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  3. Prognostic factors of early mortality in children and adolescents with relapsed/refractory solid tumors participating in dose-finding trials in the targeted and immune therapies era: An ITCC study

Prognostic factors of early mortality in children and adolescents with relapsed/refractory solid tumors participating in dose-finding trials in the targeted and immune therapies era: An ITCC study

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Carceller F.
  • Bautista F.
  • Van Tinteren H.
  • Castañeda A.
  • Surun A.
  • Wasti A.
  • Revon-Rivière G.
  • Bergamaschi L.
  • Cortés M.
  • Hladun-Álvaro R.
  • Jiménez I.
  • Giraud C.
  • Millen G.
  • Campbell-Hewson Q.
  • Juan-Ribelles A.
  • Van der Lugt J.
  • Amoroso L.
  • Bertorello N.
  • Hargrave D.
  • Vega-Piris L.
  • Fagioli F.
  • Haupt R.
  • Zwaan C.M.
  • Morland B.
  • Ceraulo A.
  • Casanova M.
  • Verschuur A.
  • André N.
  • Aerts I.
  • Doz F.
  • Pearson A.D.J.
  • Marshall L.V.
  • Vassal G.
  • Kearns P.
  • Geoerger B.
  • Moreno L.

Grupos

Abstract

Introduction: Phase I/II trials are essential to introduce novel agents for children with cancer. Defining risk factors of early mortality could maximize the efficiency of such trials. Methods: Patients < 18 years with relapsed/refractory solid tumors in their first phase I/II trial were eligible in retrospect. Mortality at 30 and 90 days on treatment (30-DM, 90-DM) were calculated. Clinical/laboratory parameters and adult prognostic scores (Royal Marsden Hospital -RMH-, MD Anderson Cancer Center -MDACC-) were assessed at baseline and correlated with 90-DM (univariate analysis, logistic regression) to devise a pediatric-specific prognostic score (ITCC). Results: N = 507. Median age 11.6 years (range 0.5–17.9); 45 % females. 30-DM and 90-DM (95 %CI) were 4.7 % (3.1–7.0 %) and 22.9 % (19.3–26.8 %), respectively. RMH (n = 348) and MDACC (n = 345) scores correlated with 90-DM (p < 0.001). Performance status = 80 %, no school attendance and lactate dehydrogenase (LDH) above normal levels strongly correlated with higher 90-DM, constituting the ITCC score (1 point each). The 90-DM with ITCC score (n = 306) of 0, 1, 2 and 3 was 2.7 %, 10.7 %, 36.4 % and 80.0 %, respectively. Odds ratios (95 %CI) for 90-DM with 1, 2 and 3 points were 4.23 (1.28–19.1); 20.0 (6.55–87.4); and 140 (37.4–720), respectively. Among patients with predicted risk of 90-DM = 75 %, those who ultimately died within 90 days represented 1.4 % (RMH, MDACC) versus 7.8 % (ITCC) of the sample; p < 0.001. Conclusions: The early mortality rates reported here will serve as a reference for future phase I/II trials. Risk scoring based on performance status, school attendance and LDH levels can estimate 90-DM in oncology phase I/II trials. © 2025 Elsevier Ltd

Datos de la publicación

ISSN/ISSNe:
0959-8049, 1879-0852

EUROPEAN JOURNAL OF CANCER  ELSEVIER SCI LTD

Tipo:
Article
Páginas:
-
PubMed:
40749414
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
2,865 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • Adolescent; Child; Child, Preschool; Clinical Trials, Phase I as Topic; Female; Humans; Immunotherapy; Infant; Male; Neoplasm Recurrence, Local; Neoplasms; Prognosis; Retrospective Studies; Risk Factors; antineoplastic agent; cytotoxic agent; immunological antineoplastic agent; lactate dehydrogenase; oncolytic virus; adolescent; Article; cancer center; cancer immunotherapy; cancer mortality; cancer prognosis; cancer recurrence; child; controlled study; correlation analysis; dose calculation; female; human; infant; major clinical study; male; molecularly targeted therapy; mortality rate; mortality risk; multicenter study (topic); pediatric patient; phase 1 clinical trial (topic); phase 2 clinical trial (topic); prognostic assessment; refractory cancer; retrospective study; school attendance; solid tumor; drug therapy; immunotherapy; mortality; neoplasm; pathology; preschool child; procedures; prognosis; risk factor; tumor recurrence

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