患者报告的三级难治性多发性骨髓瘤患者使用贝兰他单抗-马福多汀治疗的结果。

Rakesh Popat, Sagar Lonial, Peter M Voorhees, Simona Degli Esposti, Boris Gorsh, Ira Gupta, Joanna Opalinska, Sandhya Sapra, Trisha Piontek, Zangdong He, David Kleinman, Debra Schaumberg, Antoine Regnault, Juliette Meunier, Laurie Eliason
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引用次数: 1

摘要

在随机II期DREAMM-2研究中,单剂贝兰他单抗-马福多汀在三级难治性复发/难治性多发性骨髓瘤(RRMM)中表现出深刻而持久的反应和可控的安全性。我们介绍了本研究中接受批准剂量的贝兰他单抗-马福多汀(2.5 mg/kg q3w)治疗的患者的患者报告结果(PROs)。疾病和治疗相关症状、健康相关生活质量(HRQOL)、功能、,在基线、治疗期间(每3或6周)使用问卷(欧洲癌症研究和治疗组织生活质量问卷EORTC-QLQ-C30和EORTC-QRQ-MY20、眼表疾病指数[OSDI]和国家眼科研究所视觉功能问卷25[NEI VFQ-25])评估患者报告的眼部变化,以及在治疗结束时(EOT)。在基线、每个治疗周期之前和EOT时进行眼部检查。患者在OSDI和NEI VFQ-25问卷中报告了眼部症状,根据所考虑的症状,最严重程度的中位时间为45至64天。据报道,驾驶和阅读方面存在一些限制。眼部症状得到改善,中位恢复时间为23.5至44.0天。EORTC-QLQ-C30数据表明,在患者继续贝兰他单抗-马福多汀治疗的同时,即使出现视力相关症状的显著恶化,核心MM症状(包括疲劳和疼痛)、总体HRQOL和患者功能也得到了维持。这些PRO结果,加上贝兰单抗-马福多汀的临床疗效,支持其在RRMM患者中的应用,并进一步评估其在早期治疗中的应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Patient-Reported Outcomes With Belantamab Mafodotin Treatment in Patients With Triple-Class Refractory Multiple Myeloma.

Patient-Reported Outcomes With Belantamab Mafodotin Treatment in Patients With Triple-Class Refractory Multiple Myeloma.

Patient-Reported Outcomes With Belantamab Mafodotin Treatment in Patients With Triple-Class Refractory Multiple Myeloma.

Patient-Reported Outcomes With Belantamab Mafodotin Treatment in Patients With Triple-Class Refractory Multiple Myeloma.

In the randomized phase II DREAMM-2 study, single-agent belantamab mafodotin demonstrated deep and durable responses and a manageable safety profile in triple-class refractory relapsed/refractory multiple myeloma (RRMM). We present patient-reported outcomes (PROs) from this study for patients treated with the approved dose of belantamab mafodotin (2.5 mg/kg q3w). Disease and treatment-related symptoms, health-related quality of life (HRQOL), functioning, and patient-reported ocular changes were assessed using questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life questionnaires EORTC-QLQ-C30 and EORTC-QLQ-MY20, Ocular Surface Disease Index [OSDI], and the National Eye Institute Visual Functioning Questionnaire 25 [NEI VFQ-25]) at baseline, during treatment (every 3 or 6 weeks), and at the end of treatment (EOT). Eye examinations were conducted at baseline, prior to each treatment cycle, and at EOT. Patients reported ocular symptoms in the OSDI and NEI VFQ-25 questionnaires, with the median time to worst severity of 45 to 64 days depending on symptoms considered. Some limitations in driving and reading were reported. Ocular symptoms were improved and median time to recovery was 23.5 to 44.0 days. EORTC-QLQ-C30 data suggest core MM symptoms (including fatigue and pain), overall HRQOL, and patient functioning were maintained while patients continued belantamab mafodotin treatment, even if meaningful worsening of vision-related symptoms occurred. These PRO results, together with the clinical efficacy of belantamab mafodotin, support its use in patients with RRMM and further evaluation of its use at earlier lines of therapy.

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