hand foot syndrome

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  • 文章类型: Journal Article
    背景:卡培他滨已被广泛用于治疗各种癌症。手足综合征(HFS)是最麻烦的不良反应。尿素乳膏已被预先处方,尽管它的功效令人怀疑。芦荟凝胶与尿素霜可能会相互增强。该试验旨在证明该组合的功效。
    方法:研究人员进行了一项随机单盲II期研究。参与者被随机分为1:1,接受芦荟凝胶和10%尿素乳膏的组合(n=30),实验A+U臂和单独的10%尿素乳膏(n=31),U臂。样本量经计算具有90%的功效,以显示α水平=0.05的联合治疗的2-3级HFS的发生率显著降低20%。CTCAE标准第5版和皮肤病生活质量指数(DLQI)均进行了评估,以确定HFS的严重程度和生活质量,分别。
    结果:大多数参与者患有直肠癌(A+U:43.3%;U:41.9%)。在A+U组中,86.7%有0-1级HFS,13.3%有2-3级HFS。在U组,64.5%有0-1级HFS,35.5%有2-3级HFS(Mann-WhitneyU检验,p=0.045)。2-3级HFS在组合组中显著降低。
    结论:芦荟凝胶和10%尿素乳膏的组合可改善服用卡培他滨的参与者的HFS严重程度;然而,两组间DLQI无显著差异.
    BACKGROUND: Capecitabine has been widely prescribed to treat various cancers. The hand foot syndrome (HFS) is the most troublesome adverse effect. Urea cream has been pre-emptively co-prescribed, even though its efficacy is doubtful. Aloe vera gel with urea cream might potentiate each other. This trial was intended to prove the efficacy of this combination.
    METHODS: The investigators conducted a randomized single-blinded phase II study. The participants were randomized 1:1 to receive the combination of aloe vera gel and 10% urea cream (n = 30), the experimental A+U arm and 10% urea cream alone (n = 31), the U arm. The sample size was calculated to have 90% power to show the significant 20% reduction in the incidence of HFS grade 2-3 of the combination therapy with alpha level = 0.05. Both the CTCAE criteria version 5 and the dermatology life quality index (DLQI) were assessed to determine the severity of HFS and quality of life, respectively.
    RESULTS: Most of the participants had rectal cancer (A+U: 43.3%; U: 41.9%). In the A+U group, 86.7% had grade 0-1 HFS and 13.3% had grade 2-3 HFS. In the U group, 64.5% had grade 0-1 HFS and 35.5% had grade 2-3 HFS (Mann-Whitney U test, p = 0.045). Grade 2-3 HFS was significantly lower in the combination group.
    CONCLUSIONS: Combination of aloe vera gel and 10% urea cream ameliorated the severity of HFS in participants taking capecitabine; however, no significant difference in DLQI between the groups was demonstrated.
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    文章类型: Randomized Controlled Trial
    背景:手足综合征(HFS)是在接受卡培他滨化疗的患者中观察到的常见不良反应,通常导致治疗中断和剂量调整。C反应蛋白(hs-CRP)水平升高与HFS的发展有关。这项研究旨在评估未精制的特级初榨橄榄油(EVOO)补充剂在减轻接受卡培他滨化疗的个体中HFS和hs-CRP升高的潜力。
    方法:在2022年11月至2023年5月之间,有45名符合条件的参与者参加了这项随机试验。晚期结直肠癌或乳腺癌患者被随机分为三组:干预组接受未精制的EVOO补充剂(每天30mL)和卡培他滨,安慰剂组接受精制的轻质橄榄油(ELOO)补充剂(每天30mL)以及卡培他滨,对照组仅接受卡培他滨。通过相同的包装和说明确保安慰剂组和干预组的掩蔽,保持参与者和医生对指定治疗的盲目性。随机化,通过计算机生成的序列实现,确保三组之间的均匀分布。
    结果:与安慰剂组(66.7%)和对照组(80%)相比,EVOO组(13.3%)的HFS发生率明显较低。在20%的安慰剂组和40%的对照组患者中观察到2级或更严重HFS的情况。EVOO组未报告严重HFS病例。此外,与安慰剂组和对照组相比,补充EVOO导致hs-CRP水平显着降低。这些发现表明,EVOO可以作为HFS的预防措施,并在接受卡培他滨化疗的患者中表现出抗炎作用。
    结论:这项研究证明了在接受卡培他滨化疗的患者的治疗方案中加入未精制的EVOO的潜在益处。EVOO补充剂与较低的HFS发生率和hs-CRP水平降低相关,表明其在预防HFS发展和减轻炎症中的可能作用。
    BACKGROUND: Hand Foot Syndrome (HFS) is a frequent adverse effect observed in patients undergoing capecitabine chemotherapy, often leading to treatment disruptions and dose adjustments. Elevated C-Reactive Protein (hs-CRP) levels have been associated with the development of HFS. This study aimed to assess the potential of unrefined Extra Virgin Olive Oil (EVOO) supplementation in mitigating HFS and hs-CRP elevation among individuals receiving capecitabine chemotherapy.
