Patient-Reported Outcomes With First-Line Immunotherapy-Based Combination Treatment for Advanced Lung Cancer: A Prospective, Multicenter, Observational Study.

Background: This study aimed to characterize longitudinal trajectories of tumor burden and treatment-related symptoms following immune checkpoint inhibitor (ICI) therapy in patients with advanced lung cancer, based on electronic patient-reported outcomes (ePRO).

Methods: Using the MD Anderson Symptom Inventory-Lung Cancer module and an immune-related adverse event symptom item scale, we collected the ePRO data of patients undergoing first-line immunotherapy-based combination treatment for advanced unresectable primary lung cancer. Evaluating trajectories of primary symptoms and symptom differences between treatment groups using linear mixed-effects models.

Results: A total of 168 patients were included in the study. The top five symptoms with the highest severity before treatment were coughing, distress, shortness of breath, disturbed sleep, and pain. Coughing was gradually attenuated with ongoing treatment. Symptoms of distress, shortness of breath, disturbed sleep, and pain also showed an overall decreasing trend. The top five immunotherapy-related symptoms, with the highest severity, were early satiety, abdominal distension, night sweats, altered sense of taste, and bloated pain, which demonstrated a cyclical gradual increase throughout treatment. Compared to the ICIs + chemotherapy group, the ICIs + chemotherapy + VEGFR-TKIs group showed significantly lower burden in four of the top five immunotherapy-related symptoms, with the exception of night sweats, which demonstrated no significant difference.

Conclusions: Patients with advanced lung cancer experienced reduced severity of lung cancer-related symptoms after receiving immunotherapy-based combination treatment, and immune-specific symptoms showed cyclical exacerbation with ongoing treatment. The addition of VEGFR-TKIs to ICIs + chemotherapy did not increase the associated toxicity burden.