Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)

Alice Zamagni, Milly Buwenge, Gabriella Macchia, Giambattista Siepe, Savino Cilla, Francesco Cellini, Alessandra Arcelli, Eleonora Farina, Francesco Deodato, Silvia Cammelli, Alessio G Morganti

Research output: Contribution to journalArticle

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 follow-up=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.

Original languageEnglish
Pages (from-to)5065-5069
Number of pages5
JournalAnticancer Research
Volume39
Issue number9
DOIs
Publication statusPublished - Sep 2019

Keywords

  • Aged
  • Bone Neoplasms/radiotherapy
  • Combined Modality Therapy
  • Follow-Up Studies
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Prostatic Neoplasms/pathology
  • Quality of Life
  • Radiotherapy/adverse effects
  • Radiotherapy Dosage
  • Treatment Outcome

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  • Cite this

    Zamagni, A., Buwenge, M., Macchia, G., Siepe, G., Cilla, S., Cellini, F., Arcelli, A., Farina, E., Deodato, F., Cammelli, S., & Morganti, A. G. (2019). Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project). Anticancer Research, 39(9), 5065-5069. https://doi.org/10.21873/anticanres.13699