Resumen En este trabajo se estudia la estructura de datos con riesgos semicompetitivos definida por Fine et al. (2001). En esta estructura existen dos eventos de interés; uno intermedio y otro terminal, este último puede censurar el evento intermedio, pero no viceversa. Dada la posible dependencia, entre los tiempos hasta la ocurrencia de tales eventos, dos tipos de enfoques son evaluados: uno, modelando la función de supervivencia bivariada a través de cópulas Arquimedianas y el otro por medio de un modelo con fragilidad compartida. El desempeño se observa a través de simulación. Ambos enfoques son aplicados a un conjunto de datos reales de pacientes con insuficiencia renal crónica, que pueden o no presentar una recaída de la enfermedad luego de ser tratados con diálisis.

Abstract In this paper, the structure of semicompeting risks data, defined by Fine, Jiang & Chappell (2001), is studied. Two events are of interest: a nonterminal and a terminal event, the last one, can censor the non-terminal event, but not vice versa. Due to the possible dependence between the times until the occurrence of such events, two approaches are evaluated: modelling the bivariate survival function through Archimedean copulas and a shared frailty model. A simulation is conducted to examine its performance and both approaches are applied to a real data set of patients with chronic kidney disease (CKD).

ABSTRACT Background: Peripheral blood stem cell concentrations are traditionally adjusted to 20–40 × 106 leukocytes/mL prior to freezing. This low cell concentration at cryopreservation implies larger volumes with more dimethyl sulfoxide being used, and higher cost and toxicity at the time of transplant. Higher cell concentrations have been reported but this is not widely accepted. Moreover, the influence of cell concentration on engraftment has not been well documented. Therefore, this study retrospectively analyzed the influence of peripheral blood stem cell concentration at freezing on engraftment after autologous hematopoietic stem cell transplantation. Method: Leukapheresis products were plasma-depleted and cryopreserved with 5% dimethyl sulfoxide, 6% hydroxyethylamide solution and 4% albumin in a −80 °C freezer. Individual patient data from hospital records were reviewed. Results: Fifty consecutive patients with oncological diseases underwent 88 leukaphereses. Median age was six years (range: 1–32 years) and median weight was 19 kg (range: 8–94 kg). Median leukocyte concentration was 109 × 106/mL at collection and 359 × 106 (range: 58–676 × 106) at freezing with 78% viability (range: 53–95%); leukocyte recovery after thawing was 95% (range: 70–100%). In multivariate analysis, cell concentration (p-value = 0.001) had a negative impact on engraftment. Patients infused with bags frozen with <200 × 106 leukocytes/mL engrafted after a median of nine days (range: 8–12 days), 200–400 × 106 leukocytes/mL after 11 days (range: 9–20 days); 400–600 × 106 leukocytes/mL after 12 days (range: 8–19 days) and with cell concentrations >600 × 106 leukocytes/mL, engraftment was after 14 days (range: 13–22 days). Conclusion: In patients with adequate CD34 cell collections, total leukocyte concentrations of 282 × 106/mL, freezing with 5% dimethyl sulfoxide and 6% hydroxyethylamide solution without a controlled-rate freezer, and storing cells at −80 ºC yielded excellent engraftment. Further increases in cell concentration may delay engraftment, without affecting safety.