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...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Hauptverfasser: Novello, Silvia (VerfasserIn) , Torri, V. (VerfasserIn) , Grohé, Christian (VerfasserIn) , Kurz, S. (VerfasserIn) , Serke, M. (VerfasserIn) , Wehler, T. (VerfasserIn) , Meyer, A. (VerfasserIn) , Ladage, D. (VerfasserIn) , Geissler, M. (VerfasserIn) , Colantonio, I. (VerfasserIn) , Cauchi, C. (VerfasserIn) , Stoelben, E. (VerfasserIn) , Ceribelli, A. (VerfasserIn) , Kropf-Sanchen, C. (VerfasserIn) , Valmadre, G. (VerfasserIn) , Borra, G. (VerfasserIn) , Schena, M. (VerfasserIn) , Morabito, A. (VerfasserIn) , Santo, A. (VerfasserIn) , Gregorc, V. (VerfasserIn) , Chiari, R. (VerfasserIn) , Reck, M. (VerfasserIn) , Schmid-Bindert, Gerald (VerfasserIn) , Folprecht, G. (VerfasserIn) , Griesinger, Frank (VerfasserIn) , Follador, A. (VerfasserIn) , Pedrazzoli, P. (VerfasserIn) , Bearz, A. (VerfasserIn) , Caffo, O. (VerfasserIn) , Dickgreber, N. J. (VerfasserIn) , Irtelli, L. (VerfasserIn) , Wiest, G. (VerfasserIn) , Monica, V. (VerfasserIn) , Porcu, L. (VerfasserIn) , Manegold, Christian (VerfasserIn) , Scagliotti, G. V. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: January 2022
In: Annals of oncology
Year: 2022, Jahrgang: 33, Heft: 1, Pages: 57-66
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.09.017
Online-Zugang:Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.annonc.2021.09.017
Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753421044963
Volltext
Verfasserangaben: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

MARC

LEADER 00000caa a2200000 c 4500
001 1841086320
003 DE-627
005 20241205134110.0
007 cr uuu---uuuuu
008 230403s2022 xx |||||o 00| ||eng c
024 7 |a 10.1016/j.annonc.2021.09.017  |2 doi 
035 |a (DE-627)1841086320 
035 |a (DE-599)KXP1841086320 
035 |a (OCoLC)1475285491 
040 |a DE-627  |b ger  |c DE-627  |e rda 
041 |a eng 
084 |a 33  |2 sdnb 
100 1 |a Novello, Silvia  |e VerfasserIn  |0 (DE-588)1339521407  |0 (DE-627)1899154280  |4 aut 
245 1 0 |a 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  |c 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 
264 1 |c January 2022 
300 |a 10 
336 |a Text  |b txt  |2 rdacontent 
337 |a Computermedien  |b c  |2 rdamedia 
338 |a Online-Ressource  |b cr  |2 rdacarrier 
500 |a Online verfügbar: 5. Oktober 2021, Artikelversion: 16. Dezember 2021 
500 |a Gesehen am 20.08.2024 
520 |a 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. 
650 4 |a adjuvant chemotherapy 
650 4 |a excision repair cross-complementation 1 
650 4 |a messenger RNA 
650 4 |a non-small-cell lung cancer 
650 4 |a pharmacogenomics 
650 4 |a thymidylate synthase 
700 1 |a Torri, V.  |e VerfasserIn  |4 aut 
700 1 |a Grohé, Christian  |e VerfasserIn  |0 (DE-588)1222446383  |0 (DE-627)1741490987  |4 aut 
700 1 |a Kurz, S.  |e VerfasserIn  |4 aut 
700 1 |a Serke, M.  |e VerfasserIn  |4 aut 
700 1 |a Wehler, T.  |e VerfasserIn  |4 aut 
700 1 |a Meyer, A.  |e VerfasserIn  |4 aut 
700 1 |a Ladage, D.  |e VerfasserIn  |4 aut 
700 1 |a Geissler, M.  |e VerfasserIn  |4 aut 
700 1 |a Colantonio, I.  |e VerfasserIn  |4 aut 
700 1 |a Cauchi, C.  |e VerfasserIn  |4 aut 
700 1 |a Stoelben, E.  |e VerfasserIn  |4 aut 
700 1 |a Ceribelli, A.  |e VerfasserIn  |4 aut 
700 1 |a Kropf-Sanchen, C.  |e VerfasserIn  |4 aut 
700 1 |a Valmadre, G.  |e VerfasserIn  |4 aut 
700 1 |a Borra, G.  |e VerfasserIn  |4 aut 
700 1 |a Schena, M.  |e VerfasserIn  |4 aut 
700 1 |a Morabito, A.  |e VerfasserIn  |4 aut 
700 1 |a Santo, A.  |e VerfasserIn  |4 aut 
700 1 |a Gregorc, V.  |e VerfasserIn  |4 aut 
700 1 |a Chiari, R.  |e VerfasserIn  |4 aut 
700 1 |a Reck, M.  |e VerfasserIn  |4 aut 
