Common Toxicity Criteria for Adverse Events v. 4.03, up to 6 months after SABR, was the primary endpoint. The trial was registered on clinicaltrials.gov (NCT03486431). RESULTS: Between July 2017 and December 2018, 90 patients were enrolled. In total 101 metastases were treated. No ≥grade 3 toxicity was observed in any of the enrolled patients (95% CI 0.0%-12.3% for the first cohort with 28 analyzable patients; 95% CI 0.0%-11.6% for the second and third cohort with 30 analyzable patients each). Treatment-related grade 2 toxicities occurred in 4 out of 30 versus 2 out of 30 versus 2 out of 30 patients for the 5, 3 and 1 fraction schedule, respectively. Actuarial local control rate at 12 months was 94.5%. CONCLUSION: All 3 treatment schedules were feasible and effective with remarkably low toxicity rates and high local control rates. From a patient and resource point of view, the single-fraction schedule is undoubtedly most convenient.
Authors: F Lopez-Campos; J Cacicedo; F Couñago; R García; O Leaman-Alcibar; A Navarro-Martin; H Pérez-Montero; A Conde-Moreno Journal: Clin Transl Oncol Date: 2021-10-11 Impact factor: 3.405