    METHODS: Between November 2022 and May 2023, forty-five eligible participants were enrolled in this randomized trial. Patients with advanced colorectal or breast cancer were randomly allocated into three groups: an intervention group receiving unrefined EVOO supplementation (30 mL per day) alongside capecitabine, a placebo group receiving refined extra light olive oil (ELOO) supplementation (30 mL per day) alongside capecitabine, and a control group receiving capecitabine alone. The masking of both placebo and intervention groups was ensured through identical packaging and instructions, maintaining participant and physician blindness to the assigned treatments. Randomization, achieved via computer-generated sequences, ensured even distribution among the three groups.
    RESULTS: HFS incidences were notably lower in the EVOO group (13.3%) compared to the placebo (66.7%) and control (80%) groups. Instances of Grade 2 or more severe HFS were observed in 20% of placebo and 40% of control group patients. No cases of severe HFS were reported in the EVOO group. Moreover, EVOO supplementation led to a significant reduction in hs-CRP levels when contrasted with the placebo and control groups. These findings suggest that EVOO may serve as a preventive measure against HFS and exhibit anti-inflammatory effects in patients undergoing capecitabine chemotherapy.
    CONCLUSIONS: This study demonstrates the potential benefits of incorporating unrefined EVOO into the regimen of patients undergoing capecitabine chemotherapy. EVOO supplementation was associated with lower incidences of HFS and a reduction in hs-CRP levels, indicating its possible role in preventing HFS development and mitigating inflammation.
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  • 文章类型: Case Reports
    背景:巯基嘌呤(6MP)和甲氨蝶呤(MTX)通常用于急性淋巴细胞白血病(ALL)的维持化疗。这些药物与各种副作用有关,如骨髓抑制,结肠炎,和甲状腺炎以及许多皮肤不良事件。大多数报道的皮肤副作用包括粘膜炎,脱发,干燥症,还有瘙痒.我们报告了一个有趣的病例,该病例因药物代谢改变而对B细胞ALL进行维持治疗的儿童中的6MP手足综合征。
    方法:我们报告了一名10岁的男性,正在接受前BcellALL的维持化疗,他出现口腔病变恶化和红斑,手掌和脚底上的裂开的斑块。维持治疗包括静脉注射长春新碱和5天脉冲类固醇每12周,每天6MP,每周MTX,由于持续的中性粒细胞绝对计数>1500,增加到标准给药的≥150%。入院时获得的代谢物显示6MMP代谢物升高,为35,761(正常<5700)。TPMT和NUDT15酶活性正常,未发现基因分型改变。
    结果:患者口服化疗,包括6MP和MTX,停止并开始每天100毫克别嘌呤醇,这导致整体改善。
    结论:急性粘膜炎和手足综合征恶化的临床表现,在接受ALL维持治疗的儿童骨髓抑制不足的情况下,人们应该担心代谢途径的改变会导致毒性代谢物的积累.别嘌呤醇可以改善代谢改变的患者的皮肤表现和化疗剂量。
    BACKGROUND: Mercaptopurine (6MP) and methotrexate (MTX) are commonly used for maintenance chemotherapy for acute lymphoblastic leukemia (ALL). These medications have been associated with various side effects such as myelosuppression, colitis, and thyroiditis in addition to numerous cutaneous adverse events. Cutaneous side-effects most reported include mucositis, alopecia, xerosis, and pruritus. We report an interesting case of hand-foot syndrome to 6MP in a child on maintenance therapy for B-cell ALL from an alteration in medication metabolism.
    METHODS: We report a 10-year-old male on maintenance chemotherapy for pre-Bcell ALL who presented to the hospital with worsening oral lesions and erythematous, fissured plaques on the palms and soles. Maintenance therapy consisted of IV vincristine and 5-day pulse of steroids every 12 weeks, daily 6MP, and weekly MTX, which were increased to  ≥ 150% of standard dosing due to persistent absolute neutrophil counts  > 1500. Metabolites obtained on admission demonstrated elevated 6MMP metabolites at 35,761 (normal < 5700). TPMT and NUDT15 enzyme activity were normal and no alterations in genotyping were discovered.
    RESULTS: Patient\'s oral chemotherapy, including both 6MP and MTX, were stopped and allopurinol 100 mg daily was initiated, which lead to overall improvement.
