First-line nab-paclitaxel plus carboplatin for patients with advanced non-small cell lung cancer: Results of the NEPTUN study.
Autor: | Dechow T; Practice for Oncology Ravensburg, Ravensburg, Germany., Riera-Knorrenschild J; University Hospital Giessen and Marburg GmbH, Marburg, Germany., Hackanson B; University Medical Center Augsburg, Augsburg, Germany., Janssen J; Practice for Hematology and Oncology, Westerstede, Germany., Schulz H; Practice for Internal Oncology and Hematology, Frechen, Germany., Chiabudini M; Department of Biostatistics, iOMEDICO, Freiburg, Germany., Fischer von Weikersthal L; Health Center St. Marien GmbH, Amberg, Germany., Budweiser S; Hospital Rosenheim, Rosenheim, Germany., Nacke A; Practice for Hematology and Oncology, Remagen, Germany., Taeuscher D; SRH Wald-Klinikum Gera GmbH, Gera, Germany., Welslau M; Medical Care Center at Hospital Aschaffenburg GmbH, Aschaffenburg, Germany., Potthoff K; Medical Department, iOMEDICO, Freiburg, Germany. |
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Jazyk: | angličtina |
Zdroj: | Cancer medicine [Cancer Med] 2021 Nov; Vol. 10 (22), pp. 8127-8137. Date of Electronic Publication: 2021 Oct 20. |
DOI: | 10.1002/cam4.4310 |
Abstrakt: | 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. (© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.) |
Databáze: | MEDLINE |
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