Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer

New England Journal of Medicine, Год журнала: 2016, Номер 376(7), С. 629 - 640

Опубликована: Дек. 6, 2016

Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared platinum-based therapy plus pemetrexed such unknown.

Язык: Английский

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Lung cancer: current therapies and new targeted treatments

The Lancet, Год журнала: 2016, Номер 389(10066), С. 299 - 311

Опубликована: Сен. 2, 2016

Язык: Английский

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Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Annals of Oncology, Год журнала: 2016, Номер 27, С. v1 - v27

Опубликована: Сен. 1, 2016

Язык: Английский

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Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Annals of Oncology, Год журнала: 2018, Номер 29, С. iv192 - iv237

Опубликована: Июль 26, 2018

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Data show high-volume centres teams efficient managing patients low-volume non-multidisciplinary centres, providing complete staging, better adherence guidelines survival [21.Freeman R.K. Van Woerkom Vyverberg Ascioti A.J. thoracic conference treatment cancer.Eur Cardiothorac Surg. 2010; 38: 1-5Crossref (76) 22.Forrest L.M. McMillan D.C. McArdle C.S. Dunlop D.J. evaluation impact team, single centre, inoperable non-small-cell cancer.Br 93: 977-978Crossref (148) boards influence providers’ initial plans 26%–40% [23.Schmidt H.M. Roberts Bodnar A.M. al.Thoracic tumor board routinely impacts esophageal prospective cohort study.Ann Thorac 99: 1719-1724Abstract absolute reach proper precise morphological biological definition often requires challenging tissue sampling, decisions depending information obtained specimen collected diagnosis. Bronchoscopy technique ideally suited large, central lesions offers advantage minimal morbidity. used bronchial washing, brushing, transbronchial biopsy, diagnostic yield 65%–88% [24.Ost D.E. Ernst Lei X. al.Diagnostic complications bronchoscopy peripheral lesions. Results AQuIRE Registry.Am Crit Care 193: 68-77Crossref 25.Rivera M.P. Mehta A.C. Wahidi Establishing diagnosis management 3rd ed: American College Chest Physicians evidence-based clinical practice guidelines.Chest. 143: e142S-e165SAbstract (530) 26.van der Drift M.A. van Wilt G.J. Thunnissen F.B. Janssen J.P. timing cost-effectiveness washing pulmonary malignant tumors.Chest. 128: 394-400Abstract (65) By combining direct bronchoscopic airway visualisation ultrasound-guided biopsy lesion, endobronchial ultrasound (EBUS) provides 75%–85% centrally located [27.Herth Becker H.D. Conventional vs needle aspiration: randomized trial.Chest. 2004; 125: 322-325Abstract (350) 28.Paone Nicastri Lucantoni al.Endobronchial ultrasound-driven lesions.Chest. 3551-3557Abstract (185) Fibre optic allows regional lymph nodes EBUS and/or endoscopic (EUS). EBUS-guided aspiration (TBNA) invasive least accurate mediastinoscopy [29.Adams Shah P.L. Edmonds Test performance mediastinal staging systematic review meta-analysis.Thorax. 2009; 64: 757-762Crossref (291) shown cytological specimens EBUS-TBNA suitable testing epidermal growth factor receptor (EGFR), Kirsten rat sarcoma viral oncogene homologue (KRAS) anaplastic lymphoma kinase (ALK) status [30.Nakajima Kimura H. Takeuchi al.Treatment ALK inhibitor EML4-ALK fusion gene detection using aspiration.J 5: 2041-2043Abstract (21) 31.Nakajima Yasufuku Nakagawara al.Multigene mutation metastatic non-small aspiration.Chest. 