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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Analysis of the effect of adjuvant radiotherapy on outcomes and complications after radical hysterectomy in FIGO stage IB1 cervical cancer patients with intermediate risk factors (GOTIC Study)</title>
<author><name sortKey="Nakamura, Kazuto" sort="Nakamura, Kazuto" uniqKey="Nakamura K" first="Kazuto" last="Nakamura">Kazuto Nakamura</name>
<affiliation><nlm:aff id="Aff1">Department of Obstetrics and Gynecology, Gunma University Hospital, Maebashi, Gunma 371-8511 Japan</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="Aff7">Current address: Department of Gynecology, Gunma Cancer Center, Ota, Gunma 373-8550 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kitahara, Yoshikazu" sort="Kitahara, Yoshikazu" uniqKey="Kitahara Y" first="Yoshikazu" last="Kitahara">Yoshikazu Kitahara</name>
<affiliation><nlm:aff id="Aff1">Department of Obstetrics and Gynecology, Gunma University Hospital, Maebashi, Gunma 371-8511 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Satoh, Toyomi" sort="Satoh, Toyomi" uniqKey="Satoh T" first="Toyomi" last="Satoh">Toyomi Satoh</name>
<affiliation><nlm:aff id="Aff2">Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8577 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Takei, Yuji" sort="Takei, Yuji" uniqKey="Takei Y" first="Yuji" last="Takei">Yuji Takei</name>
<affiliation><nlm:aff id="Aff3">Department of Obstetrics and Gynecology, Jichi Medical University Hospital, Shimotsuke, Tochigi 329-0498 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Takano, Masashi" sort="Takano, Masashi" uniqKey="Takano M" first="Masashi" last="Takano">Masashi Takano</name>
<affiliation><nlm:aff id="Aff4">Department of Obstetrics and Gynecology, National Defense Medical College, Tokorozawa, Saitama 359-8513 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Nagao, Shoji" sort="Nagao, Shoji" uniqKey="Nagao S" first="Shoji" last="Nagao">Shoji Nagao</name>
<affiliation><nlm:aff id="Aff5">Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama 350-1298 Japan</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="Aff8">Current address: Department of Gynecology, Hyogo Cancer Center, Akashi, Hyogo 673-8558 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Sekiguchi, Isao" sort="Sekiguchi, Isao" uniqKey="Sekiguchi I" first="Isao" last="Sekiguchi">Isao Sekiguchi</name>
<affiliation><nlm:aff id="Aff6">Department of Gynecology, Tochigi Cancer Center, Utusnomiya, Tochigi, 320-0834 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Suzuki, Mitsuaki" sort="Suzuki, Mitsuaki" uniqKey="Suzuki M" first="Mitsuaki" last="Suzuki">Mitsuaki Suzuki</name>
<affiliation><nlm:aff id="Aff3">Department of Obstetrics and Gynecology, Jichi Medical University Hospital, Shimotsuke, Tochigi 329-0498 Japan</nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">27356862</idno>
<idno type="pmc">4928324</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4928324</idno>
<idno type="RBID">PMC:4928324</idno>
<idno type="doi">10.1186/s12957-016-0931-4</idno>
<date when="2016">2016</date>
<idno type="wicri:Area/Pmc/Corpus">000F02</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000F02</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Analysis of the effect of adjuvant radiotherapy on outcomes and complications after radical hysterectomy in FIGO stage IB1 cervical cancer patients with intermediate risk factors (GOTIC Study)</title>
<author><name sortKey="Nakamura, Kazuto" sort="Nakamura, Kazuto" uniqKey="Nakamura K" first="Kazuto" last="Nakamura">Kazuto Nakamura</name>
<affiliation><nlm:aff id="Aff1">Department of Obstetrics and Gynecology, Gunma University Hospital, Maebashi, Gunma 371-8511 Japan</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="Aff7">Current address: Department of Gynecology, Gunma Cancer Center, Ota, Gunma 373-8550 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kitahara, Yoshikazu" sort="Kitahara, Yoshikazu" uniqKey="Kitahara Y" first="Yoshikazu" last="Kitahara">Yoshikazu Kitahara</name>
<affiliation><nlm:aff id="Aff1">Department of Obstetrics and Gynecology, Gunma University Hospital, Maebashi, Gunma 371-8511 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Satoh, Toyomi" sort="Satoh, Toyomi" uniqKey="Satoh T" first="Toyomi" last="Satoh">Toyomi Satoh</name>
<affiliation><nlm:aff id="Aff2">Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8577 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Takei, Yuji" sort="Takei, Yuji" uniqKey="Takei Y" first="Yuji" last="Takei">Yuji Takei</name>
<affiliation><nlm:aff id="Aff3">Department of Obstetrics and Gynecology, Jichi Medical University Hospital, Shimotsuke, Tochigi 329-0498 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Takano, Masashi" sort="Takano, Masashi" uniqKey="Takano M" first="Masashi" last="Takano">Masashi Takano</name>
