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Clinical Trial
. 2018 Nov 26;13(1):234.
doi: 10.1186/s13014-018-1185-9.

Phase II trial on SBRT for unresectable liver metastases: long-term outcome and prognostic factors of survival after 5 years of follow-up

Marta Scorsetti  1   2 , Tiziana Comito  1 , Elena Clerici  1 , Ciro Franzese  1 , Angelo Tozzi  1 , Cristina Iftode  1 , Lucia Di Brina  1 , Pierina Navarria  1 , Pietro Mancosu  1 , Giacomo Reggiori  1 , Antonella Fogliata  1 , Stefano Tomatis  1 , Guido Torzilli  2   3 , Luca Cozzi  4   5   6
Affiliations
Clinical Trial

Phase II trial on SBRT for unresectable liver metastases: long-term outcome and prognostic factors of survival after 5 years of follow-up

Marta Scorsetti et al. Radiat Oncol. .

Abstract

Background: The aim of this study was to evaluate long-term efficacy and survival prognostic factors of stereotactic body radiation therapy (SBRT) for un-resectable liver metastases in patients enrolled in a prospective phase II trial.

Methods and materials: 5-year local control (LC), overall survival (OS), progression free survival (PFS) and toxicity rates were analyzed in patients with un-resectable liver metastases enrolled in a Phase II Trial on liver SBRT, with a prescription dose of 75Gy in 3 consecutive fractions.

Results: A total of 61 patients with 76 lesions were enrolled, with a median follow-up time of 6.1 years. One, three and 5 year LC rates were 94 ± 3.1%, 78.0 ± 5.9% and 78.0 ± 5.9%, without reaching the median LC time. Median OS was 27.6 months and the survival rates were 85.2 ± 4.5%, 31.1 ± 5.9% and 18.0 ± 4.9% at 1, 3 and 5-year after SBRT, respectively. Univariate analysis showed that favorable primary site (colorectal, breast and gynecological) of metastases (p = 0.001) improved survival. Toxicity was moderate. One patient experienced G3 late chest wall pain, which resolved within 1 year from SBRT. No cases of Radiation Induced Liver Disease (RILD) were detected.

Conclusions: Long-term results of this Phase II study suggest the efficacy and safety of SBRT for un-resectable liver metastases after 5-year of follow up. Selection of cases with positive prognostic factors may improve long-term survival of these oligo-metastastic patients and may confirm the role of SBRT as an effective alternative local therapy for liver metastases.

Keywords: Metastatic liver cancer; SABR; SBRT; Volumetric modulated arc therapy.

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Conflict of interest statement

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The Humanitas Ethical Committee approved the study. Informed consent to participate in the treatment was obtained from each patient at admission.

Consent for publication

Not applicable.

Competing interests

L. Cozzi acts as Scientific Advisor to Varian Medical Systems and is Clinical Research Scientist at Humanitas Cancer Center. All other co-authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
a Overall survival (OS); b OS by primary tumor
Fig. 2
Fig. 2
a Local control; b an example of a patient with complete response at 6 months from treatment
See this image and copyright information in PMC

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