    CONCLUSIONS: Clinical findings of acute mucositis and worsening of hand-foot syndrome, in the setting of inadequate myelosuppression in a child on maintenance therapy for ALL should raise concerns to consider altered metabolism pathway leading to toxic metabolite buildup. Allopurinol can play in improving cutaneous manifestation and chemotherapeutic dosing in patients with altered metabolism.
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  • 文章类型: Journal Article
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  • 文章类型: Case Reports
    手足综合征(HFS)和腹泻是以卡培他滨为基础的化疗的剂量限制性药物不良反应(ADR)。二氢嘧啶脱氢酶(DPYD)基因的四个多态性,编码负责氟嘧啶代谢的DPD酶,如卡培他滨,与严重的不良反应密切相关,他们的筛查应在开始治疗前进行。此外,卡培他滨相关毒性可能由于药物-药物和药物-补充剂的相互作用而恶化。在这里,我们调查了导致两名患者出现严重HFS和腹泻的因素,推荐的DPYD单核苷酸多态性(SNPs)的非携带者和其他遗传变异的携带者提示卡培他滨相关ADR的风险增加.通过仔细的治疗识别,我们证明了,肿瘤学家不知道,患者在接受卡培他滨治疗期间服用的叶酸剂量高于2000mg/m2,这是服用叶酸时的最大耐受剂量.为了解决ADR,治疗必须彻底改变。在一个案例中,减少卡培他滨的剂量并停用降脂药.在另一种情况下,1个月后停用卡培他滨和叶酸,并再次给予卡培他滨.遗传和环境因素应被认为是卡培他滨严重毒性的良好预测因子。应鼓励药物协调,以避免不适当治疗的有害后果。
    Hand-Foot syndrome (HFS) and diarrhoea are dose-limiting Adverse Drug Reactions (ADRs) of capecitabine-based chemotherapy. Four polymorphisms in the dihydropyrimidine dehydrogenase (DPYD) gene, encoding the DPD enzyme responsible for the metabolism of fluoropyrimidines, such as capecitabine, are strongly associated with severe ADRs, and their screening should be performed before starting treatment. Moreover, capecitabine-related toxicity may worsen due to drug-drug and drug-supplement interactions. Here we investigated factors responsible for severe HFS and diarrhoea presented by two patients, non-carriers of the recommended DPYD single nucleotide polymorphisms (SNPs) but carriers of other genetic variants suggested to increase the risk of capecitabine-related ADRs. Through careful therapy recognition, we demonstrated that, unbeknownst to the oncologists, the patients were taking folic acid during the treatment with capecitabine at a dosage higher than 2000 mg/m2, which is the maximum tolerated dose when folate is administered. To resolve the ADRs, the therapy had to be drastically changed. In one case, dose reduction of capecitabine and discontinuation of lipid-lowering agents were carried out. In the other case, discontinuation of capecitabine and folic acid and capecitabine re-administration were performed after a month. Genetic and environmental factors should be considered good predictors of severe capecitabine-related toxicity. Medication reconciliation should be encouraged to avoid the harmful consequences of inappropriate treatments.
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  • 文章类型: Clinical Trial Protocol
    背景:中型外用皮质类固醇对卡培他滨诱发的手足综合征(HFS)的预防效果的临床证据有限。尽管HFS的发病机制尚不清楚,炎症反应被认为与HFS的发生有关.本研究旨在评估中类局部皮质类固醇(0.1%丁酸氢化可的松局部治疗)对接受卡培他滨联合奥沙利铂辅助化疗的结直肠癌患者卡培他滨诱导的HFS的预防作用。
    方法:这是一个单中心,单臂,第二阶段研究。纳入计划接受卡培他滨联合奥沙利铂辅助化疗的结直肠癌患者,和局部应用0.1%丁酸氢化可的松,除标准保湿疗法外,预防性应用。主要终点是三个月内≥2级HFS的发生率。次要终点是HFS开始的时间,剂量减少率,时间表延迟,卡培他滨诱导的HFS引起的停药,和其他不良事件。所有不良事件均由临床药师和主治医师进行评估。
    结论:这项研究有望为预防HFS的新的支持性治疗提供帮助。不仅适用于结直肠癌患者接受辅助化疗,也适用于各种接受卡培他滨化疗的癌症患者。
    背景:该试验在日本临床试验注册中心(jRCT)注册为jRCTs031220002。2022年4月5日注册,https://jrct。尼夫.走吧。jp/search协议版本V.1.0,2022年2月16日。
    BACKGROUND: Clinical evidence of the preventive effectiveness of medium-class topical corticosteroids for capecitabine-induced hand foot syndrome (HFS) is limited. Although the pathogenesis and mechanism of HFS are unclear, inflammatory reactions are thought to be involved in HFS development. This study aimed to evaluate the preventive effect of medium-class topical corticosteroids (hydrocortisone butyrate 0.1% topical therapy) for capecitabine-induced HFS in patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine plus oxaliplatin.