<affiliation><nlm:aff id="Aff4">Department of Obstetrics and Gynecology, National Defense Medical College, Tokorozawa, Saitama 359-8513 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Nagao, Shoji" sort="Nagao, Shoji" uniqKey="Nagao S" first="Shoji" last="Nagao">Shoji Nagao</name>
<affiliation><nlm:aff id="Aff5">Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama 350-1298 Japan</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="Aff8">Current address: Department of Gynecology, Hyogo Cancer Center, Akashi, Hyogo 673-8558 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Sekiguchi, Isao" sort="Sekiguchi, Isao" uniqKey="Sekiguchi I" first="Isao" last="Sekiguchi">Isao Sekiguchi</name>
<affiliation><nlm:aff id="Aff6">Department of Gynecology, Tochigi Cancer Center, Utusnomiya, Tochigi, 320-0834 Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Suzuki, Mitsuaki" sort="Suzuki, Mitsuaki" uniqKey="Suzuki M" first="Mitsuaki" last="Suzuki">Mitsuaki Suzuki</name>
<affiliation><nlm:aff id="Aff3">Department of Obstetrics and Gynecology, Jichi Medical University Hospital, Shimotsuke, Tochigi 329-0498 Japan</nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">World Journal of Surgical Oncology</title>
<idno type="eISSN">1477-7819</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>There are no definitive criteria for identifying which patients with The International Federation of Gynecology and Obstetrics (FIGO) stage IB cervical cancer will benefit from adjuvant therapy after radical hysterectomy. The aims of this study were to clarify the efficacy of adjuvant therapy and assess complications after radical hysterectomy in patients with FIGO stage IB1 cervical cancer with intermediate risk factors.</p>
</sec>
<sec><title>Methods</title>
<p>Between January 2005 and December 2009, the medical records of 75 stage IB1 patients’ intermediate risk factors (i.e., tumor size 2–4 cm, lymphovascular involvement, and/or deep stromal invasion >1/2) who underwent radical hysterectomy at six institutions were collected, and these patients were enrolled in this nonrandomized retrospective study. We simplified the criteria of intermediate risk factors as much as possible, as the criteria adopted in some clinical studies are complicated in practice.</p>
</sec>
<sec><title>Results</title>
<p>The patients were grouped according to the receipt of adjuvant therapy as follows: 46 patients, no further treatment; 19 patients, external beam radiation treatment, including 9 patients who received brachytherapy; 5 patients, concurrent chemoradiotherapy (CCRT); and 5 patients, chemotherapy (CT). The clinical outcomes and complications in each group were analyzed. After an average follow-up of 82.6 months (range, 24–135 months), only one patient with all three risk factors who received radiotherapy (RT) experienced recurrence. Excluding this patient, the remaining patients who received RT, CCRT, or CT had two or three risk factors. Lymphedema was significantly more common among patients who received RT or CCRT, whereas the incidence of ileus and ureteral obstruction was not different among the treatment groups. However, an unsutured peritoneum increased the risk of ileus.</p>
</sec>
<sec><title>Conclusions</title>
<p>The findings of this study suggest that RT and CCRT after radical hysterectomy are not beneficial in patients with intermediate risk factors. In particular, RT and CCRT appeared to increase the incidence of lymphedema. A prospective randomized study is needed to verify the findings of this study.</p>
</sec>
</div>
</front>
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<author><name sortKey="Woronoff, As" uniqKey="Woronoff A">AS Woronoff</name>
</author>
<author><name sortKey="Guizard, Av" uniqKey="Guizard A">AV Guizard</name>
</author>
<author><name sortKey="Abeilard, E" uniqKey="Abeilard E">E Abeilard</name>
</author>
<author><name sortKey="Caravati Jouvenceaux, A" uniqKey="Caravati Jouvenceaux A">A Caravati-Jouvenceaux</name>
</author>
<author><name sortKey="Klein, D" uniqKey="Klein D">D Klein</name>
</author>
<author><name sortKey="Velten, M" uniqKey="Velten M">M Velten</name>
</author>
<author><name sortKey="Joly, F" uniqKey="Joly F">F Joly</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">World J Surg Oncol</journal-id>
<journal-id journal-id-type="iso-abbrev">World J Surg Oncol</journal-id>
<journal-title-group><journal-title>World Journal of Surgical Oncology</journal-title>
</journal-title-group>
<issn pub-type="epub">1477-7819</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
<publisher-loc>London</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">27356862</article-id>
<article-id pub-id-type="pmc">4928324</article-id>
<article-id pub-id-type="publisher-id">931</article-id>
<article-id pub-id-type="doi">10.1186/s12957-016-0931-4</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Research</subject>
</subj-group>
</article-categories>
<title-group><article-title>Analysis of the effect of adjuvant radiotherapy on outcomes and complications after radical hysterectomy in FIGO stage IB1 cervical cancer patients with intermediate risk factors (GOTIC Study)</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0001-5738-3418</contrib-id>
