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Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study

BACKGROUND: Adjuvant chemotherapy is beneficial in non-small-cell lung cancer (NSCLC). However, balancing toxicity and efficacy mandates improvement. PATIENTS AND METHODS: Patients with completely resected stages IB-pT3N1 NSCLC were randomly assigned to either four cycles cisplatin (C: 50 mg/m(2) da...

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1. Verfasser: Kreuter, Michael (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2013
In: Annals of oncology
Year: 2012, Jahrgang: 24, Heft: 4, Pages: 986-992
ISSN:1569-8041
DOI:10.1093/annonc/mds578
Online-Zugang:Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/annonc/mds578
Verlag, kostenfrei, Volltext: https://academic.oup.com/annonc/article/24/4/986/259172
Volltext
Verfasserangaben:M. Kreuter, J. Vansteenkiste, J. R. Fischer, W. Eberhardt, H. Zabeck, J. Kollmeier, M. Serke, N. Frickhofen, M. Reck, W. Engel-Riedel, S. Neumann, M. Thomeer, C. Schumann, P. De Leyn, T. Graeter, G. Stamatis, I. Zuna, F. Griesinger, M. Thomas, TREAT investigators

MARC

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245 1 0 |a Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine  |b the TREAT study  |c M. Kreuter, J. Vansteenkiste, J. R. Fischer, W. Eberhardt, H. Zabeck, J. Kollmeier, M. Serke, N. Frickhofen, M. Reck, W. Engel-Riedel, S. Neumann, M. Thomeer, C. Schumann, P. De Leyn, T. Graeter, G. Stamatis, I. Zuna, F. Griesinger, M. Thomas, TREAT investigators 
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520 |a BACKGROUND: Adjuvant chemotherapy is beneficial in non-small-cell lung cancer (NSCLC). However, balancing toxicity and efficacy mandates improvement. PATIENTS AND METHODS: Patients with completely resected stages IB-pT3N1 NSCLC were randomly assigned to either four cycles cisplatin (C: 50 mg/m(2) day (d)1 + 8) and vinorelbine (V: 25 mg/m(2) d1, 8, 15, 22) q4 weeks or four cycles cisplatin (75 mg/m(2) d1) and pemetrexed (Px: 500 mg/m(2) d1) q3 weeks. Primary objective was the clinical feasibility rate (no grade (G)4 neutropenia/thrombocytopenia or thrombocytopenia with bleeding, no G3/4 febrile neutropenia or non-hematological toxicity; no premature withdrawal/death). Secondary objectives were drug delivery and efficacy. RESULTS: One hundred and thirty two patients were randomized (stages: 38% IB, 10% IIA, 47% IIB, 5% pT3pN1; histology: 43% squamous, 57% non-squamous). The feasibility rates were 95.5% (cisplatin and pemetrexed, CPx) and 75.4% (cisplatin and vinorelbine, CVb) (P = 0.001); hematological G3/4 toxic effects were 10% (CPx) and 74% (CVb) (P < 0.001), non-hematological toxic effects were comparable (33% and 31%, P = 0.798). Delivery of total mean doses was 90% of planned with CPx, but 66% (cisplatin) and 64% (vinorelbine) with CVb (P < 0.0001). The median number of cycles [treatment time (weeks)] was 4 for CPx (11.2) and 3 for CVb (9.9). Time to withdrawal from therapy differed significantly between arms favoring CPx (P < 0.001). CONCLUSION: Adjuvant chemotherapy with CPx is safe and feasible with less toxicity and superior dose delivery compared with CVb. 
534 |c 2012 
650 4 |a Adult 
650 4 |a Aged 
650 4 |a Antineoplastic Combined Chemotherapy Protocols 
650 4 |a Carcinoma, Non-Small-Cell Lung 
650 4 |a Chemotherapy, Adjuvant 
650 4 |a Cisplatin 
650 4 |a Disease-Free Survival 
650 4 |a Drug-Related Side Effects and Adverse Reactions 
650 4 |a Female 
650 4 |a Glutamates 
650 4 |a Guanine 
650 4 |a Humans 
650 4 |a Lung Neoplasms 
650 4 |a Male 
650 4 |a Middle Aged 
650 4 |a Pemetrexed 
650 4 |a Survival Rate 
650 4 |a Vinblastine 
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