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Stereotactic body radiotherapy in oligometastatic cervical cancer (MITO-RT2/RAD study): a collaboration of MITO, AIRO GYN, and MaNGO groups
  1. Gabriella Macchia1,
  2. Alessia Nardangeli2,
  3. Concetta Laliscia3,
  4. Andrei Fodor4,
  5. Lorena Draghini5,
  6. Pier Carlo Gentile6,
  7. Giuseppe Roberto D’Agostino7,
  8. Vittoria Balcet8,
  9. Paolo Bonome1,
  10. Martina Ferioli9,
  11. Rosa Autorino2,
  12. Lisa Vicenzi10,
  13. Arcangela Raguso11,
  14. Simona Borghesi12,
  15. Edy Ippolito13,
  16. Vanessa Di Cataldo14,
  17. Savino Cilla15,
  18. Elisabetta Perrucci16,
  19. Maura Campitelli2,
  20. Maria Antonietta Gambacorta17,18,
  21. Francesco Deodato1,18,
  22. Giovanni Scambia19 and
  23. Gabriella Ferrandina19
  1. 1Radiation Oncology Unit, Gemelli Molise, Campobasso, Molise, Italy
  2. 2UOC di Radioterapia, Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
  3. 3Department of Translational Medicine, Division of Radiation Oncology, University of Pisa, Pisa, Italy
  4. 4Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy
  5. 5Radiation Oncology Center, S Maria Hospital, Terni, Italy
  6. 6Radiation Oncology Unit, UPMC Hillman Cancer Center San Pietro FBF, Roma, Italy
  7. 7Department of Radiotherapy, Radiosurgery Humanitas Clinical and Research Hospital IRCSS Rozzano, Milan, Italy
  8. 8UOC Radioterapia, Nuovo Ospedale degli Infermi, Biella, Italy
  9. 9Radiation Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Department of Experimental, Diagnostic and Specialty Medicine, DIMES, Alma Mater Studiorum, University of Bologna, Bologna, Italy
  10. 10Radiation Oncology Unit, Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona, Italy
  11. 11UOC Radioterapia, Fondazione "Casa Sollievo della Sofferenza", IRCCS, S. Giovanni Rotondo, Foggia, Italy
  12. 12Radiation Oncology Unit of Arezzo-Valdarno, Azienda USL Toscana sud est, Arezzo, Toscana, Italy
  13. 13Department of Radiation Oncology, Campus Bio-Medico University, Roma, Italy
  14. 14Radiation Oncology Unit, Oncology Department, University of Florence, Firenze, Italy
  15. 15Medical Physics Unit, Gemelli Molise, Campobasso, Molise, Italy
  16. 16Radiation Oncology Section, University of Perugia and Perugia General Hospital, Perugia, Italy
  17. 17UOC di Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia, Oncologia ed Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
  18. 18Istituto di Radiologia, Università Cattolica del Sacro Cuore, Roma, Italy
  19. 19UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
  1. Correspondence to Dr Gabriella Macchia, Radiation Oncology Unit, Gemelli Molise, Campobasso 86100, Molise, Italy; macchiagabriella{at}gmail.com

Abstract

Objective This retrospective, multicenter study analyzes the efficacy and safety of stereotactic body radiotherapy in a large cohort of patients with oligometastatic/persistent/recurrent cervical cancer.

Methods A standardized data collection from several radiotherapy centers that treated patients by stereotactic body radiotherapy between March 2006 and February 2021 was set up. Clinical and stereotactic body radiotherapy parameters were collected. Objective response rate was defined as a composite of complete and partial response, while clinical benefit included objective response rate plus stable disease. Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer and Common Terminology Criteria for Adverse Events scales were used to grade toxicities. The primary endpoints were the rate of complete response to stereotactic body radiotherapy, and the 2 year actuarial local control rate on a ‘per lesion’ basis. The secondary end points were progression-free survival and overall survival, as well as toxicity.

Results A total of 83 patients with oligometastatic/persistent/recurrent cervical cancer bearing 125 lesions treated by stereotactic body radiotherapy at 15 different centers were selected for analysis. Of the sites of metastatic disease, lymph node metastases were most common (55.2%), followed by parenchyma lesions (44.8%). Median total dose was 35 Gy (range 10–60), in five fractions (range 1–10), with a median dose/fraction of 7 Gy (range 4–26). Complete, partial, and stable response were found in 73 (58.4%), 29 (23.2%), and 16 (12.8%) lesions, respectively, reaching 94.4% of the clinical benefit rate. Forty-six (55.4%) patients had a complete response. Patients achieving complete response on a ‘per lesion’ basis experienced a 2 year actuarial local control rate of 89.0% versus 22.1% in lesions not achieving complete response (p<0.001). The 2 year actuarial progression-free survival rate was 42.5% in patients with complete response versus 7.8% in patients with partial response or stable or progressive disease (p=0.001). The 2 year actuarial overall survival rate was 68.9% in patients with complete response versus 44.3% in patients with partial response or stable or progressive disease (p=0.015). Fifteen patients (18.1%) had mild acute toxicity, totaling 29 side events. Late toxicity was documented in four patients (4.8%) totaling seven adverse events.

Conclusion Our analysis confirmed the efficacy of stereotactic body radiotherapy in oligometastatic/persistent/recurrent cervical cancer patients. The low toxicity profile encourages the wider use of stereotactic body radiotherapy in this setting.

  • radiation oncology
  • radiotherapy dosage
  • cervical cancer

Data availability statement

Data are available upon reasonable request. Research data are stored in an institutional repository and will be shared upon request to the corresponding author.

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Data availability statement

Data are available upon reasonable request. Research data are stored in an institutional repository and will be shared upon request to the corresponding author.

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Footnotes

  • Contributors Contributors: GM and GF conceptualized the study and wrote the study protocol together with FD, AN, MC, RA, MAG, CL, GRD, EI, LD, AF, PCG, MF, VB, LV, AR, VDC, EP, SB and GS. GM and GF are the main authors of the manuscript. SC and GF conducted the statistical analyses. All authors participated actively in conducting the study, evaluating the analyses, and critically revised the manuscript, approved the final version, and are accountable for all aspects of the work. GM is the author responsible for the overall content as the guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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