Radiotherapy in palliation of thoracic tumors: a phase I–II study (SHARON project)

Francesco Cellini, Francesco Deodato, Gabriella Macchia, Savino Cilla, Alessio Giuseppe Morganti, Eleonora Farina, Milly Buwenge, Giambattista Siepe, Alice Zamagni, Silvia Cammelli, Tigeneh Wondemagegnhu, Aynalem A. Woldemariam, A. F. M. Kamal Uddin, Mostafà Aziz Sumon, Alessio G. Morganti

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

The main clinical goal for patients with advanced or metastatic thoracic cancer is palliation of tumor-related symptoms and improvement of quality of life. The aim of this phase I–II trial was to define the maximum tolerated dose (MTD) of a short-course of palliative radiotherapy (RT) and to evaluate its efficacy in terms of palliative response. A phase I trial was planned with escalating dose increments. Total doses ranged from 16 to 20 Gy delivered (BID) in two consecutive days. Dose limiting toxicity was defined as any acute grade ≥ 3 toxicity based on the RTOG scale. MTD was used in the phase II trial to evaluate the efficacy of this regimen using a two stage Simon’s design. Fifty-four patients were enrolled. The upper dose level of 20 Gy was defined as the MTD. In patients treated with this dose, the overall palliative response rate was 96.5% (CI 0.95: 81.3–99.9%). Complete pain relief rate was 50.0%. Median survival without symptomatic progression was 3 months. The tested short course accelerated regimen was well tolerated and effective in the palliative setting of metastatic or locally advanced chest cancer. A phase III trial is ongoing to validate this RT schedule. Trial registration: NCT03465553.
Lingua originaleEnglish
pagine (da-a)739-746
Numero di pagine8
RivistaCLINICAL & EXPERIMENTAL METASTASIS
Volume35
DOI
Stato di pubblicazionePubblicato - 2018

Keywords

  • Lung cancer
  • Radiotherapy
  • Palliative care
  • Phase I–II
  • Quality of life
  • Adult
  • Aged
  • Aged, 80 and over
  • Dose-Response Relationship, Radiation
  • Female
  • Humans
  • Lung Neoplasms
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Palliative Care
  • Pain

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