The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.
Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non–High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial
Open accessAbstract
Purpose: The initial results of the APL0406 trial showed that the combination of all- trans-retinoic acid (ATRA) and arsenic trioxide (ATO) is at least not inferior to standard ATRA and chemotherapy (CHT) in first-line therapy of low- or intermediate-risk acute promyelocytic leukemia (APL). We herein report the final analysis on the complete series of patients enrolled onto this trial. Patients and Methods: The APL0406 study was a prospective, randomized, multicenter, open-label, phase III noninferiority trial. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, low- or intermediate-risk APL (WBC at diagnosis ≤ 10 × 10 9 /L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013. Results: Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively ( P = .12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3% v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively ( P < .001, P = .0013, and P = .0073, respectively). Postinduction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm. Conclusion: These results show that the advantages of ATRA-ATO over ATRA-CHT increase over time and that there is significantly greater and more sustained antileukemic efficacy of ATO-ATRA compared with ATRA-CHT in low- and intermediate-risk APL.
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Retinoic Acid and Arsenic Trioxide for Acute Promyelocytic Leukemia
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Self-citationThe "Retinoic Acid Syndrome" in Acute Promyelocytic Leukemia
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Cited by
Sanz, M. A., Fenaux, P., Tallman, M. S., Estey, E. H., Löwenberg, B., Naoe, T., Lengfelder, E., Döhner, H., Burnett, A. K., Chen, S.-J., et al. (2019) · Blood · doi:10.1182/blood-2019-01-894980 · Cited by 664
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Metadata
- Authors
- Platzbecker, U., Avvisati, G., Cicconi, L., Thiede, C., Paoloni, F., Vignetti, M., Ferrara, F., Divona, M., Albano, F., Efficace, F., Fazi, P., Sborgia, M., Di Bona, E., Breccia, M., Borlenghi, E., Cairoli, R., Rambaldi, A., Melillo, L., La Nasa, G., Fiedler, W., Brossart, P., Hertenstein, B., Salih, H. R., Wattad, M., Lübbert, M., Brandts, C. H., Hänel, M., Röllig, C., Schmitz, N., Link, H., Frairia, C., Pogliani, E. M., Fozza, C., D’Arco, A. M., Di Renzo, N., Cortelezzi, A., Fabbiano, F., Döhner, K., Ganser, A., Döhner, H., Amadori, S., Mandelli, F., Ehninger, G., Schlenk, R. F., & Lo-Coco, F.
- Venue
- Journal of Clinical Oncology
- Published
- 2017-02-20
- Volume
- 35
- Issue
- 6
- Pages
- 605-612
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2474389367
- Cited by
- 389
- References
- 22
- FWCI
- 20.16
- Type
- journal article
- Language
- en
- Open access
- green
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- CoChat. (2026). Citation check: Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non–High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial. https://app.cochat.ai/papers/10.1200/jco.2016.67.1982
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- Platzbecker, U., Avvisati, G., Cicconi, L., Thiede, C., Paoloni, F., Vignetti, M., Ferrara, F., Divona, M., Albano, F., Efficace, F., Fazi, P., Sborgia, M., Di Bona, E., Breccia, M., Borlenghi, E., Cairoli, R., Rambaldi, A., Melillo, L., La Nasa, G., . . . Lo-Coco, F. (2017). Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non–High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.67.1982
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