title: Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass.
abstract: BACKGROUND
  We examined the efficacy and safety of neoadjuvant chemotherapy (NAC) with the CPT-11 + CDDP regimen in combination with radical hysterectomy.
  
  
  METHODS
  The subjects were 42 patients with stages IB2 to IIIB squamous cell carcinoma of the uterine cervix with a bulky mass. CDDP at 70 mg/m2was intravenously administered on day 1 and CPT-11 at 70 mg/m2was intravenously administered on days 1 and 8 of a 21-day cycle. In principle, two cycles were administered followed by radical hysterectomy. We examined antitumor efficacy, adverse events, completion rate of radical hysterectomy, operative time, surgical blood loss, progression-free survival (PFS), and overall survival (OS).
  
  
  RESULTS
  The antitumor effect was complete response in 7 patients, partial response in 28, stable disease in 6, and progressive disease in 1; the response rate was 83.3 % (95 % confidence interval, 68.6-93.0). Grade 3 or more severe neutropenia, anemia, and platelet count decreases were noted in 23 (54.8 %), 4 (9.5 %), and 1 (2.4 %) patient, respectively. Grade 3 nausea occurred in 3 patients (7.1 %), vomiting in 1 (2.4 %), and grade 3 febrile neutropenia in 2 (7.1 %). The completion rate of radical hysterectomy was 88.1 %. The median operative time and surgical blood loss were 260 min (range, 210-334) and 500 ml (range, 393-898), respectively. The 5-year PFS rate was 67.2 %, and the 5-year OS rate was 68.0 %. In multivariate analysis, lymph node metastasis before NAC [hazard ratio (HR), 34.88] and non-response to NAC (HR 30.58) were significant prognostic factors.
  
  
  CONCLUSIONS
  NAC with the CDDP/CPT-11 regimen achieves a high antitumor efficacy with moderate adverse reactions, allowing safe radical hysterectomy, and is thus considered to be a useful therapeutic method that can improve prognosis.
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan. tshoji@iwate-med.ac.jp.
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Shoji
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Eriko
authors.initials: E
authors.lastname: Takatori
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Furutake
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Anna
authors.initials: A
authors.lastname: Takada
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Nagasawa
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Omi
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kagabu
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Honda
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Fumiharu
authors.initials: F
authors.lastname: Miura
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takeuchi
authors.affiliation: Department of Obstetrics and Gynecology, National Hospital Organization Kokura Medical Center, Kokura, Japan.
authors.forename: Seisuke
authors.initials: S
authors.lastname: Kumagai
authors.affiliation: Department of Gynecology, Miyama Hospital, Oshu, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Yoshizaki
authors.affiliation: Department of Gynecology, Medical Coat Hachinohe West Hospital, Hachinohe, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Sato
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Sugiyama
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D000077146:Irinotecan; D008207:Lymphatic Metastasis; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009367:Neoplasm Staging; D009503:Neutropenia / Q000175:diagnosis / Q000209:etiology; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000628:therapy
chemical_list: D000970:Antineoplastic Agents; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin
keywords: Bulky mass; CDDP; CPT-11; Cervical cancer; NAC