Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)
Identifieur interne : 002073 ( Pmc/Checkpoint ); précédent : 002072; suivant : 002074Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)
Auteurs : N. Katsumata [Japon] ; H. Yoshikawa [Japon] ; H. Kobayashi [Japon] ; T. Saito [Japon] ; K. Kuzuya [Japon] ; T. Nakanishi [Japon] ; T. Yasugi [Japon] ; N. Yaegashi [Japon] ; H. Yokota [Japon] ; S. Kodama [Japon] ; T. Mizunoe [Japon] ; M. Hiura [Japon] ; T. Kasamatsu [Japon] ; T. Shibata [Japon] ; T. Kamura [Japon]Source :
- British Journal of Cancer [ 0007-0920 ] ; 2013.
Abstract
A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival.
Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg days 1–5, vincristine 0.7 mg m−2 day 5, mitomycin 7 mg m−2 day 5, cisplatin 14 mg m−2 days 1–5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival.
A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80%
Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT.
Url:
DOI: 10.1038/bjc.2013.179
PubMed: 23640393
PubMed Central: 3671094
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery <italic>vs</italic> radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)</title><author><name sortKey="Katsumata, N" sort="Katsumata, N" uniqKey="Katsumata N" first="N" last="Katsumata">N. Katsumata</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Department of Medical Oncology, Nippon Medical School Musashikosugi Hospital</institution>, Kawasaki,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yoshikawa, H" sort="Yoshikawa, H" uniqKey="Yoshikawa H" first="H" last="Yoshikawa">H. Yoshikawa</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Department of Obstetrics and Gynecology, University of Tsukuba</institution>, Tsukuba,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kobayashi, H" sort="Kobayashi, H" uniqKey="Kobayashi H" first="H" last="Kobayashi">H. Kobayashi</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Department of Obstetrics and Gynecology, Kyushu University</institution>, Fukuoka,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Saito, T" sort="Saito, T" uniqKey="Saito T" first="T" last="Saito">T. Saito</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Gynecologic Oncology, Kyushu Cancer Center</institution>, Fukuoka,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kuzuya, K" sort="Kuzuya, K" uniqKey="Kuzuya K" first="K" last="Kuzuya">K. Kuzuya</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Kuzuya Clinic</institution>, Nagoya,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nakanishi, T" sort="Nakanishi, T" uniqKey="Nakanishi T" first="T" last="Nakanishi">T. Nakanishi</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Department of Gynecologic Oncology, Aichi Cancer Center</institution>, Nagoya,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yasugi, T" sort="Yasugi, T" uniqKey="Yasugi T" first="T" last="Yasugi">T. Yasugi</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Department of Obstetrics and Gynecology, Tokyo University</institution>, Tokyo,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yaegashi, N" sort="Yaegashi, N" uniqKey="Yaegashi N" first="N" last="Yaegashi">N. Yaegashi</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Department of Obstetrics and Gynecology, Tohoku University</institution>, Sendai,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yokota, H" sort="Yokota, H" uniqKey="Yokota H" first="H" last="Yokota">H. Yokota</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Department of Gynecologic Oncology, Saitama Cancer Center</institution>, Saitama,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kodama, S" sort="Kodama, S" uniqKey="Kodama S" first="S" last="Kodama">S. Kodama</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Department of Gynecologic Oncology, Niigata Cancer Center</institution>, Niigata,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mizunoe, T" sort="Mizunoe, T" uniqKey="Mizunoe T" first="T" last="Mizunoe">T. Mizunoe</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Department of Gynecologic Oncology, Kure Medical Center</institution>, Kure,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hiura, M" sort="Hiura, M" uniqKey="Hiura M" first="M" last="Hiura">M. Hiura</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Department of Gynecologic Oncology, Shikoku Cancer Center</institution>, Matsuyama,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kasamatsu, T" sort="Kasamatsu, T" uniqKey="Kasamatsu T" first="T" last="Kasamatsu">T. Kasamatsu</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Department of Gynecologic Oncology, National Cancer Center