Short-term and long-term prognostic value of histological response and intensified chemotherapy in osteosarcoma: a retrospective reanalysis of the BO06 trial.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
10 05 2022
Historique:
entrez: 10 5 2022
pubmed: 11 5 2022
medline: 14 5 2022
Statut: epublish

Résumé

Cure rate models accounting for cured and uncured patients, provide additional insights into long and short-term survival. We aim to evaluate the prognostic value of histological response and chemotherapy intensification on the cure fraction and progression-free survival (PFS) for the uncured patients. Retrospective analysis of a randomised controlled trial, MRC BO06 (EORTC 80931). Population-based study but proposed methodology can be applied to other trial designs. A total of 497 patients with resectable highgrade osteosarcoma, of which 118 were excluded because chemotherapy was not started, histological response was not reported, abnormal dose was reported or had disease progression during treatment. Two regimens with the same anticipated cumulative dose (doxorubicin 6×75 mg/m The primary outcome is PFS computed from end of treatment because cure, if it occurs, may happen at any time during treatment. A mixture cure model is used to study the effect of histological response and intensified chemotherapy on the cure status and PFS for the uncured patients. Histological response is a strong prognostic factor for the cure status (OR 3.00, 95% CI 1.75 to 5.17), but it has no clear effect on PFS for the uncured patients (HR 0.78, -95% CI 0.53 to 1.16). The cure fractions are 55% (46%-63%) and 29% (22%-35%), respectively, among patients with good and poor histological response (GR, PR). The intensified regimen was associated with a higher cure fraction among PR (OR 1.90, 95% CI 0.93 to 3.89), with no evidence of effect for GR (OR 0.78, 95% CI 0.38 to 1.59). Accounting for cured patients is valuable in distinguishing the covariate effects on cure and PFS. Estimating cure chances based on these prognostic factors is relevant for counselling patients and can have an impact on treatment decisions. ISRCTN86294690.

Identifiants

pubmed: 35537786
pii: bmjopen-2021-052941
doi: 10.1136/bmjopen-2021-052941
pmc: PMC9092180
doi:

Banques de données

ISRCTN
['ISRCTN86294690']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e052941

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Eni Musta (E)

Korteweg-de Vries Institute for Mathematics, University of Amsterdam, Amsterdam, The Netherlands e.musta@uva.nl.

Nan van Geloven (N)

Department of Biomedical Data Science, Leiden University Medical Center, Leiden, The Netherlands.

Jakob Anninga (J)

Department of Solid Tumours, Princess Máxima Centre, Utrecht, The Netherlands.

Hans Gelderblom (H)

Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.

Marta Fiocco (M)

Department of Biomedical Data Science, Leiden University Medical Center, Leiden, The Netherlands.
Department of Solid Tumours, Princess Máxima Centre, Utrecht, The Netherlands.
Mathematical Institute, Leiden University, Leiden, The Netherlands.

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