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Clinical Outcome of Neoadjuvant Radiochemotherapy in Locally Advanced Cervical Cancer: Results of an Open Prospective, Multicenter Phase 2 Study of the North-Eastern German Society of Gynecological Oncology
  1. Dominique Koensgen*,
  2. Jalid Sehouli,
  3. Antje Belau*,
  4. Martin Weiss,
  5. Matthias B. Stope,
  6. Vivien Großkopf*,
  7. Michael Eichbaum§,
  8. Peter Ledwon,
  9. Werner Lichtenegger,
  10. Marek Zygmunt*,
  11. Günter Köhler* and
  12. Alexander Mustea, MD*
  1. *Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald;
  2. Department of Gynecology and Gynecological Oncology, Charité Berlin, Berlin;
  3. Department of Urology, University Medicine Greifswald, Greifswald;
  4. §Department of Obstetrics and Gynecology, University Hospital Heidelberg; and
  5. Department of Obstetrics and Gynecology, Städtisches Klinikum Brandenburg, Germany.
  1. Address correspondence and reprint requests to Alexander Mustea, Department of Gynecology and Obstetrics, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, 17475 Greifswald, Germany. E-mail: mustea@uni-greifswald.de.

Abstract

Objective The aim of this study was to determine the response rate, toxicity, operability, and surgical complication rate of neoadjuvant concomitant radiochemotherapy (cRCH) (ifosfamide + carboplatin) followed by radical hysterectomy plus external-beam radiotherapy with curative intention in locally advanced primary inoperable stages IIB and IIIB squamous cell cervical cancer.

Methods Patients with cervical cancer from 8 departments were enrolled. Patients received 3 cycles of ifosfamide 1.2 mg/m2 (+mesna 20%) plus carboplatin (area under the curve = 4), every 21 days, and concomitant external-beam radiotherapy (50.4 Gy [1.8 Gy/d]). Operability and remission were evaluated by clinical gynecological examination in general anesthesia (magnetic resonance imaging was optional), 4 weeks after the third cycle of cRCH. In case of achieved operability, a radical hysterectomy with pelvic lymphadenectomy was performed within 6 weeks after cRCH. If surgery was not performed because of incomplete remission or patient preferences, vaginal brachytherapy (15 Gy [5 Gy/d]) was given additionally.

Results Forty-four patients were enrolled. Distribution of FIGO (International Federation of Gynecology and Obstetrics) tumor stage was as follows: IIB (19 patients) and IIIB (25 patients). All patients completed cRCH. Grade 3/4 hematologic toxicities (% of all cycles) were moderate: leukopenia, 7.3; thrombocytopenia, 2.4; and anemia, 3.2. In 13.8%, treatment cycles were delayed because of hematologic toxicity. Blood transfusions were given in 17.7% and granulocyte colony-stimulating factor in 39.5%. Overall, grade 3/4 nonhematologic toxicities were seldom (6.5%). Clinical overall response rate was 95.2%. Operability was achieved in 85.7%. Surgery was performed in 83.3%. Pathological response rates were as follows: pathological complete remission, 33.3%; partial remission, 63.3%; stable disease, 3.3%.

Conclusions Our study demonstrates that cRCH is an effective and tolerable regimen in locally advanced cervical cancer treatment.

  • Cervical cancer
  • Neoadjuvant treatment
  • Radiochemotherapy

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Footnotes

  • This work was supported on behalf of the the North-Eastern German Society of Gynecologic Oncology. on behalf of the North-Eastern German Society of Gynecologic Oncology

  • The authors declare no conflicts of interest.