700 1 |a Schmid-Bindert, Gerald  |d 1969-  |e VerfasserIn  |0 (DE-588)121300129  |0 (DE-627)081214170  |0 (DE-576)292636024  |4 aut 
700 1 |a Folprecht, G.  |e VerfasserIn  |4 aut 
700 1 |a Griesinger, Frank  |e VerfasserIn  |0 (DE-588)1080408916  |0 (DE-627)844436305  |0 (DE-576)453541747  |4 aut 
700 1 |a Follador, A.  |e VerfasserIn  |4 aut 
700 1 |a Pedrazzoli, P.  |e VerfasserIn  |4 aut 
700 1 |a Bearz, A.  |e VerfasserIn  |4 aut 
700 1 |a Caffo, O.  |e VerfasserIn  |4 aut 
700 1 |a Dickgreber, N. J.  |e VerfasserIn  |4 aut 
700 1 |a Irtelli, L.  |e VerfasserIn  |4 aut 
700 1 |a Wiest, G.  |e VerfasserIn  |4 aut 
700 1 |a Monica, V.  |e VerfasserIn  |4 aut 
700 1 |a Porcu, L.  |e VerfasserIn  |4 aut 
700 1 |a Manegold, Christian  |d 1946-2022  |e VerfasserIn  |0 (DE-588)108614913  |0 (DE-627)490287360  |0 (DE-576)289617200  |4 aut 
700 1 |a Scagliotti, G. V.  |e VerfasserIn  |4 aut 
773 0 8 |i Enthalten in  |t Annals of oncology  |d Amsterdam [u.a.] : Elsevier, 1990  |g 33(2022), 1 vom: Jan., Seite 57-66  |h Online-Ressource  |w (DE-627)320428796  |w (DE-600)2003498-2  |w (DE-576)098134345  |x 1569-8041  |7 nnas  |a 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 
773 1 8 |g volume:33  |g year:2022  |g number:1  |g month:01  |g pages:57-66  |g extent:10  |a 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 
787 0 8 |i Errata  |a Novello, Silvia  |t Corrigendum to “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”  |d 2022  |w (DE-627)1841086177 
856 4 0 |u https://doi.org/10.1016/j.annonc.2021.09.017  |x Verlag  |x Resolving-System  |z kostenfrei  |3 Volltext 
856 4 0 |u https://www.sciencedirect.com/science/article/pii/S0923753421044963  |x Verlag  |z kostenfrei  |3 Volltext 
951 |a AR 
992 |a 20240820 
993 |a Article 
994 |a 2022 
998 |g 108614913  |a Manegold, Christian  |m 108614913:Manegold, Christian  |d 60000  |e 60000PM108614913  |k 0/60000/  |p 35  |y j 
998 |g 121300129  |a Schmid-Bindert, Gerald  |m 121300129:Schmid-Bindert, Gerald  |d 60000  |e 60000PS121300129  |k 0/60000/  |p 23 
999 |a KXP-PPN1841086320  |e 4569080758 
BIB |a Y 
SER |a journal 
JSO |a {"title":[{"title_sort":"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","title":"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"}],"recId":"1841086320","language":["eng"],"type":{"media":"Online-Ressource","bibl":"article-journal"},"name":{"displayForm":["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"]},"person":[{"roleDisplay":"VerfasserIn","family":"Novello","given":"Silvia","display":"Novello, Silvia","role":"aut"},{"given":"V.","display":"Torri, V.","role":"aut","family":"Torri","roleDisplay":"VerfasserIn"},{"roleDisplay":"VerfasserIn","family":"Grohé","display":"Grohé, Christian","role":"aut","given":"Christian"},{"roleDisplay":"VerfasserIn","family":"Kurz","given":"S.","display":"Kurz, S.","role":"aut"},{"display":"Serke, M.","role":"aut","given":"M.","family":"Serke","roleDisplay":"VerfasserIn"},{"family":"Wehler","roleDisplay":"VerfasserIn","role":"aut","display":"Wehler, T.","given":"T."},{"given":"A.","role":"aut","display":"Meyer, A.","roleDisplay":"VerfasserIn","family":"Meyer"},{"family":"Ladage","roleDisplay":"VerfasserIn","given":"D.","display":"Ladage, D.","role":"aut"},{"family":"Geissler","roleDisplay":"VerfasserIn","display":"Geissler, M.","role":"aut","given":"M."},{"roleDisplay":"VerfasserIn","family":"Colantonio","given":"I.","role":"aut","display":"Colantonio, I."},{"family":"Cauchi","roleDisplay":"VerfasserIn","display":"Cauchi, C.","role":"aut","given":"C."