Dataset Information

Disease progression in osteosarcoma: a multistate model for the EURAMOS-1 (European and American Osteosarcoma Study) randomised clinical trial.

ABSTRACT:

Objectives

Investigating the effect of prognostic factors in a multistate framework on survival in a large population of patients with osteosarcoma. Of interest is how prognostic factors affect different disease stages after surgery, with stages of local recurrence (LR), new metastatic disease (NM), LR+NM, secondary malignancy, a second NM, and death.

Design

An open-label, international, phase 3 randomised controlled trial.

Setting

325 sites in 17 countries.

Participants

The subset of 1631 metastases-free patients from 1965 patients with high-grade resectable osteosarcoma, from the European and American Osteosarcoma Study.

Main outcome measures

The effect of prognostic factors on different disease stages, expressed as HRs; predictions of disease progression on an individual patient basis, according to patient-specific characteristics and history of intermediate events.

Results

Of 1631 patients, 526 experienced an intermediate event, and 305 died by the end of follow-up. An axial tumour site substantially increased the risk of LR after surgery (HR=10.84, 95% CI 8.46 to 13.86) and death after LR (HR=11.54, 95% CI 6.11 to 21.8). A poor histological increased the risk of NM (HR=5.81, 95% CI 5.31 to 6.36), which sharply declined after 3 years since surgery. Young patients (<12 years) had a lower intermediate event risk (eg, for LR: HR=0.66, 95% CI 0.51 to 0.86), when compared with adolescents (12-18 years), but had an increased risk of subsequent death, while patients aged >18 had a decreased risk of death after event (eg, for death after LR: HR=2.40, 95% CI 1.52 to 3.90; HR=0.35, 95% CI 0.21 to 0.56, respectively).

Conclusions

Our findings suggest that patients with axial tumours should be monitored for LR and patients with poor histological response for NM, and that for young patients (<12) with an LR additional treatment options should be investigated.

Trial registration number

NCT00134030.

SUBMITTER: Hazewinkel AD

PROVIDER: S-EPMC8900028 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Disease progression in osteosarcoma: a multistate model for the EURAMOS-1 (European and American Osteosarcoma Study) randomised clinical trial.

Hazewinkel Audinga-Dea AD Lancia Carlo C Anninga Jakob J van de Sande Michiel M Whelan Jeremy J Gelderblom Hans H Fiocco Marta M

BMJ open 20220304 3

<h4>Objectives</h4>Investigating the effect of prognostic factors in a multistate framework on survival in a large population of patients with osteosarcoma. Of interest is how prognostic factors affect different disease stages after surgery, with stages of local recurrence (LR), new metastatic disease (NM), LR+NM, secondary malignancy, a second NM, and death.<h4>Design</h4>An open-label, international, phase 3 randomised controlled trial.<h4>Setting</h4>325 sites in 17 countries.<h4>Participants ...[more]

PMID: 35246418

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Dataset Information

Disease progression in osteosarcoma: a multistate model for the EURAMOS-1 (European and American Osteosarcoma Study) randomised clinical trial.

Objectives

Design

Setting

Participants

Main outcome measures

Results

Conclusions

Trial registration number

Publications

Disease progression in osteosarcoma: a multistate model for the EURAMOS-1 (European and American Osteosarcoma Study) randomised clinical trial.

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