Hospital</institution>, Tokyo,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Shibata, T" sort="Shibata, T" uniqKey="Shibata T" first="T" last="Shibata">T. Shibata</name><affiliation wicri:level="1"><nlm:aff id="aff14"><institution>Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center</institution>, Tokyo,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kamura, T" sort="Kamura, T" uniqKey="Kamura T" first="T" last="Kamura">T. Kamura</name><affiliation wicri:level="1"><nlm:aff id="aff15"><institution>Department of Obstetrics and Gynecology, Kurume University</institution>, Kurume,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23640393</idno><idno type="pmc">3671094</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3671094</idno><idno type="RBID">PMC:3671094</idno><idno type="doi">10.1038/bjc.2013.179</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000076</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000076</idno><idno type="wicri:Area/Pmc/Curation">000076</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000076</idno><idno type="wicri:Area/Pmc/Checkpoint">002073</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">002073</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery <italic>vs</italic> radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)</title><author><name sortKey="Katsumata, N" sort="Katsumata, N" uniqKey="Katsumata N" first="N" last="Katsumata">N. Katsumata</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Department of Medical Oncology, Nippon Medical School Musashikosugi Hospital</institution>, Kawasaki,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yoshikawa, H" sort="Yoshikawa, H" uniqKey="Yoshikawa H" first="H" last="Yoshikawa">H. Yoshikawa</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Department of Obstetrics and Gynecology, University of Tsukuba</institution>, Tsukuba,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kobayashi, H" sort="Kobayashi, H" uniqKey="Kobayashi H" first="H" last="Kobayashi">H. Kobayashi</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Department of Obstetrics and Gynecology, Kyushu University</institution>, Fukuoka,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Saito, T" sort="Saito, T" uniqKey="Saito T" first="T" last="Saito">T. Saito</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Gynecologic Oncology, Kyushu Cancer Center</institution>, Fukuoka,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kuzuya, K" sort="Kuzuya, K" uniqKey="Kuzuya K" first="K" last="Kuzuya">K. Kuzuya</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Kuzuya Clinic</institution>, Nagoya,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nakanishi, T" sort="Nakanishi, T" uniqKey="Nakanishi T" first="T" last="Nakanishi">T. Nakanishi</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Department of Gynecologic Oncology, Aichi Cancer Center</institution>, Nagoya,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yasugi, T" sort="Yasugi, T" uniqKey="Yasugi T" first="T" last="Yasugi">T. Yasugi</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Department of Obstetrics and Gynecology, Tokyo University</institution>, Tokyo,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yaegashi, N" sort="Yaegashi, N" uniqKey="Yaegashi N" first="N" last="Yaegashi">N. Yaegashi</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Department of Obstetrics and Gynecology, Tohoku University</institution>, Sendai,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Yokota, H" sort="Yokota, H" uniqKey="Yokota H" first="H" last="Yokota">H. Yokota</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Department of Gynecologic Oncology, Saitama Cancer Center</institution>, Saitama,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kodama, S" sort="Kodama, S" uniqKey="Kodama S" first="S" last="Kodama">S. Kodama</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Department of Gynecologic Oncology, Niigata Cancer Center</institution>, Niigata,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mizunoe, T" sort="Mizunoe, T" uniqKey="Mizunoe T" first="T" last="Mizunoe">T. Mizunoe</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Department of Gynecologic Oncology, Kure Medical Center</institution>, Kure,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hiura, M" sort="Hiura, M" uniqKey="Hiura M" first="M" last="Hiura">M. Hiura</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Department of Gynecologic Oncology, Shikoku Cancer Center</institution>, Matsuyama,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kasamatsu, T" sort="Kasamatsu, T" uniqKey="Kasamatsu