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Title: A Phase I Study of Short-Course Accelerated Whole Brain Radiation Therapy for Multiple Brain Metastases

Abstract

Purpose: To define the maximum tolerated dose (MTD) of a SHort-course Accelerated whole brain RadiatiON therapy (SHARON) in the treatment of patients with multiple brain metastases. Methods and Materials: A phase 1 trial in 4 dose-escalation steps was designed: 12 Gy (3 Gy per fraction), 14 Gy (3.5 Gy per fraction), 16 Gy (4 Gy per fraction), and 18 Gy (4.5 Gy per fraction). Eligibility criteria included patients with unfavorable recursive partitioning analysis (RPA) class > or =2 with at least 3 brain metastases or metastatic disease in more than 3 organ systems, and Eastern Cooperative Oncology Group (ECOG) performance status {<=}3. Treatment was delivered in 2 days with twice-daily fractionation. Patients were treated in cohorts of 6-12 to define the MTD. The dose-limiting toxicity (DLT) was defined as any acute toxicity {>=}grade 3, according to the Radiation Therapy Oncology Group scale. Information on the status of the main neurologic symptoms and quality of life were recorded. Results: Characteristics of the 49 enrolled patients were as follows: male/female, 30/19; median age, 66 years (range, 23-83 years). ECOG performance status was <3 in 46 patients (94%). Fourteen patients (29%) were considered to be in recursive partitioning analysis (RPA) class 3. Grademore » 1-2 acute neurologic (26.4%) and skin (18.3%) toxicities were recorded. Only 1 patient experienced DLT (neurologic grade 3 acute toxicity). With a median follow-up time of 5 months (range, 1-23 months), no late toxicities have been observed. Three weeks after treatment, 16 of 21 symptomatic patients showed an improvement or resolution of presenting symptoms (overall symptom response rate, 76.2%; confidence interval 0.95: 60.3-95.9%). Conclusions: Short-course accelerated radiation therapy in twice-daily fractions for 2 consecutive days is tolerated up to a total dose of 18 Gy. A phase 2 study has been planned to evaluate the efficacy on overall survival, symptom control, and quality of life indices.« less

Authors:
; ;  [1];  [1];  [1];  [2];  [3]; ;  [4];  [5];  [6];  [7];  [8];  [9];
  1. Department of Radiation Oncology, Fondazione di Ricerca e Cura 'Giovanni Paolo II', Universita Cattolica del S. Cuore, Campobasso (Italy)
  2. Medical Physics Unit, Fondazione di Ricerca e Cura 'Giovanni Paolo II,' Universita Cattolica del S. Cuore, Campobasso (Italy)
  3. Department of Radiation Oncology, The Lacks Cancer Center Saint Mary's Health Care, Grand Rapids, Michigan (United States)
  4. Department of Palliative Therapies, Fondazione di Ricerca e Cura 'Giovanni Paolo II', Universita Cattolica del S. Cuore, Campobasso (Italy)
  5. Department of Oncology, A. Cardarelli Hospital, Campobasso (Italy)
  6. Madre Teresa di Calcutta Hospice, Larino (Italy)
  7. Department of Neurological Sciences, Istituto Neurologico Mediterraneo Neuromed, Istituto di Ricovero e Cura a Carattere Scientifico, Pozzilli (Italy)
  8. Department of Radiation Oncology, 'San Francesco' Hospital, Nuoro (Italy)
  9. Department of Radiotherapy, Mulago Hospital, Kampala (Uganda)
Publication Date:
OSTI Identifier:
22149630
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 84; Journal Issue: 4; Other Information: Copyright (c) 2012 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BRAIN; FEMALES; MALES; METASTASES; PATIENTS; PERFORMANCE; RADIATION DOSES; RADIOTHERAPY; SKIN; STANDARD OF LIVING; SYMPTOMS; TOXICITY

