Evaluation of efficacy and toxicity of nivolumab combined with or without docetaxel in patients with advanced NSCLC

Abstract

Background The combination of PD-1/PD-L1 inhibitor and chemotherapy has been clinically confirmed to be beneficial as the first-line treatment of patients with advanced NSCLC. This study aimed to assess the effect of nivolumab + docetaxel versus nivolumab monotherapy in patients with NSCLC after the failure of platinum doublet chemotherapy. Materials and methods The efficacy and toxicity of nivolumab + docetaxel combination therapy versus nivolumab monotherapy were compared in this retrospective study. Primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and toxicity. Results Between November 2017 and December 2019, 77 patients were included in this study, with 58 patients in the nivolumab group and 19 in the nivolumab + docetaxel group. The median follow-up was 18 months, and the PFS was 8 months for patients receiving nivolumab + docetaxel and 2 months for those receiving nivolumab alone (p = 0.001), respectively. Nivolumab + docetaxel showed superior OS compared with nivolumab, with the median OS unreached versus 7 months (p = 0.011). Among patients without EGFR/ALK variation, compared to nivolumab monotherapy, nivolumab + docetaxel showed better PFS (p = 0.04) and OS (p = 0.05). There was no significant difference in grade 3–4 adverse events (AEs) between the two groups (p = 0.253). Conclusions The combination of nivolumab and docetaxel demonstrated a meaningful improvement in progression-free survival and overall survival compared to nivolumab monotherapy, in patients with NSCLC after the failure of platinum doublet chemotherapy, irrespective of EGFR/ALK variation status.

Nivolumab combined docetaxel versus nivolumab in patients with previously treated nonsmall cell lung cancer: a phase 2 study

“…We noted the enrollments were all Japanese patients and that docetaxel was administered at a different dose and interval compared to the treatment routine. Although there was a confounding effect from comparison with recently published data, our study was consistent with the previous ICIs trials and retrospective studies in second-line therapy [25,26]. The small sample size of the study and the poor general condition of the patients enrolled may also lead to inconsistent results.…”

Clinical effect of anlotinib in combination with docetaxel in treating advanced non-small cell lung cancer

“…Docetaxel is a plant chemotherapeutic agent that can accelerate the apoptosis process of cancer cells by inhibiting microtubule depolymerization and normal recombination [5], and docetaxel alone is currently the second-line standard chemotherapy regimen for the clinical treatment of advanced NSCLC [6]. Since long-term application of docetaxel can easily result in drug resistance in patients, and then adversely affect the subsequent tumor inhibition effect, it is necessary to combine it with less dose-dependent drugs to improve the tumor inhibition effect [7]. Hence, it is essential to explore a safe as well as efficient chemotherapy regimen for advanced NSCLC patients who have failed second-line chemotherapy.…”