Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy

• Titel: Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy
• Titelzusatz: JCO flashback
• Mitwirkende: Hanna, Nasser [VerfasserIn]
• Mitwirkende: Shepherd, Frances A. [VerfasserIn]
• Mitwirkende: Fossella, Frank V. [VerfasserIn]
• Mitwirkende: Pereira, Jose R. [VerfasserIn]
• Mitwirkende: De Marinis, Filippo [VerfasserIn]
• Mitwirkende: Pawel, Joachim von [VerfasserIn]
• Mitwirkende: Gatzemeier, Ulrich [VerfasserIn]
• Mitwirkende: Tsao, Thomas Chang Yao [VerfasserIn]
• Mitwirkende: Pless, Miklos [VerfasserIn]
• Mitwirkende: Muller, Thomas [VerfasserIn]
• Mitwirkende: Lim, Hong-Liang [VerfasserIn]
• Mitwirkende: Desch, Christopher [VerfasserIn]
• Mitwirkende: Szondy, Klara [VerfasserIn]
• Mitwirkende: Gervais, Radj [VerfasserIn]
• Mitwirkende: Shaharyar, Shaharyar [VerfasserIn]
• Mitwirkende: Manegold, Christian [VerfasserIn]
• Mitwirkende: Paul, Sofia [VerfasserIn]
• Mitwirkende: Paoletti, Paolo [VerfasserIn]
• Mitwirkende: Einhorn, Lawrence [VerfasserIn]
• Mitwirkende: Bunn, Paul A. [VerfasserIn]
• Verf.angabe: Nasser Hanna, Frances A. Shepherd, Frank V. Fossella, Jose R. Pereira, Filippo De Marinis, Joachim von Pawel, Ulrich Gatzemeier, Thomas Chang Yao Tsao, Miklos Pless, Thomas Muller, Hong-Liang Lim, Christopher Desch, Klara Szondy, Radj Gervais, Shaharyar, Christian Manegold, Sofia Paul, Paolo Paoletti, Lawrence Einhorn, and Paul A. Bunn, Jr.
• E-Jahr: 2023
• Jahr: May 17, 2023
• Umfang: 9 S.
• Fussnoten: Gesehen am 29.08.2023 ; This article is a republication of jco.2004.08.163
• Titel Quelle: Enthalten in: Journal of clinical oncology
• Ort Quelle: Alexandria, Va. : American Society of Clinical Oncology, 1983
• Jahr Quelle: 2023
• Band/Heft Quelle: 41(2023), 15 vom: Mai, Seite 2682-2690
• ISSN Quelle: 1527-7755
• DOI: doi:10.1200/JCO.22.02546
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1858210984

Abstract

PURPOSE - To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy. - PATIENTS AND METHODS - Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m2 intravenously (IV) day 1 with vitamin B12, folic acid, and dexamethasone or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point was overall survival. - RESULTS - Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4% v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving pemetrexed. - CONCLUSION - Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.