Annals of oncology : official journal of the European Society for Medical Oncology
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Multicenter Study
A multinational phase II trial of bevacizumab with low-dose interferon-α2a as first-line treatment of metastatic renal cell carcinoma: BEVLiN.
Avastin and Roferon in Renal Cell Carcinoma (AVOREN) demonstrated efficacy for bevacizumab plus interferon-α2a (IFN; 9 MIU tiw) in first-line metastatic renal cell carcinoma (mRCC). We evaluated bevacizumab with low-dose IFN in mRCC to determine whether clinical benefit could be maintained with reduced toxicity. ⋯ Compared with a historical control AVOREN subgroup, low-dose IFN with bevacizumab resulted in a reduction in incidence rates of IFN-related AEs, without compromising efficacy [NCT00796757].
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To determine the frequency and predictive impact of ROS1 rearrangements on treatment outcomes in never-smoking patients with lung adenocarcinoma. ⋯ The frequency of ROS1 rearrangements in clinically selected patients is higher than that reported for unselected patients, suggesting that ROS1 rearrangement is a druggable target in East-Asian never smokers with lung adenocarcinoma. Given the different treatment outcomes to conventional therapies and availability of ROS1 inhibitors, identification of ROS1 rearrangement can lead to successful treatment in ROS1-rearranged lung adenocarcinomas.
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Randomized Controlled Trial Multicenter Study
A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC).
Combined inhibition of vascular, platelet-derived, and epidermal growth factor receptor (EGFR) pathways may overcome refractoriness to single agents in platinum-pretreated non-small-cell lung cancer (NSCLC). ⋯ The addition of sunitinib to erlotinib did not significantly improve PFS in patients with advanced, platinum-pretreated NSCLC.
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Biopharmaceuticals are complex protein molecule drugs produced by living organisms. Biopharmaceuticals as anti-neoplastic monoclonal antibodies are a major breakthrough in oncology. When the patent of innovator biopharmaceuticals expires, copies will be introduced. ⋯ Moreover, all indications for an anti-neoplastic biosimilar antibody may not have been tested for at the time of approval but extrapolated based on the indications of the reference monoclonal antibody. The limited information on biosimilar anti-neoplastic monoclonal antibodies at approval may still be justified taking into account that the aim is to reduce price. However, the risk-benefit ratio for biosimilar anti-neoplastic monoclonal antibodies should be carefully evaluated, considering that anti-neoplastic monoclonal antibody therapy has a curative intent, price reduction so far within EU of biosimilars is modest and that in the end only part of the total costs for cancer health care is related to biopharmaceuticals.