7 research outputs found
Firstâline nabâpaclitaxel plus carboplatin for patients with advanced nonâsmall cell lung cancer: results of the NEPTUN study
Abstract Background Platinumâbased chemotherapy remains a firstâline standard of care for approximately 30% of patients with nonâsmall cell lung cancer (NSCLC) not harboring a druggable alteration. Favorable efficacy and safety of the nabâpaclitaxel/carboplatin (nabâP/C) combination was shown in the pivotal phase 3 trial. However, information on effectiveness of nabâP/C in a realâworld setting in Germany is missing. The NEPTUN study prospectively investigated the effectiveness and safety of nabâP/C in patients with advanced NSCLC in a realâworld setting. Methods Patients with advanced or metastatic NSCLC received firstâline nabâP/C according to clinical routine. The primary endpoint was 6âmonth progressionâfree 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], 35.3â46.2); median PFS was 5.2Â months (95% CI, 4.5â5.7). overall response rate was 41.5% (95% CI, 36.3â46.8). Median overall survival (OS) was 10.5Â months (95% CI, 9.2â11.6). Subgroup analyses revealed median OS for squamous versus nonâsquamous histology (11.8Â months [95% CI, 9.2â13.8] vs. 9.6Â months [95% CI, 7.7â11.2]) and age â„70 versus <70Â years (11.7Â months [95% CI, 9.4â14.3] vs. 9.6Â months [95% CI, 7.5â11.2]). Most common treatmentâemergent 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%). nabâpaclitaxelârelated deaths as reported by the investigator occurred in 0.8% of patients. Conclusion These realâworld data support the effectiveness and safety of nabâP/C as firstâline 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
Development and validation of a prognostic model for survival in patients treated with venoarterial extracorporeal membrane oxygenation: the PREDICT VA-ECMO score
Aims: Several scoring systems have been introduced for prognostication after initiating venoarterial extracorporeal membrane oxygenation (VA-ECMO) therapy. However, static scores offer limited guidance once VA-ECMO is implanted, although continued allocation of healthcare resources is critical. Patients requiring continued VA-ECMO support are extremely unstable, with minimal heart function and multi-organ failure in most cases. The aim of the present study was to develop and validate a dynamic prognostic model for patients treated with VA-ECMO. Methods and results: A derivation cohort included 205 all-comers undergoing VA-ECMO implantation at a tertiary referral hospital (51% received VA-ECMO during resuscitation and 43% had severe shock). Two prediction models based on point-of-care biomarkers were developed using penalised logistic regression in an elastic net approach. A validation cohort was recruited from an independent tertiary referral hospital. Comparators for the prediction of hospital survival were the SAVE score (area under the receiver operation characteristic curve (AUC) of 0.686), the SAPS score (AUC 0.679), the APACHE score (AUC 0.662) and the SOFA score (AUC 0.732) in 6-hour survivors. The 6-hour PREDICT VA-ECMO score (based on lactate, pH and standard bicarbonate concentration) outperformed the comparator scores with an AUC of 0.823. The 12-hour PREDICT VA-ECMO integrated lactate, pH and standard bicarbonate concentration at 1 hour, 6 hours and 12 hours after ECMO insertion allowed even better prognostication (AUC 0.839). Performance of the scores in the external validation cohort was good (AUCs 0.718 for the 6-hour score and 0.735 for the 12-hour score, respectively). Conclusion: In patients requiring VA-ECMO therapy, a dynamic score using three point-of-care biomarkers predicts hospital mortality with high reliability. Furthermore, the PREDICT scores are the first scores for extracorporeal cardiopulmonary resuscitation patients