First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study

Abstract 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...

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Autores principales:	Tobias Dechow, Jorge Riera‐Knorrenschild, Björn Hackanson, Jan Janssen, Holger Schulz, Marco Chiabudini, Ludwig Fischer von Weikersthal, Stephan Budweiser, Axel Nacke, Dagmar Taeuscher, Manfred Welslau, Karin Potthoff
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	carboplatin Germany nab‐paclitaxel non‐small cell lung carcinoma (NSCLC) real‐world Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/5b6b2c18b24b4eb19418ef882658d450
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spelling	oai:doaj.org-article:5b6b2c18b24b4eb19418ef882658d4502021-11-22T09:08:48ZFirst‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study2045-763410.1002/cam4.4310https://doaj.org/article/5b6b2c18b24b4eb19418ef882658d4502021-11-01T00:00:00Zhttps://doi.org/10.1002/cam4.4310https://doaj.org/toc/2045-7634Abstract 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.Tobias DechowJorge Riera‐KnorrenschildBjörn HackansonJan JanssenHolger SchulzMarco ChiabudiniLudwig Fischer von WeikersthalStephan BudweiserAxel NackeDagmar TaeuscherManfred WelslauKarin PotthoffWileyarticlecarboplatinGermanynab‐paclitaxelnon‐small cell lung carcinoma (NSCLC)real‐worldNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancer Medicine, Vol 10, Iss 22, Pp 8127-8137 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	carboplatin Germany nab‐paclitaxel non‐small cell lung carcinoma (NSCLC) real‐world Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	carboplatin Germany nab‐paclitaxel non‐small cell lung carcinoma (NSCLC) real‐world Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Tobias Dechow Jorge Riera‐Knorrenschild Björn Hackanson Jan Janssen Holger Schulz Marco Chiabudini Ludwig Fischer von Weikersthal Stephan Budweiser Axel Nacke Dagmar Taeuscher Manfred Welslau Karin Potthoff First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study
description	Abstract 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.
format	article
author	Tobias Dechow Jorge Riera‐Knorrenschild Björn Hackanson Jan Janssen Holger Schulz Marco Chiabudini Ludwig Fischer von Weikersthal Stephan Budweiser Axel Nacke Dagmar Taeuscher Manfred Welslau Karin Potthoff
author_facet	Tobias Dechow Jorge Riera‐Knorrenschild Björn Hackanson Jan Janssen Holger Schulz Marco Chiabudini Ludwig Fischer von Weikersthal Stephan Budweiser Axel Nacke Dagmar Taeuscher Manfred Welslau Karin Potthoff
author_sort	Tobias Dechow
title	First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study
title_short	First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study
title_full	First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study
title_fullStr	First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study
title_full_unstemmed	First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study
title_sort	first‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: results of the neptun study
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/5b6b2c18b24b4eb19418ef882658d450
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First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: Results of the NEPTUN study

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