Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group

Hofheinz, Ralf–Dieter; Gencer, Deniz; Schulz, H.; Ståhl, Michael; Hegewisch‐Becker, Susanna; Loeffler, Luisa Mantovani; Kronawitter, Ursula; Bolz, Georg; Potenberg, Jochem; Tauchert, F.K.; Al‐Batran, Salah‐Eddin; Schneeweiß, Andreas

doi:10.1200/jco.2014.60.4587

Cited by 55 publications

(59 citation statements)

References 17 publications

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“…Of the eligible studies, 12 were RCTs, [9][10][11][12]18,[20][21][22][23][24][25][26] and five were cohort studies. A total of 2081 patients (mean sample size: 122; median sample size with corresponding range: 106 ) were included in this meta-analysis.…”

Section: What's New?mentioning

confidence: 99%

“…A total of 2081 patients (mean sample size: 122; median sample size with corresponding range: 106 ) were included in this meta-analysis. 11,27 The following prevention strategies were addressed in the analyzed studies: pyridoxine (10 studies) 8,11,12,[19][20][21][22]24,26,27 ; topical urea/ lactic acid (three studies) 8,10,25 ; celecoxib (two studies) 9,28 ; and moisturizing cream, topical silymarin, Fuzheng Jiedusan and neurotropin (four studies). 8,17,19,27,28 Fifteen studies only assessed the prophylactic efficacies of prevention strategies, [8][9][10][11][12][17][18][19][20][21][22][23][24][25][26][27][28] and two studies assessed prophylactic and treatment efficacies.…”

Section: What's New?mentioning

confidence: 99%

“…Among these, hand-foot syndrome (HFS) is the most common adverse event of capecitabine-containing chemotherapy. 4,6,7 Several clinical trials have evaluated different drugs, including pyridoxine, topical urea/lactic acid and a cyclooxygenase-2 (COX-2) inhibitor, for the management of capecitabineinduced HFS [8][9][10][11][12] ; however, the efficacies of prevention and treatment strategies remain controversial. 3,4 The severity of HFS symptoms depends on the drug dose, peak concentration and total cumulative dose.…”

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Clinical evidence of prevention strategies for capecitabine‐induced hand‐foot syndrome

Huang

Chen

et al. 2018

Intl Journal of Cancer

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Hand-foot syndrome (HFS) is the most common adverse effect of capecitabine-containing chemotherapy. The purpose of this study was to assess the efficacies of various prevention and treatment strategies for capecitabine-induced HFS. Searches of the PubMed and Embase databases were performed to identify relevant studies. The risk ratio (RR) with the corresponding 95% confidence interval (CI) was used as an effect measure to evaluate the efficacies of these prevention and treatment strategies. Publication bias was evaluated using Begg's and Egger's tests. Overall and subgroup analyses were conducted. All statistical analyses were conducted with Stata software version 12.0. Seventeen eligible studies were included. Our results indicated that celecoxib was significantly associated with a lower incidence of grade ≥2 capecitabine-induced HFS without heterogeneity (RR = 0.43, 95% CI = 0.23-0.81, I = 0.0%). However, pyridoxine and topical urea/lactic acid were not effective toward preventing capecitabine-induced grade 1, 2, 3, ≥1 or ≥2 HFS. Moreover, pyridoxine was not effective in treating capecitabine-induced HFS. Similar results were obtained by subgroup analysis. Our results indicate that celecoxib has potential prophylactic efficacy for capecitabine-induced HFS. However, pyridoxine and topical urea/lactic acid are not associated with a decrease in the incidence of capecitabine-induced HFS.

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Section: What's New?mentioning

confidence: 99%

Section: What's New?mentioning

confidence: 99%

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Clinical evidence of prevention strategies for capecitabine‐induced hand‐foot syndrome

Huang

Chen

et al. 2018

Intl Journal of Cancer

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“…As a consequence the excretion of toxic metabolites over the sweat glands results in formation of free radicals and hence in damaging cellular components. Thus, a prevention of HFSR using antioxidant agents seemed reasonable.PROCAPP, an open label randomized phase III trial was conducted to compare the prophylactic effect of Mapisal and urea-cream in patients receiving capecitabine therapy [11]. Mapisal is a medical device containing a huge variety of antioxidants and other nourishing ingredients.…”

mentioning

confidence: 99%

“…PROCAPP, an open label randomized phase III trial was conducted to compare the prophylactic effect of Mapisal and urea-cream in patients receiving capecitabine therapy [11]. Mapisal is a medical device containing a huge variety of antioxidants and other nourishing ingredients.…”

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confidence: 99%

Strategies for Prevention and Treatment of Chemotherapy-Induced Hand-Foot- Skin-Reaction (HFSR)

