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• W2746495642 abstract "EGFR-mutated lung cancer; ASCO: EGFR-mutated lung cancer; ASCOOsimertinib should be considered the treatment of choice as second-line or third-line treatment in EGFR T790M-mutated non-small cell lung cancer (NSCLC). As an oral irreversible EGFR tyrosine kinase inhibitor (TKI), osimertinib had promising results in patients with EGFR T790M resistance mutation of NSCLC. A new study compared efficacy and toxicities of osimertinib versus docetaxel-bevacizumab as third-line treatment in EGFR T790M-mutated NSCLC, reported Keke Nie, MD, of Qingdao Central Hospital, Qingdao University, Qingdao, China, at the 2017 ASCO Annual Meeting (Abstract 9017). EGFR Study Results Abstract 9017/9018 In this phase III, open-label, three-center study, Nie and colleagues randomly assigned patients previously treated with TKI-chemotherapy or chemotherapy-TKI recurrent or metastatic advanced non-squamous lung cancer who had acquired EGFR T790M resistance mutation, which was confirmed by tumor tissues or serum genetic test. Patients were randomly assigned to receive oral osimertinib 80 mg per day or IV infusion docetaxel 75 mg/m2 and bevacizumab 7.5 mg/kg until disease progression or unacceptable toxic effects. Docetaxel-bevacizumab group patients might crossover to osimertinib group after disease progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were response rates, toxicities, and overall survival. A total of 147 patients, median age 49 years, was treated, including 74 patients in the osimertinib group and 73 patients in the docetaxel-bevacizumab group. The median PFS was 10.2 months in the osimertinib group and 2.95 months in the docetaxel-bevacizumab group. The median overall survival time was not reached in both groups. The overall response rate (ORR) and disease control rate was 61.6 percent or 87.6 percent in osimertinib group and 8.3 percent or 43 percent in docetaxel-bevacizumab group, respectively. Among the 74 patients who received osimertinib, 41 patients had EGFR del 19 and T790M mutation and 33 patients had L858R mutation plus T790M mutation. The median PFS was 9.54 months in the del 19 plus T790M group as compared to 10.97 months in the L858R plus T790M group. The median overall survival time was not reached. The main grade 3 or 4 toxic effects were diarrhea (2.7%) and interstitial lung disease (1.2%) in the osimertinib group, and alopecia (15.1%), anorexia (12.3%), neutropenia (9.6%), and nausea (8.6%) in docetaxel-bevacizumab group. “In third-line treatment of EGFR T790M-positive NSCLC, the osimertinib patients had a high response rate, prolonged PFS, and limited toxicities compared to the docetaxel-bevacizumab group,” Nie explained. “There was no survival difference between patients with EGFR 19 Del-T790M mutation and EGFR L858R-T790M mutation.” ASCO Discussant Myung-Ju Ahn, MD, PhD, of the Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, said the results compare favorably with several other phase I and phase II trials and those in the second-line setting in terms of response rate and PFS when comparing osimertinib against docetaxel and bevacizumab.Myung-Ju Ahn, MD, PhD: Myung-Ju Ahn, MD, PhD“Osimertinib still shows significant improvement of ORR and PFS compared to docetaxel plus bevacizumab as third-line therapy in T790M NSCLC patients, which is consistent with previous results,” said Ahn. “Based on the current positive results of the AURA3 trial, osimertinib should be considered as second-line therapy in T790M-positive, TKI-resistant NSCLC patients. Considering the low ORR and short PFS of docetaxel plus bevacizumab, the role of bevacizumab combination with docetaxel is not clear.” Plasma Clearance Another ASCO presentation investigated whether changes in the levels of plasma EGFR mutations post-osimertinib treatment are associated with clinical outcome in the AURA trial (Abstract 9018). Researchers studied patients from the AURA phase I study with acquired resistance to EGFR-TKIs, T790M-positive baseline genotyping (in tumor or plasma), and plasma samples collected at baseline and 6 weeks post-osimertinib. Patients received 20 mg to 240 mg osimertinib daily. Plasma samples were analyzed for the presence of detectable EGFR mutations (ex19del, L858R, and T790M). In patients with detectable plasma EGFR mutations at baseline, clinical outcomes were compared for patients with or without detectable plasma EGFR mutations at 6 weeks. Evaluable baseline and 6-week plasma samples were collected from 160 patients with T790M-positive genotyping. Of the 160 patients, 143 patients had detectable EGFR mutations at baseline. In this cohort, the overall median PFS was 9.3 months. Clearance of plasma EGFR mutations at 6 weeks was seen in 92 of 143 patients (64%). Median PFS was longer in patients with plasma clearance (10.9 months) compared with patients without clearance (5.5 months). Objective response rates showed a similar pattern. Researchers noted further study is needed to better understand whether continued detection of plasma EGFR mutations at 6 weeks may indicate the presence of heterogeneous resistance mechanisms, which could, potentially, be targeted by combination therapies. Validation of these results in an independent cohort of patients is ongoing. Mark L. Fuerst is a contributing writer." @default.
• W2746495642 created "2017-08-31" @default.
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• W2746495642 date "2017-08-25" @default.
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• W2746495642 title "Osimertinib Improves Outcomes in EGFR-Mutated Lung Cancer" @default.
• W2746495642 doi "https://doi.org/10.1097/01.cot.0000524493.25840.61" @default.
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