The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of non-small cell lung cancer (NSCLC)

Abstract

Lung cancer is the leading cause of cancer-related mortality worldwide, with non-small cell lung cancer (NSCLC) accounting for over 85% of all cases. Until recently, chemotherapy – characterized by some benefit but only rare durable responses – was the only treatment option for patients with NSCLC whose tumors lacked targetable mutations. By contrast, immune checkpoint inhibitors have demonstrated distinctly durable responses and represent the advent of a new treatment approach for patients with NSCLC. Three immune checkpoint inhibitors, pembrolizumab, nivolumab and atezolizumab, are now approved for use in first- and/or second-line settings for selected patients with advanced NSCLC, with promising benefit also seen in patients with stage III NSCLC. Additionally, durvalumab following chemoradiation has been approved for use in patients with locally advanced disease. Due to the distinct features of cancer immunotherapy, and rapid progress in the field, clinical guidance is needed on the use of these agents, including appropriate patient selection, sequencing of therapies, response monitoring, adverse event management, and biomarker testing. The Society for Immunotherapy of Cancer (SITC) convened an expert Task Force charged with developing consensus recommendations on these key issues. Following a systematic process as outlined by the National Academy of Medicine, a literature search and panel voting were used to rate the strength of evidence for each recommendation. This consensus statement provides evidence-based recommendations to help clinicians integrate immune checkpoint inhibitors into the treatment plan for patients with NSCLC. This guidance will be updated following relevant advances in the field.Electronic supplementary materialThe online version of this article (10.1186/s40425-018-0382-2) contains supplementary material, which is available to authorized users.

The landscape of immune checkpoint inhibitor plus chemotherapy versus immunotherapy for advanced non‐small‐cell lung cancer: A systematic review and meta‐analysis

“…Thus to some extent, for patients with NSCLC with negative PD‐L1 level, high tumor mutational burden increases the chance of tumor response to immunotherapy (Anagnostou et al, ; Rosenberg et al, ). Therefore, in this study, we concluded that PD‐L1 alone was not an ideal predictive biomarker for survival benefits of advanced patients with NSCLC from immunotherapy because of the unclear function and regulation of PD‐1 pathway and technical limitations including: archived or fresh tissue for PD‐L1 testing, optimal antibody (22C3, 28‐8, SP142, or SP263) and when to conduct PD‐L1 testing or whether to retest PD‐L1 expression (Brahmer et al, ; Shen & Zhao, ).…”

“…The randomized Phase III study (KEYNOTE‐407) reported therapeutic effects of combination PEM plus PBC versus chemotherapy alone for squamous patients with NSCLC (Paz‐Ares et al, ). SITC did not take this RCT (KEYNOTE‐407) into account (Brahmer et al, ), because the Biologics License Application regarding with PEM plus chemotherapy for patients with squamous NSCLC was under review as of SITC's recommendation in 2018. Thus, we recommended PEM plus PBC as the optimal treatment approach for squamous patients with NSCLC.…”

“…Lung cancer is the leading cause of cancer death worldwide (Davies, Cheng, Field, Liu, & Li, ; Siegel, Miller, & Jemal, ). Most patients with lung cancer are diagnosed at an advanced stage with metastasis (Brahmer et al, ). At the metastatic stage, the 5‐year survival rate is no more than 5% since no curative treatment options.…”

Recommendation for the diagnosis and management of immune checkpoint inhibitor related infections

“…In recent years, programmed death 1 (PD‐1)/PD‐1 ligand (PD‐L1) inhibitors have been used in the treatment of non‐small cell lung cancer (NSCLC). Immunotherapy alone or in combination with chemotherapy has been recommended as initial therapy for advanced NSCLC without EGFR, ALK or ROS1 mutation …”

“…Immunotherapy alone or in combination with chemotherapy has been recommended as initial therapy for advanced NSCLC without EGFR, ALK or ROS1 mutation. 1 Treatment with PD-1/PD-L1 inhibitors are generally considered to result in minor side effects. It is currently believed that PD-1/PD-L1 inhibitors do not increase the risk of infection because they promote T-cell effector functions.…”