Effectiveness of Nivolumab versus Docetaxel as Second-Line Treatment in Non-Small Cell Lung Cancer Patients in Clinical Practice

Abstract

Aims: To evaluate the effectiveness of nivolumab as second-line treatment compared to standard therapy with docetaxel in adult patients with non-small cell lung cancer (NSCLC) in clinical practice. Methods: This is an observational, retrospective cohort study of adult patients diagnosed with NSCLC, stage III-IV, treated with docetaxel or nivolumab as second-line treatment. The end points evaluated were overall survival (OS) and progression-free survival (PFS). PFS and OS were described using the Kaplan-Meier method. The Cox proportional hazards model was applied to identify independent prognostic and predictive factors related to disease progression or death. Results: Thirty-three patients were included in this study (i.e., 14 in the nivolumab group and 19 in the docetaxel group). Nonsquamous NSCLC was the most frequent histological subtype. Cohorts were homogeneous. The follow-up time was 116 ± 87.3 days. The median PFS was 84 days (95% CI 39-300) for patients treated with nivolumab and 61 days (95% CI 48-76) for patients treated with docetaxel. The risk of progression was 60% lower for patients treated with nivolumab (HR 0.40; 95% CI 0.16-0.97; p = 0.043) compared to patients receiving docetaxel. Among the patients treated with docetaxel, the median OS was 129 days (95% CI 106-300). More than 50% of the patients treated with nivolumab were alive at the end of the follow-up period; nevertheless, the risk difference was not statistically significant (HR 0.55; 95% CI 0.20-1.51; p = 0.244). Conclusion: NSCLC patients treated with nivolumab as second-line therapy had a longer PFS compared to patients treated with docetaxel in a health care environment.

Effectiveness and safety of immune checkpoint inhibitors: A retrospective study in Taiwan

“…It was found that the median OS was 7.5 months [ 24 ], and another study conducted in Spain showed that it was not reached. [ 25 ] Based on the results of this study, the median OS for first line treatment was not reached, and it was 13 months for non-first line treatment, which is similar to the findings from clinical trials but it is longer than that in cohort studies. On the other hand, according to the results of previous clinical trials, the median PFS of immune-therapies for first line treatment ranged from 4.2 [ 16 ] to 13 [ 26 ] months [ 12 , 21 , 27 ], and for non-first line treatment, it ranged from 2.3[ 14 ] to 4[ 13 ] months.…”

“…[ 15 , 22 ] The results of the cohort studies for the median PFS was 2.8 months. [ 24 , 25 ] Based on the results of this study, the median PFS for first line treatment was not reached and was 4.9 months for non-first line treatment, which was a little bit longer than the findings from clinical trials and cohort studies.…”

Nivolumab provides improved effectiveness and safety compared with docetaxel as a second‐line treatment for advanced non‐small cell lung cancer: A systematic review and meta‐analysis

“…We initially identified 2667 potentially eligible studies, and after screening, six studies involving 949 patients (469 patients in the nivolumab group, and 480 patients in the docetaxel group) were included in the final analysis (Figure 1). [9][10][11][12]14,15 Of the six studies, four were RCTs (studies 11 and 12 were the two-year and three-year outcomes of studies 9 and 10), and two were retrospective studies. According to the Cochrane Risk of Bias Tool, all the included studies were of high quality (Figure S1).…”