Osimertinib compared to docetaxel-bevacizumab as third-line treatment in EGFR T790M mutated non-small cell lung cancer.

Nie, Keke; Zhang, Zhongfa; Zou, Xiao; Zhang, Chunyu; Zhuang, Xun; Yu, Zhuang; Lan, Ketao; Ji, Youxin

doi:10.1200/jco.2017.35.15_suppl.9017

Cited by 7 publications

(19 citation statements)

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“…42 In two published RCTs, osimertinib demonstrated superiority over platinum-based chemotherapy in T790M-positive NSCLC. 29,30 A confirmatory Phase III study (AURA3) showed that osimertinib exhibited significant improvements over chemotherapy in ORR (71 vs. 31%, p < 0.001) and PFS (10.1 vs. 4.4 months, p < 0.001) in chemotherapy-naïve NSCLC harboring T790M mutations after first-line EGFR-TKI therapy. 29 Based on the above evidence, osimertinib is a preferable drug for advanced NSCLC harboring T790M mutations during or after earlier-generation EGFR-TKI therapy.…”

Section: Discussionmentioning

confidence: 99%

“…1). [24][25][26][27][28][29][30][31][32][33][34] Characteristics of the studies and quality assessment A total of 11 clinical trials (three RCTs, eight single-arm trials) involving 3,086 patients with advanced NSCLC (632 in the three RCTs, 2,454 in the eight single-arm trials) were included. The patient groups in two of these studies shared partial overlap, and therefore, 90 patients in the group receiving 80 mg osimertinib were removed, leaving 163 patients from the study reported by Janne et al included in our final meta-analysis.…”

Section: Study Selectionmentioning

confidence: 99%

“…23 Recently, several clinical trials have evaluated the effect of osimertinib in treating NSCLC. [24][25][26][27][28][29][30][31][32][33][34] However, these studies were mainly Phase I or II clinical trials and had mixed results. No meta-analysis assessing the efficacy and safety of osimertinib has yet been reported.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of osimertinib in treating EGFR‐mutated advanced NSCLC: A meta‐analysis

Fan

Qian

et al. 2019

Intl Journal of Cancer

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Osimertinib is the only Food and Drug Administration‐approved third‐generation epidermal growth factor receptor (EGFR) tyrosine‐kinase inhibitor (TKI). A meta‐analysis was performed to aggregate the mixed results of published clinical trials to assess the efficacy and safety of osimertinib. A systematic search of the PubMed, Web of Science, and Cochrane Library electronic databases was performed to identify eligible literature. The primary endpoints were overall response rate (ORR), disease control rate (DCR), progression‐free survival (PFS), and adverse events (AEs). A total of 3,086 advanced nonsmall cell lung cancer (NSCLC) patients from 11 studies have been identified. The aggregate efficacy parameters for treatment‐naïve patients with EGFR‐TKI‐sensitizing mutations are as follows: ORR 79% (95% CI 75–84%), DCR 97% (95% CI 95–99%), 6‐month PFS 83% (95% CI 80–87%), and 12‐month PFS 64% (95% CI 59–69%). The aggregate efficacy parameters for advanced NSCLC harboring T790M mutations after earlier‐generation EGFR‐TKI therapy are as follows: ORR 58% (95% CI 46–71%), DCR 80% (95% CI 63–98%), 6‐month PFS 63% (95% CI 58–69%), and 12‐month PFS 32% (95% CI 17–47%). EGFR‐TKI‐naïve patients with EGFR‐positive mutations tend to have longer median PFS than EGFR‐TKI‐pretreated counterparts (19.17 vs . 10.58 months). The most common AEs were diarrhea and rash, of which the pooled incidences were 44 and 42%, respectively. Generally, osimertinib is a favorable treatment option for previously treated T790M mutation‐positive advanced NSCLC as well as a preferable therapy for untreated EGFR mutation‐positive advanced NSCLC. Additionally, osimertinib is well tolerated by most patients.

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Section: Discussionmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

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Efficacy and safety of osimertinib in treating EGFR‐mutated advanced NSCLC: A meta‐analysis

Fan

Qian

et al. 2019

Intl Journal of Cancer

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“…Osimertinib is also a category 1 recommendation for patients with metastatic NSCLC who have EGFR T790M mutation and symptomatic brain metastases [7]. As third-line treatment in EGFR T790M mutated NSCLC, PFS with osimertinib was 10.20 months compared with 2.95 months with docetaxel-bevacizumab in a recently completed phase III trial [53].…”

Section: Nonsquamous Histology: Second-line Targeted Therapiesmentioning

confidence: 99%

Role of Targeted Therapy and Immune Checkpoint Blockers in Advanced Non-Small Cell Lung Cancer: A Review

