First-line nab-paclitaxel plus carboplatin for patients with advanced non-small cell lung cancer: Results of the NEPTUN study.
Germany
carboplatin
nab-paclitaxel
non-small cell lung carcinoma (NSCLC)
real-world
Journal
Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
revised:
15
09
2021
received:
21
07
2021
accepted:
16
09
2021
pubmed:
21
10
2021
medline:
19
3
2022
entrez:
20
10
2021
Statut:
ppublish
Résumé
Platinum-based chemotherapy remains a first-line standard of care for approximately 30% of patients with non-small cell lung cancer (NSCLC) not harboring a druggable alteration. Favorable efficacy and safety of the nab-paclitaxel/carboplatin (nab-P/C) combination was shown in the pivotal phase 3 trial. However, information on effectiveness of nab-P/C in a real-world setting in Germany is missing. The NEPTUN study prospectively investigated the effectiveness and safety of nab-P/C in patients with advanced NSCLC in a real-world setting. Patients with advanced or metastatic NSCLC received first-line nab-P/C according to clinical routine. The primary endpoint was 6-month progression-free survival rate (PFS6). Other endpoints included further effectiveness parameters, safety and quality of life. Data were analyzed descriptively. 408 patients were enrolled. PFS6 was 40.8% (95% confidence interval [CI], 35.3-46.2); median PFS was 5.2 months (95% CI, 4.5-5.7). overall response rate was 41.5% (95% CI, 36.3-46.8). Median overall survival (OS) was 10.5 months (95% CI, 9.2-11.6). Subgroup analyses revealed median OS for squamous versus non-squamous histology (11.8 months [95% CI, 9.2-13.8] vs. 9.6 months [95% CI, 7.7-11.2]) and age ≥70 versus <70 years (11.7 months [95% CI, 9.4-14.3] vs. 9.6 months [95% CI, 7.5-11.2]). Most common treatment-emergent adverse events (TEAEs) were anemia (26.5%), leukopenia (25.7%), and thrombocytopenia (16.6%). Mostly reported grade 3/4 TEAEs were leukopenia (10.2%), anemia (8.6%), and pneumonia (5.1%). nab-paclitaxel-related deaths as reported by the investigator occurred in 0.8% of patients. These real-world data support the effectiveness and safety of nab-P/C as first-line treatment for patients with advanced NSCLC independent of tumor histology. The results are comparable with the pivotal phase 3 trial. No new safety signals emerged.
Sections du résumé
BACKGROUND
Platinum-based chemotherapy remains a first-line standard of care for approximately 30% of patients with non-small cell lung cancer (NSCLC) not harboring a druggable alteration. Favorable efficacy and safety of the nab-paclitaxel/carboplatin (nab-P/C) combination was shown in the pivotal phase 3 trial. However, information on effectiveness of nab-P/C in a real-world setting in Germany is missing. The NEPTUN study prospectively investigated the effectiveness and safety of nab-P/C in patients with advanced NSCLC in a real-world setting.
METHODS
Patients with advanced or metastatic NSCLC received first-line nab-P/C according to clinical routine. The primary endpoint was 6-month progression-free survival rate (PFS6). Other endpoints included further effectiveness parameters, safety and quality of life. Data were analyzed descriptively.
RESULTS
408 patients were enrolled. PFS6 was 40.8% (95% confidence interval [CI], 35.3-46.2); median PFS was 5.2 months (95% CI, 4.5-5.7). overall response rate was 41.5% (95% CI, 36.3-46.8). Median overall survival (OS) was 10.5 months (95% CI, 9.2-11.6). Subgroup analyses revealed median OS for squamous versus non-squamous histology (11.8 months [95% CI, 9.2-13.8] vs. 9.6 months [95% CI, 7.7-11.2]) and age ≥70 versus <70 years (11.7 months [95% CI, 9.4-14.3] vs. 9.6 months [95% CI, 7.5-11.2]). Most common treatment-emergent adverse events (TEAEs) were anemia (26.5%), leukopenia (25.7%), and thrombocytopenia (16.6%). Mostly reported grade 3/4 TEAEs were leukopenia (10.2%), anemia (8.6%), and pneumonia (5.1%). nab-paclitaxel-related deaths as reported by the investigator occurred in 0.8% of patients.
CONCLUSION
These real-world data support the effectiveness and safety of nab-P/C as first-line treatment for patients with advanced NSCLC independent of tumor histology. The results are comparable with the pivotal phase 3 trial. No new safety signals emerged.
Identifiants
pubmed: 34668662
doi: 10.1002/cam4.4310
pmc: PMC8607256
doi:
Substances chimiques
130-nm albumin-bound paclitaxel
0
Albumins
0
Carboplatin
BG3F62OND5
Paclitaxel
P88XT4IS4D
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
8127-8137Informations de copyright
© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
Références
N Engl J Med. 2018 Jun 14;378(24):2288-2301
pubmed: 29863955
J Clin Oncol. 2020 Jan 20;38(3):271-280
pubmed: 31751163
Front Oncol. 2018 Jul 24;8:253
pubmed: 30087850
N Engl J Med. 2016 Nov 10;375(19):1823-1833
pubmed: 27718847
Adv Exp Med Biol. 2016;893:1-19
pubmed: 26667336
Cancer Manag Res. 2018 Dec 14;10:7013-7019
pubmed: 30588105
J Clin Oncol. 2020 May 10;38(14):1608-1632
pubmed: 31990617
Front Oncol. 2018 Jul 24;8:262
pubmed: 30087851
J Clin Oncol. 2017 Oct 20;35(30):3484-3515
pubmed: 28806116
J Thorac Oncol. 2020 Aug;15(8):1351-1360
pubmed: 32302702
Lung Cancer (Auckl). 2017 Oct 30;8:207-216
pubmed: 29138610
N Engl J Med. 2018 Nov 22;379(21):2040-2051
pubmed: 30280635
Ann Oncol. 2018 Oct 1;29(Suppl 4):iv192-iv237
pubmed: 30285222
Ann Oncol. 2013 Sep;24(9):2390-6
pubmed: 23842283
J Clin Oncol. 2012 Jun 10;30(17):2055-62
pubmed: 22547591
Anticancer Res. 2019 Mar;39(3):1463-1468
pubmed: 30842183
PLoS One. 2017 Jun 23;12(6):e0178420
pubmed: 28644837
N Engl J Med. 2018 May 31;378(22):2078-2092
pubmed: 29658856
Lancet Oncol. 2019 Jul;20(7):924-937
pubmed: 31122901
Lancet. 2017 Jan 21;389(10066):299-311
pubmed: 27574741
Cancer Med. 2021 Nov;10(22):8127-8137
pubmed: 34668662
Cancer Sci. 2019 Dec;110(12):3738-3745
pubmed: 31608537
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593