    METHODS: This is a single-center, single-arm, phase 2 study. Patients with colorectal cancer scheduled to receive adjuvant chemotherapy with capecitabine plus oxaliplatin are enrolled, and topical hydrocortisone butyrate 0.1% is applied prophylactically in addition to standard moisturizing therapy. The primary endpoint is the incidence of grade ≥ 2 HFS within three months. The secondary endpoints are the time to onset of HFS, rates of dose reduction, schedule delay, discontinuation caused by capecitabine-induced HFS, and other adverse events. All adverse events are evaluated by clinical pharmacists and attending physicians.
    CONCLUSIONS: This study is expected to contribute to the establishment of new supportive care for preventing HFS, not only for colorectal cancer patients receiving adjuvant chemotherapy, but also for various cancer patients receiving capecitabine-based chemotherapy.
    BACKGROUND: This trial was registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs031220002. Registered 5 April 2022, https://jrct.niph.go.jp/search Protocol version V.1.0, 16 February 2022.
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  • 文章类型: Case Reports
    Palmar-plantar erythrodysesthesia (PPE), more commonly known as hand-foot syndrome, is a dermatologic complication following chemotherapy with selective agents. In this article, we present the case of a young lady with stage III breast cancer who developed palmar-plantar erythrodysesthesia following treatment with Herceptin (trastuzumab), an unusual complication of this particular drug. From our review of literature, this is the second known occurrence of PPE secondary to trastuzumab monotherapy.
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  • 文章类型: Journal Article
    Systemic chemotherapy and targeted agents are associated with various cutaneous toxicities. Even though cutaneous toxicities are manageable, it often results in treatment discontinuation and worsens the patients\' quality of life.
    The study aimed to determine the spectrum of cutaneous toxicities in patients receiving systemic chemotherapy and targeted agents for breast cancer patients.
    A total of 250 out of 720 patients with breast cancer who developed various cutaneous toxicities to chemotherapeutic or targeted agents were included in the study.
    Among 250 patients, 57 patients were on neoadjuvant chemotherapy, 89 patients were on adjuvant chemotherapy, 68 were on palliative chemotherapy for metastatic breast cancer and 36 were on targeted treatment for metastatic breast cancer. The most frequently affected site was hair (96%), followed by skin (92%), nail (34%), and mucosa (26%). The most common dermatological toxicity noticed in our study involved the hair in the form of chemotherapy induced alopecia (anagen effluvium) in 93.6%, followed by skin toxicity with generalized xerosis in 92% and, nail toxicity in 34%, and mucosal toxicity in 26%. The most common chemotherapeutic agent which caused frequent cutaneous toxicities in our patients was docetaxel followed by paclitaxel, capecitabine, doxorubicin, epirubicine, cyclophosphamide, 5-flurouracil and targeted agents like lapatinib, everolimus, and tamoxifen.
    Cutaneous toxicities are common following systemic chemotherapy and targeted agents. Early recognition of cutaneous side effects of these agents and prompt early interventions can reduce the significant morbidity, cosmetic disfigurement, unnecessary treatment interruptions, and psychological distress in women treated for breast cancers.
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  • 文章类型: Journal Article
    UNASSIGNED: In recent years, CapeOX therapy for patients with colorectal cancer is widely used. We previously reported that a multidisciplinary approach decreases the worsening of adverse events and increases patient satisfaction. In this study, we conducted a multicenter, prospective, observational study to evaluate the incidence of adverse events, health-related quality of life (HRQOL) of the patient, and efficacy of a management (intervention) according to the support system (SMILE study).
    UNASSIGNED: As the interventional method, the following more than one method was carried out in each institute, 1: support with telephone, 2: dosing instruction by a pharmacist, 3: skin care instruction by a nurse, and 4: patient instruction by a doctor. The primary endpoint was the incidence of hand-foot syndrome (HFS) of more than grade 2. The secondary endpoint was the HRQOL evaluation and efficacy. The questionnaire (HADS) was administered before the start of the chemotherapy and in 1, 2, 4, 5, and 8 courses to evaluate quality of life (QOL).
    UNASSIGNED: From April 2011 to September 2012, 80 patients were enrolled from 14 sites, and all patients were the subjects of analysis. The demographic background was as follows: man/woman: 46/34, age median: 63 (36-75), and management interventional method 1/2/3/4: 36/68/73/78. The overall percentage of HFS that exceeded grade 2 within 6 months was 16.3%. It was 11.1% with the telephone support group and 20.5% without the telephone support group (p = 0.26).
    UNASSIGNED: A multi-professional telephone support may reduce the deterioration of HFS. Further study which includes larger cohort is needed in the future.
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