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- Bielack, Stefan S, et al.
(författare)
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Methotrexate, Doxorubicin, and Cisplatin (MAP) Plus Maintenance Pegylated Interferon Alfa-2b Versus MAP Alone in Patients With Resectable High-Grade Osteosarcoma and Good Histologic Response to Preoperative MAP: First Results of the EURAMOS-1 Good Response Randomized Controlled Trial
- 2015
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Ingår i: Journal of Clinical Oncology. - 1527-7755. ; 33:20, s. 2279-2287
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Tidskriftsartikel (refereegranskat)abstract
- Purpose EURAMOS-1, an international randomized controlled trial, investigated maintenance therapy with pegylated interferon alfa-2b (IFN-α-2b) in patients whose osteosarcoma showed good histologic response (good response) to induction chemotherapy. Patients and Methods At diagnosis, patients age ≤ 40 years with resectable high-grade osteosarcoma were registered. Eligibility after surgery for good response random assignment included ≥ two cycles of preoperative MAP (methotrexate, doxorubicin, and cisplatin), macroscopically complete surgery of primary tumor, < 10% viable tumor, and no disease progression. These patients were randomly assigned to four additional cycles MAP with or without IFN-α-2b (0.5 to 1.0 μg/kg per week subcutaneously, after chemotherapy until 2 years postregistration). Outcome measures were event-free survival (EFS; primary) and overall survival and toxicity (secondary). Results Good response was reported in 1,041 of 2,260 registered patients; 716 consented to random assignment (MAP, n = 359; MAP plus IFN-α-2b, n = 357), with baseline characteristics balanced by arm. A total of 271 of 357 started IFN-α-2b; 105 stopped early, and 38 continued to receive treatment at data freeze. Refusal and toxicity were the main reasons for never starting IFN-α-2b and for stopping prematurely, respectively. Median IFN-α-2b duration, if started, was 67 weeks. A total of 133 of 268 patients who started IFN-α-2b and provided toxicity information reported grade ≥ 3 toxicity during IFN-α-2b treatment. With median follow-up of 44 months, 3-year EFS for all 716 randomly assigned patients was 76% (95% CI, 72% to 79%); 174 EFS events were reported (MAP, n = 93; MAP plus IFN-α-2b, n = 81). Hazard ratio was 0.83 (95% CI, 0.61 to 1.12; P = .214) from an adjusted Cox model. Conclusion At the preplanned analysis time, MAP plus IFN-α-2b was not statistically different from MAP alone. A considerable proportion of patients never started IFN-α-2b or stopped prematurely. Long-term follow-up for events and survival continues.
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- Galderisi, Maurizio, et al.
(författare)
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Recommendations of the European Association of Echocardiography : how to use echo-Doppler in clinical trials
- 2011
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Ingår i: European Journal of Echocardiography. - : Oxford University Press (OUP). - 1525-2167 .- 1532-2114. ; 12:5, s. 339-353
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Tidskriftsartikel (refereegranskat)abstract
- The European Association of Echocardiography (EAE) has developed the present recommendations to assist clinical researchers in the design, implementation, and conduction of echocardiographic protocols for clinical trials and to guarantee their quality. Clinical trials should be designed and conducted based on the knowledge of the pathophysiology of the clinical condition studied, the technical characteristics of the echo-Doppler modalities, and the variability of the tested parameters. These procedures are important to choose the most reliable and reproducible techniques and parameters. Quality assurance must be guaranteed by adequate training of peripheral site operators to obtain optimal echo-Doppler data and by using a core laboratory for accurate and reproducible data analysis.
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- Queiros, Sandro, et al.
(författare)
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Multi-centre validation of an automatic algorithm for fast 4D myocardial segmentation in cine CMR datasets
- 2016
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Ingår i: European Heart Journal Cardiovascular Imaging. - : OXFORD UNIV PRESS. - 2047-2404 .- 2047-2412. ; 17:10, s. 1118-1127
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Tidskriftsartikel (refereegranskat)abstract
- Aims Quantitative analysis of cine cardiac magnetic resonance (CMR) images for the assessment of global left ventricular morphology and function remains a routine task in clinical cardiology practice. To date, this process requires user interaction and therefore prolongs the examination (i.e. cost) and introduces observer variability. In this study, we sought to validate the feasibility, accuracy, and time efficiency of a novel framework for automatic quantification of left ventricular global function in a clinical setting. Methods and results Analyses of 318 CMR studies, acquired at the enrolment of patients in a multi-centre imaging trial (DOPPLER-CIP), were performed automatically, as well as manually. For comparative purposes, intra-and inter-observer variability was also assessed in a subset of patients. The extracted morphological and functional parameters were compared between both analyses, and time efficiency was evaluated. The automatic analysis was feasible in 95% of the cases (302/318) and showed a good agreement with manually derived reference measurements, with small biases and narrow limits of agreement particularly for end-diastolic volume (-4.08 +/- 8.98 mL), end-systolic volume (1.18 +/- 9.74 mL), and ejection fraction (-1.53 +/- 4.93%). These results were comparable with the agreement between two independent observers. A complete automatic analysis took 5.61 +/- 1.22 s, which is nearly 150 times faster than manual contouring (14 +/- 2 min, P amp;lt; 0.05). Conclusion The proposed automatic framework provides a fast, robust, and accurate quantification of relevant left ventricular clinical indices in real-world cine CMR images.
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