Table 3.
Research Topic in ICI-Pneumonitis | Proposed Research Reporting Components |
---|---|
Demographics and baseline clinical characteristics | Demographic information (sex, age, and ethnicity) |
Smoking history (categorical and quantitative [pack-years]) | |
Preexisting conditions (particularly interstitial lung disease, COPD, and systemic autoimmune diseases) | |
Tumor types | |
Prior treatments | |
Type of ICI treatment and regimen, doses, and frequency | |
Radiologic findings of ICI-pneumonitis | Use of common terminology |
Routine use of radiologic patterns rather than characteristic findings (examples below) | |
• COP pattern | |
• AIP/ARDS pattern | |
• NSIP pattern | |
• HP pattern | |
Modality: chest CT | |
Pathologic findings of ICI-pneumonitis | Use of common terminology: |
• Cellular interstitial pneumonia | |
• Fibrosing interstitial pneumonia | |
• Usual interstitial pneumonia | |
• Nonspecific interstitial pneumonia | |
• Cellular and fibrosing interstitial pneumonia | |
• Organizing pneumonia | |
• Bronchiolitis | |
• Lymphocytic interstitial pneumonia | |
• Diffuse alveolar damage | |
• Pleuritis | |
• Noncaseating granulomas | |
Clinical findings of ICI-pneumonitis | Document both CTCAE grade and clinical signs and symptoms |
Infectious complications | In ICI alone and in combination with corticosteroids and other immunosuppressive medications |
• TB and listeria (PD-[L]1) | |
• Aspergillus, CMV, and PJP (CTLA-4) | |
• Pneumonia (organism[s] when available) | |
• Sepsis (organism[s] when available) | |
• Other bacterial, viral, and fungal infections | |
Additional testing | Patient-reported functional assessments |
• Borg scale | |
• FACT-L questionnaire | |
Pulmonary function testing | |
• Spirometry and diffusing capacity (corrected for Hb) | |
• TLC | |
• Comparison with pretreatment measures | |
6-min-walk test | |
Bronchoscopy (BAL) | |
• Volume, location sampled (affected lobe), and protocol for processing | |
• Cell differential, subsets, and surface markers | |
• Measures: cytokines, chemokines, and microbiome | |
• Treatments (pre/post steroids and pre/post antibiotics) | |
• Correlation with disease severity and temporality | |
Lung biopsy | |
• Type (TBBx, cryobiopsy, or wedge) and location | |
• Uniform histologic terminology | |
• Presence/absence of malignancy and evidence of infection? | |
• Complications |
Definition of abbreviations: AIP = acute interstitial pneumonia; ARDS = acute respiratory distress syndrome; CMV = Cytomegalovirus; COP = cryptogenic organizing pneumonia; COPD = chronic obstructive pulmonary disease; CT = computed tomography; CTCAE = Common Terminology Criteria for Adverse Events; CTLA = cytotoxic T-lymphocyte–associated protein; FACT-L = Functional Assessment of Cancer Therapy–Lung; HP = hypersensitivity pneumonitis; ICI = immune checkpoint inhibitor; NSIP = nonspecific interstitial pneumonia; PD-(L)1 = PD-1 (programmed cell death protein 1) and PD-L1 (programmed death ligand 1); PJP = Pneumocystis jiroveci pneumonia; TB = tuberculosis; TBBx = transbronchial biopsy.