140: 1319-1324Abstract (97) 32.Rekhtman N. Brandt S.M. Sigel al.Suitability cytology paradigms carcinoma: accuracy subtyping feasibility EGFR KRAS testing.J 451-458Abstract (200) 33.Sakairi Nakajima al.EML4-ALK assessment node samples aspiration.Clin Res. 16: 4938-4945Crossref (140) Scholar]; however, collection broader should encouraged. case lesions, transthoracic percutaneous fine core under imaging guidance [typically computed tomography (CT)] proposed [34.Chan E.Y. Gaur Ge al.Management solitary nodule.Arch Pathol Lab 141: 927-931Crossref (8) Needle > 88% yield, sensitivity 90% false-negative 22% [25.Rivera 35.Choi S.H. Chae E.J. Kim J.E. al.Percutaneous CT-guided nodules smaller 1 cm: outcomes 305 procedures tertiary referral center.AJR Am Roentgenol. 201: 964-970Crossref 36.Fontaine-Delaruelle Gamondes al.Negative predictive value core-needle biopsy: multicenter study.Chest. 148: 472-480Abstract (36) 37.Lee Park C.M. 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Sampling primary accessible metastases, taken vision usually assistance, greatly increases (hit rate). facilitate well limited material handled accordingly; ensuring processing likely sparingly each step, since tests required [42.Dietel Bubendorf Dingemans (NSCLC): recommendations Expert Group.Thorax. 71: 177-184Crossref (89) Immunohistochemistry (IHC) become key biomarker assessment. possible morphology alone, panel IHC recommended determine subtype Thyroid transcription (TTF1) positivity probable adenocarcinoma, p40 SCC; if neither positive NSCLC-not otherwise specified (NOS). staining reduce NSCLC-NOS < 10% [IV, A]. Pathologists urged conserve every diagnosis, use sections avoid excessive investigation, clinically relevant. After next consideration therapy-predictive testing. will driven availability treatments vary widely different geopolitical health systems [43.Lindeman N.I. Cagle P.T. Beasley M.B. al.Molecular guideline selection tyrosine inhibitors: Pathologists, Molecular Pathology.J 8: 823-859Abstract (588) 44.Kerr K.M. Edelman M.J. al.Second ESMO consensus pathology biomarkers 25: 1681-1690Abstract (191) 45.Lindeman Aisner al.Updated targeted Pathology.Arch 2018; 142: 321-346Crossref (257) Contemporary now evolved into streams, one targetable, addictive, oncogenic alterations immuno-oncology therapy personalised medicine synopsis table Table 1.Table 1A NSCLCBiomarkerMethodUseLoE, GoREGFR mutationAny appropriate, validated method, subject external quality assuranceTo select EGFR-sensitising mutations respond TKI therapyI, AALK rearrangementAny assurance. FISH historical standard becoming therapy-determining test, provided method against orthogonal test approach. NGS emerging technologyTo rearrangements AROS1 rearrangementFISH trial-validated standard. confirmatory currently lacks specificity. technology. External assurance essentialTo ROS1 therapyII, ABRAF BRAF V600-sensitising inhibitor, without MEK APD-L1 expressionIHC identify PD-L1 expression appropriate level population(s) determined intended drug line therapy. Only trial assays validated. Internal enrich benefit anti-PD-1 anti-PD-L1 For pembrolizumab, companion nivolumab atezolizumab, complementaryI, AALK, kinase; EGFR, receptor; FISH, fluorescent situ hybridisation; GoR, grade recommendation; IHC, immunohistochemistry; LoE, evidence; MEK, mitogen-activated protein NGS, next-generation sequencing; NSCLC, cancer; PD-1, programmed 1; PD-L1, death-ligand TKI, inhibitor. Open tab ALK, drivers addiction strong excellent targets. They generally mutually exclusive much never- (never smoked who cigarettes lifetime), long-time ex- (> years) light-smokers (< pack-years) they smoke. vast majority oncogene-addicted adenocarcinomas. Patients, general, tend younger, gender East ethnicity enriches EGFR-mutant tumours. Nonetheless, suggest advanced, possible, definite, tested 46.Kalemkerian G.P. Narula Kennedy E.B. Clinical Oncology Endorsement Pathologists/International Cancer/Association Pathology Practice Guideline Update.J 36: 911-919PubMed SCC, except rare circumstances never-, light-smoker Testing involving genes mandatory countries. V600E rapidly approaching first-line BRAF/MEK inhibitors approved, HER2 (human 2) MET exon RET NTRK1 (neurotropic tropomyosin 1) evolving targets/biomarkers