Citation Formats

Caravatta, Luciana, Deodato, Francesco, Ferro, Marica, Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it, Massaccesi, Mariangela, Cilla, Savino, Padula, Gilbert D.A., Mignogna, Samantha, Tambaro, Rosa, Carrozza, Francesco, Flocco, Mariano, Cantore, Giampaolo, Scapati, Andrea, Buwenge, Milly, and and others. A Phase I Study of Short-Course Accelerated Whole Brain Radiation Therapy for Multiple Brain Metastases. United States: N. p., 2012. Web. doi:10.1016/J.IJROBP.2012.06.023.
Caravatta, Luciana, Deodato, Francesco, Ferro, Marica, Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it, Massaccesi, Mariangela, Cilla, Savino, Padula, Gilbert D.A., Mignogna, Samantha, Tambaro, Rosa, Carrozza, Francesco, Flocco, Mariano, Cantore, Giampaolo, Scapati, Andrea, Buwenge, Milly, & and others. A Phase I Study of Short-Course Accelerated Whole Brain Radiation Therapy for Multiple Brain Metastases. United States. doi:10.1016/J.IJROBP.2012.06.023.
Caravatta, Luciana, Deodato, Francesco, Ferro, Marica, Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it, Massaccesi, Mariangela, Cilla, Savino, Padula, Gilbert D.A., Mignogna, Samantha, Tambaro, Rosa, Carrozza, Francesco, Flocco, Mariano, Cantore, Giampaolo, Scapati, Andrea, Buwenge, Milly, and and others. Thu . "A Phase I Study of Short-Course Accelerated Whole Brain Radiation Therapy for Multiple Brain Metastases". United States. doi:10.1016/J.IJROBP.2012.06.023.
@article{osti_22149630,
title = {A Phase I Study of Short-Course Accelerated Whole Brain Radiation Therapy for Multiple Brain Metastases},
author = {Caravatta, Luciana and Deodato, Francesco and Ferro, Marica and Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it and Massaccesi, Mariangela and Cilla, Savino and Padula, Gilbert D.A. and Mignogna, Samantha and Tambaro, Rosa and Carrozza, Francesco and Flocco, Mariano and Cantore, Giampaolo and Scapati, Andrea and Buwenge, Milly and and others},
abstractNote = {Purpose: To define the maximum tolerated dose (MTD) of a SHort-course Accelerated whole brain RadiatiON therapy (SHARON) in the treatment of patients with multiple brain metastases. Methods and Materials: A phase 1 trial in 4 dose-escalation steps was designed: 12 Gy (3 Gy per fraction), 14 Gy (3.5 Gy per fraction), 16 Gy (4 Gy per fraction), and 18 Gy (4.5 Gy per fraction). Eligibility criteria included patients with unfavorable recursive partitioning analysis (RPA) class > or =2 with at least 3 brain metastases or metastatic disease in more than 3 organ systems, and Eastern Cooperative Oncology Group (ECOG) performance status {<=}3. Treatment was delivered in 2 days with twice-daily fractionation. Patients were treated in cohorts of 6-12 to define the MTD. The dose-limiting toxicity (DLT) was defined as any acute toxicity {>=}grade 3, according to the Radiation Therapy Oncology Group scale. Information on the status of the main neurologic symptoms and quality of life were recorded. Results: Characteristics of the 49 enrolled patients were as follows: male/female, 30/19; median age, 66 years (range, 23-83 years). ECOG performance status was <3 in 46 patients (94%). Fourteen patients (29%) were considered to be in recursive partitioning analysis (RPA) class 3. Grade 1-2 acute neurologic (26.4%) and skin (18.3%) toxicities were recorded. Only 1 patient experienced DLT (neurologic grade 3 acute toxicity). With a median follow-up time of 5 months (range, 1-23 months), no late toxicities have been observed. Three weeks after treatment, 16 of 21 symptomatic patients showed an improvement or resolution of presenting symptoms (overall symptom response rate, 76.2%; confidence interval 0.95: 60.3-95.9%). Conclusions: Short-course accelerated radiation therapy in twice-daily fractions for 2 consecutive days is tolerated up to a total dose of 18 Gy. A phase 2 study has been planned to evaluate the efficacy on overall survival, symptom control, and quality of life indices.},
doi = {10.1016/J.IJROBP.2012.06.023},
journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 4,
volume = 84,
place = {United States},
year = {2012},
month = {11}
}