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).
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Gunma University Hospital, Maebashi, Gunma, 371-8511, Japan. nkazuto@gunma-cc.jp.|Current address: Department of Gynecology, Gunma Cancer Center, Ota, Gunma, 373-8550, Japan. nkazuto@gunma-cc.jp.
authors.forename: Kazuto
authors.identifier: http://orcid.org/0000-0001-5738-3418
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: Department of Obstetrics and Gynecology, Gunma University Hospital, Maebashi, Gunma, 371-8511, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kitahara
authors.affiliation: Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, 305-8577, Japan.
authors.forename: Toyomi
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Department of Obstetrics and Gynecology, Jichi Medical University Hospital, Shimotsuke, Tochigi, 329-0498, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Takei
authors.affiliation: Department of Obstetrics and Gynecology, National Defense Medical College, Tokorozawa, Saitama, 359-8513, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Takano
authors.affiliation: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, 350-1298, Japan.|Current address: Department of Gynecology, Hyogo Cancer Center, Akashi, Hyogo, 673-8558, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Nagao
authors.affiliation: Department of Gynecology, Tochigi Cancer Center, Utusnomiya, Tochigi, 320-0834, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Sekiguchi
authors.affiliation: Department of Obstetrics and Gynecology, Jichi Medical University Hospital, Shimotsuke, Tochigi, 329-0498, Japan.
authors.forename: Mitsuaki
authors.initials: M
authors.lastname: Suzuki
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D001918:Brachytherapy; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D059186:Chemoradiotherapy, Adjuvant; D017024:Chemotherapy, Adjuvant; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000209:etiology*; D018714:Radiotherapy, Adjuvant; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery
keywords: Adverse event; Cervical cancer; Radiation