European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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Randomized Controlled Trial Multicenter Study
How to switch from morphine or oxycodone to methadone in cancer patients? a randomised clinical phase II trial.
Opioid switching is a treatment strategy in cancer patients with unacceptable pain and/or adverse effects (AEs). We investigated whether patients switched to methadone by the stop and go (SAG) strategy have lower pain intensity (PI) than the patients switched over three days (3DS), and whether the SAG strategy is as safe as the 3DS strategy. ⋯ The SAG patients reported a trend of more pain, had significantly more dropouts and three SAEs, which indicate that the SAG strategy should not replace the 3DS when switching from high doses of morphine or oxycodone to methadone.
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The number of cancer-related clinical trials has been rapidly increasing over the past decade. Along with this increase, oncology studies stopped early for benefit or harm have also been more common. ⋯ This review article explains the role of the Data and Safety Monitoring Committee in stopping trials early; provides examples of oncology trials stopped early; and reviews some of the controversies and statistical concepts associated with early stopping rules. In addition, a simple and practical approach to interpreting the findings of trials that are stopped early is provided to assist clinicians in deciding how to incorporate information from these studies into their daily practice.
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Axitinib (AG-013736) is an oral, selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, 2 and 3. This phase II study investigated axitinib efficacy, safety and biomarkers in Japanese patients with cytokine-refractory metastatic renal cell carcinoma (mRCC). ⋯ Axitinib showed significant antitumour activity and was well tolerated in Japanese mRCC patients. Baseline proteinuria and soluble VEGFR-2 levels may be key indicators of axitinib-induced proteinuria and efficacy, respectively.
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Randomized Controlled Trial
Influence of body mass index on outcome in advanced colorectal cancer patients receiving chemotherapy with or without targeted therapy.
Obesity is associated with an increased risk of development and recurrence of colorectal cancer. However, the role of obesity in advanced colorectal cancer (ACC) patients is unknown. We investigated the effect of body mass index (BMI) on overall survival (OS) in ACC patients receiving systemic treatment in two large phase III studies (CAIRO and CAIRO2). ⋯ These results show that BMI is an independent prognostic factor for survival in patients receiving chemotherapy, but not in patients receiving chemotherapy and targeted therapy. The possible decreased efficacy of bevacizumab in obese patients may explain this discrepant result. The role of BMI in patients receiving targeted therapy should be further tested.