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

被引:3
作者
Dechow, Tobias [1 ]
Riera-Knorrenschild, Jorge [2 ]
Hackanson, Bjoern [3 ]
Janssen, Jan [4 ]
Schulz, Holger [5 ]
Chiabudini, Marco [6 ]
Fischer von Weikersthal, Ludwig [7 ]
Budweiser, Stephan [8 ]
Nacke, Axel [9 ]
Taeuscher, Dagmar [10 ]
Welslau, Manfred [11 ]
Potthoff, Karin [12 ]
机构
[1] Practice Oncol Ravensburg, Elisabethenstr 19, D-88212 Ravensburg, Germany
[2] Univ Hosp Giessen & Marburg GmbH, Marburg, Germany
[3] Univ Med Ctr Augsburg, Augsburg, Germany
[4] Practice Hematol & Oncol, Westerstede, Germany
[5] Practice Internal Oncol & Hematol, Frechen, Germany
[6] iOMEDICO, Dept Biostat, Freiburg, Germany
[7] Hlth Ctr St Marien GmbH, Amberg, Germany
[8] Hosp Rosenheim, Rosenheim, Germany
[9] Practice Hematol & Oncol, Remagen, Germany
[10] SRH Wald Klinikum Gera GmbH, Gera, Germany
[11] Hosp Aschaffenburg GmbH, Med Care Ctr, Aschaffenburg, Germany
[12] iOMEDICO, Dept Med, Freiburg, Germany
关键词
carboplatin; Germany; nab-paclitaxel; non-small cell lung carcinoma (NSCLC); real-world; THERAPY; COMBINATION;
D O I
10.1002/cam4.4310
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:8127 / 8137
页数:11
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