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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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
January 2022
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| 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 |
| 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 |
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| 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 | |
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| 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 | |
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