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Jarushka Naidoo

Immunotherapy is now the fourth pillar of cancer treatment, but the methodology used to determine who will benefit is still a work in progress. PD-L1 is commonly used as a predictive biomarker for immunotherapy, but others—such as immunogenic tumor biomarkers, host environment biomarkers and biomarkers of nonresponse—are being actively investigated. Additionally, research in combining biomarkers is currently being conducted, with new data emerging all the time.

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Victoria T. Brown, Dana Drzayich Antol, Patrick N. Racsa, Melea A. Ward and Jarushka Naidoo

Background: Anti-PD1/PD-L1 therapy is standard-of-care for patients with a variety of advanced malignancies. Although clinical trials report a lower incidence of grade 3-4 toxicities than observed with cytotoxic agents, it is imperative that clinicians identify and manage the unique toxicities of these agents. We aimed to identify real-world incidence of immune-related toxicities and management for patients treated with anti-PD1/PD-L1 agents prior to publication of clinical practice guidelines. Methods: Patients enrolled in a Humana Medicare Advantage plan who initiated any anti-PD1/PD-L1 therapy September 1, 2014–February 28, 2018 were identified. NCCN Guidelines for immune-related toxicity were used to determine appropriate pharmacy and medical codes from administrative claims data for toxicity identification and management. ICD-10 codes were examined for patients requiring hospital or ED visits, and HCPCS and NDC codes were used for patients requiring toxicity treatment (eg, corticosteroids, anti-TNFα). Results: 6,005 patients were identified; 39.1% were female, median (IQR) age was 72 years (67–77). The majority (64.7%) had thoracic cancers; 16.3% genitourinary cancers; and 12.8% skin cancers. The median number of anti-PD1/PD-L1 doses received was 4 (2–8). Overall, 62.5% (n=3,751) of patients experienced >1 toxicity with half (n=1,913) requiring an inpatient stay or ED visit, and the other half (n=1,838) receiving outpatient toxicity medication. A similar proportion of patients developed >1 toxicity, regardless of age: <75 years, 62.4% (n=2,416); and 62.5% (n=1,335) >75 years. Systemic corticosteroids were used by 61.3% (n=2,300) of patients that experienced toxicity. The most frequently observed toxicity in this dataset by organ system was cardiovascular (18.5%, n=1,108), which was comprised largely of arrhythmias (13.7%; n=823), and endocrine toxicities (15.8%; n=950), mostly type 2 diabetes (11.9%; n=714). Conclusion: Real-world data from a large Medicare Advantage plan indicate that half of patients receiving anti-PD1/anti-PD-L1 may experience a toxicity resulting in an inpatient stay or ED visit with no difference by age. While attribution of toxicity may be challenging using claims data, the spectrum of immune-related toxicities in the real world may differ from those reported in clinical trials. Future research should evaluate incidence and management of toxicities post-guideline release and monitor changes in site of care for management.

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Alexander S. Baras, Jarushka Naidoo, Christine L. Hann, Peter B. Illei, Charles W. Reninger III and Josh Lauring

Tumor DNA sequencing can identify rare driver genomic alterations that suggest targets for cancer therapy, even when these drivers cannot be suspected on clinical grounds. In some cases, genomic alterations identified in the tumor can lead to a change in diagnosis with implications for prognosis and therapy. This report describes a case in which evaluation of tumor sequencing results by a molecular tumor board (MTB) led to rediagnosis of a non–small cell lung cancer as highly aggressive NUT midline carcinoma, with implications for targeted therapy using an investigational bromodomain and extraterminal (BET) inhibitor. We discuss the molecular biology and diagnosis of this rare tumor, and suggest how improved annotation of tumor sequencing reports and multidisciplinary expertise of MTBs can facilitate timely diagnosis of rare tumors and application of potential targeted therapies.

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John A. Thompson, Bryan J. Schneider, Julie Brahmer, Stephanie Andrews, Philippe Armand, Shailender Bhatia, Lihua E. Budde, Luciano Costa, Marianne Davies, David Dunnington, Marc S. Ernstoff, Matthew Frigault, Brianna Hoffner, Christopher J. Hoimes, Mario Lacouture, Frederick Locke, Matthew Lunning, Nisha A. Mohindra, Jarushka Naidoo, Anthony J. Olszanski, Olalekan Oluwole, Sandip P. Patel, Sunil Reddy, Mabel Ryder, Bianca Santomasso, Scott Shofer, Jeffrey A. Sosman, Momen Wahidi, Yinghong Wang, Alyse Johnson-Chilla and Jillian L. Scavone

The aim of the NCCN Guidelines for Management of Immunotherapy-Related Toxicities is to provide guidance on the management of immune-related adverse events resulting from cancer immunotherapy. The NCCN Management of Immunotherapy-Related Toxicities Panel is an interdisciplinary group of representatives from NCCN Member Institutions and ASCO, consisting of medical and hematologic oncologists with expertise in a wide array of disease sites, and experts from the fields of dermatology, gastroenterology, neuro-oncology, nephrology, emergency medicine, cardiology, oncology nursing, and patient advocacy. Several panel representatives are members of the Society for Immunotherapy of Cancer (SITC). The initial version of the NCCN Guidelines was designed in general alignment with recommendations published by ASCO and SITC. The content featured in this issue is an excerpt of the recommendations for managing toxicity related to immune checkpoint blockade and a review of existing evidence. For the full version of the NCCN Guidelines, including recommendations for managing toxicities related to chimeric antigen receptor T-cell therapy, visit