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Observational multicenter Italian study on vulvar cancer adjuvant radiotherapy (OLDLADY 1.2): a cooperation among AIRO Gyn, MITO and MaNGO groups

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Abstract

Background

Adjuvant radiotherapy (aRT) has been shown to reduce the risk of local relapse in vulvar cancer (VC). In this multicentre study (OLDLADY-1.2), several Institutions have combined their retrospective data on VC patients to produce a real-world dataset aimed at collecting data on efficacy and safety of aRT.

Methods

The primary study end-point was the 2-year-local control, secondary end-points were the 2-year-metastasis free-survival, the 2-year-overall survival and the rate and severity of acute and late toxicities. Participating centres were required to fill data sets including age, stage, tumor diameter, type of surgery, margin status, depth of invasion, histology, grading as well technical/dosimetric details of radiotherapy. Data about response, local and regional recurrence, acute and late toxicities, follow-up and outcome measures were also collected.

Results

One hundred eighty-one patients with invasive VC from 9 Institutions were retrospectively identified. The majority of patients were stage III (63%), grade 2 (62.4%) squamous carcinoma (97.2%). Positive nodes were observed in 117 patients (64.6%), moreover tumor diameter > 4 cm, positive/close margins and depth of invasion deeper than 5 mm were found in 59.1%, 38.6%, 58% of patients, respectively. Sixty-one patients (33.7%) received adjuvant chemoradiation, and 120 (66.3%) received radiotherapy alone. aRT was started 3 months after surgery in 50.8% of patients. Prescribed volumes and doses heterogeneity was recorded according to margin status and nodal disease. Overall, 42.5% locoregional recurrences were recorded. With a median follow-up of 27 months (range 1–179), the 2-year actuarial local control rate, metastasis free and overall survival were 68.7%, 84.5%, and 67.5%, respectively. In term of safety, aRT leads to a prevalence of acute skin toxicity with a low incidence of severe toxicities.

Conclusions

In the context of aRT for VC the present study reports a broad spectrum of approaches which would deserve greater standardization in terms of doses, volumes and drugs used.

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Acknowledgements

The Authors thank the Scientific Committee and Board of the AIRO for the critical revision and final approval of the paper.

Funding

The authors did not receive support from any organization for the submitted work.

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Authors and Affiliations

  1. Radiation Oncology Unit, Gemelli Molise Hospital – Università Cattolica del Sacro Cuore, Campobasso, Italy

    Gabriella Macchia, Donato Pezzulla & Mariangela Boccardi

  2. Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

    Calogero Casà, Valentina Lancellotta & Luca Tagliaferri

  3. Radiation Oncology, Department of Experimental, Diagnostic and Specialty Medicine – DIMES, IRCCS Azienda Ospedaliero, Universitaria di Bologna - Alma Mater Studiorum University of Bologna, Bologna, Italy

    Martina Ferioli & Alessio Giuseppe Morganti

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

    Brigida Pappalardi

  5. Department of New Technologies and Translational Research, Division of Radiation Oncology, University of Pisa, Pisa, Italy

    Concetta Laliscia

  6. Radiation Oncology, Università Campus Bio-Medico, Rome, Italy

    Edy Ippolito

  7. Dipartimento di Oncologia P.O. S. Anna - SS Radioterapia, A.O.U “Città della Salute e della Scienza”, Turin, Italy

    Jacopo Di Muzio

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

    Alessandra Huscher

  9. U.O.C. Radiotherapy, S. Giovanni Calibita Fatebenefratelli Hospital - Amethyst Radioterapia Italia, Rome, Italy

    Francesca Tortoreto

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

    Roberta Lazzari

  11. Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero, Universitaria di Bologna - Alma Mater Studiorum University of Bologna, Bologna, Italy

    Pierandrea De Iaco

  12. Gynecologic Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

    Francesco Raspagliesi

  13. Department of Clinical and Experimental Medicine, Division of Gynecology and Obstetrics, University of Pisa, Pisa, Italy

    Angiolo Gadducci

  14. Gynecology and Breast Care Center, Mater Olbia Hospital, Olbia, Italy

    Giorgia Garganese

  15. Unità Operativa Complessa Ginecologia Oncologica, Dipartimento per la Salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCCS – Università Cattolica del Sacro Cuore, Rome, Italy

    Gabriella Ferrandina

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  1. Gabriella Macchia
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  2. Calogero Casà
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Corresponding author

Correspondence to Valentina Lancellotta.

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Conflict of interest

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.

Human and animal rights

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.

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Ethical approval was waived by the local Ethics Committee of University A. Gemelli in view of the retrospective nature of the study and all the procedures being performed were part of the routine care.

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Macchia, G., Casà, C., Ferioli, M. et al. Observational multicenter Italian study on vulvar cancer adjuvant radiotherapy (OLDLADY 1.2): a cooperation among AIRO Gyn, MITO and MaNGO groups. Radiol med 127, 1292–1302 (2022). https://doi.org/10.1007/s11547-022-01538-w

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