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Title: | Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study | Authors: | Kreuter, M Vansteenkiste, J Fischer, J Eberhardt, W Zabeck, H Kollmeier, J Serke, M Frickhofen, N Reck, M Engel-Riedel, W Neumann, S THOMEER, Michiel Schumann, C De Leyn, P Graeter, T Stamatis, G Zuna, I Griesinger, F Thomas, M |
Issue Date: | 2013 | Publisher: | OXFORD UNIV PRESS | Source: | Annals of oncology, 24 (4) , p. 986 -992 | Abstract: | 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. Adjuvant chemotherapy is beneficial in non-small-cell lung cancer (NSCLC). However, balancing toxicity and efficacy mandates improvement.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.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).Adjuvant chemotherapy with CPx is safe and feasible with less toxicity and superior dose delivery compared with CVb. |
Keywords: | adjuvant chemotherapy;clinical feasibility;dose delivery;non-small-cell lung cancer;pemetrexed;toxicity | Document URI: | http://hdl.handle.net/1942/31737 | ISSN: | 0923-7534 | e-ISSN: | 1569-8041 | DOI: | 10.1093/annonc/mds578 | ISI #: | WOS:000316701300018 | Rights: | The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology.All rights reserved. For permissions, please email: journals.permissions@oup.com. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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