NCCN Guidelines Insights: Non–Small Cell Lung Cancer, Version 5.2018

Ettinger, David S.; Aisner, Dara L.; Wood, Douglas E.; Akerley, Wallace; Bauman, Jessica R.; Chang, Joe Y.; Chirieac, Lucian R.; D’Amico, Thomas A.; Dilling, Thomas J.; Dobelbower, M.C.; Govindan, Ramaswamy; Gubens, Matthew A.; Hennon, Mark; Horn, Leora; Lackner, Rudy P.; Lanuti, Michael; Leal, Ticiana; Lilenbaum, Rogério; Lin, Jules; Loo, Billy W.; Martins, Renato; Otterson, Gregory A.; Patel, Sandip Pravin; Reckamp, Karen L.; Riely, Gregory J.; Schild, Steven E.; Shapiro, Theresa A.; Stevenson, James P.; Swanson, Scott J.; Tauer, Kurt W.; Yang, Stephen C.; Gregory, Kristina M.; Hughes, Miranda

doi:10.6004/jnccn.2018.0062

Cited by 523 publications

(463 citation statements)

References 70 publications

(103 reference statements)

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“…The clinical development of other PD-(L)1-targeting antibodies, including pembrolizumab and atezolizumab, strongly focuses on PD-L1-positive NSCLC 42 . Although the current NIV label is understandable, it is questionable from a socio-economic viewpoint and will need reconsideration when checkpoint inhibitors are used as first-line therapy or in combination with other drugs 43 .…”

Section: Accepted Manuscriptmentioning

confidence: 99%

A Cost-Effectiveness Analysis of Nivolumab versus Docetaxel for Advanced Nonsquamous NSCLC Including PD-L1 Testing

Matter-Walstra

Schwenkglenks

Aebi

et al. 2016

Journal of Thoracic Oncology

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Section: Accepted Manuscriptmentioning

confidence: 99%

A Cost-Effectiveness Analysis of Nivolumab versus Docetaxel for Advanced Nonsquamous NSCLC Including PD-L1 Testing

Matter-Walstra

Schwenkglenks

Aebi

et al. 2016

Journal of Thoracic Oncology

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“…The 2018 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Non‐Small Cell Lung Cancer (NSCLC) recommend epidermal growth factor receptor (EGFR)‐tyrosine kinase inhibitors (TKIs) as first‐line treatment for unresectable, EGFR mutation‐positive, advanced NSCLC . It is known that lung cancer patients with activated EGFR mutations respond to first‐ or second‐generation EGFR‐TKIs, such as gefitinib, erlotinib, and afatinib .…”

Section: Introductionmentioning

confidence: 99%

Osimertinib, a third‐generation EGFR tyrosine kinase inhibitor: A retrospective multicenter study of its real‐world efficacy and safety in advanced/recurrent non‐small cell lung carcinoma

et al. 2020

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Background Osimertinib is recommended for T790M mutation‐positive advanced non‐small cell lung cancer (NSCLC) resistant to first‐ and second‐generation epidermal growth factor receptor (EGFR)‐tyrosine kinase inhibitors (TKIs). Recently, some reports exist on the real‐world use of osimertinib; however, reports involving third/later‐line use are few. Hence, this study was conducted to evaluate the efficacy and safety of osimertinib used in various treatment lines for T790M‐positive NSCLC patients. Methods This retrospective, observational, multicenter study included T790M‐positive advanced/recurrent NSCLC patients treated with osimertinib from May 2016 to March 2018. The clinical characteristics, efficacy, and adverse events were retrospectively investigated. The Kaplan‐Meier method was used to analyze progression‐free survival (PFS) and overall survival (OS). PFS‐associated clinical characteristics were evaluated using the Cox proportional hazards model. Results The objective response rate (ORR) and disease control rate (DCR) were 60.7% and 91.1%, respectively; the median PFS was 11.0 months. There were no significant differences in the median PFS for patients treated with osimertinib as second‐line and third−/later‐line (14.5 vs. 11.0 months respectively, P = 0.327). Analysis using the Cox proportional hazards model for clinical features affecting PFS also revealed no significant factors. Adverse events of grade ≥ 3 were reported in 15 patients (26.8%); the most common were anemia (n = 3) and cutaneous toxicity (n = 3). Grade 4 neutropenia was observed in one patient; any‐grade pneumonitis was observed in six patients (10.7%), including one with grade 3 pneumonitis. Conclusions Osimertinib demonstrated efficacy even when administered as third−/later‐line treatment to NSCLC patients. Osimertinib‐related pneumonitis was observed more frequently than previously reported. Key points Significant findings of the studyOsimertinib shows efficacy even as later‐line treatment in T790M mutation‐positive NSCLC patients previously treated with EGFR‐TKIs. However, the incidence of ≥ grade 3 adverse events, especially pneumonitis, was higher than that previously reported by other studies. What this study addsOsimertinib was approved for previously EGFR‐TKI‐treated EGFR T790M‐positive NSCLC. With the increasing frequency of its use as first‐line treatment, this study provides valuable evidence for the efficacy and safety of osimertinib for previously EGFR‐TKI‐treated NSCLC.

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“…Both nivolumab and pembrolizumab have approximately a 20% ORR, lower toxicity and increase median survival by 2-3 months versus docetaxel; therefore, they represent a new standard of care as salvage therapy. This is reflected in the most recent NCCN guideline recommendations for 'second-line and beyond (subsequent)' systemic therapy in advanced (metastatic) NSCLC [93]. In previously untreated NSCLC the combination of PD-1 inhibitors and chemotherapy appears to result in higher ORR and impressive 1-year OS rates.…”

Section: Resultsmentioning

confidence: 81%

Immune Checkpoint Inhibitors as First-Line and Salvage Therapy for Advanced Non-Small-Cell Lung Cancer

Decatris

O’Byrne

2016

Future Oncol.

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Advanced non-small-cell lung cancer (NSCLC) has a poor prognosis with few treatment options available for patients after failure of first-line therapy. Nivolumab is the first immune checkpoint inhibitor targeting the PD-1 to be approved in recurrent NSCLC with squamous and nonsquamous histology. More recently, pembrolizumab has also been approved as salvage therapy in PD-L1-positive recurrent NSCLC. The success of immunotherapy in malignant melanoma, previously a disease with no effective treatment, has generated optimism and expectation that some of the checkpoint inhibitors currently in clinical development will soon become available as first-line therapy and hence improve outcomes for the vast majority of patients with advanced NSCLC. This article summarizes the progress accomplished in the field and discusses controversies surrounding the use of immune checkpoint inhibitors.

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NCCN Guidelines Insights: Non–Small Cell Lung Cancer, Version 5.2018

Cited by 523 publications

References 70 publications

A Cost-Effectiveness Analysis of Nivolumab versus Docetaxel for Advanced Nonsquamous NSCLC Including PD-L1 Testing

A Cost-Effectiveness Analysis of Nivolumab versus Docetaxel for Advanced Nonsquamous NSCLC Including PD-L1 Testing

Osimertinib, a third‐generation EGFR tyrosine kinase inhibitor: A retrospective multicenter study of its real‐world efficacy and safety in advanced/recurrent non‐small cell lung carcinoma

Immune Checkpoint Inhibitors as First-Line and Salvage Therapy for Advanced Non-Small-Cell Lung Cancer

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