Karim

Kelly

2019

The Oncologist

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Advanced non‐small cell lung cancer (NSCLC) is a complex disease comprising molecularly distinct tumor types, each with a unique biology that is becoming increasingly better characterized. The aim of this review is to present an optimized treatment schema and the accompanying diagnostic testing approach for patients with advanced NSCLC. There are a number of therapies currently approved for patients with advanced NSCLC, including agents that target particular oncogenic drivers, as well as immune checkpoint blockers (ICBs) that elicit an antitumor response. Identification of genetic alterations (e.g., epidermal growth factor receptor, anaplastic lymphoma kinase, reactive oxygen species proto‐oncogene 1, B‐Raf proto‐oncogene) or programmed cell death ligand‐1 expression levels in NSCLC requires diligent molecular testing at initial diagnosis and, in some cases, at disease progression to ensure the most efficacious treatment is delivered. Accurate molecular diagnostic testing, along with the careful selection of currently approved targeted agents, ICBs, or systemic chemotherapy, provides therapy that is personalized according to patients’ needs to achieve the best possible outcome. Enrollment in clinical trials that further the development of tailored therapies is highly recommended at all stages of treatment. Implications for Practice Targeted therapies and immune checkpoint blockers provide effective and tailored options for patients with non‐small cell lung cancer. Careful molecular analysis of tumor samples is necessary to identify the genetic alterations that are present, to ensure that each patient receives the most efficacious treatment for their specific tumor type. Personalized therapy provides each patient with the best probability for prolonged survival. Enrolling patients in clinical trials should be the first consideration before making each treatment decision.

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“…Treatment of EGFR-mutant adenocarcinoma was widely reshaped during 2017 by the introduction of compelling new drugs in patients with both TKI-naive and pretreated NSCLC. Table 1 6,[37][38][39][40][41][42][43][44] summarizes efficacy results of the major clinical trials in patients with EGFR-mutated NSCLC published or presented during 2017. Figure 4 represents possible sequential treatment strategies and corresponding cumulative PFS with firstand next-generation EGFR TKIs in EGFR-mutated NSCLC.…”

Section: Egfr Mutationsmentioning

confidence: 99%

Progress in the Management of Advanced Thoracic Malignancies in 2017

Ferrara

Mezquita

Besse

2018

Journal of Thoracic Oncology

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The treatment paradigm of NSCLC underwent a major revolution during the course of 2017. Immune checkpoint inhibitors (ICIs) brought remarkable improvements in response and overall survival both in unselected pretreated patients and in untreated patients with programmed death ligand 1 expression of 50% or more. Furthermore, compelling preliminary results were reported for new combinations of anti-programmed cell death 1/programmed death ligand 1 agents with chemotherapy or anti-cytotoxic T-lymphocyte associated protein 4 inhibitors. The success of the ICIs appeared to extend to patients with SCLC, mesothelioma, or thymic tumors. Furthermore, in SCLC, encouraging activity was reported for an experimental target therapy (rovalpituzumab teserine) and a new chemotherapeutic agent (lurbinectedin). For oncogene-addicted NSCLC, next-generation tyrosine kinase inhibitors (TKIs) (such as osimertinib or alectinib) have demonstrated increased response rates and progression-free survival compared with first-generation TKIs in patients with both EGFR-mutated and ALK receptor tyrosine kinase gene (ALK)-rearranged NSCLC. However, because of the lack of mature overall survival data and considering the high efficacy of these drugs in patients with NSCLC previously exposed to first- or second-generation TKIs, definitive conclusions concerning the best treatment sequence cannot yet be drawn. In addition, new oncogenes such as mutant BRAF, tyrosine-protein kinase met gene (MET) and erb-b2 receptor tyrosine kinase 2 gene (HER2), and ret proto-oncogene (RET) rearrangements have joined the list of potential targetable drivers. In conclusion, the field of thoracic oncology is on the verge of a breakthrough that will open up many promising new therapeutic options for physicians and patients. The characterization of biomarkers predictive of sensitivity or resistance to immunotherapy and the identification of the optimal therapeutic combinations (for ICIs) and treatment sequence (for oncogene-addicted NSCLC) represent the toughest upcoming challenges in the domain of thoracic oncology.

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Osimertinib compared to docetaxel-bevacizumab as third-line treatment in EGFR T790M mutated non-small cell lung cancer.

Cited by 7 publications

References 0 publications

Efficacy and safety of osimertinib in treating EGFR‐mutated advanced NSCLC: A meta‐analysis

Efficacy and safety of osimertinib in treating EGFR‐mutated advanced NSCLC: A meta‐analysis

Role of Targeted Therapy and Immune Checkpoint Blockers in Advanced Non-Small Cell Lung Cancer: A Review

Progress in the Management of Advanced Thoracic Malignancies in 2017

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