Investigators reported a median over-all survival (OS) of 30.0 months (95% CI, 18.3–not reached ) in the pembrolizumab arm and 14.2 months (95% CI, 9.8-19.0) in the chemotherapy arm with a hazard ratio of 0.63 (95% CI, 0.47-0.86) in patients with a PD-L1 tumor proportion score (TPS) of at least 50% by immunohistochemistry (IHC) 22C3 pharmDX assay. In KEYNOTE-024 (NCT02142738), 1 pembrolizumab (Keytruda) was com-pared with platinum-based chemotherapy. Several studies have evaluated the role of immunotherapy as monotherapy in patients with PD-L1 expression of at least 50%. PD-L1–High Metastatic NSCLC: Immunotherapy Alone Data from completed studies evaluating IO alone or in combination with chemotherapy show that a breakdown of populations by PD-L1 status and additional considerations such as toxicity profiles should guide treatment decisions. Recent studies have demonstrated a role for immuno-oncology (IO) agents in the first line, but the added benefit of combining them with chemotherapy (chemo IO) is not clear in all populations. Despite these advances, the best treatment options for patients with nondriver met-astatic NSCLC remain unclear. Progress made in the area of targeted therapies has pushed treatment with small-molecule inhibitors to the front-line setting for patients with aberrations in EGFR, ALK, ROS1, BRAF, MET, and RET.
#KEYNOTE 407 PLUS#
These results support use of pembrolizumab plus chemotherapy as first-line therapy for metastatic squamous NSCLC.The therapeutic landscape for first-line treatment of metastatic non–small cell lung cancer (NSCLC) contains many options. 125).Īddition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18. Median time to deterioration in cough, chest pain, or dyspnea was not reached in either group (hazard ratio, 0.79 95% CI, 0.58 to 1.06] nominal P =. Between-group differences were improved for the pembrolizumab-combination group (difference in LS mean scores: week 9, 3.6, nominal P =. GHS/QoL score improved for the pembrolizumab-combination group (least squares mean change from baseline: week 9, 1.8 week 18, 4.3 ) and deteriorated in the placebo-combination group (week 9, -1.8 week 18, -0.57 ). Two-sided, nominal P values are provided.Ī total of 554 and 553 patients completed ≥ 1 QLQ-C30 or ≥ 1 QLQ-LC13 assessment, respectively.
#KEYNOTE 407 PRO#
Key PRO endpoints were change from baseline to weeks 9 and 18 (during and after platinum therapy) in the QLQ-C30 global health status/quality of life (GHS/QoL) score and time to deterioration in the composite endpoint of cough, chest pain, or dyspnea from the QLQ-C30 and QLQ-LC13. Health-related quality of life (HRQoL) was evaluated using the European Organisation for Research and Treatment of Cancer Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13).
Patients were randomly assigned to receive 4 cycles of pembrolizumab 200 mg or placebo once every 3 weeks plus carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo for an additional 31 cycles. We present patient-reported outcomes (PROs) from KEYNOTE-407. In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel significantly improved overall survival, progression-free survival, and objective response rate in patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC), with little impact on severe toxicity.
10 Oncology Center, Medica Sur Hospital, Mexico City, Mexico.8 Universitätsklinikum Tübingen, Tübingen, Germany.Blokhin Russian Cancer Research Center, Moscow, Russia. 6 Istanbul Medeniyet University Hospital, Istanbul, Turkey.5 Wollongong Oncology and University of Wollongong, Wollongong, NSW, Australia.4 Hospital Universitario Virgen Macarena, Seville, Spain.3 Leningrad Regional Clinical Hospital, St Petersburg, Russia.2 Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland.1 Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.
0 kommentar(er)
