Abstract：
UNASSIGNED: This article provides a short summary of 5-year results from the iNNOVATE trial. The original paper was published in the Journal of Clinical Oncology in October 2021. People with Waldenström\'s macroglobulinemia (WM) were randomly divided into two groups of 75 people each. One group received a combination treatment composed of two drugs, ibrutinib plus rituximab, and the other group took placebo (\"sugar pill\") plus rituximab. Ibrutinib (also known by the brand name Imbruvica®) is a drug that reduces cancer cells\' ability to multiply and survive. Ibrutinib is an FDA-approved drug for the treatment of WM. Rituximab is a drug that helps the immune system find and kill cancer cells. Participants in the trial were treated and their health monitored for up to 5 years (63 months).
UNASSIGNED: During the 5 years of monitoring, more people who took ibrutinib plus rituximab experienced an improvement in their disease and lived longer without their disease getting worse compared to those who took placebo plus rituximab. Side effects from ibrutinib and rituximab were manageable and generally decreased over time. Participants in both study groups reported improvements in quality of life, but those who took ibrutinib plus rituximab reported significantly greater improvement in their quality of life (as measured by FACT-An score) compared to those who took placebo plus rituximab.
UNASSIGNED: These results show that ibrutinib plus rituximab is better than rituximab alone in people with WM and that ibrutinib plus rituximab is safe and effective in the long term. This information confirms the role of ibrutinib plus rituximab as a standard of care for WM. Clinical Trial Registration: NCT02165397 (ClinicalTrials.gov).
UNASSIGNED: During the 5 years of monitoring, more people who took ibrutinib plus rituximab experienced an improvement in their disease and lived longer without their disease getting worse compared to those who took placebo plus rituximab. Side effects from ibrutinib and rituximab were manageable and generally decreased over time. Participants in both study groups reported improvements in quality of life, but those who took ibrutinib plus rituximab reported significantly greater improvement in their quality of life (as measured by FACT-An score) compared to those who took placebo plus rituximab.
UNASSIGNED: These results show that ibrutinib plus rituximab is better than rituximab alone in people with WM and that ibrutinib plus rituximab is safe and effective in the long term. This information confirms the role of ibrutinib plus rituximab as a standard of care for WM. Clinical Trial Registration: NCT02165397 (ClinicalTrials.gov).
摘要：
本文简要总结了iNNOVATE试验的5年结果。原始论文于2021年10月发表在《临床肿瘤学杂志》上。Waldenström巨球蛋白血症（WM）患者随机分为两组，每组75人。一组接受由两种药物组成的联合治疗，伊布替尼加利妥昔单抗,另一组服用安慰剂（“糖丸”）加利妥昔单抗。Ibrutinib（也称为Imbruvica®）是一种降低癌细胞繁殖和生存能力的药物。Ibrutinib是FDA批准的用于治疗WM的药物。利妥昔单抗是一种帮助免疫系统发现和杀死癌细胞的药物。该试验的参与者接受了治疗，他们的健康状况监测长达5年（63个月）。
在监测的5年中，与服用安慰剂加利妥昔单抗的人相比,服用依鲁替尼加利妥昔单抗的人病情改善,且寿命延长,病情没有恶化.依鲁替尼和利妥昔单抗的副作用是可控的，并且随着时间的推移通常会减少。两个研究组的参与者都报告了生活质量的改善，但与服用安慰剂+利妥昔单抗的患者相比,服用依鲁替尼+利妥昔单抗的患者的生活质量显著改善(通过FACT-An评分衡量).
这些结果表明，在WM患者中，依鲁替尼联合利妥昔单抗优于单用利妥昔单抗，并且依鲁替尼联合利妥昔单抗长期安全有效。该信息证实了依鲁替尼联合利妥昔单抗作为WM护理标准的作用。临床试验注册：NCT02165397（ClinicalTrials.gov）。
在监测的5年中，
这些结果表明，在WM患者中，依鲁替尼联合利妥昔单抗优于单用利妥昔单抗，并且依鲁替尼联合利妥昔单抗长期安全有效。
