Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma
In this multicenter, single‐arm, phase II study, the efficacy and safety of ibrutinib were examined in Japanese patients with relapsed or refractory mantle cell lymphoma (MCL). Patients (age ≥20 years) with relapsed or refractory MCL who had progressed after receiving at least one prior treatment re...
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John Wiley and Sons Inc.
2016
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| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198949/ |
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pubmed-5198949 |
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pubmed-51989492016-12-30 Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma Maruyama, Dai Nagai, Hirokazu Fukuhara, Noriko Kitano, Toshiyuki Ishikawa, Takayuki Shibayama, Hirohiko Choi, Ilseung Hatake, Kiyohiko Uchida, Toshiki Nishikori, Momoko Kinoshita, Tomohiro Matsuno, Yoshihiro Nishikawa, Tomoaki Takahara, Satoko Tobinai, Kensei Original Articles In this multicenter, single‐arm, phase II study, the efficacy and safety of ibrutinib were examined in Japanese patients with relapsed or refractory mantle cell lymphoma (MCL). Patients (age ≥20 years) with relapsed or refractory MCL who had progressed after receiving at least one prior treatment regimen, were enrolled. Patients were treated with oral ibrutinib (560 mg once daily; 28‐day cycle) until disease progression (or relapse), unacceptable toxicity, or study end. The primary end‐point was overall response rate. Secondary end‐points included duration of response (DOR), time to response, progression‐free survival (PFS), overall survival, and safety. Of the 16 patients who received treatment, 5 patients discontinued the study (progressive disease, 4; sepsis, 1). Median duration of ibrutinib exposure was 6.5 months (range, 2.8–8.3 months). The overall response rate was 87.5% (90% confidence interval, 65.6–97.7; complete response = 2 [12.5%]; partial response = 12 [75.0%]). Median time to response for all responders (n = 14) was 1.8 months (range, 0.7–5.3 months). The median DOR and PFS were not estimable due to censoring (range: DOR, 1.1–6.4+ months; PFS, 2.8–8.0+ months). Overall survival data were immature due to the limited observation period. A total of 8/16 patients (50%) had at least one grade 3 adverse event (AE), and 5 (31.3%) patients reported serious AEs. The most commonly reported AEs were diarrhea and stomatitis (37.5% each), platelet count decrease (31.3%), and anemia (25%). Overall, orally administered single agent ibrutinib was efficacious with an acceptable safety profile in Japanese patients with relapsed or refractory MCL. Clinical trial registration NCT02169180 (ClinicalTrials.gov). John Wiley and Sons Inc. 2016-11-25 2016-12 /pmc/articles/PMC5198949/ /pubmed/27616553 http://dx.doi.org/10.1111/cas.13076 Text en © 2016 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
| repository_type |
Open Access Journal |
| institution_category |
Foreign Institution |
| institution |
US National Center for Biotechnology Information |
| building |
NCBI PubMed |
| collection |
Online Access |
| language |
English |
| format |
Online |
| author |
Maruyama, Dai Nagai, Hirokazu Fukuhara, Noriko Kitano, Toshiyuki Ishikawa, Takayuki Shibayama, Hirohiko Choi, Ilseung Hatake, Kiyohiko Uchida, Toshiki Nishikori, Momoko Kinoshita, Tomohiro Matsuno, Yoshihiro Nishikawa, Tomoaki Takahara, Satoko Tobinai, Kensei |
| spellingShingle |
Maruyama, Dai Nagai, Hirokazu Fukuhara, Noriko Kitano, Toshiyuki Ishikawa, Takayuki Shibayama, Hirohiko Choi, Ilseung Hatake, Kiyohiko Uchida, Toshiki Nishikori, Momoko Kinoshita, Tomohiro Matsuno, Yoshihiro Nishikawa, Tomoaki Takahara, Satoko Tobinai, Kensei Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma |
| author_facet |
Maruyama, Dai Nagai, Hirokazu Fukuhara, Noriko Kitano, Toshiyuki Ishikawa, Takayuki Shibayama, Hirohiko Choi, Ilseung Hatake, Kiyohiko Uchida, Toshiki Nishikori, Momoko Kinoshita, Tomohiro Matsuno, Yoshihiro Nishikawa, Tomoaki Takahara, Satoko Tobinai, Kensei |
| author_sort |
Maruyama, Dai |
| title |
Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma |
| title_short |
Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma |
| title_full |
Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma |
| title_fullStr |
Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma |
| title_full_unstemmed |
Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma |
| title_sort |
efficacy and safety of ibrutinib in japanese patients with relapsed or refractory mantle cell lymphoma |
| description |
In this multicenter, single‐arm, phase II study, the efficacy and safety of ibrutinib were examined in Japanese patients with relapsed or refractory mantle cell lymphoma (MCL). Patients (age ≥20 years) with relapsed or refractory MCL who had progressed after receiving at least one prior treatment regimen, were enrolled. Patients were treated with oral ibrutinib (560 mg once daily; 28‐day cycle) until disease progression (or relapse), unacceptable toxicity, or study end. The primary end‐point was overall response rate. Secondary end‐points included duration of response (DOR), time to response, progression‐free survival (PFS), overall survival, and safety. Of the 16 patients who received treatment, 5 patients discontinued the study (progressive disease, 4; sepsis, 1). Median duration of ibrutinib exposure was 6.5 months (range, 2.8–8.3 months). The overall response rate was 87.5% (90% confidence interval, 65.6–97.7; complete response = 2 [12.5%]; partial response = 12 [75.0%]). Median time to response for all responders (n = 14) was 1.8 months (range, 0.7–5.3 months). The median DOR and PFS were not estimable due to censoring (range: DOR, 1.1–6.4+ months; PFS, 2.8–8.0+ months). Overall survival data were immature due to the limited observation period. A total of 8/16 patients (50%) had at least one grade 3 adverse event (AE), and 5 (31.3%) patients reported serious AEs. The most commonly reported AEs were diarrhea and stomatitis (37.5% each), platelet count decrease (31.3%), and anemia (25%). Overall, orally administered single agent ibrutinib was efficacious with an acceptable safety profile in Japanese patients with relapsed or refractory MCL. Clinical trial registration NCT02169180 (ClinicalTrials.gov). |
| publisher |
John Wiley and Sons Inc. |
| publishDate |
2016 |
| url |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198949/ |
| _version_ |
1613844157523034112 |