Background and importance Durvalumab is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (QT-RDT).
Aim and objectives To evaluate the effectiveness and safety of durvalumab in NSCLC according to the conditions of use indicated in the data sheet.
Material and methods An observational retrospective study was conducted. We identified all patients with advanced NSCLC treated with durvalumab from September 2018 to September 2021.
Patients’ demographics (sex, age), clinical (diagnosis, stage, Eastern Cooperative Oncology Group (ECOG), PD-L1 expression) and therapy-related data (cycles received, duration of treatment) were analysed. Adverse effects (AE) were recorded from electronic medical records.
Results 23 patients were included (6 women, 17 men) and mean age was 66 years (38–80).
Histology was squamous in 14 patients (60.87%) and adenocarcinoma in 9 (39.13%). Mean time from the end of QT-RDT and the initiation of therapy with durvalumab was 91 (36–146) days. Mean number of cycles received was 18 (4–27).
At the time of analysis 3 patients (13.04%) continued therapy with durvalumab, 8 (34.78%) completed 12 months of therapy and 12 (52.17%) discontinued. Progression was the main reason for discontinuation, specifically in 9/12 patients (75%).
At the end of the study, with an average follow-up of 17 (4–37) months per patient, 5 patients (21.74%) died. None of these patients completed 12 months of durvalumab (1 due to intolerance and 4 due to disease progression).
Neither median progression-free survival nor median overall survival were reached at the data cut-off date.
All patients except 4 presented AEs (83%). The most frequents were asthenia (48%), skin disorders (48%), gastrointestinal disorders (35%), musculoskeletal disorders (22%), cough (22%), respiratory tract infections (17%), hypothyroidism (3%). Others: dizziness, mucosal inflammation, anaemia, paraesthesia, sweats, renal disorders, weight gain, dysgeusia.
Conclusion and relevance 39.13% (9/23) of the patients presented progression of the disease during durvalumab therapy.
Mortality rate during the follow-up period was 21.74%. None of these patients completed 12 months of therapy with durvalumab.
Most AEs were mild, in accordance with those described in the clinical trials. One patient (4.35%) had to discontinue the treatment because of grade IV AE.
Conflict of interest No conflict of interest
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