Background and importance Unresectable locally advanced non-small cell lung cancer (LA-NSCLC) long-term survival is poor. Durvalumab is approved as consolidation treatment in unresectable LA-NSCLC, without progression after chemoradiotherapy including platinum, with PD-L1 ≥1%.
Aim and objectives To analyse the effectiveness and safety of durvalumab in the treatment of unresectable LA-NSCLC compared with the results of the pivotal study (PACIFIC). Secondary objective was influence of PD-L1 expression on effectiveness.
Material and methods Retrospective observational study of patients with unresectable LA-NSCLC treated with durvalumab in a tertiary hospital (August 2018–October 2021).
Variables studied (electronic medical history): sex, age, Eastern Cooperative Oncology Group (ECOG), smoking, PD-L1, histology, disease stage. Variable to evaluate effectiveness: progression-free survival (PFS) from the start of treatment. For safety: adverse events (AE) and toxicity grade according to the Common Terminology Criteria for Adverse Events v5.0. Statistical analysis performed with SPSS v.23 software.
Results Thirty-one patients were included, mean age 66.45 (±9.45) years, male (74.2%), smokers (64.5%), ex-smokers (35.5%), World Health Organization (WHO) performance status: ECOG 0 (74.2%), ECOG 1 (25.8%). Disease stage IIIA (25.8%), IIIB (48.4%), IIIC (25.8%), squamous histology (41.9%), adenocarcinoma (41.9%) and unspecified (16.1%).
41.9% received induction chemotherapy. Most common chemotherapy was cisplatin-vinorelbine (48.4%). Durvalumab was initiated a median of 55 (35–70) days after chemoradiotherapy. After initiating durvalumab, the median follow-up was 15 (5–22) months. Received a median of 13 (8–26) cycles. 35.5% (n=11) of patients completed 12 months of treatment, 29% (n=9) remain on treatment. Treatment discontinuation was 22.6% (n=7) due to disease progression and 12.9% (n = 4) due to severe toxicity. 51.6% (n = 16) presented toxicity associated with durvalumab: 68% (n=11) grade 1–2 toxicity. Main AEs: thyroid (19.32%) and cutaneous (22.54%) alterations.
Median PFS was 14 (95% CI 7.59 to 20.4) months, with a PFS rate at 12 months (PFS12m): 70.6%. PFS12m was: 25% in PD-L1 <1% (n=4); 50% in PD-L1 1%–49% (n=10) and 73.33% in PD-L1 ≥50% (n=15).
Conclusion and relevance Our results showed, compared with the PACIFIC study, a lower median PFS (14 vs 17 months) and a higher PFS12m (70.6% vs 55.7%), results that seem comparable. In terms of safety, the results are similar to those of the PACIFIC study, so there is a good safety profile in our patients. The data analysed showed a lower effectiveness in PD-L1 <1%. However, a larger sample and follow-up are required to obtain conclusive results.
Conflict of interest No conflict of interest