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. 2021 Jun;26(6):1057-1064.
doi: 10.1007/s10147-021-01896-x. Epub 2021 Mar 14.

Outcomes of patients with non-small cell lung cancer and poor performance status treated with immune checkpoint inhibitors in the real-world setting

Manglio Miguel Rizzo  1 , María Virginia Bluthgen  2 , Gonzalo Recondo  3 , Martin Naveira  4 , Aldo Perfetti  5 , Florencia Rizzi  2 , Alejandro Kuzminin  3 , Victoria Faura  4 , Matías Cerini  6 , Alejandro Videla  7 , Carlos Silva  7 , Lorena Lupinacci  6 , Nicolás Minatta  6
Affiliations

Outcomes of patients with non-small cell lung cancer and poor performance status treated with immune checkpoint inhibitors in the real-world setting

Manglio Miguel Rizzo et al. Int J Clin Oncol. 2021 Jun.

Abstract

Background: Immune-checkpoint inhibitors (ICIs) are standard treatments for metastatic non-small cell lung cancer (NSCLC). Patients with poor performance status (PS) are underrepresented in clinical trials. We evaluate the efficacy and safety of ICIs in a real-world setting.

Methods: We conducted a multi-institutional retrospective study to assess clinical outcomes of NSCLC treated with ICIs. We categorized pts within two groups (PS 0-1 vs 2) and assessed clinical outcomes and safety.

Results: Two hundred and sixty nine patients were included, 44 patients (16.4%) had baseline PS 2 and 223 patients (82.9%) PS 0-1. The overall response rate (ORR) was 30.4%, median PFS was 7.26 months (95% CI 5.1-9.4), and median OS was 15.18 months (95% CI 9.5-20.9). Patients with a PS 2 were most likely to received ICIs in the second or later line (84.1% vs 64.6%; p = 0.01), had baseline steroids (21.4% vs 8.2%; p 0.010), lower response rate (16.7% vs 34.5%; p 0.02) and clinical benefit (35.7% vs 71%; p 0.000) compared to PS 0-1 pts. Moreover, PS ≥ 2 patients had shorter PFS, median 2.2 months (95% CI 1.3-3.1) compared to 9.9 months (95% CI 6.7-13.1] and shorter OS, 3.3 months (95% CI 2.6-4.2) versus 24.1 months (95% CI 16.1-32.1), respectively. PS was significantly associated with PFS and OS in multivariate analysis. As it was expected, immunotherapy was well tolerated with a safety profile comparable to the previous published data.

Conclusion: Based on these retrospective results, patients with poor baseline performance status seem to have poor clinical outcomes with ICIs in the real-world setting.

Keywords: Immunotherapy; Non-small cell lung cancer; Performance status; Real-world data.

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References

    1. Reck M et al (2016) Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 375(19):1823–1833 - DOI
    1. Herbst RS, de Marinis F, Jassem J et al (2015) Phase III clinical trials of atezolizumab compared with standard chemotherapy in PD-L1-selected chemotherapy-naïve patients with advanced NSCLC. Ann Oncol 26(Suppl 9):ix105–ix106
    1. Mok TSK et al (2019) Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet 393(10183):1819–1830 - DOI
    1. Hellmann MD et al (2019) Nivolumab plus ipilimumab in advanced non-small-cell lung cancer. N Engl J Med 381(21):2020–2031 - DOI
    1. Gandhi L et al (2018) Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med 378(22):2078–2092 - DOI

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