Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy
Identifieur interne : 001924 ( Main/Exploration ); précédent : 001923; suivant : 001925Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy
Auteurs : Wenze Sun [République populaire de Chine] ; Tao Wang [République populaire de Chine] ; Fan Shi [République populaire de Chine] ; Jiquan Wang [République populaire de Chine] ; Juan Wang [République populaire de Chine] ; Beina Hui [République populaire de Chine] ; Yingbing Zhang [République populaire de Chine] ; Jinli Lu [République populaire de Chine] ; Hongwei Chen [République populaire de Chine] ; Zi Liu [République populaire de Chine]Source :
- BMC Cancer [ 1471-2407 ] ; 2015.
Abstract
In cervical cancer patients with intermediate-risk factors, the optimal adjuvant therapy is still controversial. We undertook a randomized trial (ClinicalTrials.gov Identifier: NCT01418859) to compare the efficacy and toxicity of concurrent chemoradiotherapy with topotecan and cisplatin with radiotherapy alone in intermediate-risk cervical cancer patients.
Eligible patients were randomly assigned to one of three treatment arms including arm A (radiotherapy only,RT), arm B(concurrent chemoradiotherapy only, CCRT), and arm C (concurrent chemoradiotherapy with following consolidation chemotherapy, CCRT + CT). All eligible patients completed external RT (IMRT or 3D-CRT), receiving 45-50Gy /25f uniformly to the pelvis. Concurrent chemotherapy regimen was topotecan 0.75 mg/m2 for days 1, 2 and 3, followed by cisplatin 25 mg/m2 for days 1, 2 and 3. Three cycles of consolidation chemotherapy regimen was topotecan 1.5 mg/m2 for days 1 and 2, and 0.75 mg/m2 for day 3; followed by cisplatin 25 mg/m2 for days 1, 2 and 3, repeated every 21 days. Adverse events of each group were investigated and compared.
Thirty-nine patients enrolled onto the remaining regimens: 14 to RT, 15 to CCRT and 10 to CCRT + CT. Six patients (15.4%) did not complete the protocol treatment. Hematologic toxicity was more frequent and more severe in the CCRT and CCRT + CT arms compared with the RT arm. The incidence of grade 3-4 neutropenia was significantly different statistically between the RT, CCRT and CCRT + RT groups (15.4%, 46.7% and 100%, respectively;
Concurrent chemoradiotherapy with topotecan and cisplatin showed severe hematologic toxicity in intermediate-risk cervical cancer patients after radical hysterectomy. Thus, the study was closed ahead of schedule.
ClinicalTrials.gov Identifier:
Url:
DOI: 10.1186/s12885-015-1355-1
PubMed: 25935645
PubMed Central: 4425857
Affiliations:
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China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Hui, Beina" sort="Hui, Beina" uniqKey="Hui B" first="Beina" last="Hui">Beina Hui</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Yingbing" sort="Zhang, Yingbing" uniqKey="Zhang Y" first="Yingbing" last="Zhang">Yingbing Zhang</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Lu, Jinli" sort="Lu, Jinli" uniqKey="Lu J" first="Jinli" last="Lu">Jinli Lu</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of 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University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25935645</idno><idno type="pmc">4425857</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425857</idno><idno type="RBID">PMC:4425857</idno><idno type="doi">10.1186/s12885-015-1355-1</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000C22</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000C22</idno><idno type="wicri:Area/Pmc/Curation">000C21</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000C21</idno><idno type="wicri:Area/Pmc/Checkpoint">000F29</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000F29</idno><idno type="wicri:Area/Ncbi/Merge">007333</idno><idno type="wicri:Area/Ncbi/Curation">007333</idno><idno type="wicri:Area/Ncbi/Checkpoint">007333</idno><idno type="wicri:Area/Main/Merge">001926</idno><idno type="wicri:Area/Main/Curation">001924</idno><idno type="wicri:Area/Main/Exploration">001924</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy</title><author><name sortKey="Sun, Wenze" sort="Sun, Wenze" uniqKey="Sun W" first="Wenze" last="Sun">Wenze Sun</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Tao" sort="Wang, Tao" uniqKey="Wang T" first="Tao" last="Wang">Tao Wang</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Shi, Fan" sort="Shi, Fan" uniqKey="Shi F" first="Fan" last="Shi">Fan Shi</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Jiquan" sort="Wang, Jiquan" uniqKey="Wang J" first="Jiquan" last="Wang">Jiquan Wang</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Juan" sort="Wang, Juan" uniqKey="Wang J" first="Juan" last="Wang">Juan Wang</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Hui, Beina" sort="Hui, Beina" uniqKey="Hui B" first="Beina" last="Hui">Beina Hui</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Yingbing" sort="Zhang, Yingbing" uniqKey="Zhang Y" first="Yingbing" last="Zhang">Yingbing Zhang</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Lu, Jinli" sort="Lu, Jinli" uniqKey="Lu J" first="Jinli" last="Lu">Jinli