Topical non-occlusive polymers in hand-foot syndrome

Gabriella Fabbrocini, Antonio Cristaudo, Marius-Anton Ionescu, Luigia Panariello, Geraldine Robert, Marcello Pellicano, Fabio Ayala

Research output: Contribution to journalArticle

Abstract

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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).

CONCLUSIONS: 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.

Original languageEnglish
Pages (from-to)165-171
Number of pages7
JournalGiornale Italiano di Dermatologia e Venereologia
Volume153
Issue number2
DOIs
Publication statusPublished - Apr 2018

Fingerprint

Hand-Foot Syndrome
Polymers
Foot
Hand
Dermatology
Topical Administration
docetaxel
Quality of Life
Hemorrhagic Fever with Renal Syndrome
Skin
Ointments
Pharmaceutical Preparations
Multicenter Studies
Therapeutics

Cite this

Fabbrocini, G., Cristaudo, A., Ionescu, M-A., Panariello, L., Robert, G., Pellicano, M., & Ayala, F. (2018). Topical non-occlusive polymers in hand-foot syndrome. Giornale Italiano di Dermatologia e Venereologia, 153(2), 165-171. https://doi.org/10.23736/S0392-0488.17.05709-1

Topical non-occlusive polymers in hand-foot syndrome. / Fabbrocini, Gabriella; Cristaudo, Antonio; Ionescu, Marius-Anton; Panariello, Luigia; Robert, Geraldine; Pellicano, Marcello; Ayala, Fabio.

In: Giornale Italiano di Dermatologia e Venereologia, Vol. 153, No. 2, 04.2018, p. 165-171.

Research output: Contribution to journalArticle

Fabbrocini, G, Cristaudo, A, Ionescu, M-A, Panariello, L, Robert, G, Pellicano, M & Ayala, F 2018, 'Topical non-occlusive polymers in hand-foot syndrome', Giornale Italiano di Dermatologia e Venereologia, vol. 153, no. 2, pp. 165-171. https://doi.org/10.23736/S0392-0488.17.05709-1
Fabbrocini, Gabriella ; Cristaudo, Antonio ; Ionescu, Marius-Anton ; Panariello, Luigia ; Robert, Geraldine ; Pellicano, Marcello ; Ayala, Fabio. / Topical non-occlusive polymers in hand-foot syndrome. In: Giornale Italiano di Dermatologia e Venereologia. 2018 ; Vol. 153, No. 2. pp. 165-171.
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T1 - Topical non-occlusive polymers in hand-foot syndrome

AU - Fabbrocini, Gabriella

AU - Cristaudo, Antonio

AU - Ionescu, Marius-Anton

AU - Panariello, Luigia

AU - Robert, Geraldine

AU - Pellicano, Marcello

AU - Ayala, Fabio

PY - 2018/4

Y1 - 2018/4

N2 - BACKGROUND: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.

AB - BACKGROUND: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.

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DO - 10.23736/S0392-0488.17.05709-1

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JO - Giornale Italiano di Dermatologia e Venereologia

JF - Giornale Italiano di Dermatologia e Venereologia

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