Background/Aims: The incorporation of bortezomib into the chemotherapeutic regimens for non-transplant patients with multiple myeloma resulted in improved outcomes in controlled studies. This prospective, non-interventional study assessed the effectiveness and safety of bortezomib-containing regimens in daily practice. Methods: Patients with untreated or relapsed multiple myeloma not eligible for high-dose chemotherapy followed by autologous stem cell transplantation and who were scheduled for bortezomib mono- or combination therapy or melphalan-prednisone (MP) alone were included in this study. Dosage and treatment decisions were at the discretion of the physicians. Results: 353 patients received bortezomib-containing therapies and 37 patients MP alone. Overall response rates at treatment end were 65.9% for bortezomib-containing therapies and 50.0% for MP. Partial or complete remissions considered best responses were achieved in 82.6% (first line) and 63.8% (second or later line) of the bortezomib-treated patients. The median duration of response to bortezomib-containing therapies was 18.2 months in 109 first-line and 11.3 months in 110 second- or later-line patients. Adverse drug reactions of any grade were reported during the treatment phase in 79.6% (bortezomib) and 70.3% (MP) of treated patients. Conclusion: Bortezomib-containing therapies were effective in patients with multiple myeloma in a real-life setting. The increasingly individualized treatment regimens of multiple myeloma require standardized assessments of response in daily practice.
Background: Only few data have been published regarding the frequency and type of infectious complications after high-dose therapy (HDT) and autologous blood stem cell transplantation (ASCT). The purpose of this study was to evaluate early infectious complications after this type of treatment and to identify predictive factors. Patients and Methods: The clinical data of 100 patients (50 with hematologic neoplasms, 50 with solid tumors) treated with 133 HDT-courses in a single institution were analyzed retrospectively. For 34 courses CD34+ cells were positively enriched. Results: In 86% of the courses fever occurred during neutropenia. In response to an empirical antibiotic therapy with ceftazidime and either vancomycin or flucloxacillin the patients defervesced after a median of 3 days. No invasive fungal infection was diagnosed. There was no infection-related death. Comparing hematologic neoplasms and solid tumors, a significant difference in the duration of fever was found: median 4 vs. 2 days. We observed a correlation between the duration of fever and the duration of morphin needing mucositis. Apart from a group of ‘myeloablative’ busulfan- and/or TBI-containing regimens we separated two different aggressive groups of HDT-regimens using duration of severe neutropenia and morphine-needing mucositis. A multivariate analysis demonstrated that the type of HDT-regimen is a predictive factor for the number of fever days and freedom from infection. The diagnosis (hematologic neoplasia vs. solid tumor) is predictive only for pneumonia/ pneumonitis. Conclusion: Early infectious complications after HDT and ASCT are usually not severe. The application of first-line vancomycin and amphotericin B is generally not necessary. The type of HDT-regimen has to be considered in further prospective investigations of predictive infection-related factors.
Bartikoski et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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