<name><surname>Nakamura</surname>
<given-names>Kazuto</given-names>
</name>
<address><phone>+81-276-38-0771</phone>
<fax>+81-276-38-8386</fax>
<email>nkazuto@gunma-cc.jp</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
<xref ref-type="aff" rid="Aff7"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kitahara</surname>
<given-names>Yoshikazu</given-names>
</name>
<address><email>kitahara@gunma-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Satoh</surname>
<given-names>Toyomi</given-names>
</name>
<address><email>toyomi-s@md.tsukuba.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff2"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Takei</surname>
<given-names>Yuji</given-names>
</name>
<address><email>ytakei@jichi.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff3"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Takano</surname>
<given-names>Masashi</given-names>
</name>
<address><email>mastkn@ndmc.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff4"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nagao</surname>
<given-names>Shoji</given-names>
</name>
<address><email>nagao@hp.pref.hyogo.jp</email>
</address>
<xref ref-type="aff" rid="Aff5"></xref>
<xref ref-type="aff" rid="Aff8"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Sekiguchi</surname>
<given-names>Isao</given-names>
</name>
<address><email>isekiguc@tcc.pref.tochigi.lg.jp</email>
</address>
<xref ref-type="aff" rid="Aff6"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Suzuki</surname>
<given-names>Mitsuaki</given-names>
</name>
<address><email>p-suzuki@pc5.so-net.ne.jp</email>
</address>
<xref ref-type="aff" rid="Aff3"></xref>
</contrib>
<aff id="Aff1"><label></label>
Department of Obstetrics and Gynecology, Gunma University Hospital, Maebashi, Gunma 371-8511 Japan</aff>
<aff id="Aff2"><label></label>
Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8577 Japan</aff>
<aff id="Aff3"><label></label>
Department of Obstetrics and Gynecology, Jichi Medical University Hospital, Shimotsuke, Tochigi 329-0498 Japan</aff>
<aff id="Aff4"><label></label>
Department of Obstetrics and Gynecology, National Defense Medical College, Tokorozawa, Saitama 359-8513 Japan</aff>
<aff id="Aff5"><label></label>
Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama 350-1298 Japan</aff>
<aff id="Aff6"><label></label>
Department of Gynecology, Tochigi Cancer Center, Utusnomiya, Tochigi, 320-0834 Japan</aff>
<aff id="Aff7"><label></label>
Current address: Department of Gynecology, Gunma Cancer Center, Ota, Gunma 373-8550 Japan</aff>
<aff id="Aff8"><label></label>
Current address: Department of Gynecology, Hyogo Cancer Center, Akashi, Hyogo 673-8558 Japan</aff>
</contrib-group>
<pub-date pub-type="epub"><day>29</day>
<month>6</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>29</day>
<month>6</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="collection"><year>2016</year>
</pub-date>
<volume>14</volume>
<elocation-id>173</elocation-id>
<history><date date-type="received"><day>7</day>
<month>2</month>
<year>2016</year>
</date>
<date date-type="accepted"><day>23</day>
<month>6</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>© The Author(s). 2016</copyright-statement>
<license license-type="OpenAccess"><license-p><bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>
) applies to the data made available in this article, unless otherwise stated.</license-p>
</license>
</permissions>
<abstract id="Abs1"><sec><title>Background</title>
<p>There are no definitive criteria for identifying which patients with The International Federation of Gynecology and Obstetrics (FIGO) stage IB cervical cancer will benefit from adjuvant therapy after radical hysterectomy. The aims of this study were to clarify the efficacy of adjuvant therapy and assess complications after radical hysterectomy in patients with FIGO stage IB1 cervical cancer with intermediate risk factors.</p>
</sec>
<sec><title>Methods</title>
<p>Between January 2005 and December 2009, the medical records of 75 stage IB1 patients’ intermediate risk factors (i.e., tumor size 2–4 cm, lymphovascular involvement, and/or deep stromal invasion >1/2) who underwent radical hysterectomy at six institutions were collected, and these patients were enrolled in this nonrandomized retrospective study. We simplified the criteria of intermediate risk factors as much as possible, as the criteria adopted in some clinical studies are complicated in practice.</p>
</sec>
<sec><title>Results</title>
<p>The patients were grouped according to the receipt of adjuvant therapy as follows: 46 patients, no further treatment; 19 patients, external beam radiation treatment, including 9 patients who received brachytherapy; 5 patients, concurrent chemoradiotherapy (CCRT); and 5 patients, chemotherapy (CT). The clinical outcomes and complications in each group were analyzed. After an average follow-up of 82.6 months (range, 24–135 months), only one patient with all three risk factors who received radiotherapy (RT) experienced recurrence. Excluding this patient, the remaining patients who received RT, CCRT, or CT had two or three risk factors. Lymphedema was significantly more common among patients who received RT or CCRT, whereas the incidence of ileus and ureteral obstruction was not different among the treatment groups. However, an unsutured peritoneum increased the risk of ileus.</p>
