Scholarlink

Abstract <p>Ibrutinib is a first-in-class oral inhibitor of Bruton’s tyrosine kinase, which was investigated for the first-line treatment of mantle cell lymphoma (MCL) in the randomized, double-blind, phase 3 SHINE study. In SHINE, ibrutinib plus bendamustine and rituximab (BR) demonstrated superior progression-free survival (PFS) versus placebo plus BR in patients aged ≥ 65 years with previously untreated stage II–IV MCL. In this secondary efficacy analysis of SHINE, we assessed the correlation between best response and PFS (<i>n</i> = 523; 70% male; median age 71.0 years). After a median follow-up of 94.5 months, patients achieving complete response (CR) had longer median PFS in the ibrutinib (97.8 months) and placebo (87.9 months) arms than those with partial response (PR; 27.6 and 16.7 months, respectively) or progressive/stable disease (2.9 and 3.4 months, respectively). In the multivariate logistic regression analysis, patients receiving ibrutinib plus BR were more likely to achieve CR than those receiving placebo plus BR (odds ratio 1.48; 95% confidence interval 1.00–2.22). In conclusion, prolonged long-term PFS was more likely in patients with MCL who achieved CR following treatment with either ibrutinib plus BR or placebo plus BR, while CR was more likely in patients who had received ibrutinib plus BR.</p> Trial registration <p>EU Clinical Trials Register (EudraCT) identifier 2012-004056-11 (registered 15 January 2013) WHO Universal Trial Number U1111-1137-0389.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Impact of best response to ibrutinib plus Bendamustine and rituximab on PFS in MCL: a secondary analysis of SHINE

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月13日

查看全文
  • Yuko Mishima,
  • Daigo Hashimoto,
  • Michiko Ichii,
  • Noriko Fukuhara,
  • Toshiki Uchida,
  • Koji Kato,
  • Ai Omi,
  • Yosuke Koroki,
  • Kaname Shiga,
  • Dai Maruyama

摘要

Abstract

Ibrutinib is a first-in-class oral inhibitor of Bruton’s tyrosine kinase, which was investigated for the first-line treatment of mantle cell lymphoma (MCL) in the randomized, double-blind, phase 3 SHINE study. In SHINE, ibrutinib plus bendamustine and rituximab (BR) demonstrated superior progression-free survival (PFS) versus placebo plus BR in patients aged ≥ 65 years with previously untreated stage II–IV MCL. In this secondary efficacy analysis of SHINE, we assessed the correlation between best response and PFS (n = 523; 70% male; median age 71.0 years). After a median follow-up of 94.5 months, patients achieving complete response (CR) had longer median PFS in the ibrutinib (97.8 months) and placebo (87.9 months) arms than those with partial response (PR; 27.6 and 16.7 months, respectively) or progressive/stable disease (2.9 and 3.4 months, respectively). In the multivariate logistic regression analysis, patients receiving ibrutinib plus BR were more likely to achieve CR than those receiving placebo plus BR (odds ratio 1.48; 95% confidence interval 1.00–2.22). In conclusion, prolonged long-term PFS was more likely in patients with MCL who achieved CR following treatment with either ibrutinib plus BR or placebo plus BR, while CR was more likely in patients who had received ibrutinib plus BR.

Trial registration

EU Clinical Trials Register (EudraCT) identifier 2012-004056-11 (registered 15 January 2013) WHO Universal Trial Number U1111-1137-0389.