Fabbrocini Gabriella, Cristaudo Antonio, Ionescu Marius-Anton, Panariello Luigia, Robert Geraldine, Pellicano Marcello, Ayala Fabio
University of Naples Federico II, Naples, Italy.
San Gallicano Dermatologic Institute, IRCCS, Rome, Italy -
G Ital Dermatol Venereol. 2018 Apr;153(2):165-171. doi: 10.23736/S0392-0488.17.05709-1.
Many cytotoxic and biological drugs are cause of severe dermatological side effects, such as hand-foot syndrome (HFS) and hand-foot skin reaction (HFSR). Oncologic patients with HFS or HFSR presents relevant symptoms that interferes with daily activities and with adherence to anticancer treatment. The HFRS control and treatment are important goals to enhance the quality of life of oncologic patients. The aim of this study was to assess the efficacy and tolerability of a b.i.d. (bis in die) topical administration of an anhydric ointment based on topical non-occlusive polymers (TNOP) in patients with HFS on current anticancer drug regiments.
A prospective, open, multicenter clinical study was conducted in oncologic patients with HFS attended two hospital-based Italian dermatological unit. A global-non-instrumental evaluation, based on different standardized tools (i.e., Sum Score System Index [SRRC] Score, Dermatology Life Qualiy Index [DLQI] and global efficacy) was conducted using measurements at baseline, at 4 and 8 weeks. Non-parametric test for two correlate samples, was used to assess changes in means of the different scores. The protocol was approved by ethical committee of both dermatology service pariticipating to the study.
Twenty-one oncologic patients were enrolled. Thirteen (61.9%) of participants were female. The median age was 63 years (range: 37-73). Seventeen (80.9%) patients presenting a HFS associated to capecitabine, and four patients (19.1%) associated to docetaxel. At the enrollment, 33.3% (7/21) of patients showed at level of the hands a HFS of grade 2 and 9.5% (2/21) of grade 3. At level of the feet, 28.6% (6/21) showed a HFS of grade 2, and 17.4% (4/21) of grade 3. The SRRC scores were significantly decreased after 8 weeks of treatment compared to baseline, for both sites. In particular, SRRC score decreased from 4.38 to 1.67 (Z=-3.60, P=0.00) and from 4.48 to 1.43 (Z=-3.87, P=0.00) for hands and feet, respectively. A consistent significant improvement in the perceived QoL of patients was also observed. From baseline to visit 3, the total mean score of DLQI decreased from 10.62 to 4.57 (Δ=-57%, Z=-4.020, P=0.000).
In a sample of oncologic patients with HFS, the b.i.d. administration of TNOP for eight weeks, induced a progressive and significant decrease of the SRRC Score and a relevant improvement in the perceived quality of life.
许多细胞毒性药物和生物药物会导致严重的皮肤副作用，如手足综合征（HFS）和手足皮肤反应（HFSR）。患有HFS或HFSR的肿瘤患者会出现相关症状，这些症状会干扰日常活动以及对抗癌治疗的依从性。控制和治疗HFRS是提高肿瘤患者生活质量的重要目标。本研究的目的是评估基于局部非封闭性聚合物（TNOP）的无水软膏每日两次局部给药，对正在接受抗癌药物治疗方案且患有HFS的患者的疗效和耐受性。
在意大利两家医院的皮肤科对患有HFS的肿瘤患者进行了一项前瞻性、开放性、多中心临床研究。使用不同的标准化工具（即总和评分系统指数[SRRC]评分、皮肤病生活质量指数[DLQI]和总体疗效），在基线、第4周和第8周进行测量，进行整体非仪器评估。使用两个相关样本的非参数检验来评估不同评分均值的变化。该方案获得了参与研究的两个皮肤科服务伦理委员会的批准。
招募了21名肿瘤患者。13名（61.9%）参与者为女性。中位年龄为63岁（范围：37 - 73岁）。17名（80.9%）患者的HFS与卡培他滨相关，4名（19.1%）患者与多西他赛相关。在入组时，33.3%（7/21）的患者手部HFS为2级，9.5%（2/21）为3级。在足部，28.6%（6/21）的患者HFS为2级，17.4%（4/21）为3级。与基线相比，治疗8周后两个部位的SRRC评分均显著降低。特别是，手部的SRRC评分从4.38降至1.67（Z = -3.60，P = ），足部从4.48降至1.43（Z = -3.87，P = ）。还观察到患者的感知生活质量有持续显著改善。从基线到第3次就诊，DLQI的总平均分从10.62降至4.57（Δ = -57%，Z = -4.020，P = ）。
在患有HFS的肿瘤患者样本中，TNOP每日两次给药8周，可使SRRC评分逐渐显著降低，并使感知生活质量有显著改善。