Gencer¹,

Hofheinz²

2016

J Clin Exp Dermatol Res

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DescriptionHand-foot-skin-reaction (HFSR), also known as palmoplantar erythrodysesthesia, is a frequently occurring side effect of many antineoplastic therapies. Interruption, dose reduction or even discontinuation of anti-tumor therapy due to missing strategies in prevention or treatment of HFSR can be the consequence. According to severity grade of HFSR restrictions in activities of daily life can occur, which can lead to an impairment of quality of life (QOL). Especially skin-related QOL, which actually can be assessed by a variety of different questionnaires, often decreases when HFSR occurs, which can be underlined by some lately published investigations. Nardone and coworkers used the skindex-16 questionnaire to measure the skin-related QOL of patients treated with sunitinib and sorafenib. Patients with higher grades of HFSR showed lower results in the symptoms and emotions scores of the skindex-16 [1]. Chan et al. report in a lately published review that CTCAE grading of HFSR seems to correlate well with skin-related QOL, irrespective of the available questionnaires used for assessment [2].Main agents potentially causing HFSR are tyrosine kinase inhibitors such as sorafenib, sunitinib or regorafenib as well as cytostatic agents like pegylated liposomal doxorubicin (PLD), taxanes and pyrimidine analogues (infusional 5-Fluorouracil or capecitabine). The overall incidence rate of HFSR differs from 20% to 60%, depending on trialdesigns and analyzed anti-cancer drugs [3][4][5][6][7][8].The pathomechanism of HFSR actually seems not to be sufficiently explained. Almost 20 years ago the observed skin reaction in patients treated with a high-dosed chemotherapy led to one of the leading theories for development of HFSR [9]. According to this theory, toxic active metabolites resulting from the applied chemotherapy were eliminated over the eccrine sweat glands of the skin and caused severe damage. Especially at the palms of the hands and the planta of the feet as well as intertrigineous areas the count of sweat glands is highest in human body. Additionally, the thick stratum corneum of the skin in these areas serves as a reservoir for the toxic metabolites leading to severe skin reaction. Recently, other potential pathomechanism were suggested by Lademann and coworkers. New optical methods were used to detect fluorescent substances such as anthracyclines on the skin surface and around the sweat glands during or after administration [10]. As a consequence the excretion of toxic metabolites over the sweat glands results in formation of free radicals and hence in damaging cellular components. Thus, a prevention of HFSR using antioxidant agents seemed reasonable.PROCAPP, an open label randomized phase III trial was conducted to compare the prophylactic effect of Mapisal and urea-cream in patients receiving capecitabine therapy [11]. Mapisal is a medical device containing a huge variety of antioxidants and other nourishing ingredients. Patients with gastrointestinal or breast cancer not pretreated with tyrosine kinase inh...

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Patient Experience Captured by Quality-of-Life Measurement in Oncology Clinical Trials

et al. 2020

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IMPORTANCE Quality of life (QoL) is an important consideration in cancer medicine, especially because drugs are becoming more costly and may only result in modest gains in overall survival.However, there has been no descriptive analysis for the points at which QoL is measured in cancer trials.OBJECTIVE To estimate the prevalence of studies that measure QoL at different points and see how many studies measure QoL for the entirety of a patient's life. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional analysis includes all articles ononcology clinical trials in the 3 highest-impact oncology journals, published between July 2015 and June 2018, that reported QoL outcomes. MAIN OUTCOMES AND MEASURESData were abstracted on when QoL was assessed and the characteristics of these studies. RESULTSFor all 149 studies that met inclusion criteria, QoL assessment was high during treatment (104 articles [69.8%]), during follow-up (81 articles [54.4%]), and after the end of the intervention (68 articles [45.6%]). In 5 of the 149 studies (3.4%), QoL was assessed until death, including in only 1 of the 74 studies on metastatic or incurable cancers. Among these 5 studies, only 1 (20%) used a drug intervention, 1 (20%) used a behavioral intervention, and 2 (40%) used a radiation intervention; only 1 of 5 was in the metastatic setting. The number of studies that reported a positive QoL outcome (ie, QoL outcome was more favorable in the intervention group than in the control group) was between 42 of 81 articles (51.9%) and 16 of 28 articles (57.1%) for most QoL assessment points but only 1 of 5 articles (20%) for studies measuring QoL until death. CONCLUSIONS AND RELEVANCEThis study found that most clinical trials assessed QoL during the treatment or intervention and often during a given amount of follow-up but infrequently assessed QoL on disease progression and rarely followed QoL until the end of the patient's life. Most studies reporting QoL until the end of life reported worse QoL outcomes for the intervention group than the control group. Future research and policy recommendations should consider not just short-term QoL outcomes but QoL outcomes throughout the patient's cancer care. Question How often do oncology studies assess quality of life (QoL) throughout a patient's disease course? Findings This cross-sectional analysis of 149 oncology studies published in highimpact medical and oncology journals found that most studies (69.8%) assessed QoL during the intervention, whereas only 3.4% of studies assessed QoL until the time of death. Meaning These findings suggest that many oncology studies only assess QoL during the intervention; future research should consider the long-term outcomes throughout the patient's life.Oncology, and JAMA Oncology. For each of the journals, we searched for the term quality of life on the journal's website, and we limited the search to research articles only. Selected articles needed to (1) be an RCT, (2) have performed the analysis in the originally randomized groups, (3) have evaluated QoL in ...

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Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group

Abstract: This trial demonstrated that 10% urea cream was superior to the new ointment at preventing HFS over the first 6 weeks of treatment with capecitabine.

Cited by 55 publications

References 17 publications

Clinical evidence of prevention strategies for capecitabine‐induced hand‐foot syndrome

Clinical evidence of prevention strategies for capecitabine‐induced hand‐foot syndrome

Strategies for Prevention and Treatment of Chemotherapy-Induced Hand-Foot- Skin-Reaction (HFSR)

Patient Experience Captured by Quality-of-Life Measurement in Oncology Clinical Trials

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