T" first="T" last="Kasamatsu">T. Kasamatsu</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Department of Gynecologic Oncology, National Cancer Center Hospital</institution>, Tokyo,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Shibata, T" sort="Shibata, T" uniqKey="Shibata T" first="T" last="Shibata">T. Shibata</name><affiliation wicri:level="1"><nlm:aff id="aff14"><institution>Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center</institution>, Tokyo,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kamura, T" sort="Kamura, T" uniqKey="Kamura T" first="T" last="Kamura">T. Kamura</name><affiliation wicri:level="1"><nlm:aff id="aff15"><institution>Department of Obstetrics and Gynecology, Kurume University</institution>, Kurume,<country>Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">British Journal of Cancer</title><idno type="ISSN">0007-0920</idno><idno type="eISSN">1532-1827</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background:</title><p>A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival.</p></sec><sec><title>Methods:</title><p>Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg days 1–5, vincristine 0.7 mg m<sup>−2</sup> day 5, mitomycin 7 mg m<sup>−2</sup> day 5, cisplatin 14 mg m<sup>−2</sup> days 1–5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival.</p></sec><sec><title>Results:</title><p>A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80% <italic>P</italic>=0.015). The 5-year overall survival was 70.0% in the NACT group and 74.4% in the RS group (<italic>P</italic>=0.85).</p></sec><sec><title>Conclusion:</title><p>Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Buda, A" uniqKey="Buda A">A Buda</name></author><author><name sortKey="Fossati, R" uniqKey="Fossati R">R Fossati</name></author><author><name sortKey="Colombo, N" uniqKey="Colombo N">N Colombo</name></author><author><name sortKey="Fei, F" uniqKey="Fei F">F Fei</name></author><author><name sortKey="Floriani, I" uniqKey="Floriani I">I Floriani</name></author><author><name sortKey="Gueli Alletti, D" uniqKey="Gueli Alletti D">D Gueli Alletti</name></author><author><name sortKey="Katsaros, D" uniqKey="Katsaros D">D Katsaros</name></author><author><name sortKey="Landoni, F" 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Br J Cancer</journal-id><journal-id journal-id-type="iso-abbrev">Br. J. Cancer</journal-id><journal-title-group><journal-title>British Journal of Cancer</journal-title></journal-title-group><issn pub-type="ppub">0007-0920</issn><issn pub-type="epub">1532-1827</issn><publisher><publisher-name>Nature Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">23640393</article-id><article-id pub-id-type="pmc">3671094</article-id><article-id pub-id-type="pii">bjc2013179</article-id><article-id pub-id-type="doi">10.1038/bjc.2013.179</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical Study</subject></subj-group></article-categories><title-group><article-title>Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery <italic>vs</italic> radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)</article-title><alt-title alt-title-type="running">Phase III trial of NACT plus RS <italic>vs</italic> RS alone in cervical cancer</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Katsumata</surname><given-names>N</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="corresp" rid="caf1">*</xref></contrib><contrib contrib-type="author"><name><surname>Yoshikawa</surname><given-names>H</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Kobayashi</surname><given-names>H</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Saito</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Kuzuya</surname><given-names>K</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Nakanishi</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Yasugi</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Yaegashi</surname><given-names>N</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Yokota</surname><given-names>H</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Kodama</surname><given-names>S</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Mizunoe</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Hiura</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff12">12</xref></contrib><contrib contrib-type="author"><name><surname>Kasamatsu</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff13">13</xref></contrib><contrib contrib-type="author"><name><surname>Shibata</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff14">14</xref></contrib><contrib contrib-type="author"><name><surname>Kamura</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><on-behalf-of>on