دورية أكاديمية
Ascend: Phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia
| العنوان: | Ascend: Phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia |
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| المؤلفون: | Ghia P., Pluta A., Wach M., Lysak D., Kozak T., Simkovic M., Kaplan P., Kraychok I., Illes A., de la Serna J., Dolan S., Campbell P., Musuraca G., Jacob A., Avery E., Lee J. H., Liang W., Patel P., Quah C., Jurczak W. |
| المساهمون: | Ghia, P., Pluta, A., Wach, M., Lysak, D., Kozak, T., Simkovic, M., Kaplan, P., Kraychok, I., Illes, A., de la Serna, J., Dolan, S., Campbell, P., Musuraca, G., Jacob, A., Avery, E., Lee, J. H., Liang, W., Patel, P., Quah, C., Jurczak, W. |
| بيانات النشر: | American Society of Clinical Oncology |
| سنة النشر: | 2020 |
| الوصف: | PURPOSE Acalabrutinib, a highly selective, potent, Bruton tyrosine kinase inhibitor, was evaluated in this global, multicenter, randomized, open-label, phase III study in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). METHODS Eligible patients, aged $ 18 years with R/R CLL, were randomly assigned 1:1 centrally and stratified by del(17p) status, Eastern Cooperative Oncology Group performance status score, and number of prior lines of therapy. Patients received acalabrutinib monotherapy or investigator’s choice (idelalisib plus rituximab [I-R] or bendamustine plus rituximab [B-R]). The primary end point was progression-free survival (PFS) assessed by an independent review committee (IRC) in the intent-to-treat population. Key secondary end points included IRC-assessed overall response rate, overall survival, and safety. RESULTS From February 21, 2017, to January 17, 2018, a total of 398 patients were assessed for eligibility; 310 patients were randomly assigned to acalabrutinib monotherapy (n 5 155) or investigator’s choice (n 5 155; I-R, n 5 119; B-R, n 5 36). Patients had received a median of two prior therapies (range, 1-10). After a median follow-up of 16.1 months (range, 0.03-22.4 months), median PFS was significantly longer with acalabrutinib monotherapy (PFS not reached) compared with investigator’s choice (16.5 months [95% CI, 14.0 to 17.1 months]; hazard ratio, 0.31 [95% CI, 0.20 to 0.49]; P, .0001). Estimated 12-month PFS was 88% (95% CI, 81% to 92%) for acalabrutinib and 68% (95% CI, 59% to 75%) for investigator’s choice. Serious adverse events occurred in 29% of patients (n 5 44 of 154) treated with acalabrutinib monotherapy, 56% (n 5 66 of 118) with I-R, and 26% (n 5 9 of 35) with B-R. Deaths occurred in 10% (n 5 15 of 154), 11% (n 5 13 of 118), and 14% (n 5 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively. CONCLUSION Acalabrutinib significantly improved PFS compared with I-R or B-R and has an acceptable safety profile in patients with ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/wos/WOS:000567569100002; volume:38; issue:25; firstpage:2849; lastpage:2861; numberofpages:13; journal:JOURNAL OF CLINICAL ONCOLOGY; http://hdl.handle.net/20.500.11768/107412Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85087491901 |
| DOI: | 10.1200/JCO.19.03355 |
| الإتاحة: | https://doi.org/20.500.11768/107412Test https://doi.org/10.1200/JCO.19.03355Test https://hdl.handle.net/20.500.11768/107412Test |
| رقم الانضمام: | edsbas.5661DC39 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1200/JCO.19.03355 |
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