C43.9
Conditions
Interventions
Group 1: Observation group (patients treated with ICB)
Intervention/investigation: Prospective observation of patients with malignant skin tumors who are treated with PD-1-based immune checkpoint inh
Sponsors
Universitätsmedizin Rostock
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients were eligible if they were at least 18 years of age, suffered from melanoma, were able to perform pulmonary function tests, and were treated with an immune-chechpoint-blockade therapy either in the adjuvant or metastatic setting. This therapy included the anti-PD-1 antibodies nivolumab and pembrolizumab and the combination of nivolumab and ipilimumab. Patients were always treated with the approved dose and schedule.
Exclusion criteria
Exclusion criteria: Exclusion criteria were if immunotherapy was discontinued, if immunosuppressive medications were administered due to immune-related adverse events, or if patients were no longer willing or able to perform the given pulmonary function tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: To determine subclinical pulmonary toxicity associated with immune checkpoint blockade (ICB) in patients with skin malignancies as measured by significant deterioration in lung diffusion capacity for carbon monoxide (DLCO). WHEN: PFT-1: Before starting ICB therapy PFT-2: After 6-21 weeks of therapy PFT-3: After 24-35 weeks of therapy PFT-4: After 36-48 weeks of therapy HOW: Measure DLCO (adjusted for hemoglobin) using the EasyOnePro† LAB device according to American Thoracic Society/European Respiratory Society guidelines. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lung function measured by spirometry parameters: WHAT: Assessment of FEV1 (Forced Expiratory Volume in 1 second), FVC (Forced Vital Capacity) and FEV1/FVC ratio to detect obstructive or restrictive lung disease. WHEN: Time points identical to the primary endpoint (PFT-1 to PFT-4). HOW: Spirometry using EasyOnePro† LAB, with at least two valid measurements (quality level C or better). Assessment of Lung Clearance Index (LCI): WHAT: Determination of ventilation irregularities in the peripheral airways (< 2 mm diameter). WHEN: PFT-1 to PFT-4. HOW: Multiple breath washout (MBW) test with 100% oxygen, calculation of LCI based on nitrogen concentration fall. Correlation of lung function parameters with prognostic laboratory parameters: WHAT: Investigation of the relationship between DLCO and the tumor markers S100, LDH (lactate dehydrogenase) and CRP (C-reactive protein). WHEN: Parallel to the PFT measurements. HOW: Blood sampling to determine the laboratory values, statistical evaluation using Spearman correlation coefficient. Radiological assessment of the lungs: WHAT: Review of CT images to detect lung changes, especially signs of checkpoint inhibitor pneumonitis (CIP). WHEN: Staging CTs according to national guidelines (every 6 months for stage III, every 3 months for stage IV). HOW: Computed tomography (CT) of the chest as part of routine staging examinations. | — |
Countries
Germany
Contacts
Public ContactJulia Tietze
Universitätsmedizin Rostock
Outcome results
None listed