Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases
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RESEARCH PAPER
Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases Ciro Franzese1,2 · Tiziana Comito1 · Antonella Tripoli1 · Davide Franceschini1 · Elena Clerici1 · Pierina Navarria1 · Marco Badalamenti1 · Giuseppe D’agostino1 · Mauro Loi1 · Pietro Mancosu1 · Giacomo Reggiori1 · Stefano Tomatis1 · Marta Scorsetti1,2 Received: 23 April 2020 / Accepted: 12 June 2020 © Springer Nature B.V. 2020
Abstract Lymph nodes are common sites of oligometastases for several primaries. Stereotactic body radiation therapy (SBRT) represents an effective treatment but no consensus exists regarding dose and fractionation. Aim of this trial was to evaluate safety and efficacy of high-dose SBRT. We included patients with 1 to 3 lymph node metastases. Primary end-point was safety, while secondary end-points were in-field local control (LC), out-field lymph nodal progression free survival (LPFS), distant metastasis free survival (DMFS), progression free survival (PFS) and overall survival (OS). 64 lesions in 52 patients were treated from 2015 to 2019. Most common primary tumor was genitourinary cancer (75%), in particular prostate cancer (65.4%). With a median follow-up of 24.4 months (range 3–49), treatment was very well tolerated, with only 4 (7.7%) patients reporting acute side effects, all classified as grade 1, in the form of pain, fatigue, nocturia and dysuria. No toxicity ≥ grade 2 were reported. Rates of LC at 1, 2 and 3 years were 97.9%, 82.1% and 82.1%. Male sex (HR 0.12, p value 0.014) was associated with improved LC. LPFS at 1, 2 and 3 years were 69.6%, 49.6% and 46.1%, respectively, and DMFS was 81.74%, 67.5% and 58.5%, respectively. Presence of lesions in other organs was correlated with inferior DMFS (HR 3.82, p = 0.042). PFS at 1, 2 and 3 years were 67.4%, 42.4% and 31.86%, respectively. OS at 1, 2 and 3 years were 97.3%, 94.2%, 84%, respectively and significantly correlated with in-field recurrence (HR 8.72, p = 0.000). Our prospective trial confirms safety and efficacy of SBRT in the management of lymph node metastases. Registered Clinical trial NCT02570399. Keywords SBRT · Stereotactic body radiation therapy · Radiotherapy · Lymph node metastases · Oligometastases
Introduction The oligometastatic setting is nowadays an interesting area of research due to the advancement both in diagnostic imaging and local treatments. The term "oligometastases" was coined by Hellman and Weichselbaum [1] in 1995, claiming that cancer includes a broad biological spectrum of disease, ranging from localized to systemic disease with intermediate stages that include the clinical status of oligometastases, * Ciro Franzese [email protected] 1
Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center – IRCCS, via Manzoni 56, Rozzano, 20089 Milan, Italy
Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20090 Milan, Italy
2
characterized by a limited number of clinically detectable metastases. The oligometasta
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