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Ablative Radiation Therapy to Restrain Everything Safely Treatable (ARREST): A Phase 1 Study of Stereotactic Ablative Radiation Therapy for Polymetastatic Disease.
Nguyen, Timothy K; Ramadan, Sherif; Palma, David A; Corkum, Mark T; O' Neil, Melissa; Celinski, Anders; Fakir, Hatim; Warner, Andrew; Hallock, Abhirami; Correa, Rohann J M; Qu, X Melody; Lock, Michael; Lang, Pencilla; Velker, Vikram; Bauman, Glenn S.
Afiliación
  • Nguyen TK; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Ramadan S; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Palma DA; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Corkum MT; Division of Radiation Oncology, Department of Radiology, The Ottawa Hospital, Ottawa, Ontario, Canada.
  • O' Neil M; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Celinski A; Department of Medical Biophysics, Western University, London, Ontario, Canada.
  • Fakir H; Department of Medical Biophysics, Western University, London, Ontario, Canada.
  • Warner A; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Hallock A; Department of Radiation Oncology, Niagara Health, St. Catherine's, Ontario, Canada.
  • Correa RJM; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Qu XM; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Lock M; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Lang P; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Velker V; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada.
  • Bauman GS; Division of Radiation Oncology, Department of Oncology, Western University and London Health Sciences Centre, London, Ontario, Canada. Electronic address: Glenn.Bauman@lhsc.on.ca.
Int J Radiat Oncol Biol Phys ; 2024 Jul 09.
Article en En | MEDLINE | ID: mdl-38986914
ABSTRACT

PURPOSE:

This phase 1 study aimed to assess the safety and feasibility of SABR therapy delivery to all sites of polymetastatic disease (>10 metastases). METHODS AND MATERIALS A 3 + 3 study design was used with 5 dose levels from 6 Gy (6 Gy × 1) to 30 Gy (6 Gy weekly × 5). Dose-limiting toxicity (DLT) was defined as any grade 4 or 5 toxicity or more than 3 grade 3 toxicities within 6 weeks of treatment. The primary endpoint was the maximal tolerated dose, defined as the dose level where ≥2/6 of patients experienced DLT. Secondary endpoints included quality of life (Functional Assessment of Cancer Therapy - General and European Quality of Life 5 Dimension 5 Level) at 6 weeks posttreatment, progression-free survival, and overall survival.

RESULTS:

Thirteen patients were accrued 12 Gy (n = 3), 18 Gy (n = 3), 24 Gy (n = 4), and 30 Gy (n = 3), and 207 lesions were treated. Nine patients (69%) had acute toxicity grade 1 (n = 6, 46%), grade 2 (n = 2, 15%; n = 1 pneumonitis and n = 1 fatigue), and grade 3 (n = 1, 7.7% neutropenia). There were no grade 4 or 5 toxicities. Mean ± SD quality of life (Functional Assessment of Cancer Therapy - General and European Quality of Life 5 Dimension 5 Level health state) was 80.4 ± 21.9 and 77.4 ± 20.9 at baseline versus 76.4 ± 21.8 and 68.0 ± 24.2 at 6-week follow-up, respectively (p = .009 and p = .055, respectively). With a median follow-up of 8.7 months posttreatment (IQR, 2.4-24 months), 8 of 13 patients had disease progression (62%). The median and 12-month progression-free survival were 3.6 months and 11.3%, respectively. The median and 12-month overall survival were 13.8 months and 62%, respectively.

CONCLUSIONS:

In this phase 1 trial, SABR therapy for polymetastatic disease was technically feasible with acceptable acute toxicity at dose levels up to 30 Gy (6 Gy weekly × 5). DLT was not observed.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Int J Radiat Oncol Biol Phys Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Int J Radiat Oncol Biol Phys Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos