Caspofungin as first-line therapy of invasive aspergillosis in haematological patients: impact of baseline characteristics on response rate at end of treatment and survival
Abstract number: P1016
Maertens J., Herbrecht R., Akan H., Baila L., Doyen C., Gallamini A., Giagounidis A., Marchetti O., Martino R., Meert L., Paesmans M., Ameye L., Shivaprakash M., Ullmann A., Viscoli C.
Caspofungin (C) (70 mg day 1 and 50 mg daily thereafter) was evaluated as first-line therapy of probable/proven IA (first trial ever to strictly adhere to EORTC-MSG criteria) in 61 haematological pts receiving either standard chemotherapy or autologous HSCT (EORTC trial 65041). Confirmation of diagnosis and assessment of efficacy were performed by a Data Review Committee (DRC). The primary efficacy endpoint was the proportion of patients with complete and partial response at the end of C treatment (EOT), defined with standard response assessment criteria. Survival at day 84 was among the secondary endpoints.
In the Modified Intention to Treat analysis (including all patients with proven/probable IA receiving > 1 day of C treatment), 38 of 61 pts (62%) had acute leukaemia (mostly myeloid leukaemia) and 51 (85%) were neutropenic (<500 cells/mm3) at study entry. Forty-six patients (75%) had uncontrolled cancer. Median age was 64 years (range 1986). Fifty percent of patients had a Karnofsky score < 50. Median and mean duration of C treatment were 15 and 27 days, respectively (384). At EOT, 20 of 61 (33%) pts had a favourable outcome (95% CI 21%46%), while 9 (15%) and 31 (51%) had stable and worsening disease, respectively. Survival at day 84 was 54% (33 of 61).
The response rate at EOT was not influenced by age, gender, type of underlying haematological disease, status of the underlying disease, certainty of diagnosis of IA, site of infection or presence of baseline neutropenia; however, the median Karnofsky performance score at start of C therapy was higher (p = 0.04) in patients with a favourable outcome (median 70) compared to patients with an unfavourable outcome (median 50). Similarly, patients with stable disease had a higher performance score (p = 0.02) compared to those without disease stabilisation.
Survival at day 84 was significantly influenced by the status of the haematological disease at start of C therapy (uncontrolled cancer 40%-controlled cancer 93%; p<0.001) and by the Karnofsky score at baseline (15% survival for score <50, 57% for a score 5060 and 69% for score >60; p = 0.009).
In conclusion, we identified Karnofsky performance score and status of the underlying haematological disease as significant baseline variables for response at EOT and/or survival at day 84. In future clinical studies in IA, consideration should be given towards stratification of patients according to these baseline findings.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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