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International Tailored Chemotherapy Adjuvant (ITACA) trial, a phase III multicenter randomized trial comparing adjuvant pharmacogenomic-driven chemotherapy versus standard adjuvant chemotherapy in completely resected stage II-IIIA non-small-cell lung cancer

Background - Several strategies have been investigated to improve the 4% survival advantage of adjuvant chemotherapy in early-stage non-small-cell lung cancer (NSCLC). In this investigator-initiated study we aimed to evaluate the predictive utility of the messenger RNA (mRNA) expression levels of ex...

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Main Authors: Novello, Silvia (Author) , Torri, V. (Author) , Grohé, Christian (Author) , Kurz, S. (Author) , Serke, M. (Author) , Wehler, T. (Author) , Meyer, A. (Author) , Ladage, D. (Author) , Geissler, M. (Author) , Colantonio, I. (Author) , Cauchi, C. (Author) , Stoelben, E. (Author) , Ceribelli, A. (Author) , Kropf-Sanchen, C. (Author) , Valmadre, G. (Author) , Borra, G. (Author) , Schena, M. (Author) , Morabito, A. (Author) , Santo, A. (Author) , Gregorc, V. (Author) , Chiari, R. (Author) , Reck, M. (Author) , Schmid-Bindert, Gerald (Author) , Folprecht, G. (Author) , Griesinger, Frank (Author) , Follador, A. (Author) , Pedrazzoli, P. (Author) , Bearz, A. (Author) , Caffo, O. (Author) , Dickgreber, N. J. (Author) , Irtelli, L. (Author) , Wiest, G. (Author) , Monica, V. (Author) , Porcu, L. (Author) , Manegold, Christian (Author) , Scagliotti, G. V. (Author)
Format: Article (Journal)
Language:English
Published: January 2022
In: Annals of oncology
Year: 2022, Volume: 33, Issue: 1, Pages: 57-66
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.09.017
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.annonc.2021.09.017
Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753421044963
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Author Notes:S. Novello, V. Torri, C. Grohe, S. Kurz, M. Serke, T. Wehler, A. Meyer, D. Ladage, M. Geissler, I. Colantonio, C. Cauchi, E. Stoelben, A. Ceribelli, C. Kropf-Sanchen, G. Valmadre, G. Borra, M. Schena, A. Morabito, A. Santo, V. Gregorc, R. Chiari, M. Reck, G. Schmid-Bindert, G. Folprecht, F. Griesinger, A. Follador, P. Pedrazzoli, A. Bearz, O. Caffo, N.J. Dickgreber, L. Irtelli, G. Wiest, V. Monica, L. Porcu, C. Manegold and G.V. Scagliotti
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Summary:Background - Several strategies have been investigated to improve the 4% survival advantage of adjuvant chemotherapy in early-stage non-small-cell lung cancer (NSCLC). In this investigator-initiated study we aimed to evaluate the predictive utility of the messenger RNA (mRNA) expression levels of excision repair cross complementation group 1 (ERCC1) and thymidylate synthase (TS) as assessed in resected tumor. - Patients and methods - Seven hundred and seventy-three completely resected stage II-III NSCLC patients were enrolled and randomly assigned in each of the four genomic subgroups to investigator’s choice of platinum-based chemotherapy (C, n = 389) or tailored chemotherapy (T, n = 384). All anticancer drugs were administered according to standard doses and schedules. Stratification factors included stage and smoking status. The primary endpoint of the study was overall survival (OS). - Results - Six hundred and ninety patients were included in the primary analysis. At a median follow-up of 45.9 months, 85 (24.6%) and 70 (20.3%) patients died in arms C and T, respectively. Five-year survival for patients in arms C and T was of 65.4% (95% CI (confidence interval): 58.5% to 71.4%) and 72.9% (95% CI: 66.5% to 78.3%), respectively. The estimated hazard ratio (HR) was 0.77 (95% CI: 0.56-1.06, P value: 0.109) for arm T versus arm C. HR for recurrence-free survival was 0.89 (95% CI: 0.69-1.14, P value: 0.341) for arm T versus arm C. Grade 3-5 toxicities were more frequently reported in arm C than in arm T. - Conclusion - In completely resected stage II-III NSCLC tailoring adjuvant chemotherapy conferred a non-statistically significant trend for OS favoring the T arm. In terms of safety, the T arm was associated with better efficacy/toxicity ratio related to the different therapeutic choices in the experimental arm.
Item Description:Online verfügbar: 5. Oktober 2021, Artikelversion: 16. Dezember 2021
Gesehen am 20.08.2024
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.09.017

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