Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial
- Autores
- Iseas, Soledad; Roca, Enrique Luis; O´Connor, Juan M.; Eleta, Martin; Sánchez Luceros, Analía Gabriela; Di Leo, Maria Daniela; Tinelli, Marcelo; Fara, Maria L.; Spitzer, Eduardo; Demarco, Ignacio A.; Ripoll, Giselle Vanina; Pifano, Marina; Garona, Juan; Alonso, Daniel Fernando
- Año de publicación
- 2020
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Purpose: The vasopressin analog desmopressin (dDAVP) is known to increase plasma levels of hemostatic factors,and preclinical studies in colorectal cancer models have demonstrated that it hampers tumor vascularization and metastatic progression. We evaluated safety and preliminary efficacy of dDAVP in rectal cancer patients with bleeding, before receiving specific oncologic treatment with surgery, chemotherapy and/or radiotherapy. Methods: Patients with rectal cancer having moderate or severe rectal bleeding were enrolled in an open-label, dose-finding trial. Intravenous infusions of dDAVP were administered during two consecutive days in doses from 0.25 to 2.0 µg/kg, using single or twice daily regimen. Bleeding was graded using a score based on the Chutkan scale and tumor perfusion was evaluated by dynamic contrast-enhanced magnetic resonance imaging. Results: The trial accrued a total of 32 patients. Dose-limiting toxicity occurred in patients receiving 1 µg/kg or higher. The most prominent treatment-related severe adverse event was hyponatremia. Most patients receiving the maximum tolerated dose of 0.5 µg/kg showed at least a partial hemostatic response and 58% developed a complete response with absence of bleeding at day 4 and/or at the last follow-up at day 14. Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment. Conclusions: dDAVP appeared as a promising hemostatic agent in rectal cancer patients with bleeding. Randomized clinical trials to confirm its effectiveness are warranted.
Fil: Iseas, Soledad. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología "Dr. Carlos B. Udaondo"; Argentina
Fil: Roca, Enrique Luis. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología "Dr. Carlos B. Udaondo"; Argentina
Fil: O´Connor, Juan M.. Instituto Alexander Fleming; Argentina
Fil: Eleta, Martin. Imaxe Centro de Diagnóstico por Imágenes; Argentina
Fil: Sánchez Luceros, Analía Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Academia Nacional de Medicina de Buenos Aires; Argentina
Fil: Di Leo, Maria Daniela. Laboratorio Elea; Argentina
Fil: Tinelli, Marcelo. Laboratorio Elea-Phoenix; Argentina
Fil: Fara, Maria L.. Laboratorio Elea-Phoenix; Argentina
Fil: Spitzer, Eduardo. Laboratorio Elea-Phoenix; Argentina
Fil: Demarco, Ignacio A.. Romikin S.A. Laboratorio de Investigación y Desarrollo; Argentina
Fil: Ripoll, Giselle Vanina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina
Fil: Pifano, Marina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina
Fil: Garona, Juan. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina
Fil: Alonso, Daniel Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina - Materia
-
DESMOPRESSIN
RECTAL CANCER
BLEEDING CONTROL
ANTITUMORAL
VASOPRESSIN PEPTIDE ANALOG
DRUG REPURPOSING
TUMOR PERFUSION
HEMOSTASIS
VON WILLEBRAND FACTOR
GASTROINTESTINAL CANCER - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by/2.5/ar/
- Repositorio
.jpg)
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/156955
Ver los metadatos del registro completo
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Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trialIseas, SoledadRoca, Enrique LuisO´Connor, Juan M.Eleta, MartinSánchez Luceros, Analía GabrielaDi Leo, Maria DanielaTinelli, MarceloFara, Maria L.Spitzer, EduardoDemarco, Ignacio A.Ripoll, Giselle VaninaPifano, MarinaGarona, JuanAlonso, Daniel FernandoDESMOPRESSINRECTAL CANCERBLEEDING CONTROLANTITUMORALVASOPRESSIN PEPTIDE ANALOGDRUG REPURPOSINGTUMOR PERFUSIONHEMOSTASISVON WILLEBRAND FACTORGASTROINTESTINAL CANCERhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Purpose: The vasopressin analog desmopressin (dDAVP) is known to increase plasma levels of hemostatic factors,and preclinical studies in colorectal cancer models have demonstrated that it hampers tumor vascularization and metastatic progression. We evaluated safety and preliminary efficacy of dDAVP in rectal cancer patients with bleeding, before receiving specific oncologic treatment with surgery, chemotherapy and/or radiotherapy. Methods: Patients with rectal cancer having moderate or severe rectal bleeding were enrolled in an open-label, dose-finding trial. Intravenous infusions of dDAVP were administered during two consecutive days in doses from 0.25 to 2.0 µg/kg, using single or twice daily regimen. Bleeding was graded using a score based on the Chutkan scale and tumor perfusion was evaluated by dynamic contrast-enhanced magnetic resonance imaging. Results: The trial accrued a total of 32 patients. Dose-limiting toxicity occurred in patients receiving 1 µg/kg or higher. The most prominent treatment-related severe adverse event was hyponatremia. Most patients receiving the maximum tolerated dose of 0.5 µg/kg showed at least a partial hemostatic response and 58% developed a complete response with absence of bleeding at day 4 and/or at the last follow-up at day 14. Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment. Conclusions: dDAVP appeared as a promising hemostatic agent in rectal cancer patients with bleeding. Randomized clinical trials to confirm its effectiveness are warranted.Fil: Iseas, Soledad. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología "Dr. Carlos B. Udaondo"; ArgentinaFil: Roca, Enrique Luis. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología "Dr. Carlos B. Udaondo"; ArgentinaFil: O´Connor, Juan M.. Instituto Alexander Fleming; ArgentinaFil: Eleta, Martin. Imaxe Centro de Diagnóstico por Imágenes; ArgentinaFil: Sánchez Luceros, Analía Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Academia Nacional de Medicina de Buenos Aires; ArgentinaFil: Di Leo, Maria Daniela. Laboratorio Elea; ArgentinaFil: Tinelli, Marcelo. Laboratorio Elea-Phoenix; ArgentinaFil: Fara, Maria L.. Laboratorio Elea-Phoenix; ArgentinaFil: Spitzer, Eduardo. Laboratorio Elea-Phoenix; ArgentinaFil: Demarco, Ignacio A.. Romikin S.A. Laboratorio de Investigación y Desarrollo; ArgentinaFil: Ripoll, Giselle Vanina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; ArgentinaFil: Pifano, Marina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; ArgentinaFil: Garona, Juan. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; ArgentinaFil: Alonso, Daniel Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; ArgentinaSpringer2020-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/156955Iseas, Soledad; Roca, Enrique Luis; O´Connor, Juan M.; Eleta, Martin; Sánchez Luceros, Analía Gabriela; et al.; Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial; Springer; Investigational New Drugs; 38; 3-2020; 1580-15870167-6997CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://link.springer.com/10.1007/s10637-020-00914-5info:eu-repo/semantics/altIdentifier/doi/10.1007/s10637-020-00914-5info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:09:38Zoai:ri.conicet.gov.ar:11336/156955instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 10:09:39.201CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
| dc.title.none.fl_str_mv |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial |
| title |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial |
| spellingShingle |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial Iseas, Soledad DESMOPRESSIN RECTAL CANCER BLEEDING CONTROL ANTITUMORAL VASOPRESSIN PEPTIDE ANALOG DRUG REPURPOSING TUMOR PERFUSION HEMOSTASIS VON WILLEBRAND FACTOR GASTROINTESTINAL CANCER |
| title_short |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial |
| title_full |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial |
| title_fullStr |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial |
| title_full_unstemmed |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial |
| title_sort |
Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial |
| dc.creator.none.fl_str_mv |
Iseas, Soledad Roca, Enrique Luis O´Connor, Juan M. Eleta, Martin Sánchez Luceros, Analía Gabriela Di Leo, Maria Daniela Tinelli, Marcelo Fara, Maria L. Spitzer, Eduardo Demarco, Ignacio A. Ripoll, Giselle Vanina Pifano, Marina Garona, Juan Alonso, Daniel Fernando |
| author |
Iseas, Soledad |
| author_facet |
Iseas, Soledad Roca, Enrique Luis O´Connor, Juan M. Eleta, Martin Sánchez Luceros, Analía Gabriela Di Leo, Maria Daniela Tinelli, Marcelo Fara, Maria L. Spitzer, Eduardo Demarco, Ignacio A. Ripoll, Giselle Vanina Pifano, Marina Garona, Juan Alonso, Daniel Fernando |
| author_role |
author |
| author2 |
Roca, Enrique Luis O´Connor, Juan M. Eleta, Martin Sánchez Luceros, Analía Gabriela Di Leo, Maria Daniela Tinelli, Marcelo Fara, Maria L. Spitzer, Eduardo Demarco, Ignacio A. Ripoll, Giselle Vanina Pifano, Marina Garona, Juan Alonso, Daniel Fernando |
| author2_role |
author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
DESMOPRESSIN RECTAL CANCER BLEEDING CONTROL ANTITUMORAL VASOPRESSIN PEPTIDE ANALOG DRUG REPURPOSING TUMOR PERFUSION HEMOSTASIS VON WILLEBRAND FACTOR GASTROINTESTINAL CANCER |
| topic |
DESMOPRESSIN RECTAL CANCER BLEEDING CONTROL ANTITUMORAL VASOPRESSIN PEPTIDE ANALOG DRUG REPURPOSING TUMOR PERFUSION HEMOSTASIS VON WILLEBRAND FACTOR GASTROINTESTINAL CANCER |
| purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.2 https://purl.org/becyt/ford/3 |
| dc.description.none.fl_txt_mv |