behalf of the Japan Clinical Oncology Group</on-behalf-of><aff id="aff1"><label>1</label><institution>Department of Medical Oncology, Nippon Medical School Musashikosugi Hospital</institution>, Kawasaki,<country>Japan</country></aff><aff id="aff2"><label>2</label><institution>Department of Obstetrics and Gynecology, University of Tsukuba</institution>, Tsukuba,<country>Japan</country></aff><aff id="aff3"><label>3</label><institution>Department of Obstetrics and Gynecology, Kyushu University</institution>, Fukuoka,<country>Japan</country></aff><aff id="aff4"><label>4</label><institution>Department of Gynecologic Oncology, Kyushu Cancer Center</institution>, Fukuoka,<country>Japan</country></aff><aff id="aff5"><label>5</label><institution>Kuzuya Clinic</institution>, Nagoya,<country>Japan</country></aff><aff id="aff6"><label>6</label><institution>Department of Gynecologic Oncology, Aichi Cancer Center</institution>, Nagoya,<country>Japan</country></aff><aff id="aff7"><label>7</label><institution>Department of Obstetrics and Gynecology, Tokyo University</institution>, Tokyo,<country>Japan</country></aff><aff id="aff8"><label>8</label><institution>Department of Obstetrics and Gynecology, Tohoku University</institution>, Sendai,<country>Japan</country></aff><aff id="aff9"><label>9</label><institution>Department of Gynecologic Oncology, Saitama Cancer Center</institution>, Saitama,<country>Japan</country></aff><aff id="aff10"><label>10</label><institution>Department of Gynecologic Oncology, Niigata Cancer Center</institution>, Niigata,<country>Japan</country></aff><aff id="aff11"><label>11</label><institution>Department of Gynecologic Oncology, Kure Medical Center</institution>, Kure,<country>Japan</country></aff><aff id="aff12"><label>12</label><institution>Department of Gynecologic Oncology, Shikoku Cancer Center</institution>, Matsuyama,<country>Japan</country></aff><aff id="aff13"><label>13</label><institution>Department of Gynecologic Oncology, National Cancer Center Hospital</institution>, Tokyo,<country>Japan</country></aff><aff id="aff14"><label>14</label><institution>Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center</institution>, Tokyo,<country>Japan</country></aff><aff id="aff15"><label>15</label><institution>Department of Obstetrics and Gynecology, Kurume University</institution>, Kurume,<country>Japan</country></aff></contrib-group><author-notes><corresp id="caf1"><label>*</label>E-mail: <email>nkatsuma@nms.ac.jp</email></corresp></author-notes><pub-date pub-type="ppub"><day>28</day><month>05</month><year>2013</year></pub-date><pub-date pub-type="epub"><day>02</day><month>05</month><year>2013</year></pub-date><volume>108</volume><issue>10</issue><fpage>1957</fpage><lpage>1963</lpage><history><date date-type="received"><day>30</day><month>11</month><year>2012</year></date><date date-type="rev-recd"><day>17</day><month>03</month><year>2013</year></date><date date-type="accepted"><day>01</day><month>04</month><year>2013</year></date></history><permissions><copyright-statement>Copyright © 2013 Cancer Research UK</copyright-statement><copyright-year>2013</copyright-year><copyright-holder>Cancer Research UK</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-sa/3.0/"><license-p>From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/</license-p></license></permissions><abstract><sec><title>Background:</title><p>A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival.</p></sec><sec><title>Methods:</title><p>Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg days 1–5, vincristine 0.7 mg m<sup>−2</sup> day 5, mitomycin 7 mg m<sup>−2</sup> day 5, cisplatin 14 mg m<sup>−2</sup> days 1–5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival.</p></sec><sec><title>Results:</title><p>A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80% <italic>P</italic>=0.015). The 5-year overall survival was 70.0% in the NACT group and 74.4% in the RS group (<italic>P</italic>=0.85).</p></sec><sec><title>Conclusion:</title><p>Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT.</p></sec></abstract><kwd-group><kwd>cervical cancer</kwd><kwd>neoadjuvant chemotherapy</kwd><kwd>phase III trial</kwd><kwd>radical surgery</kwd></kwd-group></article-meta></front><floats-group><fig id="fig1"><label>Figure 1</label><caption><p><bold>Trial profile.</bold></p></caption><graphic xlink:href="bjc2013179f1"></graphic></fig><fig id="fig2"><label>Figure 2</label><caption><p><bold>Survival curves of all randomised patients.