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Phase II Clinical Study of the Combination Chemotherapy Regimen of Irinotecan Plus Oral Etoposide for the Treatment of Recurrent Ovarian Cancer (Tohoku Gynecologic Cancer Unit 101 Group Study)
  1. Tadahiro Shoji, MD, PhD*,
  2. Eriko Takatori, MD, PhD*,
  3. Hideo Omi, MD, PhD*,
  4. Seisuke Kumagai, MD, PhD*,
  5. Akira Yoshizaki, MD, PhD*,
  6. Yoshihito Yokoyama, MD, PhD,
  7. Hideki Mizunuma, MD, PhD,
  8. Toshio Fujimoto, MD, PhD,
  9. Tadao Takano, MD, PhD§,
  10. Nobuo Yaegashi, MD, PhD§,
  11. Toru Tase, MD, PhD,
  12. Kenji Nakahara, MD, PhD,
  13. Hirohisa Kurachi, MD, PhD,
  14. Hiroshi Nishiyama, MD, PhD** and
  15. Toru Sugiyama, MD, PhD*
  1. * Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka;
  2. Department of Obstetrics and Gynecology, Hirosaki University School of Medicine, Hirosaki;
  3. Department of Obstetrics and Gynecology, Akita University School of Medicine, Akita;
  4. § Department of Obstetrics and Gynecology, Tohoku University School of Medicine, Sendai;
  5. Department of Gynecology, Miyagi Cancer Center, Natori;
  6. Department of Obstetrics and Gynecology, Yamagata University School of Medicine; Yamagata; and
  7. ** Department of Obstetrics and Gynecology, Fukushima Medical University School of Medicine, Fukushima, Japan.
  1. Address correspondence and reprint requests to Tadahiro Shoji, MD, PhD, Uchimaru 19-1, Morioka. E-mail: tshoji{at}iwate-med.ac.jp.

Abstract

Objective: To evaluate the efficacy and safety of the combination chemotherapy regimen of irinotecan plus oral etoposide for the treatment of patients with recurrent ovarian cancer after previous treatment with platinum and taxane agents.

Patients and Methods: A total of 42 patients with recurrent ovarian cancer who had an evaluable lesion and provided informed consent for participation in the present study were analyzed. Irinotecan was administered intravenously at a dose of 60 mg/m2 on days 1 and 15. Etoposide was administered orally at a daily dose of 50 mg/body weight from days 1 to 21. A 28-day period comprised one cycle. The tumor response, adverse events, progression-free survival, and overall survival were examined. Tumor response was evaluated based on the Response Evaluation Criteria in Solid Tumors and the serum CA125 levels (Gynecologic Cancer Intergroup criteria). Adverse events were assessed according to the NCI-CTCAE (version 3.0).

Results: Partial response was observed in 21 patients, stable disease in 14 patients, and progressive disease in 7 patients. The response rate was 50.0%, and the clinical benefit (partial response + stable disease) rate was 83.3%. Hematological toxicities of at least grade 3 severity included leukopenia in 21 patients (50.0%), neutropenia in 22 patients (52.4%), thrombocytopenia in 1 patient (2.4%), anemia in 9 patients (21.4%), and febrile neutropenia in 3 patients (7.1%). Nonhematological toxicities of at least grade 3 severity included queasy feeling in 5 patients (11.9%), vomiting in 3 patients (7.1%), and diarrhea in 2 patients (4.8%). Acute myeloid leukemia occurred in one patient (2.4%).

Conclusions: It is suggested that combination chemotherapy with irinotecan plus oral etoposide offers significant clinical benefit to patients with recurrent ovarian cancer previously treated with platinum and taxane agents.

  • Recurrent ovarian cancer
  • Irinotecan
  • Oral etoposide
  • Chemotherapy

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Footnotes

  • The authors have no conflict of interest to declare.

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