Background and importance Immunotherapy represents a revolution in the therapeutic strategy of non-small cell lung cancer (NSCLC), expanding the number of targets and available therapeutic options. Among the new pharmacological groups that have appeared for the treatment of metastatic NSCLC, we highlight anti-PD1 (nivolumab, pembrolizumab) and anti-PDL1 (atezolizumab) immune checkpoint inhibitors (ICIs). Sometimes patients treated in our hospitals differ from those treated in clinical trials and we do not get the results that we expected.
Aim and objectives To assess the effectiveness and safety of nivolumab, pembrolizumab and atezolizumab in real clinical practice in a second level university hospital.
Material and methods This was a retrospective observational study in NSCLC patients treated with first or secondline pembrolizumab, secondline nivolumab and secondline or later atezolizumab, between 1 September 2016 and 31 December 2019. Data were collected from the patient medical records and the oncology prescription programme (SPOQ) in our centre. The database included demographic, tumour related and treatment related variables.
To assess effectiveness, we analysed response according to the RECIST criteria, categorised as stable disease (SD) or progressive disease (PD), and progression free survival (PFS). To assess safety, a description of the side effects related to the treatment was carried out according to the common toxicity criteria (CTCAE V.5). Statistical analysis was performed with IBM SPSS Statistics V.26. The Kaplan–Meier statistical method was used to perform the survival analysis.
Results 63 patients, median age 67 years, 86% men, 92% ECOG-PS1 and 100% stage IV disease were studied. Median PFS for the global population was 3.1 months (95% CI 2.58 to 3.55). Objective global response rate was 17.5%. 50.1% of patients experienced toxicity. The most frequent toxicity was asthenia in 22.2% of patients.
Patients with firstline pembrolizumab (9.5%) had a PFS of 11.2 months (95% CI 0 to 28.22). For secondline pembrolizumab treated patients (4.8%), PFS was not achieved, in patients treated with atezolizumab (14.3%), PFS was 3.2 months (95% CI 2.6 to 3.98) and in patients treated with nivolumab (71.4%), PFS was 2.7 months (95% CI 1.93 to 3.53). The most frequent adverse events for the three drugs were asthenia, anorexia and immune mediated effects.
Conclusion and relevance The drugs had an efficacy similar to that demonstrated in clinical trials. Safety was acceptable and similar to that published in pivotal trials.
Conflict of interest No conflict of interest