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Multicenter Study
. 2024 Jun 19;24(1):747.
doi: 10.1186/s12885-024-12498-x.

Prolonged 14-day continuous infusion of high-dose ifosfamide for patients with relapsed and refractory high-grade osteosarcoma: a retrospective multicentre cohort study

Elisa Tirtei  1   2 , Anna Campello  3 , Veronica Sciannameo  4 , Sebastian Dorin Asaftei  1 , Cristina Meazza  5 , Giovanna Sironi  5 , Alessandra Longhi  6 , Toni Ibrahim  6 , Angela Tamburini  7 , Luca Coccoli  8 , Fanj Crocco  9 , Celeste Cagnazzo  1 , Elvira De Luna  1 , Paola Quarello  1   2 , Paola Berchialla  10 , Franca Fagioli  1   2
Affiliations
Multicenter Study

Prolonged 14-day continuous infusion of high-dose ifosfamide for patients with relapsed and refractory high-grade osteosarcoma: a retrospective multicentre cohort study

Elisa Tirtei et al. BMC Cancer. .

Abstract

Background: The prognosis of patients with Relapsed/Refractory Osteosarcoma (R/R OS) remains dismal without an agreement on systemic therapy. The use of High-Dose Ifosfamide (14 g/sqm) with an external pump in outpatient setting (14-IFO) in R/R OS patients is limited. This study represents the first retrospective cohort analysis focused on evaluating the activity and toxicity of 14-IFO in this setting.

Patients and methods: The study investigated 14-IFO activity, in terms of tumour response according to RECIST 1.1 criteria, as well as survival rates and toxicity, according to CTCAE v.5.

Results: The trial enrolled 26 patients with R/R OS. The Overall Response Rate (ORR) and Disease Control Rate (DCR) obtained was 23% and 57.5%, respectively. Patients with relapsed OS showed a higher ORR (45%) and DCR (82%) compared to refractory patients, irrespective of the number of prior treatment lines received. The achievement of disease control with 14-IFO administration enabled 27% of patients to undergo new local treatment. Four-month Progression-Free Survival (PFS) was 54% for all patients and 82% for the relapsed OS sub-group. Median Overall Survival (OSurv) was 13.7 months, with 1-year OSurv of 51% for all patients and 71% for relapsed patients. Age over 18 years and the presence of refractory disease were identified as negative prognostic factors for this patient cohort. A total of 101 cycles were evaluated for toxic assessment, demonstrating a tolerable profile without grade 3-4 non-haematological toxicities.

Conclusions: 14-IFO should be considered a viable treatment option for R/R OS, particularly due to its well tolerated toxicity profile and the potential for home-administration, which can improve patient quality of life without compromising efficacy.

Keywords: Chemotherapy; Ifosfamide; Osteosarcoma; Relapse.

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Conflict of interest statement

The authors declare no competing interests.

The authors have declared no potential conflicts of interest.

Figures

Fig. 1
Fig. 1
CT Scan images showing complete response according to RECIST Criteria v1.1 in a patient with relapses OS after 3 14-IFO cycles
Fig. 2
Fig. 2
Kaplan-Meier curve for Progression Free Survival (A), Progression Free Survival according to status pre 14-IFO (B), Overall Survival (C), Overall Survival according to status pre 14-IFO (D)
See this image and copyright information in PMC

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