</bold></p></caption><graphic xlink:href="bjc2013179f2"></graphic></fig><table-wrap id="tbl1"><label>Table 1</label><caption><title>Patient characteristics</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="center"></col><col align="center"></col><col align="center"></col><col align="center"></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> <hr></hr></th><th colspan="2" align="center" valign="top" charoff="50"><bold>Radical hysterectomy (</bold><italic><bold>n</bold></italic><bold>=67)</bold><hr></hr></th><th colspan="2" align="center" valign="top" charoff="50"><bold>Neoadjuvant chemotherapy (</bold><italic><bold>n</bold></italic><bold>=67)</bold><hr></hr></th></tr><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" charoff="50"><bold>No. of patients</bold></th><th align="center" valign="top" charoff="50"><bold>%</bold></th><th align="center" valign="top" charoff="50"><bold>No. of patients</bold></th><th align="center" valign="top" charoff="50"><bold>%</bold></th></tr></thead><tbody valign="top"><tr><td colspan="5" align="left" valign="top" charoff="50"><bold>Age, years</bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Median</td><td colspan="2" align="center" valign="top" charoff="50">46</td><td colspan="2" align="center" valign="top" charoff="50">47</td></tr><tr><td align="left" valign="top" charoff="50">Range<hr></hr></td><td colspan="2" align="center" valign="top" charoff="50">22–67<hr></hr></td><td colspan="2" align="center" valign="top" charoff="50">28–70<hr></hr></td></tr><tr><td colspan="5" align="left" valign="top" charoff="50"><bold>ECOG performance status</bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">0<hr></hr></td><td align="center" valign="top" charoff="50">59<hr></hr></td><td align="center" valign="top" charoff="50">88<hr></hr></td><td align="center" valign="top" charoff="50">62<hr></hr></td><td align="center" valign="top" charoff="50">93<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">1<hr></hr></td><td align="center" valign="top" charoff="50">8<hr></hr></td><td align="center" valign="top" charoff="50">12<hr></hr></td><td align="center" valign="top" charoff="50">5<hr></hr></td><td align="center" valign="top" charoff="50">8<hr></hr></td></tr><tr><td colspan="5" align="left" valign="top" charoff="50"><bold>FIGO stage</bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">IB2<hr></hr></td><td align="center" valign="top" charoff="50">26<hr></hr></td><td align="center" valign="top" charoff="50">39<hr></hr></td><td align="center" valign="top" charoff="50">24<hr></hr></td><td align="center" valign="top" charoff="50">36<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">IIA<hr></hr></td><td align="center" valign="top" charoff="50">7<hr></hr></td><td align="center" valign="top" charoff="50">10<hr></hr></td><td align="center" valign="top" charoff="50">5<hr></hr></td><td align="center" valign="top" charoff="50">8<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">IIB<hr></hr></td><td align="center" valign="top" charoff="50">34<hr></hr></td><td align="center" valign="top" charoff="50">51<hr></hr></td><td align="center" valign="top" charoff="50">38<hr></hr></td><td align="center" valign="top" charoff="50">57<hr></hr></td></tr><tr><td colspan="5" align="left" valign="top" charoff="50"><bold>Histology in biopsy</bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Squamous cell<hr></hr></td><td align="center" valign="top" charoff="50">66<hr></hr></td><td align="center" valign="top" charoff="50">99<hr></hr></td><td align="center" valign="top" charoff="50">67<hr></hr></td><td align="center" valign="top" charoff="50">100<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Adenosquamous cell</td><td align="center" valign="top" charoff="50">1</td><td align="center" valign="top" charoff="50">1</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">0</td></tr></tbody></table><table-wrap-foot><fn id="t1-fn1"><p>Abbreviations: ECOG=Eastern Cooperative Oncology Group; FIGO=International Federation of Gynaecology and Obstetrics surgical staging system.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl2"><label>Table 2</label><caption><title>Clinical response of neoadjuvant chemotherapy</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="char" char="("></col><col align="left"></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><bold>Response category</bold></th><th align="char" valign="top" char="(" charoff="50"><bold>Investigator assessment</bold><bold>(</bold><italic><bold>n</bold></italic><bold>=67)</bold></th><th align="left" valign="top" charoff="50"><bold>Independent central review</bold><bold>(</bold><italic><bold>n</bold></italic><bold>=67)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">CR<hr></hr></td><td align="char" valign="top" char="(" charoff="50">9 (13)<hr></hr></td><td