Caspofungin (C) as first-line therapy of invasive aspergillosis (IA) in haematological patients (pts): a study of the EORTC Infectious Diseases Group

Viscoli, C., Herbrecht, R., Akan, H., Baila, L., Doyen, C., Gallamini, A., Giagounidis, A., Marchetti, O., Martino, R., Meerts, L., Paesmans, M., Shivaprakash, M., Ullmann, A.J., Maertens, J.

Author address: 

Infectious Disease Group of the EORTC

Abstract: 

C (70 mg day 1 and 50 mg daily thereafter) was evaluated as first-line therapy of probable/proven IA in 61 haematological pts receiving either standard chemotherapy or an autologous BMT procedure (allo BMT pts excluded). Unlike previous studies, probable/proven IA was defined strictly according to EORTC/MSG criteria (pts with halo or air crescent sign only not included). Pts with possible IA were included only if upgraded to probable/proven within 7 days from enrolment, based on tests performed prior to or within 48 hours after registration. Confirmation of diagnosis and assessment of efficacy were performed by an independent Data Review Committee (DRC). The primary efficacy endpoint was complete or partial response at the end of C treatment (EOT), defined with standard (as in previous studies) response assessment criteria. Secondary endpoints included: (1) overall response at day 84 using standard response criteria, (2) overall response at EOT and day 84 using alternative response criteria (RECIST), (3) 84-days survival and (4) safety. Based on response rates (RR) observed in previous studies and according to a "œFleming’s" study design, 52 eligible and evaluable pts were needed to show that the true RR was higher that 35% (with a power of 90% in case of a true RR of 55%). To recommend the drug for further investigation for this indication (i.e. to reject the null hypothesis of a true RR of 35% or lower) 23 or more complete or partial responses were required (observed RR 44%). At the end of the study, more than 52 eligible pts were included. Therefore, results will be shown both in the overall population (61 pts) and in the first 52 pts enrolled. In the Modified Intention to Treat analysis, 38 of 61 pts (62%) had acute leukaemia (mostly myeloid leukaemia) and 51 (85%) were neutropenic (
2007

abstract No: 

O.12

Full conference title: 

3rd Trends in Medical Mycology
    • TIMM 3rd (2011)