</sec>
<sec><title>Conclusions</title>
<p>The findings of this study suggest that RT and CCRT after radical hysterectomy are not beneficial in patients with intermediate risk factors. In particular, RT and CCRT appeared to increase the incidence of lymphedema. A prospective randomized study is needed to verify the findings of this study.</p>
</sec>
</abstract>
<kwd-group xml:lang="en"><title>Keywords</title>
<kwd>Cervical cancer</kwd>
<kwd>Radiation</kwd>
<kwd>Adverse event</kwd>
</kwd-group>
<custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name>
<meta-value>© The Author(s) 2016</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
<body><sec id="Sec1"><title>Background</title>
<p>Cervical cancer is the fourth most common cancer among women worldwide and the second most diagnosed cancer in developing countries [<xref ref-type="bibr" rid="CR1">1</xref>
]. Radical hysterectomy with pelvic lymphadenectomy has been a primary treatment in women with stage IB cervical cancer, and the procedure is associated with a 5-year survival rate of 87–92 % [<xref ref-type="bibr" rid="CR2">2</xref>
]. Radiotherapy (RT) is a feasible technique that provides similar outcomes as radical hysterectomy [<xref ref-type="bibr" rid="CR2">2</xref>
–<xref ref-type="bibr" rid="CR4">4</xref>
]. Surgery enables pathological examination by surgeons, permitting identification of risk factors for cancer recurrence. In general, patients with parametrial invasion, a positive vaginal margin, or positive pelvic lymph nodes who are diagnosed as being at high risk are assigned to receive adjuvant therapies. By contrast, large tumor size, deep stromal invasion, and lymphovascular invasion are classified as intermediate risk factors, and adjuvant therapy for patients with these risk factors remains controversial. Although the criteria for intermediate risk factors defined by the Gynecologic Oncology Group (GOG) study [<xref ref-type="bibr" rid="CR5">5</xref>
] have been widely accepted, each institution offers adjuvant therapy to patients based on its own protocol. Thus, there is always a problem of interpreting discrepant results between studies because of the different study models. On the contrary, it has been recognized that postoperative RT results in a significant increase in the incidence of adverse events affecting quality of life, such as lymphedema, ileus, and ureteral obstruction [<xref ref-type="bibr" rid="CR6">6</xref>
–<xref ref-type="bibr" rid="CR8">8</xref>
].</p>
<p>The GOG study concluded that pelvic RT after radical hysterectomy significantly improves progression-free survival and benefits patients with histological types of adenocarcinoma and adenosquamous carcinoma [<xref ref-type="bibr" rid="CR9">9</xref>
]. The aims of the current retrospective study were to evaluate the effect of RT and treatment-related morbidity after radical hysterectomy for patients with intermediate risk as defined by simplified criteria.</p>
</sec>
<sec id="Sec2"><title>Methods</title>
<p>Between 2005 and 2009, the medical records of 89 stage IB1 patients with intermediate risk factors (i.e., tumor size 2–4 cm, lymphovascular involvement, and/or deep stromal invasion >1/2) who underwent type III radical hysterectomy as defined by Piver et al. [<xref ref-type="bibr" rid="CR10">10</xref>
] and bilateral pelvic lymphadenectomy were obtained for this retrospective study from six institutions belonging to the Gynecologic Oncology Trial and Investigation Consortium of North Kanto (GOTIC): Gunma University, Tsukuba University, Jichi Medical University, National Defense Medical College, Saitama Medical University International Medical Center, and Tochigi Prefectural Cancer Center. None of the patients had received preoperative treatment such as neoadjuvant chemotherapy (CT) or RT. Informed consent was not obtained from each participant because this was a retrospective study. Instead of that, all participants were given the right to withdraw the use of the data. The protocol of this study was approved based on the necessity of the individual institutions’ ethical committees.</p>
<p>Based on each institution’s criteria, patients received adjuvant therapy, including RT, CT, or concurrent chemoradiotherapy (CCRT). RT consisted of conventional external beam (EBRT) to the pelvis (28–42 Gy) in fractions of 1.8–2.0 Gy for 28–42 days. Nine patients in the RT group also received vaginal brachytherapy (BRA) in fractions of 4–7 Gy for a total dose of 7–21 Gy. In the CCRT group, cisplatin (40 mg/m<sup>2</sup>
) was infused intravenously every week. In the CT group, patients received paclitaxel (175 mg/m<sup>2</sup>
