11/6/2023 0 Comments Keynote 407 final analysis![]() Tumor responses were assessed by the investigator according to local standards and clinical routine.Īdverse events (AEs) were reported until 30 days after the last dose of nab‐paclitaxel. All assessments and procedures were performed as per local clinical practice. min/ml infusion on day 1 of each 21‐day cycle. ![]() According to current SmPC, nab‐paclitaxel was administered as 100 mg/m² infusion on day 1, 8, and 15 of each 21‐day cycle, and carboplatin was administered as area under the curve 6 mg Patients received study medication according to clinical routine and current German nab‐paclitaxel summary of product characteristic (SmPC the decision for nab‐P/C prescription was clearly separated from and prior to the decision to include patients into the study). ![]() These results were confirmed in the consecutive ABOUND studies where elderly patients and patients with poor performance status were treated with nab‐P/C.īut real‐world data for the nab‐P/C combination regimen are scarce.Īim of the NEPTUN study was to prospectively investigate the effectiveness and safety of nab‐P/C in patients with advanced NSCLC in a real‐world setting. In addition, patients suffered significantly less from neuropathy and arthralgia grade 3 and 4 when treated with nab‐paclitaxel compared to those treated with solvent‐based paclitaxel. The nab‐paclitaxel combination showed an increased overall response rate (ORR) mainly driven by patients with squamous NSCLC. The pivotal phase 3 trial compared solvent‐based paclitaxel with a 130‐nm albumin‐bound paclitaxel ( nab‐paclitaxel) formulation, both in combination with carboplatin. Nab‐P/C was approved for first‐line treatment of advanced NSCLC in 2012. In addition, patients with specific comorbidities can benefit from treatment with nab‐P/C, as for example efficacy and safety in patients with interstitial lung disease has recently been reported. Some of these immunotherapy regimens make use of the nab‐P/C combination as chemotherapy backbone.įor example, the KEYNOTE‐407 trial used pembrolizumab in combination with nab‐P/C. Efficacy of immunotherapy (‐combinations) proved to be superior to sole chemotherapy regimensĪnd lead to an improved quality of life (QoL). In recent years, immunotherapy was approved as first‐line therapy either as monotherapy for NSCLC patients with PD‐L1 expression ≥50% or in combination with different chemotherapy backbones independent of PD‐L1 expression based on pivotal phase 3 trials Keynote‐024, Keynote‐189, Keynote‐407, IMpower150, IMpower133. According to current guidelines of the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) the nab‐paclitaxel plus carboplatin combination ( nab‐P/C) is a recommended standard first‐line treatment regimen for patients with advanced NSCLC without druggable alteration. the remaining majority is thus frequently treated with chemotherapy‐based therapy regimens. But only a small fraction of patients currently benefits from targeted therapies like EGFR‐, ALK‐, ROS1‐, or BRAF‐inhibitors due to the relatively low mutation frequency.Ībout one‐third of the NSCLC patients without targetable alteration show high programmed cell death‐ligand 1 (PD‐L1) expression ≥50% and therefore qualify for pembrolizumab monotherapy Tyrosine kinase inhibitors have markedly improved treatment options for patients with genetic aberrations such as epidermal growth factor (EGFR) and anaplastic lymphoma kinase (ALKs). Systemic therapy for advanced NSCLC usually consists of chemotherapy, targeted therapy or immunotherapy, or a combination of these. Nevertheless, the 5‐year survival rate is very poor. Surgery remains the key treatment option for the treatment of early‐stage NSCLC, accompanied by various systemic therapies and radiation. Squamous cell carcinoma presents the second most common NSCLC subtype and is strongly associated with tobacco smoking. It is the most common histologic subtype in never‐smokers and females. Adenocarcinoma is the most common form of lung cancer, accounting for about 40% of all NSCLC cases. Regarding histological classification, adenocarcinoma and squamous cell carcinoma account for the majority of cases. ![]() Non‐small cell lung cancer (NSCLC) is one of the most common malignancies and the leading cause of cancer death among both men and women worldwide.
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