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      Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

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          Abstract

          Purpose Provide evidence-based recommendations updating the 2015 ASCO guideline on systemic therapy for patients with stage IV non-small-cell lung cancer (NSCLC). Methods The ASCO NSCLC Expert Panel made recommendations based on a systematic review of randomized controlled trials from February 2014 to December 2016 plus the Cancer Care Ontario Program in Evidence-Based Care's update of a previous ASCO search. Results This guideline update reflects changes in evidence since the previous guideline update. Fourteen randomized controlled trials provide the evidence base; earlier phase trials also informed recommendation development. Recommendations New or revised recommendations include the following. Regarding first-line treatment for patients with non-squamous cell carcinoma or squamous cell carcinoma (without positive markers, eg, EGFR/ALK /ROS1), if the patient has high programmed death ligand 1 (PD-L1) expression, pembrolizumab should be used alone; if the patient has low PD-L1 expression, clinicians should offer standard chemotherapy. All other clinical scenarios follow 2015 recommendations. Regarding second-line treatment in patients who received first-line chemotherapy, without prior immune checkpoint therapy, if NSCLC tumor is positive for PD-L1 expression, clinicians should use single-agent nivolumab, pembrolizumab, or atezolizumab; if tumor has negative or unknown PD-L1 expression, clinicians should use nivolumab or atezolizumab. All immune checkpoint therapy is recommended alone plus in the absence of contraindications. For patients who received a prior first-line immune checkpoint inhibitor, clinicians should offer standard chemotherapy. For patients who cannot receive immune checkpoint inhibitor after chemotherapy, docetaxel is recommended; in patients with nonsquamous NSCLC, pemetrexed is recommended. In patients with a sensitizing EGFR mutation, disease progression after first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy, and T790M mutation, osimertinib is recommended; if NSCLC lacks the T790M mutation, then chemotherapy is recommended. Patients with ROS1 gene rearrangement without prior crizotinib may be offered crizotinib, or if they previously received crizotinib, they may be offered chemotherapy.

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          Checkpoint Inhibitors in Metastatic EGFR-Mutated Non-Small Cell Lung Cancer-A Meta-Analysis.

          We performed a meta-analysis to assess the role of immune checkpoint inhibitors as second-line therapy in EGFR-mutant advanced NSCLC.
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            Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study.

            Osimertinib (AZD9291) is an oral, potent, irreversible EGFR tyrosine-kinase inhibitor selective for EGFR tyrosine-kinase inhibitor sensitising mutations, and the EGFR Thr790Met resistance mutation. We assessed the efficacy and safety of osimertinib in patients with EGFR Thr790Met-positive non-small-cell lung cancer (NSCLC), who had progressed after previous therapy with an approved EGFR tyrosine-kinase inhibitor.
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              How quickly do systematic reviews go out of date? A survival analysis.

              Systematic reviews are often advocated as the best source of evidence to guide clinical decisions and health care policy, yet we know little about the extent to which they require updating. To estimate the average time to changes in evidence that are sufficiently important to warrant updating systematic reviews. Survival analysis of 100 quantitative systematic reviews. Systematic reviews published from 1995 to 2005 and indexed in ACP Journal Club. Eligible reviews evaluated a specific drug or class of drug, device, or procedure and included only randomized or quasi-randomized, controlled trials. Quantitative signals for updating were changes in statistical significance or relative changes in effect magnitude of at least 50% involving 1 of the primary outcomes of the original systematic review or any mortality outcome. Qualitative signals included substantial differences in characterizations of effectiveness, new information about harm, and caveats about the previously reported findings that would affect clinical decision making. The cohort of 100 systematic reviews included a median of 13 studies and 2663 participants per review. A qualitative or quantitative signal for updating occurred for 57% of reviews (95% CI, 47% to 67%). Median duration of survival free of a signal for updating was 5.5 years (CI, 4.6 to 7.6 years). However, a signal occurred within 2 years for 23% of reviews and within 1 year for 15%. In 7%, a signal had already occurred at the time of publication. Only 4% of reviews had a signal within 1 year of the end of the reported search period; 11% had a signal within 2 years of the search. Shorter survival was associated with cardiovascular topics (hazard ratio, 2.70 [CI, 1.36 to 5.34]) and heterogeneity in the original review (hazard ratio, 2.15 [CI, 1.12 to 4.11]). Judgments of the need for updating were made without involving content experts. In a cohort of high-quality systematic reviews directly relevant to clinical practice, signals for updating occurred frequently and within a relatively short time.
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                Author and article information

                Journal
                Journal of Clinical Oncology
                JCO
                American Society of Clinical Oncology (ASCO)
                0732-183X
                1527-7755
                October 20 2017
                October 20 2017
                : 35
                : 30
                : 3484-3515
                Article
                10.1200/JCO.2017.74.6065
                28806116
                193df519-a68e-4477-9e1b-e8ea5c86cdb9
                © 2017
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