align="left" valign="top" charoff="50">8 (12)<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">PR<hr></hr></td><td align="char" valign="top" char="(" charoff="50">38 (57)<hr></hr></td><td align="left" valign="top" charoff="50">36 (54)<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">SD<hr></hr></td><td align="char" valign="top" char="(" charoff="50">18 (27)<hr></hr></td><td align="left" valign="top" charoff="50">20 (30)<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">PD<hr></hr></td><td align="char" valign="top" char="(" charoff="50">0 (0)<hr></hr></td><td align="left" valign="top" charoff="50">0 (0)<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">NE<hr></hr></td><td align="char" valign="top" char="(" charoff="50">1 (1)<hr></hr></td><td align="left" valign="top" charoff="50">2 (3)<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Overall response<hr></hr></td><td align="char" valign="top" char="(" charoff="50">47 (70)<hr></hr></td><td align="left" valign="top" charoff="50">44 (66)<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">95% CI</td><td align="char" valign="top" char="(" charoff="50">58–81</td><td align="left" valign="top" charoff="50">53–77</td></tr></tbody></table><table-wrap-foot><fn id="t2-fn1"><p>Abbreviations: CI=confidence interval; CR=complete response; NE=not evaluable; PD=progressive disease; PR=partial response; SD=stable disease. Values are presented as <italic>n</italic> (%).</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl3"><label>Table 3</label><caption><title>Toxicity of chemotherapy (<italic>n</italic>=66)</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" char="." charoff="50"><bold>Grade 3</bold></th><th align="center" valign="top" char="." charoff="50"><bold>Grade 4</bold></th><th align="center" valign="top" char="." charoff="50"><bold>Grade 3 or 4 (%)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">Leukopenia<hr></hr></td><td align="char" valign="top" char="." charoff="50">24<hr></hr></td><td align="char" valign="top" char="." charoff="50">3<hr></hr></td><td align="char" valign="top" char="." charoff="50">41<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Neutropenia<hr></hr></td><td align="char" valign="top" char="." charoff="50">21<hr></hr></td><td align="char" valign="top" char="." charoff="50">15<hr></hr></td><td align="char" valign="top" char="." charoff="50">56<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Haemoglobin<hr></hr></td><td align="char" valign="top" char="." charoff="50">11<hr></hr></td><td align="char" valign="top" char="." charoff="50">5<hr></hr></td><td align="char" valign="top" char="." charoff="50">24<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Thrombocytopenia<hr></hr></td><td align="char" valign="top" char="." charoff="50">18<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">27<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Hyponatraemia<hr></hr></td><td align="char" valign="top" char="." charoff="50">3<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">5<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Hyperkalaemia<hr></hr></td><td align="char" valign="top" char="." charoff="50">1<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">2<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Nausea<hr></hr></td><td align="char" valign="top" char="." charoff="50">11<hr></hr></td><td align="center" valign="top" char="." charoff="50">—<hr></hr></td><td align="char" valign="top" char="." charoff="50">17<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Vomiting<hr></hr></td><td align="char" valign="top" char="." charoff="50">4<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">6<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Febrile neutropenia<hr></hr></td><td align="char" valign="top" char="." charoff="50">2<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">3<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Fatigue<hr></hr></td><td align="char" valign="top" char="." charoff="50">3<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">5<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Hypersensitivity</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">3</td></tr></tbody></table></table-wrap><table-wrap id="tbl4"><label>Table 4</label><caption><title>Surgical findings</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="center"></col><col align="center"></col><col align="center"></col><col align="center"></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> <hr></hr></th><th colspan="2" align="center" valign="top" charoff="50"><bold>Radical hysterectomy (</bold><italic><bold>n</bold></italic><bold>=62)</bold><hr></hr></th><th