Brunner Christine, Egle Daniel, Ritter Magdalena, Kofler Ricarda, Giesinger Johannes M, Schneitter Lisa, Sztankay Monika, Emmelheinz Miriam, Abdel Azim Samira, Wieser Verena, Oberguggenberger Anne
Department of Gynecology and Obstetrics, Medical University of Innsbruck, Innsbruck, Austria.
Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.
Breast Cancer (Dove Med Press). 2023 Jul 17;15:485-494. doi: 10.2147/BCTT.S412338. eCollection 2023.
Alopecia has been reported a distressing side-effect of chemotherapy for breast cancer patients (BCP) that is highly relevant for quality of life during treatment. For the prevention of chemotherapy-induced alopecia, scalp cooling (SC) has been reported to be an effective and safe intervention. However, data on the patient's perspective on effectiveness and applicability of SC in a clinical routine setting are scarce. In this comparative study, we aimed at a longitudinal assessment of patient-reported outcome (PRO) data on the effect of SC on alopecia and its effect on symptoms and functional health when applied in clinical routine in BCP receiving taxane or anthracycline-based chemotherapy.
Study participants were allocated either to the intervention group receiving SC or to the control group based on patient preference (non-randomized study). All patients completed PRO-measures on hair preservation (EORTC Item Library items on hair loss), symptom and functional health measures (EORTC QLQ-C30 and -BR23) and the Body Image Scale (BIS). Outcomes were assessed at chemotherapy start (baseline), mid-chemotherapy, last chemotherapy cycle, 3 months follow-up and 6-9 months follow-up.
Overall, we included 113 patients: 75 patients underwent SC (mean age = 51.3 years, 52.7% premenopausal); 38 patients standard care (mean age = 55.6 years, 39.5% premenopausal). A total of 53 patients (70.7%) discontinued SC, with 39 patients (73.5%) stating alopecia as the primary reason. On average, BCP stayed on treatment with the cooling cap for 40.2% of the duration of their chemotherapy (SD 25.3%). In an intention-to-treat analysis, we found no difference between the SC group and the control group with regard to their patient-reported hair loss (=0.831) across the observation period, overall QOL (=0.627), emotional functioning (=0.737), social functioning (=0.635) and body image (=0.463) did not differ between groups.
We found a high rate of SC-decliners and no beneficial effects of SC for patient-reported hair loss, symptoms and functional health. The efficacy and tolerability of SC applied in a clinical routine setting hence appeared to be limited. The further determination and up-front definition of criteria prognostic for effectiveness of SC may be helpful to identify patient subgroups that may experience a treatment benefit.
脱发是乳腺癌患者化疗时令人苦恼的副作用，与治疗期间的生活质量高度相关。据报道，头皮冷却（SC）是预防化疗引起脱发的一种有效且安全的干预措施。然而，关于患者对SC在临床常规环境中的有效性和适用性的看法的数据却很少。在这项比较研究中，我们旨在纵向评估患者报告的结局（PRO）数据，以了解SC对脱发的影响，以及其在接受紫杉烷或蒽环类化疗的乳腺癌患者临床常规治疗中对症状和功能健康的影响。
根据患者偏好将研究参与者分配到接受SC的干预组或对照组（非随机研究）。所有患者均完成了关于头发保留的PRO测量（欧洲癌症研究与治疗组织（EORTC）项目库中关于脱发的项目）、症状和功能健康测量（EORTC QLQ-C30和-BR23）以及身体意象量表（BIS）。在化疗开始时（基线）、化疗中期、最后一个化疗周期、3个月随访和6 - 9个月随访时评估结果。
总体而言，我们纳入了113例患者：75例患者接受了SC（平均年龄 = 51.3岁，52.7%为绝经前患者）；38例患者接受标准护理（平均年龄 = 55.6岁，39.5%为绝经前患者）。共有53例患者（70.7%）停止了SC，其中39例患者（73.5%）表示脱发是主要原因。平均而言，乳腺癌患者使用冷却帽的时间占其化疗总时长的40.2%（标准差25.3%）。在意向性分析中，我们发现在整个观察期内，SC组和对照组在患者报告的脱发方面没有差异（=0.831），两组之间的总体生活质量（=0.627）、情绪功能（=0.737）、社会功能（=0.635）和身体意象（=0.463）也没有差异。
我们发现SC停用率很高，且SC对患者报告的脱发、症状和功能健康没有有益影响。因此，在临床常规环境中应用SC的疗效和耐受性似乎有限。进一步确定和预先定义SC有效性的预后标准可能有助于识别可能从治疗中获益的患者亚组。
