Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trial
Introduction: The use of capecitabine is associated with hand-foot syndrome (HFS). Since there is anecdotal evidence that lanolin-based creams and topical steroids are useful for the treatment of HFS, we conducted a three- arm phase III trial to compare observation, lanolin-based cream w...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Sociedade Brasileira de Oncologia Clínica, Sociedade Brasileira de Cirurgia Clínica and Sociedade Brasileira de Radioterapia
2022-12-01
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| Series: | Brazilian Journal of Oncology |
| Subjects: | |
| Online Access: | https://www.brazilianjournalofoncology.com.br/details/228/en-US/lanolin-based-dexpanthenol-cream--topical-hydrocortisone-or-observation-in-the-prevention-of-capecitabine-induced-hand-foot-syndrome--a-phase-iii-tria |
| _version_ | 1797673853502095360 |
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| author | Cintia Sayuri Kurokawa La-Scala Artur Malzyner Carmen Silvia Passos Lima Daniela Dornelles Rosa Fabio André Franke Fernanda Maris Peria Giuliano Santos Borges Gustavo Colagiovanni Girotto Leandro Brust Magda Conceição Barbosa Gomes Nilciza Maria de Carvalho Tavares Calux Roberto Magnus Duarte Sales Ruffo Freitas Sergio Vicente Serrano |
| author_facet | Cintia Sayuri Kurokawa La-Scala Artur Malzyner Carmen Silvia Passos Lima Daniela Dornelles Rosa Fabio André Franke Fernanda Maris Peria Giuliano Santos Borges Gustavo Colagiovanni Girotto Leandro Brust Magda Conceição Barbosa Gomes Nilciza Maria de Carvalho Tavares Calux Roberto Magnus Duarte Sales Ruffo Freitas Sergio Vicente Serrano |
| author_sort | Cintia Sayuri Kurokawa La-Scala |
| collection | DOAJ |
| description | Introduction:
The use of capecitabine is associated with hand-foot syndrome (HFS). Since there is anecdotal evidence that lanolin-based creams and topical steroids are useful for the treatment of HFS, we conducted a three- arm phase III trial to compare observation, lanolin-based cream with dexpanthenol (L-D), and topical hydrocortisone in the prevention of HFS.
Material and Methods:
Patients with breast or colorectal cancer with indication to use capecitabine as a single agent or in combination were randomized in an open-label fashion to one of the three arms. The initial capecitabine dose was 1,000 or 1,250mg/m2, according to the physicians discretion and clinical practice, and dose adjustments followed the local label. The primary endpoint was the frequency of HFS of any grade in the intent-to-treat population, whereas quality of life (QoL), change from baseline in performance status and adverse events were secondary endpoints.
Results:
Mean age among the 595 patients randomized was 58 years, and 69% were women. 37% of patients had advanced breast cancer and 63% of patients had colorectal cancer. Capecitabine was used as a single agent in 67% of patients; among the remaining 33% of patients, 82% were treated with oxaliplatin-based combinations. HFS of any grade was seen in 35.6% of patients in the observation group, 24.9% with L-D, and 34.3% with hydrocortisone (p=0.039). The unadjusted odds ratio for the frequency of HFS in the arm treated with L-D was 0.60 (95%CI, 0.39 to 0.92). Only between 2.6% and 9.4% of patients had grade 3 HFS. There were no statistically significant differences in mean change from baseline in any of the QoL scores, the distribution of performance status, or the frequency of adverse events among the three arms.
Conclusion:
L-D could be considered a standard strategy in the attempt to prevent capecitabine-induced HFS. |
| first_indexed | 2024-03-11T21:51:22Z |
| format | Article |
| id | doaj.art-57621c52911f4c95b152b88f4558d0e9 |
| institution | Directory Open Access Journal |
| issn | 2526-8732 |
| language | English |
| last_indexed | 2024-03-11T21:51:22Z |
| publishDate | 2022-12-01 |
| publisher | Sociedade Brasileira de Oncologia Clínica, Sociedade Brasileira de Cirurgia Clínica and Sociedade Brasileira de Radioterapia |
| record_format | Article |
| series | Brazilian Journal of Oncology |
| spelling | doaj.art-57621c52911f4c95b152b88f4558d0e92023-09-26T09:00:21ZengSociedade Brasileira de Oncologia Clínica, Sociedade Brasileira de Cirurgia Clínica and Sociedade Brasileira de RadioterapiaBrazilian Journal of Oncology2526-87322022-12-01180010.5935/2526-8732.20220355Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trialCintia Sayuri Kurokawa La-Scala0Artur Malzyner1Carmen Silvia Passos Lima2Daniela Dornelles Rosa3Fabio André Franke4Fernanda Maris Peria5Giuliano Santos Borges6Gustavo Colagiovanni Girotto7Leandro Brust8Magda Conceição Barbosa Gomes9Nilciza Maria de Carvalho Tavares Calux10Roberto Magnus Duarte Sales11Ruffo Freitas12Sergio Vicente Serrano13Produtos Roche Químicos e Farmacêuticos S.A., Departamento Médico - São Paulo - São Paulo - BrazilClinonco - Clinica de Oncologia Médica, Oncologia - São Paulo - São Paulo - BrazilFaculdade de Ciências Médicas, Universidade Estadual de Campinas, Departamento de Clínica Médica - Campinas - São Paulo - BrazilUniversidade Federal de Ciências da Saúde de Porto Alegre, Programa de Pós-Graduação em Patologia - Porto Alegre - Rio Grande do Sul - BrazilHospital de Caridade de Ijuí, Centro de Alta Complexidade em Oncologia Clínica (CACON) - Ijuí - Rio Grande do Sul - BrazilFaculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (FMRP-USP), Divisão de Oncologia Clínica do Departamento de Imagens Médicas, Hematologia e Oncologia Clínica – Ribeirão Preto – São Paulo - BrazilClínica de Neoplasias Litoral, Centro de Novos Tratamentos Itajaí - Itajaí - Santa Catarina - BrazilHospital de Base de São José do Rio Preto, Centro Integrado de Pesquisa e Serviço de Oncologia Clínica - São José do Rio Preto - São Paulo - BrazilHospital Bruno Born, Disciplina de Oncologia, Curso de Medicina da UNIVATES - Lajeado - Rio Grande do Sul - BrazilUniversidade Federal Fluminense, Hospital Universitário Antônio Pedro - Rio de Janeiro - Rio de Janeiro - BrazilEscola Paulista de Medicina, Universidade Federal de São Paulo, Departamento de Ginecologia - São Paulo - São Paulo - BrazilLiga Norte Riograndense contra o Câncer - Natal - Rio Grande do Norte - BrazilUniversidade Federal de Goiás, Programa de Mastologia - Goiânia - Goiás - BrazilHospital de Câncer de Barretos, Departamento de Oncologia Clínica - Barretos - São Paulo - BrazilIntroduction: The use of capecitabine is associated with hand-foot syndrome (HFS). Since there is anecdotal evidence that lanolin-based creams and topical steroids are useful for the treatment of HFS, we conducted a three- arm phase III trial to compare observation, lanolin-based cream with dexpanthenol (L-D), and topical hydrocortisone in the prevention of HFS. Material and Methods: Patients with breast or colorectal cancer with indication to use capecitabine as a single agent or in combination were randomized in an open-label fashion to one of the three arms. The initial capecitabine dose was 1,000 or 1,250mg/m2, according to the physicians discretion and clinical practice, and dose adjustments followed the local label. The primary endpoint was the frequency of HFS of any grade in the intent-to-treat population, whereas quality of life (QoL), change from baseline in performance status and adverse events were secondary endpoints. Results: Mean age among the 595 patients randomized was 58 years, and 69% were women. 37% of patients had advanced breast cancer and 63% of patients had colorectal cancer. Capecitabine was used as a single agent in 67% of patients; among the remaining 33% of patients, 82% were treated with oxaliplatin-based combinations. HFS of any grade was seen in 35.6% of patients in the observation group, 24.9% with L-D, and 34.3% with hydrocortisone (p=0.039). The unadjusted odds ratio for the frequency of HFS in the arm treated with L-D was 0.60 (95%CI, 0.39 to 0.92). Only between 2.6% and 9.4% of patients had grade 3 HFS. There were no statistically significant differences in mean change from baseline in any of the QoL scores, the distribution of performance status, or the frequency of adverse events among the three arms. Conclusion: L-D could be considered a standard strategy in the attempt to prevent capecitabine-induced HFS.https://www.brazilianjournalofoncology.com.br/details/228/en-US/lanolin-based-dexpanthenol-cream--topical-hydrocortisone-or-observation-in-the-prevention-of-capecitabine-induced-hand-foot-syndrome--a-phase-iii-triabreast neoplasmscapecitabinecolorectal neoplasmsglucocorticoidshand-foot syndromedexpanthenol |
| spellingShingle | Cintia Sayuri Kurokawa La-Scala Artur Malzyner Carmen Silvia Passos Lima Daniela Dornelles Rosa Fabio André Franke Fernanda Maris Peria Giuliano Santos Borges Gustavo Colagiovanni Girotto Leandro Brust Magda Conceição Barbosa Gomes Nilciza Maria de Carvalho Tavares Calux Roberto Magnus Duarte Sales Ruffo Freitas Sergio Vicente Serrano Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trial Brazilian Journal of Oncology breast neoplasms capecitabine colorectal neoplasms glucocorticoids hand-foot syndrome dexpanthenol |
| title | Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trial |
| title_full | Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trial |
| title_fullStr | Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trial |
| title_full_unstemmed | Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trial |
| title_short | Lanolin-based dexpanthenol cream, topical hydrocortisone or observation in the prevention of capecitabine-induced hand-foot syndrome: a phase III trial |
| title_sort | lanolin based dexpanthenol cream topical hydrocortisone or observation in the prevention of capecitabine induced hand foot syndrome a phase iii trial |
| topic | breast neoplasms capecitabine colorectal neoplasms glucocorticoids hand-foot syndrome dexpanthenol |
| url | https://www.brazilianjournalofoncology.com.br/details/228/en-US/lanolin-based-dexpanthenol-cream--topical-hydrocortisone-or-observation-in-the-prevention-of-capecitabine-induced-hand-foot-syndrome--a-phase-iii-tria |
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