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PT006/#314  Stereotactic ablative radiotherapy for oligometastatic ovarian cancer lymph node disease: the MITO-RT3/rad phase II trial
  1. Gabriella Macchia1,
  2. Maura Campitelli2,
  3. Donato Pezzulla3,
  4. Simona Lucci2,
  5. Andrei Fodor4,
  6. Donatella Russo5,
  7. Vittoria Balcet6,
  8. Paolo Bonome3,
  9. Stefano Durante7,
  10. Lorena Draghini8,
  11. Francesca Titone9,
  12. Giuseppe D’Agostino10,
  13. Marinella Tamburo11,
  14. Martina Ferioli12,
  15. Edy Ippolito13,
  16. Francesca Tortoreto14,
  17. Luciana Caravatta15,
  18. Francesca De Felice16,
  19. Aida Di Stefano17,
  20. Mara Fanelli3,
  21. Savino Cilla18,
  22. Francesco Cosentino19,
  23. Claudia Marchetti20,
  24. Serena Maria Boccia20,
  25. Vanda Salutari20,
  26. Alessio Morganti21,
  27. Maria Antonietta Gambacorta2,
  28. Anna Fagotti20,
  29. Sandro Pignata22,
  30. Giovanni Scambia23,
  31. Gabriella Ferrandina24 and
  32. Francesco Deodato3
  1. 1Università Cattolica del S. Cuore, Gemelli Molise Hospital, Campobasso, Italy
  2. 23. Fondazione Policlinico Universitario A. Gemelli IRCCS, Unità Operativa Complessa di Radioterapia, Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Roma, Italy
  3. 3Responsible Research hospital, Radiation Oncology, Campobasso, Italy
  4. 4IRCCS San Raffaele Scientific Institute, Department of Radiation Oncology, Milano, Italy
  5. 5Radiotherapy Unit, Ospedale ‘Vito Fazzi’, Lecce, Italy
  6. 6Nuovo Ospedale degli Infermi, UOC Radioterapia, Biella, Italy
  7. 7IEO European Institute of Oncology IRCCS, Division of radiation oncology, Milano, Italy
  8. 8S Maria Hospital, Radiation Oncology Center, Terni, Italy
  9. 9University Hospital Udine, Department of Radiation Oncology, Udine, Italy
  10. 10Humanitas Clinical and Research Center-IRCCS, Radiotherapy and Radiosurgery Department, Milano, Italy
  11. 11Azienda Ospedaliera ‘Cannizzaro’, UOC di Radioterapia, Catania, Italy
  12. 12Azienda USL – IRCCS di Reggio Emilia, Radiation oncology, Reggio Emilia, Italy
  13. 13Campus Bio-Medico University, Department of Radiation Oncology, Roma, Italy
  14. 14Fatebenefratelli Isola Tiberina. Gemelli Isola, UOC di Radioterapia, Roma, Italy
  15. 15SS Annunziata Hospital, Department of Radiation Oncology, Chieti, Italy
  16. 16Policlinico Umberto I, Department of Radiological, Oncological and Pathological Sciences, ‘Sapienza’ University of Rome, Department of Radiotherapy, Roma, Italy
  17. 17Responsible Research Hospital, Medical Oncology Unit, Campobasso, Italy
  18. 18Responsible Research hospital, Medical Physics Unit, Campobasso, Italy
  19. 19Department of Gynecologic Oncology, Responsible Research Hospital and Università degli studi del Molise, Campobasso, Italy
  20. 20UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
  21. 21IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Radiation Oncology, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Radiation Oncology, Bologna, Italy
  22. 22Istituto Nazionale Tumori, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fondazione G Pascale, 9. Uro-Gynecological Medical Oncology, Napoli, Italy
  23. 23Policlinico Gemelli, Rome, Italy
  24. 246. 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

Abstract

Introduction MITO-RT3/RAD(NCT04593381) is a prospective multicenter Phase II trial designed to assess the effectiveness and safety of stereotactic radiotherapy(SBRT) in patients diagnosed with oligometastatic ovarian cancer(oligo-MPR-OC).In this report, we provide the results of the trial in the setting of lymph node disease.

Methods The primary endpoint was the complete response(CR) rate,secondary endpoints included local control(LC), progression-free survival(PFS), overall survival(OS), treatment-free interval(TFI),and toxicity rates.Sample size was based on a previous study reporting an average 70.0% CR with SBRT.The study was powered to detect an improvement in the CR rate from 70.0% to 85.0%, with an α error of 0.05 (two-sided) and a β error of 0.1.

Results The study met its primary endpoint of a statistically significant improvement of CR.135 patients with 249 lesions were enrolled across fifteen Institutions from May 2019 to November 2023. CR were observed in 194 lesions(77.9%), PR in 40(16.1%), SD in 14(5.6%), and Progressive Disease(PD) in one lesion(0.4%).The ORR was 94%, with an overall clinical benefit rate of 99.6%. CR lesions exhibited a significantly higher LC rate than partial or not responding lesions(12-month LC: 92.7% vs. 63.1%, p<0.001).The 12- actuarial rates for PFS and for OS were 36.6% and 97.2%,respectively.The 12- actuarial rate for Treatment Free Interval was 52.7%.Twenty-three patients (17.0%) experienced mild acute toxicity. Late toxicity was reported in 9 patients (6.7%), mostly Grade 1.

Conclusion/Implications This trial confirms the efficacy of ablative SBRT, with minimal toxicity observed. SBRT offered a high CR rate, promising long-term outcomes and systemic-therapy-free survival rate for complete responders.

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