) plus carboplatin (AUC 6) every 3 weeks for 6 cycles.</p>
<p>Data regarding tumor size (MS), histopathological findings, depth of stromal invasion [<xref ref-type="bibr" rid="CR11">11</xref>
], and lymphovascular space invasion (LVSI) are summarized in Table <xref rid="Tab1" ref-type="table">1</xref>
. All patients received regular follow-up. During follow-up, complications such as ileus and ureteral obstruction were classified according to the Common Toxicity Criteria. The severity of lymphedema was rated according to the staging system of the International Society of Lymphology as follows: stage 0, a latent or sub-clinical condition in which swelling in not evident; stage 1, temporary visible swelling that can be reduced by elevation of the limb; stage 2, clear pitting and limb elevation cannot reduce tissue swelling; and stage 3, also known as lymphostatic elephantiasis, tissue becomes extremely swollen, leading to skin changes such as acanthosis, fat deposits, and warty overgrowths [<xref ref-type="bibr" rid="CR12">12</xref>
].<table-wrap id="Tab1"><label>Table 1</label>
<caption><p>Patient characteristics (<italic>n</italic>
= 75)</p>
</caption>
<table frame="hsides" rules="groups"><thead><tr><th></th>
<th colspan="6">RT/CCRT</th>
</tr>
<tr><th rowspan="2"></th>
<th>NFT</th>
<th>EBRT</th>
<th>EBRT + BRA</th>
<th>EBRT (CCRT)</th>
<th>EBRT + BRA (CCRT)</th>
<th>CT</th>
</tr>
<tr><th><italic>n</italic>
= 46</th>
<th><italic>n</italic>
= 10</th>
<th><italic>n</italic>
= 9</th>
<th><italic>n</italic>
= 2</th>
<th><italic>n</italic>
= 3</th>
<th><italic>n</italic>
= 5</th>
</tr>
</thead>
<tbody><tr><td>Age (years)</td>
<td>46.8 (27–78)</td>
<td>44.7 (27–67)</td>
<td>49.9 (31–69)</td>
<td>63.5 (55–72)</td>
<td>38.0 (33–43)</td>
<td>53.0 (34–66)</td>
</tr>
<tr><td>Follow-up time (months)</td>
<td>78.7 (51–118)</td>
<td>90.6 (64–117)</td>
<td>77.8 (24–120)</td>
<td>98.0 (61–135)</td>
<td>113.3 (110–117)</td>
<td>86.8 (61–134)</td>
</tr>
<tr><td colspan="7">Tumor size</td>
</tr>
<tr><td> <2 cm</td>
<td>6 (13.0 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
</tr>
<tr><td> 2 cm ≤ tumor < 4 cm</td>
<td>40 (87.0 %)</td>
<td>10 (100.0 %)</td>
<td>9 (100.0 %)</td>
<td>2 (100.0 %)</td>
<td>3 (100.0 %)</td>
<td>5 (100.0 %)</td>
</tr>
<tr><td colspan="7">Histologic type</td>
</tr>
<tr><td> Squamous</td>
<td>31 (67.4 %)</td>
<td>10 (100.0 %)</td>
<td>9 (100.0 %)</td>
<td>1 (50.0 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
</tr>
<tr><td> Adenocarcinoma</td>
<td>12 (26.1 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
<td>1 (50.0 %)</td>
<td>2 (66.7 %)</td>
<td>5 (100.0 %)</td>
</tr>
<tr><td> Adenosquamous</td>
<td>3 (6.5 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
<td>1 (33.3 %)</td>
<td>0 (0.0 %)</td>
</tr>
<tr><td colspan="7">Stromal invasion</td>
</tr>
<tr><td> <1/2</td>
<td>24 (52.2 %)</td>
<td>3 (30.0 %)</td>
<td>2 (22.2 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
<td>0 (0.0 %)</td>
</tr>
<tr><td> ≥1/2</td>
<td>22 (47.8 %)</td>
<td>7 (70.0 %)</td>
<td>7 (77.8 %)</td>
<td>2 (100.0 %)</td>
<td>3 (100.0 %)</td>
<td>5 (100.0 %)</td>
</tr>
<tr><td colspan="7">Lymphovascular invasion</td>
</tr>
<tr><td> –</td>
<td>37 (80.4 %)</td>
<td>1 (10.0 %)</td>
<td>3 (33.3 %)</td>
<td>0 (0.0 %)</td>
<td>1 (33.3 %)</td>
<td>1 (20.0 %)</td>
</tr>
<tr><td> +</td>
<td>9 (19.6 %)</td>
<td>9 (90.0 %)</td>
<td>6 (66.7 %)</td>
<td>2 (100.0 %)</td>
<td>2 (66.7 %)</td>
<td>4 (80.0 %)</td>
</tr>
</tbody>
</table>
<table-wrap-foot><p><italic>Abbreviations</italic>
: <italic>NFT</italic>
no further treatment, <italic>RT</italic>
radiation therapy, <italic>CCRT</italic>
concurrent chemoradiotherapy, <italic>EBRT</italic>
external beam radiation therapy, <italic>BRA</italic>
brachytherapy, <italic>CT</italic>
chemotherapy</p>
</table-wrap-foot>
</table-wrap>
</p>
<p>Statistically significant differences in the severity of adverse events, namely lymphedema, ileus, and ureteral obstruction, as a result of no further treatment (NFT, <italic>n</italic>
= 46), RT and CCRT (<italic>n</italic>
= 24), or CT (<italic>n</italic>
= 5) were analyzed using the Kruskal-Wallis or chi-squared test. All tests were two-tailed, and a <italic>P</italic>
value <0.05 was considered statistically significant.</p>
<p>The presence or absence of complications was determined, and cross-tabulation was performed when the retroperitoneum was opened or closed during surgery and when RT was or was not administered. In addition, odds ratios and 95 % confidence intervals for the presence or absence of complications were calculated using logistic regression analyses based on whether the retroperitoneum was opened or whether RT was performed.</p>
<p>JMP ver. 9 (SAS Institution Japan Inc., Tokyo, Japan) was used for all analyses.</p>
</sec>
<sec id="Sec3"><title>Results</title>