},{"role":"aut","display":"Stoelben, E.","given":"E.","family":"Stoelben","roleDisplay":"VerfasserIn"},{"display":"Ceribelli, A.","role":"aut","given":"A.","family":"Ceribelli","roleDisplay":"VerfasserIn"},{"roleDisplay":"VerfasserIn","family":"Kropf-Sanchen","display":"Kropf-Sanchen, C.","role":"aut","given":"C."},{"given":"G.","display":"Valmadre, G.","role":"aut","roleDisplay":"VerfasserIn","family":"Valmadre"},{"given":"G.","role":"aut","display":"Borra, G.","family":"Borra","roleDisplay":"VerfasserIn"},{"family":"Schena","roleDisplay":"VerfasserIn","role":"aut","display":"Schena, M.","given":"M."},{"role":"aut","display":"Morabito, A.","given":"A.","family":"Morabito","roleDisplay":"VerfasserIn"},{"roleDisplay":"VerfasserIn","family":"Santo","given":"A.","role":"aut","display":"Santo, A."},{"roleDisplay":"VerfasserIn","family":"Gregorc","role":"aut","display":"Gregorc, V.","given":"V."},{"family":"Chiari","roleDisplay":"VerfasserIn","given":"R.","display":"Chiari, R.","role":"aut"},{"given":"M.","role":"aut","display":"Reck, M.","family":"Reck","roleDisplay":"VerfasserIn"},{"given":"Gerald","role":"aut","display":"Schmid-Bindert, Gerald","roleDisplay":"VerfasserIn","family":"Schmid-Bindert"},{"roleDisplay":"VerfasserIn","family":"Folprecht","display":"Folprecht, G.","role":"aut","given":"G."},{"role":"aut","display":"Griesinger, Frank","given":"Frank","family":"Griesinger","roleDisplay":"VerfasserIn"},{"family":"Follador","roleDisplay":"VerfasserIn","display":"Follador, A.","role":"aut","given":"A."},{"given":"P.","display":"Pedrazzoli, P.","role":"aut","family":"Pedrazzoli","roleDisplay":"VerfasserIn"},{"roleDisplay":"VerfasserIn","family":"Bearz","given":"A.","display":"Bearz, A.","role":"aut"},{"display":"Caffo, O.","role":"aut","given":"O.","family":"Caffo","roleDisplay":"VerfasserIn"},{"display":"Dickgreber, N. J.","role":"aut","given":"N. J.","roleDisplay":"VerfasserIn","family":"Dickgreber"},{"roleDisplay":"VerfasserIn","family":"Irtelli","given":"L.","display":"Irtelli, L.","role":"aut"},{"role":"aut","display":"Wiest, G.","given":"G.","family":"Wiest","roleDisplay":"VerfasserIn"},{"family":"Monica","roleDisplay":"VerfasserIn","given":"V.","display":"Monica, V.","role":"aut"},{"family":"Porcu","roleDisplay":"VerfasserIn","role":"aut","display":"Porcu, L.","given":"L."},{"given":"Christian","display":"Manegold, Christian","role":"aut","roleDisplay":"VerfasserIn","family":"Manegold"},{"given":"G. V.","display":"Scagliotti, G. V.","role":"aut","roleDisplay":"VerfasserIn","family":"Scagliotti"}],"note":["Online verfügbar: 5. Oktober 2021, Artikelversion: 16. Dezember 2021","Gesehen am 20.08.2024"],"physDesc":[{"extent":"10 S."}],"relHost":[{"part":{"issue":"1","volume":"33","extent":"10","text":"33(2022), 1 vom: Jan., Seite 57-66","pages":"57-66","year":"2022"},"pubHistory":["1.1990 -"],"language":["eng"],"type":{"media":"Online-Ressource","bibl":"periodical"},"corporate":[{"roleDisplay":"Herausgebendes Organ","display":"European Society for Medical Oncology","role":"isb"}],"recId":"320428796","title":[{"title":"Annals of oncology","title_sort":"Annals of oncology","subtitle":"official journal of the European Society for Medical Oncology"}],"disp":"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 cancerAnnals of oncology","origin":[{"publisherPlace":"Amsterdam [u.a.] ; Dordrecht [u.a.] ; Oxford","publisher":"Elsevier ; Kluwer ; Oxford Univ. Press","dateIssuedKey":"1990","dateIssuedDisp":"1990-"}],"id":{"zdb":["2003498-2"],"issn":["1569-8041"],"eki":["320428796"]},"physDesc":[{"extent":"Online-Ressource"}],"note":["Gesehen am 12.11.20","Ungezählte Beil.: Supplement"]}],"id":{"eki":["1841086320"],"doi":["10.1016/j.annonc.2021.09.017"]},"origin":[{"dateIssuedDisp":"January 2022","dateIssuedKey":"2022"}]} 
SRT |a NOVELLOSILINTERNATIO2022