colspan="2" align="center" valign="top" charoff="50"><bold>Neoadjuvant chemotherapy (</bold><italic><bold>n</bold></italic><bold>=62)</bold><hr></hr></th></tr><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" charoff="50"><bold>No. of patients</bold></th><th align="center" valign="top" charoff="50"><bold>%</bold></th><th align="center" valign="top" charoff="50"><bold>No. of patients</bold></th><th align="center" valign="top" charoff="50"><bold>%</bold></th></tr></thead><tbody valign="top"><tr><td colspan="5" align="left" valign="top" charoff="50"><bold>Tumour diameter (cm)</bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Median</td><td colspan="2" align="center" valign="top" charoff="50">5.1</td><td colspan="2" align="center" valign="top" charoff="50">3</td></tr><tr><td align="left" valign="top" charoff="50">Range<hr></hr></td><td colspan="2" align="center" valign="top" charoff="50">2.5–13.5<hr></hr></td><td colspan="2" align="center" valign="top" charoff="50">0–10.3<hr></hr></td></tr><tr><td colspan="5" align="left" valign="top" charoff="50"><bold>Postsurgical T classification (pT)</bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">0–IB1<hr></hr></td><td align="center" valign="top" charoff="50">5<hr></hr></td><td align="center" valign="top" charoff="50">8<hr></hr></td><td align="center" valign="top" charoff="50">25<hr></hr></td><td align="center" valign="top" charoff="50">40<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">IB2–pT2B<hr></hr></td><td align="center" valign="top" charoff="50">57<hr></hr></td><td align="center" valign="top" charoff="50">92<hr></hr></td><td align="center" valign="top" charoff="50">34<hr></hr></td><td align="center" valign="top" charoff="50">55<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">>2B<hr></hr></td><td align="center" valign="top" charoff="50">0<hr></hr></td><td align="center" valign="top" charoff="50">0<hr></hr></td><td align="center" valign="top" charoff="50">3<hr></hr></td><td align="center" valign="top" charoff="50">5<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Positive pelvic nodes<hr></hr></td><td align="center" valign="top" charoff="50">27<hr></hr></td><td align="center" valign="top" charoff="50">44<hr></hr></td><td align="center" valign="top" charoff="50">17<hr></hr></td><td align="center" valign="top" charoff="50">27<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Invasion to muscle layer ⩾2/3<hr></hr></td><td align="center" valign="top" charoff="50">52<hr></hr></td><td align="center" valign="top" charoff="50">84<hr></hr></td><td align="center" valign="top" charoff="50">38<hr></hr></td><td align="center" valign="top" charoff="50">61<hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Parametrial invasion</td><td align="center" valign="top" charoff="50">28</td><td align="center" valign="top" charoff="50">45</td><td align="center" valign="top" charoff="50">25</td><td align="center" valign="top" charoff="50">40</td></tr></tbody></table></table-wrap><table-wrap id="tbl5"><label>Table 5</label><caption><title>Radiation morbidity</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> <hr></hr></th><th colspan="3" align="center" valign="top" char="." charoff="50"><bold>Radical hysterectomy (</bold><italic><bold>n</bold></italic><bold>=66)</bold><hr></hr></th><th colspan="3" align="center" valign="top" char="." charoff="50"><bold>Neoadjuvant chemotherapy (</bold><italic><bold>n</bold></italic><bold>=67)</bold><hr></hr></th></tr><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" char="." charoff="50"><bold>Grade 3</bold></th><th align="center" valign="top" char="." charoff="50"><bold>Grade 4</bold></th><th align="center" valign="top" char="." charoff="50"><bold>Grade 3 or 4 (%)</bold></th><th align="center" valign="top" char="." charoff="50"><bold>Grade 3</bold></th><th align="center" valign="top" char="." charoff="50"><bold>Grade 4</bold></th><th align="center" valign="top" char="." charoff="50"><bold>Grade 3 or 4 (%)</bold></th></tr></thead><tbody valign="top"><tr><td colspan="7" align="left" valign="top" charoff="50"><bold>Early adverse events</bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Leukocytes</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">1</td></tr><tr><td align="left" valign="top" charoff="50">Haemoglobin</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">4</td></tr><tr><td align="left" valign="top" charoff="50">Thrombocytes</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">1</td></tr><tr><td align="left" valign="top" charoff="50">Diarrhoea</td><td