<p>Eighty-nine patients were enrolled in this retrospective study from six institutions; meanwhile, 14 patients were excluded because of incompatibility with the inclusion criteria and incomplete follow-up data. Overall, the study included 51, 20, and 4 patients with squamous cell carcinoma, adenocarcinoma, and adenosquamous histology, respectively (Table <xref rid="Tab1" ref-type="table">1</xref>
). One patient with all three intermediate risk factors who received EBRT and BRA died of a recurrent tumor in the lungs 24 months later. All other patients are alive without recurrence, and they have been followed up for an average of 84.3 months (range, 47–135 months).</p>
<p>Table <xref rid="Tab2" ref-type="table">2</xref>
shows the characteristics of intermediate risk factors in this group of patients. Among the 75 patients, 24 received either RT or CCRT and 5 were treated with CT alone. Only a single patient who had one intermediate risk factor received EBRT and BRA. By contrast, 19/24 (79.2 %) patients who had all three intermediate risk factors as defined in this study received adjuvant therapy.<table-wrap id="Tab2"><label>Table 2</label>
<caption><p>Pathological characteristics of intermediate risk cervical cancer</p>
</caption>
<table frame="hsides" rules="groups"><thead><tr><th rowspan="3">Risk factor</th>
<th colspan="3">Adjuvant therapy</th>
</tr>
<tr><th>NFT</th>
<th>RT/CCRT</th>
<th>CT</th>
</tr>
<tr><th><italic>n</italic>
= 46</th>
<th><italic>n</italic>
= 24</th>
<th><italic>n</italic>
= 5</th>
</tr>
</thead>
<tbody><tr><td>MS</td>
<td>18</td>
<td>1</td>
<td>0</td>
</tr>
<tr><td>SI</td>
<td>4</td>
<td>0</td>
<td>0</td>
</tr>
<tr><td>LVSI</td>
<td>1</td>
<td>0</td>
<td>0</td>
</tr>
<tr><td>MS + SI</td>
<td>12</td>
<td>4</td>
<td>1</td>
</tr>
<tr><td>MS + LVSI</td>
<td>5</td>
<td>4</td>
<td>0</td>
</tr>
<tr><td>SI + LVSI</td>
<td>1</td>
<td>0</td>
<td>0</td>
</tr>
<tr><td>MS + SI + LVSI</td>
<td>5</td>
<td>15</td>
<td>4</td>
</tr>
</tbody>
</table>
<table-wrap-foot><p><italic>Abbreviations</italic>
: <italic>NFT</italic>
no further treatment, <italic>RT</italic>
radiation therapy, <italic>CCRT</italic>
concurrent chemoradiotherapy, <italic>CT</italic>
chemotherapy, <italic>MS</italic>
mass size (2 ≤ tumor < 4 cm), <italic>SI</italic>
stromal invasion, <italic>LVSI</italic>
lymphovascular space involvement</p>
</table-wrap-foot>
</table-wrap>
</p>
<p>Lymphedema was observed more frequently in patients who received postoperative RT than in those who did not receive RT or CT (<italic>P</italic>
< 0.001). The risks of ileus and ureteral obstruction were not significantly different between patients who received NFT/CT or RT/CCRT. Other radiation-related adverse effects such as cystitis and proctitis were extremely rare (Table <xref rid="Tab3" ref-type="table">3</xref>
). We further assessed the severity of lymphedema associated with RT, finding that more patients who receive RT developed grade 2 or 3 lymphedema (<italic>P</italic>
< 0.001) (Table <xref rid="Tab4" ref-type="table">4</xref>
).<table-wrap id="Tab3"><label>Table 3</label>
<caption><p>The frequency of complications by treatment regimens</p>
</caption>
<table frame="hsides" rules="groups"><thead><tr><th></th>
<th colspan="3">Treatment</th>
<th><italic>P</italic>
value<sup>a</sup>
</th>
</tr>
<tr><th></th>
<th>NFT (<italic>n</italic>
= 46)</th>
<th>RT/CCRT (<italic>n</italic>
= 24)</th>
<th>CT (<italic>n</italic>
= 5)</th>
<th></th>
</tr>
</thead>
<tbody><tr><td>Lymphedema</td>
<td>8</td>
<td>14</td>
<td>0</td>
<td>0.001</td>
</tr>
<tr><td>Ileus</td>
<td>9</td>
<td>4</td>
<td>0</td>
<td>0.544</td>
</tr>
<tr><td>Ureter obstruction</td>
<td>1</td>
<td>2</td>
<td>1</td>
<td>0.184</td>
</tr>
<tr><td>Radiation cystitis</td>
<td></td>
<td>0</td>
<td></td>
<td>–</td>
</tr>
<tr><td>Radiation proctitis</td>
<td></td>
<td>2</td>
<td></td>
<td>–</td>
</tr>
</tbody>
</table>
<table-wrap-foot><p>Lymphedema level is rated according to the staging system by the International Society of Lymphology</p>
<p><italic>Abbreviations</italic>
: <italic>NFT</italic>
no further treatment, <italic>CT</italic>
chemotherapy, <italic>RT</italic>
radiation therapy</p>
<p><sup>a</sup>
Chi-squared test</p>
</table-wrap-foot>
</table-wrap>
<table-wrap id="Tab4"><label>Table 4</label>
<caption><p>Incidences of lymphedema grades by treatment regimens</p>
</caption>
<table frame="hsides" rules="groups"><thead><tr><th></th>
<th colspan="3">Treatment</th>
<th><italic>P</italic>
value<sup>a</sup>
</th>
</tr>
<tr><th></th>
<th>NFT (<italic>n</italic>
= 46)</th>
<th>RT/CCRT (<italic>n</italic>
= 24)</th>
<th>CT (<italic>n</italic>
= 5)</th>
<th></th>
</tr>
</thead>
<tbody><tr><td>Lymphedema</td>
<td></td>
<td></td>
<td></td>
<td>0.001</td>
</tr>
<tr><td> Grade 0</td>
<td>38</td>
<td>10</td>
<td>5</td>
<td></td>
</tr>
<tr><td> Grade 1</td>
<td>7</td>
<td>7</td>
<td>0</td>
<td></td>
</tr>
<tr><td> Grade 2</td>
<td>1</td>
<td>6</td>
<td>0</td>
<td></td>
</tr>
<tr><td> Grade 3</td>
<td>0</td>
<td>1</td>
<td>0</td>
<td></td>
</tr>
</tbody>
</table>
<table-wrap-foot><p>Lymphedema level is rated according to the staging system by the International Society of Lymphology</p>
<p><italic>Abbreviations</italic>
