Abstract
SummaryThe aim of this prospective study is to evaluate the clinical use and real-world efficacy of durvalumab maintenance treatment after chemoradiotherapy (CRT) in unresectable stage, locally advanced non-small cell lung cancer (NSCLC). All consecutive patients with unresectable, locally advanced NSCLC and PD-L1 expression (≥1%) treated after October 2018 were included. Regular follow up, including physical examination, PET/CT and/or contrast-enhanced CT-Thorax/Abdomen were performed every three months after CRT. Descriptive treatment pattern analyses, including reasons of discontinuation and salvage treatment, were undertaken. Statistics were calculated from the last day of thoracic irradiation (TRT). Twenty-six patients were included. Median follow up achieved 20.6 months (range: 1.9–30.6). Durvalumab was initiated after a median of 25 (range: 13–103) days after completion of CRT. In median 14 (range: 2–24) cycles of durvalumab were applied within 6.4 (range 1–12.7) months. Six patients (23%) are still in treatment and seven (27%) have completed treatment with 24 cycles. Maintenance treatment was discontinued in 13 (50%) patients: 4 (15%) patients developed grade 3 pneumonitis according to CTCAE v5 after a median of 3.9 (range: 0.5–11.6) months and 7 (range: 2–17) cycles of durvalumab. Four (15%) patients developed grade 2 skin toxicity. One (4%) patient has discontinued treatment due to incompliance. Six and 12- month progression-free survival (PFS) rates were 82% and 62%, median PFS was not reached. No case of hyperprogression was documented. Eight (31%) patients have relapsed during maintenance treatment after a median of 4.8 (range: 2.2–11.3) months and 11 (range: 6–17) durvalumab cycles. Two patients (9%) developed a local-regional recurrence after 14 and 17 cycles of durvalumab. Extracranial distant metastases and brain metastases as first site of failure were detected in 4 (15%) and 2 (8%) patients, respectively. Three (13%) patients presented with symptomatic relapse. Our prospective study confirmed a favourable safety profile of durvalumab maintenance treatment after completion of CRT in unresectable stage, locally advanced NSCLC in a real-world setting. In a median follow-up time of 20.6 months, durvalumab was discontinued in 27% of all patients due to progressive disease. All patients with progressive disease were eligible for second-line treatment.
Highlights
Lung cancer is the leading cause of malignancy-related mortality [1]
Median age at diagnosis was 67.6 years, 16 (62%) patients were older than 65 years and 9 (35%) patients were female
Ten (39%) patients were diagnosed with squamous cell carcinomas and 12 (46%) with adenocarcinomas, 4 (15.4%) were classified as Non-otherwise specified (NOS)
Summary
Lung cancer is the leading cause of malignancy-related mortality [1]. Unresectable and locally advanced non-small cell lung cancer (NSCLC) is associated with a poor local and distant control resulting in a unfavorable survival [2,3,4,5,6]. After CRT and a follow-up CT scan, durvalumab was administered intravenously at a dose of 10 mg/kg every two weeks for up to 24 cycles until progression or unacceptable toxicity according to the Common Terminology Criteria of Adverse Events Version 5 (CTCAE v5). This prospective study included twenty-six consecutive patients who received concurrent or sequential conventionally fractionated CRT with consolidation durvalumab for unresectable and locally advanced NSCLC between 2018 and 2020. CT/PET-CT scans, routine blood work, pulmonary function testing and clinical examinations were performed every 3 months during durvalumab treatment; contrast-enhanced brain MRI, bone-scintigraphy and bronchoscopy were only performed if clinically indicated.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
