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Observational Study
. 2020 Oct;9(19):6923-6932.
doi: 10.1002/cam4.3120. Epub 2020 May 15.

Duration of nivolumab for pretreated, advanced non-small-cell lung cancer

Affiliations
Observational Study

Duration of nivolumab for pretreated, advanced non-small-cell lung cancer

Margaux Geier et al. Cancer Med. 2020 Oct.

Abstract

Background: A standard of care for pretreated, advanced non-small-cell lung cancers (NSCLCs), nivolumab has demonstrated long-term benefit when administered for 2 years. We aimed to better discern an optimized administration duration by retrospectively analyzing real-life long-term efficacy in a prospective cohort.

Methods: All nivolumab-treated adults with advanced NSCLCs (01/09/2015 to 30/09/2016) from nine French centers were eligible. On 31/12/2018, patients who are alive ≥ 2 years after starting nivolumab were defined as long-term survivors (LTSs) and were divided into three nivolumab treatment groups: <2, 2, or > 2 years. Co-primary endpoints were LTSs' progression-free survival (PFS) and overall survival (OS).

Results: The median follow-up was 32 months (95% CI, 31.0 to 34.0). The 3-year OS rate for the 259 cohort patients was 16.6%. Among them, 65 were LTSs: 47 treated < 2 years, 7 for 2 years, and 11 > 2 years. Their respective characteristics were: median age: 59, 52, and 58 years; smoking history: 92.9, 100, and 100%; adenocarcinomas: 66, 57.1, and 54.5%. LTSs' median (m)PFS was 28.4 months; mOS was not reached. LTSs' objective response rate was 61.6%. mOS was 32.7 months for those treated < 2 years and not reached for the others. The > 2-year group's 3-year OS was longer. Twenty-eight LTSs experienced no disease progression; 7 had durable complete responses. However, LTSs had more frequent and more severe adverse events.

Conclusion: In real-life, prolonged nivolumab use provided long-term benefit with 16.6% 3-year OS and 25% LTSs. Survival tended to be prolonged with nivolumab continued beyond 2 years. Prospective randomized trials with adequate design are needed.

Keywords: immunotherapy; long-term survivors; nivolumab; non-small-cell lung cancer; real-life; treatment duration.

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Conflict of interest statement

The authors have stated that they have no conflicts of interest.

The authors confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome.

Figures

Figure 1
Figure 1
Kaplan‐Meier estimates of the probability of (A) progression‐free survival and (B) overall survival for the 65 long‐term survivors
Figure 2
Figure 2
Kaplan‐Meier estimates of the probability of (A) progression‐free survival and (B) overall survival for the 65 long‐term survivors according to nivolumab treatment duration
Figure 3
Figure 3
Kaplan‐Meier estimates of the probability of overall survival among long‐term survivors with progression‐free survival ≥ 12 mo, according to nivolumab administration duration
Figure 4
Figure 4
Kaplan‐Meier estimates of the probability of overall survival for the 65 long‐term survivors according to any‐grade adverse event occurrence

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