title: A phase II study of postoperative concurrent carboplatin and paclitaxel combined with intensity-modulated pelvic radiotherapy followed by consolidation chemotherapy in surgically treated cervical cancer patients with positive pelvic lymph nodes.
abstract: OBJECTIVE
  A phase II study was conducted to evaluate the efficacy and toxicity of carboplatin plus paclitaxel (TC)-based postoperative concurrent chemoradiotherapy (CCRT) followed by TC-based consolidation chemotherapy in surgically-treated early-stage cervical cancer patients.
  
  
  METHODS
  Women with surgically-treated early-stage cervical cancer with positive pelvic lymph nodes were eligible for this study. The patients were postoperatively treated with pelvic intensity modulated radiotherapy (50.4Gy) and concurrent weekly carboplatin (AUC: 2) and paclitaxel (35mg/m(2)) (TC-based CCRT). Three cycles of consolidation chemotherapy involving carboplatin (AUC: 5) and paclitaxel (175mg/m(2)) were administered after TC-based CCRT.
  
  
  RESULTS
  Thirty-one patients were enrolled and treated. Overall, the treatment was well tolerated, and 26 patients (83.9%) completed the planned TC-based CCRT. The most frequently observed acute grade 3/4 hematological toxicities were leukopenia and neutropenia, and diarrhea was the most common acute grade 3/4 non-hematological toxicity. After a median follow-up period of 36.5months, 2 patients (6.5%) had developed recurrent disease. The patients' estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 88.5% and 93.8%, respectively. In comparisons with historical control groups, TC-based CCRT followed by TC-based consolidation chemotherapy was found to be significantly superior to CCRT involving a single platinum agent in terms of PFS (p=0.026) and significantly superior to extended-field radiotherapy in terms of both PFS (p=0.0004) and OS (p=0.034).
  
  
  CONCLUSIONS
  In women with surgically treated early-stage cervical cancer, pelvic TC-based CCRT followed by TC-based consolidation chemotherapy is feasible and highly effective. Future randomized trials are needed to verify the efficacy of this regimen.
authors.affiliation: Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: smabuchi@gyne.med.osaka-u.ac.jp.
authors.forename: Seiji
authors.initials: S
authors.lastname: Mabuchi
authors.affiliation: Radiation Oncology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Isohashi
authors.affiliation: Department of Obstetrics and Gynecology, Kaizuka Municipal Hospital, 3-10-20 Hori, Kaizuka, Osaka, 597-0015, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yokoi
authors.affiliation: Department of Obstetrics and Gynecology, Osaka General Medical Center, 3-1-56 Mandaihigashi, Sumiyoshi, Osaka 558-8558, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Takemura
authors.affiliation: Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Yoshino
authors.affiliation: Department of Obstetrics and Gynecology, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-8511, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Shiki
authors.affiliation: Department of Obstetrics and Gynecology, Osaka Rosai Hospital, 1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Japan.
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Ito
authors.affiliation: Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Enomoto
authors.affiliation: Department of Obstetrics and Gynecology, Kaizuka Municipal Hospital, 3-10-20 Hori, Kaizuka, Osaka, 597-0015, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Ogawa
authors.affiliation: Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D059186:Chemoradiotherapy, Adjuvant; D060830:Consolidation Chemotherapy; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011182:Postoperative Care / Q000379:methods; D050397:Radiotherapy, Intensity-Modulated; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery
chemical_list: D016190:Carboplatin; D017239:Paclitaxel
keywords: Carboplatin; Cervical cancer; Consolidation chemotherapy; IMRT; Paclitaxel; Phase II study