NCCN Extensively Updates Guideline for NSCLC

11/06/18

The National Comprehensive Cancer Network (NCCN) has updated their guideline for non-small cell lung cancer (NSCLC) to include new additions for consolidation therapy for unresectable disease, first-line therapy for ALK-positive metastatic disease, and principles of molecular and biomarker analysis, among others.

Version 1 of 2019 includes an update on consolidation therapy for patients with unresectable stage III NSCLC, performance status of 0-1, and no disease progression after two or more cycles of definitive chemoradiation. In this section, durvalumab was changed from a category 2A to a category 1 recommendation.

In the section for testing and testing results of adenocarcinoma, large cell, and NSCLC not otherwise specified, PD-L1 testing was changed from a category 2A to a category 1 recommendation. The same update was applied to squamous cell carcinoma.

In the first-line therapy for sensitizing EGFR-positive metastatic NSCLC, osimertinib is now listed as a preferred therapy and dacomitinib was added as a category 1 treatment option. For subsequent therapy for sensitizing EGFR-positive metastatic NSCLC, “continue dacomitinib” was added as a treatment option in asymptomatic, brain, and isolated lesion settings.

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In the first-line therapy for ALK-positive metastatic disease, brigatinib was added as a category 1 recommendation for rearrangement discovery prior to first-line systemic therapy. In ALK rearrangement discovered during first-line systemic therapy, alectinib is noted as the preferred therapy and brigatinib was added as a treatment option. The section for subsequent therapy for ALK-positive metastatic NSCLC has removed “continue crizotinib” for symptomatic brain progression and added “continue brigatinib” for subsequent therapy.

In the section for principles of molecular and biomarker analysis, a new sub-section was added for plasma cell-free/circulating tumor DNA testing. Among the included bullet points in this new sub-section include:

  • Cell-free/circulating tumor DNA testing should not be used in lieu of a tissue diagnosis.
  • Standards for analytical performance characteristics of cell-free tumor DNA have not been established, and in contrast to tissue-based testing, no guidelines exist regarding the recommended performance characteristics of this type of testing.
  • Cell-free tumor DNA testing can identify alterations that are unrelated to a lesion of interest, for example, clonal hematopoiesis of indeterminate potential.
  • The use of cell-free/circulating tumor DNA testing can be considered in specific clinical circumstances, most notably:
  • If a patient is medically unfit for invasive tissue sampling 
  • In the initial diagnostic setting, if following pathologic confirmation of a NSCLC diagnosis there is insufficient material for molecular analysis, cell-free/circulating tumor DNA should be used only if follow-up tissue-based analysis is planned for all patients in which an oncogenic driver is not identified

The guideline has significant updates to many other sections, including emerging biomarkers to identify patients for therapies, systemic therapy for advanced or metastatic disease, initial systemic therapy options for squamous cell carcinoma, principles of radiation therapy, principles of pathology, first-line therapy for BRAF V600E-positive metastatic disease, and first-line therapy for PD-L1 expression positive disease.—Zachary Bessette