Background/Aim: The primary endpoint of this phase I study was the maximum tolerated dose (MTD) of middle half body (MHB) accelerated radiotherapy (RT) in multiple bone metastatic (BM) prostate cancer (PCa) patients. Patients and Methods: Three step dose escalation [13 Gy (3.25 Gy/fraction), 14 Gy (3.5 Gy/fraction), and 15 Gy (3.75 Gy/fraction)] in three consecutive patient cohorts were planned. RT was delivered in two consecutive days and two daily fractions. Six patients were enrolled in the first two cohorts and 12 in the third cohort. Grade ≥3 toxicity was considered as a dose-limiting toxicity (DLT). Results: Twenty-five patients (median age=71 years, median followup=7.4 months) were enrolled. Defined MTD dose was 15 Gy. Overall pain response rate was 76%: 9 patients (36%) showed complete and 10 patients (40%) reported partial response of pain. Conclusion: MHB accelerated RT (total dose: 15 Gy) delivered in two consecutive days and two daily fractions is well tolerated.
Zamagni, A., Buwenge, M., Macchia, G., Siepe, G., Cilla, S., Cellini, F., Arcelli, A., Farina, E., Deodato, F., Cammelli, S., Morganti, A. G., Accelerated middle half body radiotherapy in bone metastases from prostate cancer: A phase I study (SHARON project), <<ANTICANCER RESEARCH>>, 2019; 39 (9): 5065-5069. [doi:10.21873/anticanres.13699] [http://hdl.handle.net/10807/203505]
Accelerated middle half body radiotherapy in bone metastases from prostate cancer: A phase I study (SHARON project)
Macchia, Gabriella;Cilla, Savino;Cellini, Francesco;Deodato, Francesco;Morganti, Alessio Giuseppe
2019
Abstract
Background/Aim: The primary endpoint of this phase I study was the maximum tolerated dose (MTD) of middle half body (MHB) accelerated radiotherapy (RT) in multiple bone metastatic (BM) prostate cancer (PCa) patients. Patients and Methods: Three step dose escalation [13 Gy (3.25 Gy/fraction), 14 Gy (3.5 Gy/fraction), and 15 Gy (3.75 Gy/fraction)] in three consecutive patient cohorts were planned. RT was delivered in two consecutive days and two daily fractions. Six patients were enrolled in the first two cohorts and 12 in the third cohort. Grade ≥3 toxicity was considered as a dose-limiting toxicity (DLT). Results: Twenty-five patients (median age=71 years, median followup=7.4 months) were enrolled. Defined MTD dose was 15 Gy. Overall pain response rate was 76%: 9 patients (36%) showed complete and 10 patients (40%) reported partial response of pain. Conclusion: MHB accelerated RT (total dose: 15 Gy) delivered in two consecutive days and two daily fractions is well tolerated.
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