We describe herein 98 hematopoietic stem cell transplant (HSCT) recipients with invasive aspergillosis (IA) (refractory in 83) who received micafungin either alone (8 patients) or in combination with other licensed antifungal therapies (OLAT) (90 patients). Of the 8 monotherapy patients, 4 were failing OLAT, received de novo micafungin, or were intolerant to prior OLAT (2 patients each). Of the 90 patients treated with combination, 7 had de novo IA and 83 had refractory infection. Most patients (81) had pulmonary IA, 42 (43%) had graft-versus-host disease (GVHD), and 26 (27%) were neutropenic (absolute neutrophil count <500 cells/mm(3)) at onset of treatment. Successful response was seen in 25/98 (26%); an additional 12 patients achieved stable disease. Response was seen in 2/9 (22%) in de novo treatment, 21/87 (24%) in refractory patients, and 2/2 (100%) in toxicity failure patients. Additionally, response was seen in 22 of the 90 (24%) patients treated with combination therapy, and in 3 of 8 (38%) patients who were treated with micafungin alone. No significant differences in responses were found based on type of HSCT, GVHD status, site of IA, or Aspergillus species, and no significant toxicity was seen. Micafungin was well tolerated, even at high doses, and is a reasonable option for treatment of IA in this high-risk patient population.
Aims:The MOSAIC trial showed that FOLFOX4 improves overall survival as compared to 5-FU/LV and is feasible and safe in early stage colon cancer patients worldwide. Based on these positive results, the present study MASCOT (Multicenter Asia Study in adjuvant treatment of Colon cancer with Oxalipla Tin/5-FU/LV), aimed to evaluate the safety and tolerability of FOLFOX4 in postoperative adjuvant treatment of colon cancer in Asian patients.
Methods:In this open-label, non-randomized, single arm feasibility study, stage II/III colon cancer patients who had undergone complete resection of a primary tumor were treated using the FOLFOX4 regimen (2 weeks/cycle, 12 cycles) and followed up for 12 months. Results: A total of 159 patients (28.3% stage II and 71.7% stage III) from 17 hospitals in five Asian countries were included in the study. Overall 130 (81.8%) patients completed all 12 planned treatment cycles. There were 60% and 11% patients who experienced Ն grade 3 pre-listed and non pre-listed toxicities, respectively. The incidences of grade 3 and 4 neuropathy were 5.7% and 0%, respectively. A total of 25 serious adverse events (SAE) were experienced by 21 (13%) patients, with one life-threatening SAE. At 12 months follow-up two patients were known to be dead due to disease relapse or recurrence. Conclusion: The MASCOT study demonstrates a favorable safety profile of FOLFOX4 in Asian patients. Based on these results and the safety and efficacy results from MOSAIC, FOLFOX4 may be considered a standard for the adjuvant treatment of colon cancer in the Asian population.
The objective of this study was to assess the psychometric properties of the Thai version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0. The questionnaire was completed by 310 cancer patients during their follow-up at 2 teaching hospital oncology clinics. About 70% of participants had advanced stage of cancer and 72% had been receiving chemotherapy. Cronbach's alpha coefficients of the six scales were above 0.7, except for cognitive and social function scales. All test-retest reliability coefficients were high. Multi trait scaling analysis showed that all item-scale correlation coefficients met the standards of convergent and discriminant validity. Most scales and items could discriminate between subgroups of patients with different clinical status assessed with the Eastern Cooperative Oncology Group (ECOG) scale. The results suggested that the EORTC QLQ-C30 and the Functional Assessment of Cancer Therapy - General (FACT-G) measured different aspects of quality of life and should be independently used. Testing psychometric properties of the EORTC QLQ-C30 in heterogeneous diagnostic group yield similar results as found in homogeneous group. These results support that the EORTC QLQ-C30 (version 3.0) has proven to be a reliable and valid measure of the quality of life in Thai patients with various types of cancer.
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