: <italic>NFT</italic>
no further treatment, <italic>CT</italic>
chemotherapy, <italic>RT</italic>
radiation therapy</p>
<p><sup>a</sup>
Kruskal-Wallis test</p>
</table-wrap-foot>
</table-wrap>
</p>
<p>Retroperitoneal suturing after lymphadenectomy was also assessed to evaluate the prophylactic effect of an unsutured pelvic peritoneum on lymphedema risk. The overall lymphedema rate was comparable between patients with an unsutured pelvic peritoneum and those with a sutured pelvic peritoneum (Table <xref rid="Tab5" ref-type="table">5</xref>
). However, an unsutured pelvic peritoneum was significantly associated with ileus among patients who did not receive adjuvant RT (Fig. <xref rid="Fig1" ref-type="fig">1</xref>
).<table-wrap id="Tab5"><label>Table 5</label>
<caption><p>Adverse events in unsutured and sutured peritoneum status</p>
</caption>
<table frame="hsides" rules="groups"><thead><tr><th></th>
<th>Not sutured (<italic>n</italic>
= 36)</th>
<th>Sutured (<italic>n</italic>
= 39)</th>
</tr>
</thead>
<tbody><tr><td>Radiation (−)</td>
<td></td>
<td></td>
</tr>
<tr><td> Ileus (−)</td>
<td>21</td>
<td>22</td>
</tr>
<tr><td> Ileus (+)</td>
<td>9</td>
<td>0</td>
</tr>
<tr><td> Lymphedema (−)</td>
<td>24</td>
<td>19</td>
</tr>
<tr><td> Lymphedema (+)</td>
<td>6</td>
<td>3</td>
</tr>
<tr><td>Radiation (+)</td>
<td></td>
<td></td>
</tr>
<tr><td> Ileus (−)</td>
<td>5</td>
<td>14</td>
</tr>
<tr><td> Ileus (+)</td>
<td>1</td>
<td>3</td>
</tr>
<tr><td> Lymphedema (−)</td>
<td>3</td>
<td>7</td>
</tr>
<tr><td> Lymphedema (+)</td>
<td>3</td>
<td>10</td>
</tr>
</tbody>
</table>
</table-wrap>
<fig id="Fig1"><label>Fig. 1</label>
<caption><p>Adverse events for patients with an unsutured pelvic peritoneum who did not receive radiotherapy. <italic>Horizontal lines</italic>
represent odds ratio (<italic>diamonds</italic>
) with 95 % confidence intervals (CIs)</p>
</caption>
<graphic xlink:href="12957_2016_931_Fig1_HTML" id="MO1"></graphic>
</fig>
</p>
</sec>
<sec id="Sec4"><title>Discussion</title>
<p>The outcome of surgery with or without adjuvant RT in patients with early-stage cervical cancer has been debated by many researchers. In general, RT has been demonstrated to significantly decrease the risk of local recurrence. However, overall survival is not conclusively improved, whereas certain subset analyses illustrated a positive effect of RT on the reduction of recurrence, for example, the GOG 92 study suggested that RT is effective for patients with a combination of deep stromal invasion and large tumor size (≥4 cm) [<xref ref-type="bibr" rid="CR9">9</xref>
]. Tumor size ≥4 cm has been strongly correlated with recurrence [<xref ref-type="bibr" rid="CR13">13</xref>
–<xref ref-type="bibr" rid="CR17">17</xref>
]. As we assumed that tumor size ≥4 cm was a high risk factor even in the intermediate risk group, we excluded patients with tumor diameters ≥4 cm in this study. It is also accepted that stromal invasion by tumors is an important prognostic factor, and a majority of studies evaluated invasion depth via measurements in absolute millimeters or fractions of muscle layer [<xref ref-type="bibr" rid="CR9">9</xref>
, <xref ref-type="bibr" rid="CR17">17</xref>
]. Stromal invasion in fractional seconds was used in this study because variable thickness in the cervical wall might not reflect the extent of stromal invasion. In addition, measurement in fractional thirds appeared difficult, especially in patients with a thin cervical wall, and it might increase discrepancies because of the multi-institutional nature of the study. Previously, a combination of intermediate risk factors, such as large tumor size, LVSI, and stromal invasion, was associated with incremental recurrence rates of up to 15–20 % [<xref ref-type="bibr" rid="CR5">5</xref>
, <xref ref-type="bibr" rid="CR13">13</xref>
, <xref ref-type="bibr" rid="CR16">16</xref>
, <xref ref-type="bibr" rid="CR17">17</xref>
]. In this study, only one patient (1/24) with a single risk factor received adjuvant RT, whereas 28/51 patients with multiple risk factors received adjuvant therapy (Table <xref rid="Tab2" ref-type="table">2</xref>
). However, this study has some limitations, including its retrospective nature and the possible diversity of treatment modalities among institutions, resulting in heterogeneity among the treatment groups. For example, the introduction of CCRT for treating high risk cervical cancer probably influenced some institutions to utilize CCRT, as 4/5 patients who received CCRT had all three risk factors (Table <xref rid="Tab1" ref-type="table">1</xref>
), which may result in bias in interpreting the results. In this study, only one patient with all three intermediate risk factors who received RT and BRA died of recurrent tumor in the lungs 24 months later. This finding suggests that adjuvant RT does not benefit patients with intermediate risk factors as defined in this study. These issues can be addressed via a randomized design study in the future.</p>