Purpose: The vasopressin analog desmopressin (dDAVP) is known to increase plasma levels of hemostatic factors,and preclinical studies in colorectal cancer models have demonstrated that it hampers tumor vascularization and metastatic progression. We evaluated safety and preliminary efficacy of dDAVP in rectal cancer patients with bleeding, before receiving specific oncologic treatment with surgery, chemotherapy and/or radiotherapy. Methods: Patients with rectal cancer having moderate or severe rectal bleeding were enrolled in an open-label, dose-finding trial. Intravenous infusions of dDAVP were administered during two consecutive days in doses from 0.25 to 2.0 µg/kg, using single or twice daily regimen. Bleeding was graded using a score based on the Chutkan scale and tumor perfusion was evaluated by dynamic contrast-enhanced magnetic resonance imaging. Results: The trial accrued a total of 32 patients. Dose-limiting toxicity occurred in patients receiving 1 µg/kg or higher. The most prominent treatment-related severe adverse event was hyponatremia. Most patients receiving the maximum tolerated dose of 0.5 µg/kg showed at least a partial hemostatic response and 58% developed a complete response with absence of bleeding at day 4 and/or at the last follow-up at day 14. Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment. Conclusions: dDAVP appeared as a promising hemostatic agent in rectal cancer patients with bleeding. Randomized clinical trials to confirm its effectiveness are warranted. Fil: Iseas, Soledad. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología "Dr. Carlos B. Udaondo"; Argentina Fil: Roca, Enrique Luis. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología "Dr. Carlos B. Udaondo"; Argentina Fil: O´Connor, Juan M.. Instituto Alexander Fleming; Argentina Fil: Eleta, Martin. Imaxe Centro de Diagnóstico por Imágenes; Argentina Fil: Sánchez Luceros, Analía Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Academia Nacional de Medicina de Buenos Aires; Argentina Fil: Di Leo, Maria Daniela. Laboratorio Elea; Argentina Fil: Tinelli, Marcelo. Laboratorio Elea-Phoenix; Argentina Fil: Fara, Maria L.. Laboratorio Elea-Phoenix; Argentina Fil: Spitzer, Eduardo. Laboratorio Elea-Phoenix; Argentina Fil: Demarco, Ignacio A.. Romikin S.A. Laboratorio de Investigación y Desarrollo; Argentina Fil: Ripoll, Giselle Vanina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina Fil: Pifano, Marina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina Fil: Garona, Juan. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina Fil: Alonso, Daniel Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de Quilmes. Departamento de Ciencia y Tecnología. Laboratorio de Oncología Molecular; Argentina |
| description |
Purpose: The vasopressin analog desmopressin (dDAVP) is known to increase plasma levels of hemostatic factors,and preclinical studies in colorectal cancer models have demonstrated that it hampers tumor vascularization and metastatic progression. We evaluated safety and preliminary efficacy of dDAVP in rectal cancer patients with bleeding, before receiving specific oncologic treatment with surgery, chemotherapy and/or radiotherapy. Methods: Patients with rectal cancer having moderate or severe rectal bleeding were enrolled in an open-label, dose-finding trial. Intravenous infusions of dDAVP were administered during two consecutive days in doses from 0.25 to 2.0 µg/kg, using single or twice daily regimen. Bleeding was graded using a score based on the Chutkan scale and tumor perfusion was evaluated by dynamic contrast-enhanced magnetic resonance imaging. Results: The trial accrued a total of 32 patients. Dose-limiting toxicity occurred in patients receiving 1 µg/kg or higher. The most prominent treatment-related severe adverse event was hyponatremia. Most patients receiving the maximum tolerated dose of 0.5 µg/kg showed at least a partial hemostatic response and 58% developed a complete response with absence of bleeding at day 4 and/or at the last follow-up at day 14. Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment. Conclusions: dDAVP appeared as a promising hemostatic agent in rectal cancer patients with bleeding. Randomized clinical trials to confirm its effectiveness are warranted. |
| publishDate |
2020 |
| dc.date.none.fl_str_mv |
2020-03 |
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article |
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publishedVersion |
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http://hdl.handle.net/11336/156955 Iseas, Soledad; Roca, Enrique Luis; O´Connor, Juan M.; Eleta, Martin; Sánchez Luceros, Analía Gabriela; et al.; Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial; Springer; Investigational New Drugs; 38; 3-2020; 1580-1587 0167-6997 CONICET Digital CONICET |
| url |
http://hdl.handle.net/11336/156955 |
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Iseas, Soledad; Roca, Enrique Luis; O´Connor, Juan M.; Eleta, Martin; Sánchez Luceros, Analía Gabriela; et al.; Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial; Springer; Investigational New Drugs; 38; 3-2020; 1580-1587 0167-6997 CONICET Digital CONICET |
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eng |
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eng |
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info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by/2.5/ar/ |
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