title: Adjuvant sequential chemoradiation therapy in high-risk endometrial cancer: results of a prospective, multicenter phase-II study of the NOGGO (North-Eastern German Society of Gynaecological Oncology).
abstract: OBJECTIVE
  The management of high-risk endometrial cancer (HREC) remains controversial. We conducted a prospective multicenter phase-II clinical trial to evaluate an adjuvant chemotherapy (CT) with sequential radiotherapy (RT) in patients with HREC.
  
  
  METHODS
  Patients with HREC from 8 institutions in Germany were enrolled. After surgery, patients received four cycles of paclitaxel 175 mg/m² (P) and carboplatin AUC5 (C) (d1, q21d) and subsequent external pelvic radiation therapy (1.8 Gy/d, d1-5) at a total dose of 45 Gy with vaginal brachytherapy (3 × 5 Gy). Quality of life (QoL) was assessed using the EORTC-QLQ-C30 questionnaire. Primary endpoints were tolerability, toxicity and QoL. Progression-free survival (PFS) was defined as secondary endpoint.
  
  
  RESULTS
  Thirty-five patients were enrolled from 2004 through 2008. Median follow-up was 24 months (range 3-24 months). All patients received 4 cycles of P and C and completed RT. Overall, grade 3/4 haematological toxicity was 25.6 %. Three cycles were delayed because of leukopenia. Grade 3/4 non-haematologic toxicities were rare (≤3 %). No overall change in QoL occurred during treatment. Two-year median PFS and OS rates were both 75.8 %.
  
  
  CONCLUSIONS
  Adjuvant combination CT with P + C and sequential RT is well tolerated and a feasible regimen in patients with HREC. Subsequent phase-III trials are warranted.
authors.affiliation: Department of Gynaecology and Obstetrics, University Hospital Greifswald, Ferdinand-Sauerbruch-Str., 17475, Greifswald, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Mustea
authors.forename: D
authors.initials: D
authors.lastname: Koensgen
authors.forename: A
authors.initials: A
authors.lastname: Belau
authors.forename: J
authors.initials: J
authors.lastname: Sehouli
authors.forename: W
authors.initials: W
authors.lastname: Lichtenegger
authors.forename: L
authors.initials: L
authors.lastname: Schneidewind
authors.forename: H
authors.initials: H
authors.lastname: Sommer
authors.forename: S
authors.initials: S
authors.lastname: Markmann
authors.forename: J P
authors.initials: JP
authors.lastname: Scharf
authors.forename: M
authors.initials: M
authors.lastname: Ehmke
authors.forename: P
authors.initials: P
authors.lastname: Ledwon
authors.forename: I
authors.initials: I
authors.lastname: Braicu
authors.forename: M
authors.initials: M
authors.lastname: Zygmunt
authors.forename: G
authors.initials: G
authors.lastname: Koehler
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001918:Brachytherapy / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D016889:Endometrial Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D004717:Endometrium / Q000187:drug effects* / Q000473:pathology / Q000528:radiation effects* / Q000601:surgery; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006402:Hematologic Diseases / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011379:Prognosis; D011788:Quality of Life; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin; D017239:Paclitaxel