A Large, Multicenter, Retrospective Study on Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Ovarian Cancer (MITO RT1 Study): A Collaboration of MITO, AIRO GYN, and MaNGO Groups

Author:

Macchia Gabriella1,Lazzari Roberta2,Colombo Nicoletta3,Laliscia Concetta4,Capelli Giovanni5,D'Agostino Giuseppe Roberto6,Deodato Francesco1,Maranzano Ernesto7,Ippolito Edy8,Ronchi Sara2,Paiar Fabiola4,Scorsetti Marta69,Cilla Savino10,Ingargiola Rossana211,Huscher Alessandra12,Cerrotta Anna Maria13,Fodor Andrei14,Vicenzi Lisa15,Russo Donatella16,Borghesi Simona17,Perrucci Elisabetta18,Pignata Sandro19,Aristei Cynthia18,Morganti Alessio Giuseppe20,Scambia Giovanni2122,Valentini Vincenzo12324,Jereczek-Fossa Barbara Alicja211,Ferrandina Gabriella2122

Affiliation:

1. Fondazione “Giovanni Paolo II,” Unità Operativa di Radioterapia, Università Cattolica del Sacro Cuore, Campobasso, Italy

2. Division of Radiotherapy, IEO European Institute of Oncology, IRCCS, Milan, Italy

3. Division of Medical Gynecologic Oncology, IEO European Institute of Oncology, IRCCS and University of Milan-Bicocca, Milan, Italy

4. Department of Translational Medicine, Division of Radiation Oncology, University of Pisa, Pisa, Italy

5. Department of Human Sciences, Society and Health, University of Cassino and Southern Lazio, Cassino, Italy

6. Department of Radiotherapy and Radiosurgery, Humanitas Clinical and Research Hospital, IRCSS, Rozzano, Milan, Italy

7. Radiation Oncology Centre, S. Maria Hospital, Terni, Italy

8. Department of Radiation Oncology, Campus Bio-Medico University, Rome, Italy

9. Humanitas University, Department of Biomedical Sciences, Rozzano, Milano, Italy

10. Fondazione “Giovanni Paolo II,” Unità Operativa di Fisica Medica, Università Cattolica del Sacro Cuore, Campobasso, Italy

11. Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy

12. U.O. di Radioterapia Oncologica “Guido Berlucchi,” Fondazione Poliambulanza, Brescia, Italy

13. Radiotherapy Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

14. Department of Radiation Oncology, San Raffaele Scientific Institute, Milan, Italy

15. Department of Oncology and Radiotherapy, Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona, Italy

16. Radiotherapy Unit, Ospedale “Vito Fazzi”, Lecce, Italy

17. Radiotherapy Department, Azienda USL Toscana sud est, San Donato Hospital-Arezzo, Italy

18. Radiation Oncology Section, University of Perugia and Perugia General Hospital, Perugia, Italy

19. Istituto Nazionale Tumori di Napoli, Fondazione Pascale IRCCS, Naples, Italy

20. Department of Experimental, Diagnostic and Specialty Medicine – DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

21. Fondazione Policlinico Universitario A. Gemelli, IRCCS, Unità Operativa Complessa Ginecologia Oncologica, Dipartimento per la Salute della Donna e del Bambino e della Salute Pubblica, Roma, Italy

22. Università Cattolica del Sacro Cuore, Istituto di Ginecologia e Ostetricia, Roma, Italy

23. Università Cattolica del Sacro Cuore, Istituto di Radiologia, Roma, Italy

24. Fondazione Policlinico Universitario A. Gemelli, IRCCS, Unità Operativa Complessa di Radioterapia, Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Roma, Italy

Abstract

Abstract Background Recent studies have reported improvement of outcomes (progression-free survival, overall survival, and prolongation of androgen deprivation treatment-free survival) with stereotactic body radiotherapy (SBRT) in non-small cell lung cancer and prostate cancer. The aim of this retrospective, multicenter study (MITO RT-01) was to define activity and safety of SBRT in a very large, real-world data set of patients with metastatic, persistent, and recurrent ovarian cancer (MPR-OC). Materials and Methods The endpoints of the study were the rate of complete response (CR) to SBRT and the 24-month actuarial local control (LC) rate on “per-lesion” basis. The secondary endpoints were acute and late toxicities and the 24-month actuarial late toxicity-free survival. Objective response rate (ORR) included CR and partial response (PR). Clinical benefit (CB) included ORR and stable disease (SD). Toxicity was evaluated by the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) and Common Terminology Criteria for Adverse Events (CTCAE) scales, according to center policy. Logistic and Cox regression were used for the uni- and multivariate analysis of factors predicting clinical CR and actuarial outcomes. Results CR, PR, and SD were observed in 291 (65.2%), 106 (23.8%), and 33 (7.4%) lesions, giving a rate of CB of 96.4%. Patient aged ≤60 years, planning target volume (PTV) ≤18 cm3, lymph node disease, and biologically effective dose α/β10 > 70 Gy were associated with higher chance of CR in the multivariate analysis. With a median follow-up of 22 months (range, 3–120), the 24-month actuarial LC rate was 81.9%. Achievement of CR and total dose >25 Gy were associated with better LC rate in the multivariate analysis. Mild toxicity was experienced in 54 (20.7%) patients; of 63 side effects, 48 were grade 1, and 15 were grade 2. The 24-month late toxicity-free survival rate was 95.1%. Conclusions This study confirms the activity and safety of SBRT in patients with MPR-OC and identifies clinical and treatment parameters able to predict CR and LC rate.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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