<p>Another purpose of this study was to assess adverse events associated with RT, as adjuvant RT has long been known to increase complications [<xref ref-type="bibr" rid="CR18">18</xref>
, <xref ref-type="bibr" rid="CR19">19</xref>
]. Adjuvant CT alone for post-radical hysterectomy patients has been revealed to provide a better postoperative quality of life by eliminating RT-related morbidities such as small-bowel obstruction or leg edema [<xref ref-type="bibr" rid="CR6">6</xref>
, <xref ref-type="bibr" rid="CR8">8</xref>
], as also supported by our results (Table <xref rid="Tab3" ref-type="table">3</xref>
). Based on the small number of cases of ileus and ureteral obstruction, there was no difference between NFT/CT and RT/CCRT, which was consistent with a meta-analysis [<xref ref-type="bibr" rid="CR11">11</xref>
] of two combined trials by Bilek et al. [<xref ref-type="bibr" rid="CR20">20</xref>
] and GOG 92 [<xref ref-type="bibr" rid="CR9">9</xref>
]. Conversely, the incidence of lymphedema was significantly higher and the adverse event was of greater severity for patients who received RT or CCRT (<italic>P</italic>
< 0.001). Several studies indicated that an unsutured peritoneum after pelvic lymphadenectomy reduced the risk of lymphocyst formation [<xref ref-type="bibr" rid="CR21">21</xref>
, <xref ref-type="bibr" rid="CR22">22</xref>
]. In this study, we assessed whether the incidence of lymphedema improved when the retroperitoneum was left open. In contrast to a previous report suggesting that an unsutured peritoneum significantly reduced the risk of lymphedema [<xref ref-type="bibr" rid="CR23">23</xref>
], this strategy did not provide a significant advantage in avoiding lymphedema in this study (Table <xref rid="Tab5" ref-type="table">5</xref>
). Lymphedema is most commonly diagnosed within the first year, but a certain number of patients manifest symptoms in later years [<xref ref-type="bibr" rid="CR24">24</xref>
, <xref ref-type="bibr" rid="CR25">25</xref>
]. Thus, the possible reason for discrepant results between studies may be attributable to the follow-up duration; specifically, the average observation period was 82.6 months in our study, whereas other studies evaluated patients for 3 years after surgery. Intriguingly, our study demonstrated that an unsutured peritoneum without RT significantly increased the incidence of ileus, whereas there was no difference between an unsutured and sutured peritoneum regarding the risks of lymphedema and ureteral obstruction (Fig. <xref rid="Fig1" ref-type="fig">1</xref>
).</p>
</sec>
<sec id="Sec5"><title>Conclusions</title>
<p>In the present study, postoperative adjuvant RT significantly increased adverse events for intermediate risk patients as defined in this study. To date, no trial has established a solid consensus regarding RT after surgery for early-stage cervical cancer. Although this retrospective study included a limited number of patients, the results provide useful information for further consideration in the management of patients with intermediate risk cervical cancer.</p>
</sec>
<sec id="Sec6"><title>Abbreviations</title>
<p>BRA, brachytherapy; EBRT, external beam radiation therapy; CCRT, concurrent chemoradiotherapy; CT, chemotherapy; LVSI, lymphovascular space invasion; MS, tumor size; NFT, no further treatment; RT, radiation treatment; SI, stromal invasion</p>
</sec>
</body>
<back><ack><title>Acknowledgements</title>
<p>We do not have anyone to acknowledge for this study.</p>
<sec id="FPar1"><title>Funding</title>
<p>This study was not supported by any funding resource.</p>
</sec>
<sec id="FPar2"><title>Availability of data and materials</title>
<p>We did not use particular software or databases for this study.</p>
</sec>
<sec id="FPar3"><title>Authors’ contributions</title>
<p>KN designed the study. YK analyzed the data. KN, TS, YT, MT, SN, IS, and MS collected the clinical data. KN drafted the manuscript. All authors read and approved the final manuscript.</p>
</sec>
<sec id="FPar4"><title>Competing interests</title>
<p>The authors declare that they have no competing interests.</p>
</sec>
<sec id="FPar5"><title>Consent for publication</title>
<p>Consent to publish was not obtained because an individual person’s information is not included in this study.</p>
</sec>
<sec id="FPar6"><title>Ethics approval and consent to participate</title>
<p>Informed consent was not obtained from each participant because this was a retrospective study. Instead of that, all participants were given the right to withdraw the use of the data. The protocol of this study was approved based on the necessity of the individual institutions’ ethical committees since we do not need to obtain the IRB approval for retrospective non-invasive research in Japan. Thus, some of the institutions involved in this research claimed IRB consent: the acquisition numbers of IRB for Gunma University, Tsukuba University, and National Defense Medical College are 11-3, H23-20, and #52, respectively.</p>
</sec>
</ack>
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