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

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...

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Main Authors: Hanna, Nasser (Author) , Shepherd, Frances A. (Author) , Fossella, Frank V. (Author) , Pereira, Jose R. (Author) , De Marinis, Filippo (Author) , Pawel, Joachim von (Author) , Gatzemeier, Ulrich (Author) , Tsao, Thomas Chang Yao (Author) , Pless, Miklos (Author) , Muller, Thomas (Author) , Lim, Hong-Liang (Author) , Desch, Christopher (Author) , Szondy, Klara (Author) , Gervais, Radj (Author) , Shaharyar, Shaharyar (Author) , Manegold, Christian (Author) , Paul, Sofia (Author) , Paoletti, Paolo (Author) , Einhorn, Lawrence (Author) , Bunn, Paul A. (Author)
Format: Article (Journal)
Language:English
Published: May 17, 2023
In: Journal of clinical oncology
Year: 2023, Volume: 41, Issue: 15, Pages: 2682-2690
ISSN:1527-7755
DOI:10.1200/JCO.22.02546
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.22.02546
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/abs/10.1200/JCO.22.02546
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Author Notes: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.
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Summary: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.
Item Description:Gesehen am 29.08.2023
This article is a republication of jco.2004.08.163
Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.22.02546

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