Development and validation of a Clinical Index of Severe Febrile Neutropenia: A prospective multicenter study.
2015; Lippincott Williams & Wilkins; Volume: 33; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2015.33.15_suppl.9617
ISSN1527-7755
AutoresJuan Virizuela Echaburu, Ana Blasco, J. Pérez Martínez, Carme Font, Maite Antonio Rebollo, M. Biosca, Avinash Ramchandani, Jorge Hernando-Cubero, Eva Martínez de Castro, Javier Espinosa, Carmen Beato, Isabel Aragón Manrique, Francisco Javier García Navalón, I. Ghanem Cañete, Elena Sevillano, Aránzazu Manzano, Marcelo Garrido, Eduardo Castañón, Paula Jiménez‐Fonseca, Alberto Carmona‐Bayonas,
Tópico(s)Hematological disorders and diagnostics
Resumo9617 Background: To develop and validate a prognostic score for serious neutropenic events based on characteristics available prior to starting chemotherapy Methods: FINITE is a prospective, multicenter study to assess prognostic factors and patterns of care in adult cancer patients with seemingly stable febrile neutropenia. For this analysis, we used only those clinical variables that are routinely available on Day 1 of chemotherapy in all solid tumor patients. The main outcome measure was occurrence of serious complications. A logistic regression with Penalized Maximum Likelihood Estimations (PMLE) was applied; to build an additive score, estimates were rounded as integers. To validate the model, the bootstrap bias-corrected c-index was calculated as a measure of prediction performance. A separate dataset with 216 patients was used for external validation. Results: We enrolled 1238 patients from 25 centers. The primary end point (serious complications) ensued in 161 patients (13%; 95% CI, 11.1%-14.9%) and 21 patients died (1.7%; 95% CI, 1.1%-2.6%). We developed a Clinical Index of Severe Febrile Neutropenia(CISFN) with six baseline explanatory covariates associated with serious complications: Eastern Cooperative Oncology Group Performance Status ≥ 2 (2 points), chronic obstructive pulmonary disease (1 point), chronic cardiovascular disease (1 point), protein-energy malnutrition (1 point), chronic corticoids (1 point), and inoperable locally advanced or metastatic cancer (1 point). We integrated these predictors into a score from 0 to 7, which classifies patients into three risk groups: low (0 points), intermediate (1-2 points), and high risk ( ≥ 3 points). Complications rates were 4.1% in low, 8.7% in intermediate, and 38% in high risk groups (p < 0.001). Mortality within each class was 0.2%, 1.4%, and 4.9%, respectively (p < 0.001). This model was well calibrated (Hosmer-Lemeshow test, p > 0.1) and resulted in an optimism-corrected c-index of 0.762 (95% CI, 0.759-0.763). The validation in a separate dataset yielded a c-index of 0.745 (95% CI, 0.665-0.825). Conclusions: This study identified predictive factors for serious neutropenic events with potential implications for G-CSF prophylaxis.
Referência(s)