Язык: Английский

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Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial

The Lancet Respiratory Medicine, Год журнала: 2019, Номер 7(5), С. 387 - 401

Опубликована: Март 26, 2019

Язык: Английский

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Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non–Small-Cell Lung Cancer

Journal of Clinical Oncology, Год журнала: 2016, Номер 34(28), С. 3375 - 3382

Опубликована: Июнь 29, 2016

Purpose Third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have demonstrated potent activity against TKI resistance mediated by EGFR T790M. We studied whether noninvasive genotyping of cell-free plasma DNA (cfDNA) is a useful biomarker for prediction outcome from third-generation EGFR-TKI, osimertinib. Methods Plasma was collected all patients in the first-in-man study Patients who were included had acquired EGFR-TKI and evidence common EGFR-sensitizing mutation. Genotyping performed using BEAMing. accuracy assessed tumor central laboratory as reference. Objective response rate (ORR) progression-free survival (PFS) analyzed T790M-positive or T790M-negative patients. Results Sensitivity detection T790M 70%. Of 58 with tumors, detected 18 (31%). ORR median PFS similar (ORR, 63%; PFS, 9.7 months) 62%; results. Although overall favorable outcomes 46%; 8.2 months), distinguished subset positive better 69%; 16.5 well negative poor 25%; 2.8 months). Conclusion In this retrospective analysis, osimertinib that are equivalent to tissue-based assay. This suggests that, upon availability validated assays, some could avoid biopsy genotyping. As result 30% false-negative genotyping, those results still need determine presence absence

Язык: Английский

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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

The Lancet Oncology, Год журнала: 2016, Номер 17(12), С. 1643 - 1652

Опубликована: Окт. 17, 2016

Язык: Английский

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Mechanisms of acquired resistance to first- and second-generation EGFR tyrosine kinase inhibitors

Annals of Oncology, Год журнала: 2018, Номер 29, С. i10 - i19

Опубликована: Янв. 1, 2018

Язык: Английский

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Osimertinib in Pretreated T790M-Positive Advanced Non–Small-Cell Lung Cancer: AURA Study Phase II Extension Component

Journal of Clinical Oncology, Год журнала: 2017, Номер 35(12), С. 1288 - 1296

Опубликована: Фев. 21, 2017

Purpose Osimertinib is an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) selective for both EGFR-TKI sensitizing ( EGFRm) and T790M resistance mutations. AURA (NCT01802632) a phase I/II clinical trial to determine the dose, safety, efficacy of osimertinib. This article reports results from II extension component. Patients Methods with EGFR-TKI–pretreated EGFRm- T790M-positive advanced non–small-cell lung cancer (NSCLC) received once-daily osimertinib 80 mg. status was confirmed by central testing tumor sample taken after most recent disease progression. asymptomatic, stable CNS metastases that did not require corticosteroids were allowed enroll. The primary end point objective response rate (ORR) independent radiology assessment. Secondary points control rate, duration response, progression-free survival (PFS), safety. Patient-reported outcomes comprised exploratory objective. Results In total, 201 patients treatment, median treatment 13.2 months at time data cutoff (November 1, 2015). evaluable (n = 198), ORR 62% (95% CI, 54% 68%), 90% 85 94). Median in 122 responding 15.2 11.3 calculable). PFS 12.3 9.5 13.8). common possibly causally related adverse events (investigator assessed) diarrhea (43%; grade ≥ 3, < 1%) rash (grouped terms; 40%; 1%). Interstitial terms) reported eight (4%; n 2; 3; 5, 3). Conclusion EGFRm NSCLC who progress provides high ORR, encouraging PFS, durable response.

Язык: Английский

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New and emerging targeted treatments in advanced non-small-cell lung cancer

The Lancet, Год журнала: 2016, Номер 388(10048), С. 1012 - 1024

Опубликована: Сен. 1, 2016

Язык: Английский

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