F Deodato1, S Cilla2, G Macchia3, G Torre4, L Caravatta1, G Mariano1, S Mignogna4, M Ferro1, G C Mattiucci5, M Balducci5, V Frascino5, A Piermattei6, G Ferrandina7, V Valentini5, A G Morganti8. 1. Radiation Oncology Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Campobasso, Italy. 2. Medical Physics Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Campobasso, Italy. 3. Radiation Oncology Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Campobasso, Italy. Electronic address: gmacchia@rm.unicatt.it. 4. Palliative Therapies Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Campobasso, Italy. 5. Radiation Oncology Department, Policlinico Universitario "A. Gemelli", Università Cattolica del Sacro Cuore, Rome, Italy. 6. Medical Physics Department, Policlinico Universitario "A. Gemelli", Università Cattolica del Sacro Cuore, Rome, Italy. 7. Gynaecologic Oncology Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Campobasso, Italy. 8. Radiation Oncology Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Campobasso, Italy; Palliative Therapies Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Campobasso, Italy; Radiation Oncology Department, Policlinico Universitario "A. Gemelli", Università Cattolica del Sacro Cuore, Rome, Italy.
Abstract
AIMS: To present the interim results of a phase I trial on stereotactic radiosurgery (SRS) delivered using volumetric modulated arc therapy (VMAT) in patients with primary or metastatic tumours in different extracranial sites. MATERIALS AND METHODS: Patients were enrolled in different arms according to tumour site and clinical stage, and sequentially assigned to a given dose level. Acute toxicity, tumour response and early local control were investigated and reported. RESULTS: One hundred lesions in 65 consecutive patients (male/female: 30/35, median age: 66 years; range: 40-89) were treated. Of these 100 lesions, 21 were primary or metastatic lung tumours, 24 were liver metastases, 30 were bone metastases, 24 were nodal metastases and one was a primary vulvar melanoma. The prescribed dose ranged from 12 (BED(2Gy,α/β:10) = 26.4 Gy) to 28 Gy (BED(2Gy,α/β:10) = 106.4 Gy) to the planning target volume. Twenty-one patients (32.3%) experienced grade 1-2 acute toxicity, which was grade 2 in only two cases. The overall response rate based on computed tomography/magnetic resonance imaging was 52% (95% confidence interval 40.1-63.2%) and based on positron emission tomography scan was 90% (95% confidence interval 76.2-96.4%). As of November 2013, the median duration of follow-up was 11 months (range = 1-38). Recurrence/progression within the SRS-VMAT treated field was observed in nine patients (total lesions = 18): the inside SRS-VMAT field local control expressed on a per lesion basis was 87.8% at 12 months and 71.9% at 24 months. CONCLUSIONS: The maximum tolerable dose has not yet been reached in any study arm. SRS-VMAT resulted in positive early clinical results in terms of tumour response, local control rate and acute toxicity.
AIMS: To present the interim results of a phase I trial on stereotactic radiosurgery (SRS) delivered using volumetric modulated arc therapy (VMAT) in patients with primary or metastatic tumours in different extracranial sites. MATERIALS AND METHODS:Patients were enrolled in different arms according to tumour site and clinical stage, and sequentially assigned to a given dose level. Acute toxicity, tumour response and early local control were investigated and reported. RESULTS: One hundred lesions in 65 consecutive patients (male/female: 30/35, median age: 66 years; range: 40-89) were treated. Of these 100 lesions, 21 were primary or metastatic lung tumours, 24 were liver metastases, 30 were bone metastases, 24 were nodal metastases and one was a primary vulvar melanoma. The prescribed dose ranged from 12 (BED(2Gy,α/β:10) = 26.4 Gy) to 28 Gy (BED(2Gy,α/β:10) = 106.4 Gy) to the planning target volume. Twenty-one patients (32.3%) experienced grade 1-2 acute toxicity, which was grade 2 in only two cases. The overall response rate based on computed tomography/magnetic resonance imaging was 52% (95% confidence interval 40.1-63.2%) and based on positron emission tomography scan was 90% (95% confidence interval 76.2-96.4%). As of November 2013, the median duration of follow-up was 11 months (range = 1-38). Recurrence/progression within the SRS-VMAT treated field was observed in nine patients (total lesions = 18): the inside SRS-VMAT field local control expressed on a per lesion basis was 87.8% at 12 months and 71.9% at 24 months. CONCLUSIONS: The maximum tolerable dose has not yet been reached in any study arm. SRS-VMAT resulted in positive early clinical results in terms of tumour response, local control rate and acute toxicity.
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