Int J Clin Oncol. 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.

International journal of clinical oncology

Manglio Miguel Rizzo, María Virginia Bluthgen, Gonzalo Recondo, Martin Naveira, Aldo Perfetti, Florencia Rizzi, Alejandro Kuzminin, Victoria Faura, Matías Cerini, Alejandro Videla, Carlos Silva, Lorena Lupinacci, Nicolás Minatta

PMID: 33715058 DOI: 10.1007/s10147-021-01896-x

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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