Outcomes of patients with non-small cell lung cancer and poor performance status treated with immune checkpoint inhibitors in the real-world setting.
Immunotherapy
Non-small cell lung cancer
Performance status
Real-world data
Journal
International journal of clinical oncology
ISSN: 1437-7772
Titre abrégé: Int J Clin Oncol
Pays: Japan
ID NLM: 9616295
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
received:
20
09
2020
accepted:
25
02
2021
pubmed:
15
3
2021
medline:
15
3
2021
entrez:
14
3
2021
Statut:
ppublish
Résumé
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. 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. 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. Based on these retrospective results, patients with poor baseline performance status seem to have poor clinical outcomes with ICIs in the real-world setting.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
Based on these retrospective results, patients with poor baseline performance status seem to have poor clinical outcomes with ICIs in the real-world setting.
Identifiants
pubmed: 33715058
doi: 10.1007/s10147-021-01896-x
pii: 10.1007/s10147-021-01896-x
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1057-1064Références
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: 10.1056/NEJMoa1606774
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
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: 10.1016/S0140-6736(18)32409-7
Hellmann MD et al (2019) Nivolumab plus ipilimumab in advanced non-small-cell lung cancer. N Engl J Med 381(21):2020–2031
doi: 10.1056/NEJMoa1910231
Gandhi L et al (2018) Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med 378(22):2078–2092
doi: 10.1056/NEJMoa1801005
Paz-Ares L et al (2018) Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med 379:2040
doi: 10.1056/NEJMoa1810865
Socinski MA et al (2018) Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med 378(24):2288–2301
doi: 10.1056/NEJMoa1716948
Brahmer J et al (2015) Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 373(2):123–135
doi: 10.1056/NEJMoa1504627
Borghaei H et al (2015) Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 373(17):1627–1639
doi: 10.1056/NEJMoa1507643
Gandara DR et al (2018) Atezolizumab treatment beyond progression in advanced NSCLC: results from the randomized, phase III OAK study. J Thorac Oncol 13(12):1906–1918
doi: 10.1016/j.jtho.2018.08.2027
Herbst RS et al (2016) Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 387(10027):1540–1550
doi: 10.1016/S0140-6736(15)01281-7
Lilenbaum RC et al (2008) Prevalence of poor performance status in lung cancer patients: implications for research. J Thorac Oncol 3(2):125–129
doi: 10.1097/JTO.0b013e3181622c17
Salloum RG et al (2012) Survival among non-small cell lung cancer patients with poor performance status after first line chemotherapy. Lung Cancer 77(3):545–549
doi: 10.1016/j.lungcan.2012.04.019
Network N.C.C. (2020) Non-small-cell lung cancer (Version, 3.2020)
Eisenhauer EA et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228–247
doi: 10.1016/j.ejca.2008.10.026
Rittmeyer A et al (2017) Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet 389(10066):255–265
doi: 10.1016/S0140-6736(16)32517-X
Barlesi F et al (2018) Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol 19(11):1468–1479
doi: 10.1016/S1470-2045(18)30673-9
Carbone DP et al (2017) First-line nivolumab in stage IV or recurrent non-small-cell lung cancer. N Engl J Med 376(25):2415–2426
doi: 10.1056/NEJMoa1613493
Govindan R et al (2017) Phase III trial of ipilimumab combined with paclitaxel and carboplatin in advanced squamous non-small-cell lung cancer. J Clin Oncol 35(30):3449–3457
doi: 10.1200/JCO.2016.71.7629
Antonia SJ et al (2018) Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med 379(24):2342–2350
doi: 10.1056/NEJMoa1809697
Bersanelli M et al (2018) Patient performance status and cancer immunotherapy efficacy: a meta-analysis. Med Oncol 35(10):132
doi: 10.1007/s12032-018-1194-4
Bellmunt J et al (2017) Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med 376(11):1015–1026
doi: 10.1056/NEJMoa1613683
Middleton G et al (2018) Pembrolizumab in performance status 2 patients with non-samll-cell lung cancer (NSCLC): results of the PEPS2 trial. Annal Oncol 29(Suppl_8):viii893–viii547
Juergens RA et al (2018) Real-world benefit of nivolumab in a Canadian non-small-cell lung cancer cohort. Curr Oncol 25(6):384–392
doi: 10.3747/co.25.4287
Areses Manrique MC et al (2018) Real world data of nivolumab for previously treated non-small cell lung cancer patients: a Galician lung cancer group clinical experience. Transl Lung Cancer Res 7(3):404–415
doi: 10.21037/tlcr.2018.04.03
Spigel DR et al (2019) Safety, efficacy, and patient-reported health-related quality of life and symptom burden with nivolumab in patients with advanced non-small cell lung cancer, including patients aged 70 years or older or with poor performance status (CheckMate 153). J Thorac Oncol 14(9):1628–1639
doi: 10.1016/j.jtho.2019.05.010
Popat S et al (2017) Nivolumab in previously treated patients with metastatic squamous NSCLC: results of a European single-arm, phase 2 trial (CheckMate 171) including patients agde ≥70 years and with poor performance status. Annal Oncol 28(Suppl_5):463
doi: 10.1093/annonc/mdx380.006
Juergens R et al (2017) CheckMate 169: safety/efficacy of nivolumab in Canadian pretreated advanced NSCLC (including elderly and PS 2) patients. J Thorac Oncol 12(11):S2426–S2427
doi: 10.1016/j.jtho.2017.11.088
Khozin S et al. (2018) Real-world outcomes of patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors in the year following U.S. Regulatory Approval. Oncologist
Yamada T et al. (2019) Retrospective efficacy analysis of immune checkpoint inhibitors in patients with EGFR-mutated non-small cell lung cancer. Cancer Med
Cavanna L, Citterio C, Orlandi E (2019) Immune checkpoint inhibitors in EGFR-mutation positive TKI-treated patients with advanced non-small-cell lung cancer network meta-analysis. Oncotarget 10(2):209–215
doi: 10.18632/oncotarget.26541
Arbour KC et al (2018) Impact of baseline steroids on efficacy of programmed cell death-1 and programmed death-ligand 1 blockade in patients with non-small-cell lung cancer. J Clin Oncol 36(28):2872–2878
doi: 10.1200/JCO.2018.79.0006
Ricciuti B et al (2019) Immune checkpoint inhibitor outcomes for patients with non-small-cell lung cancer receiving baseline corticosteroids for palliative versus nonpalliative indications. J Clin Oncol 37(22):1927–1934
doi: 10.1200/JCO.19.00189