align="char" valign="top" char="." charoff="50">5</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">8</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">3</td></tr><tr><td align="left" valign="top" charoff="50">Nausea</td><td align="char" valign="top" char="." charoff="50">0</td><td align="center" valign="top" char="." charoff="50">—</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">1</td><td align="center" valign="top" char="." charoff="50">—</td><td align="char" valign="top" char="." charoff="50">1</td></tr><tr><td align="left" valign="top" charoff="50">Vomiting</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">1</td></tr><tr><td align="left" valign="top" charoff="50">Lymphedema</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Dysuria</td><td align="char" valign="top" char="." charoff="50">1</td><td align="center" valign="top" char="." charoff="50">—</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">0</td><td align="center" valign="top" char="." charoff="50">—</td><td align="char" valign="top" char="." charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Urinary retention<hr></hr></td><td align="char" valign="top" char="." charoff="50">9<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">14<hr></hr></td><td align="char" valign="top" char="." charoff="50">5<hr></hr></td><td align="char" valign="top" char="." charoff="50">0<hr></hr></td><td align="char" valign="top" char="." charoff="50">7<hr></hr></td></tr><tr><td colspan="7" align="left" valign="top" charoff="50"><bold>Late adverse events<xref ref-type="fn" rid="t5-fn1">a</xref></bold><hr></hr></td></tr><tr><td align="left" valign="top" charoff="50">Lymphedema</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">3</td><td align="char" valign="top" char="." charoff="50">5</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">7</td></tr><tr><td align="left" valign="top" charoff="50">Urinary retention</td><td align="char" valign="top" char="." charoff="50">7</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">11</td><td align="char" valign="top" char="." charoff="50">3</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">6</td></tr><tr><td align="left" valign="top" charoff="50">Vesicovaginal fistula</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">3</td></tr><tr><td align="left" valign="top" charoff="50">Bowel obstruction</td><td align="char" valign="top" char="." charoff="50">6</td><td align="char" valign="top" char="." charoff="50">0</td><td align="char" valign="top" char="." charoff="50">9</td><td align="char" valign="top" char="." charoff="50">1</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">4</td></tr></tbody></table><table-wrap-foot><fn id="t5-fn1"><label>a</label><p>Late adverse events were defined as the adverse events that were observed more than 90 days after radiation therapy.</p></fn></table-wrap-foot></table-wrap></floats-group></pmc><affiliations><list><country><li>Japon</li></country></list><tree><country name="Japon"><noRegion><name sortKey="Katsumata, N" sort="Katsumata, N" uniqKey="Katsumata N" first="N" last="Katsumata">N. Katsumata</name></noRegion><name sortKey="Hiura, M" sort="Hiura, M" uniqKey="Hiura M" first="M" last="Hiura">M. Hiura</name><name sortKey="Kamura, T" sort="Kamura, T" uniqKey="Kamura T" first="T" last="Kamura">T. Kamura</name><name sortKey="Kasamatsu, T" sort="Kasamatsu, T" uniqKey="Kasamatsu T" first="T" last="Kasamatsu">T. Kasamatsu</name><name sortKey="Kobayashi, H" sort="Kobayashi, H" uniqKey="Kobayashi H" first="H" last="Kobayashi">H. Kobayashi</name><name sortKey="Kodama, S" sort="Kodama, S" uniqKey="Kodama S" first="S" last="Kodama">S. Kodama</name><name sortKey="Kuzuya, K" sort="Kuzuya, K" uniqKey="Kuzuya K" first="K" last="Kuzuya">K. Kuzuya</name><name sortKey="Mizunoe, T" sort="Mizunoe, T" uniqKey="Mizunoe T" first="T" last="Mizunoe">T. Mizunoe</name><name sortKey="Nakanishi, T" sort="Nakanishi, T" uniqKey="Nakanishi T" first="T" last="Nakanishi">T. Nakanishi</name><name sortKey="Saito, T" sort="Saito, T" uniqKey="Saito T" first="T" last="Saito">T. Saito</name><name sortKey="Shibata, T" sort="Shibata, T" uniqKey="Shibata T" first="T" last="Shibata">T. Shibata</name><name sortKey="Yaegashi, N" sort="Yaegashi, N" uniqKey="Yaegashi N" first="N" last="Yaegashi">N. Yaegashi</name><name sortKey="Yasugi, T" sort="Yasugi, T" uniqKey="Yasugi T" first="T" last="Yasugi">T. Yasugi</name><name sortKey="Yokota, H" sort="Yokota, H" uniqKey="Yokota H" first="H" last="Yokota">H. Yokota</name><name sortKey="Yoshikawa, H" sort="Yoshikawa, H" uniqKey="Yoshikawa H" first="H" last="Yoshikawa">H. Yoshikawa</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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