Background Between 2016 and 2017 the National Agency of Medicines and Medical Devices regulated the use of nivolumab and pembrolizumab for the treatment of non-small-cell lung cancer (NSCLC).
In clinical trials conducted, patients with ECOG 0–1 and a life expectancy of at least 3 months were included since the benefit of immunotherapy can be delayed and even present a response after progression (pseudo-progression).
Purpose To analyse characteristics of patients with NSCLC treated with nivolumab and pembrolizumab for less than 3 months at our centre.
Material and methods Observational descriptive study was conducted. Patients diagnosed with NSCLC treated for less than 3 months (with six or less cycles of nivolumab and four or less cycles of pembrolizumab) from the approval date of these drugs until October 2018 were included.
Data from clinical and pharmacotherapeutic records was collected: age, sex, ECOG, histology, brain metastases, PDL-1 expression, number of previous lines, time elapsed since previous treatment if any and reason for discontinuation.
Overall survival (OS) and progression-free survival (PFS) medians were calculated with SPSS 22.0 using the Kaplan–Meier method.
Results Sixty-two patients were included (males 64.5%, mean age 68±9.7), 82.1% ECOG 0–1, 75.4% non-squamous histology and 14.5% with brain metastases). PDL-1 expression was positive in 100% of patients treated with pembrolizumab and in 4.8% of those treated with nivolumab (57.1% of them without determination).
75.8% had received previous treatment, 61.7% of them in less than 3 months and with less than three previous lines (97.2%). Forty-one patients were treated with pembrolizumab and 21 with nivolumab. The median treatment duration was 42 days (3–115).
Seven patients discontinued due to drug toxicity.
The global median OS and PFS were 361.5 and 61.5 days, with no statistically significant differences between both treatments (p=0.191 and p=0.279 respectively).
Conclusion With the aim of improving the rational use of medicines and optimising results, these findings encourage us to carry out studies with a larger sample of patients in order to select the patients who would benefit most from these therapies.
The possible presence of pseudoprogression in those who did not reach at least 3 months of treatment constitutes a limitation on observing the possible clinical benefits.
References and/or acknowledgements No conflict of interest.
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