Popat Rakesh, Lonial Sagar, Voorhees Peter M, Esposti Simona Degli, Gorsh Boris, Gupta Ira, Opalinska Joanna, Sapra Sandhya, Piontek Trisha, He Zangdong, Kleinman David, Schaumberg Debra, Regnault Antoine, Meunier Juliette, Eliason Laurie
From NIHR University College London Hospitals Clinical Research Facility, University College London Hospitals NHS Foundation Trust, London, UK.
Emory University, Winship Cancer Institute, Atlanta, Georgia, USA.
J Adv Pract Oncol. 2023 Sep;14(6):503-518. doi: 10.6004/jadpro.2023.14.6.4. Epub 2023 Sep 1.
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.
在随机II期DREAMM-2研究中,单药贝利司他单抗在三重耐药复发/难治性多发性骨髓瘤(RRMM)中显示出深度且持久的缓解以及可控的安全性。我们展示了该研究中接受批准剂量贝利司他单抗(2.5mg/kg,每3周一次)治疗的患者的患者报告结局(PRO)。使用问卷(欧洲癌症研究与治疗组织生活质量问卷EORTC-QLQ-C30和EORTC-QLQ-MY20、眼表疾病指数[OSDI]以及美国国立眼科研究所视觉功能问卷25[NEI VFQ-25])在基线、治疗期间(每3或6周)和治疗结束时(EOT)评估疾病和治疗相关症状、健康相关生活质量(HRQOL)、功能以及患者报告的眼部变化。在基线、每个治疗周期前和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,最严重症状出现的中位时间为45至64天。报告了一些驾驶和阅读方面的限制。眼部症状得到改善,恢复的中位时间为23.5至44.0天。EORTC-QLQ-C30数据表明,在患者继续接受贝利司他单抗治疗期间,即使与视力相关的症状出现有意义的恶化,MM核心症状(包括疲劳和疼痛)、总体HRQOL和患者功能仍得以维持。这些PRO结果与贝利司他单抗的临床疗效一起,支持其在RRMM患者中的使用,并进一步评估其在早期治疗线中的应用。