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The addition of the immunomodulator mifamurtide to adjuvant chemotherapy for early osteosarcoma: a retrospective analysis

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Summary

Background. Current treatment recommendations for high grade non-metastatic osteosarcoma include perioperative chemotherapy and surgery. Despite this intensive protocol, approximately 40% of patients will relapse. The addition of the immunomodulator mifamurtide to adjuvant cytotoxic chemotherapy was associated with a significant improvement in 6-year overall survival (OS) in young patients with resectable osteosarcoma, leading to its approval in Europe and other countries. Very limited real-world data are reported on its use. Methods. We retrospectively evaluated data from osteosarcoma patients who received mifamurtide in the adjuvant setting. Data were obtained from medical records in 2 high-volume bone sarcoma centers. The aim of this study was to collect real-world data on mifamurtide safety and efficacy in Greece. Results. We identified 15 patients with completely resected osteosarcoma who received mifamurtide from September 2015 to January 2020. Median age at diagnosis was 24 years old (16–76). Osteosarcoma arose in the lower extremities (n = 12), in the upper extremities (n = 2) or in the ilium (n = 1). The majority of patients (n = 13) received cisplatin/doxorubicin/methotrexate as perioperative chemotherapy and the remaining patients cisplatin/doxorubicin. After a median follow-up of 46.9 months (range, 32.8–61.1), the median recurrence-free survival was 58.7 months (range, 18.5–98.8) and the median OS 64.1 months (range, 25.6–102.6). Except for fever and chills, the only adverse event probably related to mifamurtide was pericarditis (n = 1). Conclusions. Mifamurtide was well tolerated in a Greek osteosarcoma population, including patients older than 30 years. The small sample size and the non-comparative design do not allow drawing conclusions on the drug benefit in terms of survival.

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Data availability

The data used and/or analyzed during the current study are available from the corresponding author upon request.

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Acknowledgements

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Funding

This research received no external funding.

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Authors and Affiliations

  1. First Medical Oncology Clinic, Saint-Savvas Cancer Hospital, Athens, Greece

    Stefania Kokkali, Elpida Magou, Talagani Sophia & Alexandros Ardavanis

  2. Section of Medical Oncology, 2nd Department of Medicine and Laboratory, Faculty of Medicine, National and Kapodistrian University of Athens, Hippocratio General Hospital of Athens, Athens, Greece

    Stefania Kokkali

  3. Section of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, National and Kapodistrian Univeristy of Athens, Attikon University Hospital, Athens, Greece

    Ioannis Kotsantis, Nikolaos Spathas & Amanda Psyrri

  4. Department of Orthopedic Surgery, Saint-Savvas Cancer Hospital, Athens, Greece

    Theodoros Kormas & Giakoumis Diakoumis

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  1. Stefania Kokkali
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Contributions

S.K., A.A. and A.P. participated in study conception and drafting of the manuscript. I.K., E.M., T.K., G.D., S.T. and N.S. participated in data acquisition and interpretation, and in critical revision. All authors have read and agreed to the published version of the manuscript.

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Correspondence to Stefania Kokkali.

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Ethics approval

Ethics committee approval was waived due to its retrospective, non-interventional nature.

Informed consent

Patient consent was waived due to its retrospective analysis of standard routine management. Furthermore, the data were provided in an anonymised format and patients cannot be identified.

Research involving human participants and/or animals

The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.

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Patient consent was waived due to its retrospective analysis of standard routine management. Furthermore, the data were provided in an anonymised format and patients cannot be identified.

Conflicts of interest

S.K., I.K., A.P. and A.A. received honoraria from Genesis Pharma outside the scope of this study.

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Kokkali, S., Kotsantis, I., Magou, E. et al. The addition of the immunomodulator mifamurtide to adjuvant chemotherapy for early osteosarcoma: a retrospective analysis. Invest New Drugs 40, 668–675 (2022). https://doi.org/10.1007/s10637-022-01225-7

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