Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy
with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study.
Author(s): Kreuter M(1), Vansteenkiste J, Fischer JR, Eberhardt W, Zabeck H, Kollmeier J,
Serke M, Frickhofen N, Reck M, Engel-Riedel W, Neumann S, Thomeer M, Schumann C,
De Leyn P, Graeter T, Stamatis G, Zuna I, Griesinger F, Thomas M; TREAT
investigators.
Affiliation(s): Author information:
(1)Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of
Heidelberg, Amalienstr. 5, 69126 Heidelberg, Germany.
michael.kreuter@thoraxklinik-heidelberg.de
Publication date & source: 2013, Ann Oncol. , 24(4):986-92
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.
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