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Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer

BACKGROUND: We conducted a phase I trial to determine the safety of systemic chemotherapy prior to abdominopelvic robotic stereotactic ablative radiotherapy (SABR) in women with persistent or recurrent gynecologic cancers. METHODS: Patients were assigned to dose-finding cohorts of day 1 carboplatin...

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Autores principales: Kunos, Charles A., Sherertz, Tracy M., Mislmani, Mazen, Ellis, Rodney J., Lo, Simon S., Waggoner, Steven E., Zanotti, Kristine M., Herrmann, Karin, Debernardo, Robert L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4456851/
https://www.ncbi.nlm.nih.gov/pubmed/26097831
http://dx.doi.org/10.3389/fonc.2015.00126
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author Kunos, Charles A.
Sherertz, Tracy M.
Mislmani, Mazen
Ellis, Rodney J.
Lo, Simon S.
Waggoner, Steven E.
Zanotti, Kristine M.
Herrmann, Karin
Debernardo, Robert L.
author_facet Kunos, Charles A.
Sherertz, Tracy M.
Mislmani, Mazen
Ellis, Rodney J.
Lo, Simon S.
Waggoner, Steven E.
Zanotti, Kristine M.
Herrmann, Karin
Debernardo, Robert L.
author_sort Kunos, Charles A.
collection PubMed
description BACKGROUND: We conducted a phase I trial to determine the safety of systemic chemotherapy prior to abdominopelvic robotic stereotactic ablative radiotherapy (SABR) in women with persistent or recurrent gynecologic cancers. METHODS: Patients were assigned to dose-finding cohorts of day 1 carboplatin (AUC 2 or 4) and gemcitabine (600 or 800 mg/m(2)) followed by day 2 to day 4 Cyberknife SABR (8 Gy × three consecutive daily doses). Toxicities were graded prospectively by common terminology criteria for adverse events, version 4.0. SABR target and best overall treatment responses were recorded according to response evaluation criteria in solid tumors, version 1.1. FINDINGS: The maximum tolerated dose of chemotherapy preceding SABR was carboplatin AUC 4 and gemcitabine 600 mg/m(2). One patient experienced manageable, dose-limiting grade 4 neutropenia, grade 4 hypokalemia, and grade 3 nausea attributed to study treatment. One patient had a late grade 3 rectovaginal fistula 16 months after trial therapy. Among 28 SABR targets, 22 (79%) showed a partial response and 6 (21%) remained stable. INTERPRETATION: Systemic chemotherapy may be given safely prior to abdominopelvic robotic SABR with further investigation warranted.
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spelling pubmed-44568512015-06-19 Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer Kunos, Charles A. Sherertz, Tracy M. Mislmani, Mazen Ellis, Rodney J. Lo, Simon S. Waggoner, Steven E. Zanotti, Kristine M. Herrmann, Karin Debernardo, Robert L. Front Oncol Oncology BACKGROUND: We conducted a phase I trial to determine the safety of systemic chemotherapy prior to abdominopelvic robotic stereotactic ablative radiotherapy (SABR) in women with persistent or recurrent gynecologic cancers. METHODS: Patients were assigned to dose-finding cohorts of day 1 carboplatin (AUC 2 or 4) and gemcitabine (600 or 800 mg/m(2)) followed by day 2 to day 4 Cyberknife SABR (8 Gy × three consecutive daily doses). Toxicities were graded prospectively by common terminology criteria for adverse events, version 4.0. SABR target and best overall treatment responses were recorded according to response evaluation criteria in solid tumors, version 1.1. FINDINGS: The maximum tolerated dose of chemotherapy preceding SABR was carboplatin AUC 4 and gemcitabine 600 mg/m(2). One patient experienced manageable, dose-limiting grade 4 neutropenia, grade 4 hypokalemia, and grade 3 nausea attributed to study treatment. One patient had a late grade 3 rectovaginal fistula 16 months after trial therapy. Among 28 SABR targets, 22 (79%) showed a partial response and 6 (21%) remained stable. INTERPRETATION: Systemic chemotherapy may be given safely prior to abdominopelvic robotic SABR with further investigation warranted. Frontiers Media S.A. 2015-06-05 /pmc/articles/PMC4456851/ /pubmed/26097831 http://dx.doi.org/10.3389/fonc.2015.00126 Text en Copyright © 2015 Kunos, Sherertz, Mislmani, Ellis, Lo, Waggoner, Zanotti, Herrmann and Debernardo. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Kunos, Charles A.
Sherertz, Tracy M.
Mislmani, Mazen
Ellis, Rodney J.
Lo, Simon S.
Waggoner, Steven E.
Zanotti, Kristine M.
Herrmann, Karin
Debernardo, Robert L.
Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
title Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
title_full Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
title_fullStr Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
title_full_unstemmed Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
title_short Phase I Trial of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Ablative Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
title_sort phase i trial of carboplatin and gemcitabine chemotherapy and stereotactic ablative radiosurgery for the palliative treatment of persistent or recurrent gynecologic cancer
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4456851/
https://www.ncbi.nlm.nih.gov/pubmed/26097831
http://dx.doi.org/10.3389/fonc.2015.00126
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