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Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies

Identifieur interne : 003E56 ( Pmc/Curation ); précédent : 003E55; suivant : 003E57

Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies

Auteurs : Charles A. Kunos [États-Unis] ; James Brindle [États-Unis] ; Steven Waggoner [États-Unis] ; Kristine Zanotti [États-Unis] ; Kimberly Resnick [États-Unis] ; Nancy Fusco [États-Unis] ; Ramon Adams [États-Unis] ; Robert Debernardo [États-Unis]

Source :

RBID : PMC:3514687

Abstract

Background: Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT) in women with metastatic gynecologic cancers. Methods: A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4) metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses). Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0). SBRT target responses were recorded following RECIST criteria (version 1.0). Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan–Meier method and the Cox proportional hazards model was used to control for prognostic variables. Findings: SBRT was safely delivered, with 49 (98%) of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%), nausea (8%), and diarrhea (4%). One (2%) grade four hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients). A 6-month clinical benefit was recorded in 34 [68% (95% CI, 53.2, 80.1)] patients. No SBRT targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62%) patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6). Median overall survival was 20.2 months (95% CI, 10.9, 29.5). Interpretation: SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway. Funding: Case Comprehensive Cancer Center.


Url:
DOI: 10.3389/fonc.2012.00181
PubMed: 23227452
PubMed Central: 3514687

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PMC:3514687

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<bold>Background:</bold>
Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT) in women with metastatic gynecologic cancers.
<bold>Methods:</bold>
A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4) metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses). Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0). SBRT target responses were recorded following RECIST criteria (version 1.0). Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan–Meier method and the Cox proportional hazards model was used to control for prognostic variables.
<bold>Findings:</bold>
SBRT was safely delivered, with 49 (98%) of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%), nausea (8%), and diarrhea (4%). One (2%) grade four hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients). A 6-month clinical benefit was recorded in 34 [68% (95% CI, 53.2, 80.1)] patients. No SBRT targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62%) patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6). Median overall survival was 20.2 months (95% CI, 10.9, 29.5).
<bold>Interpretation:</bold>
SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway.
<bold>Funding:</bold>
Case Comprehensive Cancer Center.</p>
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<pmc article-type="research-article">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Front Oncol</journal-id>
<journal-id journal-id-type="iso-abbrev">Front Oncol</journal-id>
<journal-id journal-id-type="publisher-id">Front. Oncol.</journal-id>
<journal-title-group>
<journal-title>Frontiers in Oncology</journal-title>
</journal-title-group>
<issn pub-type="epub">2234-943X</issn>
<publisher>
<publisher-name>Frontiers Media S.A.</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">23227452</article-id>
<article-id pub-id-type="pmc">3514687</article-id>
<article-id pub-id-type="doi">10.3389/fonc.2012.00181</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Oncology</subject>
<subj-group>
<subject>Clinical Trial</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group>
<article-title>Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Kunos</surname>
<given-names>Charles A.</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>1</sup>
</xref>
<xref ref-type="author-notes" rid="fn001">*</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Brindle</surname>
<given-names>James</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Waggoner</surname>
<given-names>Steven</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Zanotti</surname>
<given-names>Kristine</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Resnick</surname>
<given-names>Kimberly</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Fusco</surname>
<given-names>Nancy</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Adams</surname>
<given-names>Ramon</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Debernardo</surname>
<given-names>Robert</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
</contrib>
</contrib-group>
<aff id="aff1">
<sup>1</sup>
<institution>Department of Radiation Oncology, University Hospitals Case Medical Center and Case Western Reserve University, School of Medicine</institution>
<country>Cleveland, OH, USA</country>
</aff>
<aff id="aff2">
<sup>2</sup>
<institution>Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University Hospitals Case Medical Center and Case Western Reserve University, School of Medicine</institution>
<country>Cleveland, OH, USA</country>
</aff>
<author-notes>
<fn fn-type="edited-by">
<p>Edited by: Brian Timothy Collins, Georgetown University Hospital, USA</p>
</fn>
<fn fn-type="edited-by">
<p>Reviewed by: Sean Collins, Georgetown University Hospital, USA; John E. Mignano, Tufts Medical Center, USA</p>
</fn>
<corresp id="fn001">*Correspondence: Charles A. Kunos, Department of Radiation Oncology, University Hospitals of Cleveland, 11100 Euclid Avenue, LTR 6068, Cleveland, OH 44106, USA. e-mail:
<email xlink:type="simple">charles.kunos@uhhospitals.org</email>
</corresp>
<fn fn-type="other" id="fn002">
<p>This article was submitted to Frontiers in Radiation Oncology, a specialty of Frontiers in Oncology.</p>
</fn>
</author-notes>
<pub-date pub-type="epreprint">
<day>03</day>
<month>11</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="epub">
<day>05</day>
<month>12</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="collection">
<year>2012</year>
</pub-date>
<volume>2</volume>
<elocation-id>181</elocation-id>
<history>
<date date-type="received">
<day>08</day>
<month>10</month>
<year>2012</year>
</date>
<date date-type="accepted">
<day>10</day>
<month>11</month>
<year>2012</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright © 2012 Kunos, Brindle, Waggoner, Zanotti, Resnick, Fusco, Adams and Debernardo.</copyright-statement>
<copyright-year>2012</copyright-year>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/3.0/">
<license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc.</license-p>
</license>
</permissions>
<abstract>
<p>
<bold>Background:</bold>
Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT) in women with metastatic gynecologic cancers.
<bold>Methods:</bold>
A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4) metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses). Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0). SBRT target responses were recorded following RECIST criteria (version 1.0). Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan–Meier method and the Cox proportional hazards model was used to control for prognostic variables.
<bold>Findings:</bold>
SBRT was safely delivered, with 49 (98%) of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%), nausea (8%), and diarrhea (4%). One (2%) grade four hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients). A 6-month clinical benefit was recorded in 34 [68% (95% CI, 53.2, 80.1)] patients. No SBRT targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62%) patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6). Median overall survival was 20.2 months (95% CI, 10.9, 29.5).
<bold>Interpretation:</bold>
SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway.
<bold>Funding:</bold>
Case Comprehensive Cancer Center.</p>
</abstract>
<kwd-group>
<kwd>robotic radiosurgery</kwd>
<kwd>Cyberknife</kwd>
<kwd>gynecologic cancer</kwd>
</kwd-group>
<counts>
<fig-count count="1"></fig-count>
<table-count count="3"></table-count>
<equation-count count="0"></equation-count>
<ref-count count="19"></ref-count>
<page-count count="6"></page-count>
<word-count count="4476"></word-count>
</counts>
</article-meta>
</front>
</pmc>
</record>

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