Lu</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Chen, Hongwei" sort="Chen, Hongwei" uniqKey="Chen H" first="Hongwei" last="Chen">Hongwei Chen</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author><author><name sortKey="Liu, Zi" sort="Liu, Zi" uniqKey="Liu Z" first="Zi" last="Liu">Zi Liu</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an, 710061 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Radiation Oncology, First Affiliated Hospital of Xi’an Jiaotong University, 277 Yanta West Road, Yanta District, Xi’an</wicri:regionArea><wicri:noRegion>Xi’an</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>In cervical cancer patients with intermediate-risk factors, the optimal adjuvant therapy is still controversial. We undertook a randomized trial (ClinicalTrials.gov Identifier: NCT01418859) to compare the efficacy and toxicity of concurrent chemoradiotherapy with topotecan and cisplatin with radiotherapy alone in intermediate-risk cervical cancer patients.</p></sec><sec><title>Methods</title><p>Eligible patients were randomly assigned to one of three treatment arms including arm A (radiotherapy only,RT), arm B(concurrent chemoradiotherapy only, CCRT), and arm C (concurrent chemoradiotherapy with following consolidation chemotherapy, CCRT + CT). All eligible patients completed external RT (IMRT or 3D-CRT), receiving 45-50Gy /25f uniformly to the pelvis. Concurrent chemotherapy regimen was topotecan 0.75 mg/m<sup>2</sup> for days 1, 2 and 3, followed by cisplatin 25 mg/m<sup>2</sup> for days 1, 2 and 3. Three cycles of consolidation chemotherapy regimen was topotecan 1.5 mg/m<sup>2</sup> for days 1 and 2, and 0.75 mg/m<sup>2</sup> for day 3; followed by cisplatin 25 mg/m<sup>2</sup> for days 1, 2 and 3, repeated every 21 days. Adverse events of each group were investigated and compared.</p></sec><sec><title>Results</title><p>Thirty-nine patients enrolled onto the remaining regimens: 14 to RT, 15 to CCRT and 10 to CCRT + CT. Six patients (15.4%) did not complete the protocol treatment. Hematologic toxicity was more frequent and more severe in the CCRT and CCRT + CT arms compared with the RT arm. The incidence of grade 3-4 neutropenia was significantly different statistically between the RT, CCRT and CCRT + RT groups (15.4%, 46.7% and 100%, respectively; <italic>P</italic> = 0.002). Specially, three patients in CCRT + CT arm of all six patients who did not complete the protocol treatment discontinued planned therapy because of persistent grade 4 neutropenia. However, there were no significant differences in grade 3-4 non-hematologic toxicities between the three groups(all <italic>P</italic> > 0.05). Recurrence-free survival and overall survival of each group were not analyzed on account of a median follow-up of only 16 months.</p></sec><sec><title>Conclusions</title><p>Concurrent chemoradiotherapy with topotecan and cisplatin showed severe hematologic toxicity in intermediate-risk cervical cancer patients after radical hysterectomy. Thus, the study was closed ahead of schedule.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov/ct2/show/NCT01418859?term=NCT01418859&rank=1">NCT01418859</ext-link>.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Bidus, Ma" uniqKey="Bidus M">MA Bidus</name></author><author><name sortKey="Elcas, Jc" uniqKey="Elcas J">JC Elcas</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hacker, Nf" uniqKey="Hacker N">NF Hacker</name></author><author><name sortKey="Friedlander, Ml" uniqKey="Friedlander M">ML Friedlander</name></author><author><name sortKey="Berek, Js" uniqKey="Berek J">JS Berek</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Peters, Wa" uniqKey="Peters W">WA Peters</name></author><author><name sortKey="Liu, Py" uniqKey="Liu P">PY 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Hatch</name></author><author><name sortKey="Orr, Jw" uniqKey="Orr J">JW Orr</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>République populaire de Chine</li></country></list><tree><country name="République populaire de Chine"><noRegion><name sortKey="Sun, Wenze" sort="Sun, Wenze" uniqKey="Sun W" first="Wenze" last="Sun">Wenze Sun</name></noRegion><name sortKey="Chen, Hongwei" sort="Chen, Hongwei" uniqKey="Chen H" first="Hongwei" last="Chen">Hongwei Chen</name><name sortKey="Hui, Beina" sort="Hui, Beina" uniqKey="Hui B" first="Beina" last="Hui">Beina Hui</name><name sortKey="Liu, Zi" sort="Liu, Zi" uniqKey="Liu Z" first="Zi" last="Liu">Zi Liu</name><name sortKey="Lu, Jinli" sort="Lu, Jinli" uniqKey="Lu J" first="Jinli" last="Lu">Jinli Lu</name><name sortKey="Shi, Fan" sort="Shi, Fan" uniqKey="Shi F" first="Fan" last="Shi">Fan Shi</name><name sortKey="Wang, Jiquan" sort="Wang, Jiquan" uniqKey="Wang J" first="Jiquan" last="Wang">Jiquan Wang</name><name sortKey="Wang, Juan" sort="Wang, Juan" uniqKey="Wang J" first="Juan" last="Wang">Juan Wang</name><name sortKey="Wang, Tao" sort="Wang, Tao" uniqKey="Wang T" first="Tao" last="Wang">Tao Wang</name><name sortKey="Zhang, Yingbing" sort="Zhang, Yingbing" uniqKey="Zhang Y" first="Yingbing" last="Zhang">Yingbing Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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