Hillmen Peter, Janssens Ann, Babu K Govind, Kloczko Janusz, Grosicki Sebastian, Manson Stephanie, McKeown Astrid, Gupta Ira, Chang Chai-Ni, Offner Fritz
a St James's Institute of Oncology , Leeds , West Yorkshire , UK.
b Universitaire Ziekenhuizen Leuven , Leuven , Belgium.
Acta Oncol. 2016 Sep-Oct;55(9-10):1115-1120. doi: 10.1080/0284186X.2016.1205217. Epub 2016 Aug 5.
Patients diagnosed with chronic lymphocytic leukemia (CLL) are usually elderly and frequently have a number of comorbidities. Health-related quality of life (HRQoL) for these patients is of utmost importance and should be taken into consideration when assessing new treatment options. The combination of ofatumumab with chlorambucil has shown longer progression-free survival compared with chlorambucil alone. In this study, we aim to assess how this treatment combination affects patients' health-related quality of life and patient-reported symptoms.
In this open-label phase III trial, patients with previously untreated CLL for whom fludarabine-based treatment was contra-indicated, were randomized 1:1 to receive oral chlorambucil (10 mg/m) on Days 1-7 of a 28-day treatment cycle or to receive chlorambucil by this schedule plus intravenous ofatumumab (Cycle 1: 300 mg on Day 1 and 1000 mg on Day 8; subsequent cycles: 1000 mg Day 1) for 3-12 cycles. The EORTC QLQ-C30 and QLQ-CLL16 questionnaires were administered to patients before and during treatment, in follow-up and at the time of disease progression. The primary specified patient-reported outcomes were HRQoL and fatigue.
Patient-reported improvements from baseline in Global Health Status (GHS)/HRQoL scores and fatigue scores were recorded during treatment with both chlorambucil monotherapy and ofatumumab in combination with chlorambucil. There were no significant differences between the two treatment arms for GHS/HRQoL (p = 0.667) or fatigue (p = 0.103). Following treatment, numerical improvements to GHS/HRQoL and fatigue scores were reported, with no significant differences between the two treatment arms.
Small but detectable improvements in patients' quality of life were reported as a result of treatment. The addition of ofatumumab to chlorambucil did not negatively impact HRQoL. Quality of life was maintained in the months following treatment.
被诊断为慢性淋巴细胞白血病（CLL）的患者通常年事已高，且常常伴有多种合并症。这些患者的健康相关生活质量（HRQoL）至关重要，在评估新的治疗方案时应予以考虑。与单独使用苯丁酸氮芥相比，奥法木单抗联合苯丁酸氮芥已显示出更长的无进展生存期。在本研究中，我们旨在评估这种治疗组合如何影响患者的健康相关生活质量以及患者报告的症状。
在这项开放标签的III期试验中，将之前未接受过治疗且氟达拉滨治疗禁忌的CLL患者按1:1随机分组，在28天治疗周期的第1 - 7天接受口服苯丁酸氮芥（10 mg/m²），或按此方案接受苯丁酸氮芥加静脉注射奥法木单抗（第1周期：第1天300 mg，第8天1000 mg；后续周期：第1天1000 mg），共治疗3 - 12个周期。在治疗前、治疗期间、随访时以及疾病进展时，向患者发放欧洲癌症研究与治疗组织（EORTC）的QLQ - C30和QLQ - CLL16问卷。主要指定的患者报告结局为健康相关生活质量和疲劳。
在苯丁酸氮芥单药治疗以及奥法木单抗联合苯丁酸氮芥治疗期间，均记录到患者报告的全球健康状况（GHS）/健康相关生活质量评分和疲劳评分较基线有所改善。在GHS/健康相关生活质量（p = 0.667）或疲劳（p = 0.103）方面，两个治疗组之间没有显著差异。治疗后，报告了GHS/健康相关生活质量和疲劳评分的数值改善，两个治疗组之间没有显著差异。
据报告，治疗使患者的生活质量有虽小但可检测到的改善。在苯丁酸氮芥中添加奥法木单抗对健康相关生活质量没有负面影响。治疗后的几个月里生活质量得以维持。
