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ATL: Results of a Multi-Institutional Phase 2 Study (JGOG1066)
  1. Takafumi Toita, MD*,
  2. Ryo Kitagawa, MD,
  3. Tetsutaro Hamano, MS,
  4. Kenji Umayahara, MD§,
  5. Yasuyuki Hirashima, MD,
  6. Yoichi Aoki, MD,
  7. Masahiko Oguchi, MD#,
  8. Mikio Mikami, MD** and
  9. Ken Takizawa, MD§
  1. *Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa;
  2. Department of Obstetrics and Gynecology, NTT Medical Center Tokyo, Tokyo;
  3. Division of Biostatistics, School of Pharmaceutical Sciences, Kitasato University, Tokyo;
  4. §Department of Gynecology, Cancer Institute Hospital, Tokyo;
  5. Department of Gynecology, Shizuoka Cancer Center Hospital, Shizuoka;
  6. Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of the Ryukyus, Okinawa;
  7. #Department of Radiation Oncology, Cancer Institute Hospital, Tokyo; and
  8. **Department of Obstetrics and Gynecology, Tokai University School of Medicine, Kanagawa, Japan.
  1. Address correspondence and reprint requests to Takafumi Toita, MD, Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, 207 Uehara, Nishihara-cho, Okinawa, 903-0215, Japan. E-mail: b983255{at}med.u-ryukyu.ac.jp.
  1. Presented in part at the 2012 Annual Meeting on Women’s Cancer, Austin, Texas, March 24–27, 2012, and World Congress of Brachytherapy, Barcelona, Spain, 10–12 May, 2012.

Abstract

Objective To assess the feasibility and acute toxicity of concurrent chemoradiotherapy (CCRT) with high–dose rate intracavitary brachytherapy (HDR-ICBT) and standard dose delivery of cisplatin for Japanese patients with cervical cancer.

Materials and Methods The phase 2 study included Japanese patients with International Federation of Gynecology and Obstetrics stage III to IVA uterine cervical cancer who had no para-aortic lymphadenopathy (>10 mm) assessed by computed tomography. Patients were 20 to 70 years of age and had Eastern Cooperative Oncology Group performance status of 0 to 1. The radiotherapy protocol consisted of whole-pelvis external beam radiotherapy and HDR-ICBT. The cumulative linear quadratic equivalent dose (EQD2) was 62 to 65 Gy prescribed at point A. Cisplatin was administered weekly at a dose of 40 mg/m2 for 5 courses.

Results Between March 2008 and January 2009, 72 patients from 25 institutions were enrolled, and 71 patients were eligible and evaluable for compliance and severe toxicity. The median age of the patients was 57 years (range, 32–70 years). Sixty-five patients (92%) received the planned 5 courses of chemotherapy. Four patients had cisplatin dose reduction according to the protocol. Radiotherapy was completed per protocol in 68 patients (96%). Median overall treatment time was 50 days (range, 37–66 days). The following grade 3 or 4 acute adverse events were observed: neutropenia in 31 patients (44%), anemia in 10 patients (14%), diarrhea in 4 patients (6%), and anorexia in 3 patients (4%).

Conclusions Concurrent chemoradiotherapy with HDR-ICBT and standard weekly delivery of cisplatin was feasible with acceptable toxicity in Japanese patients with cervical cancer.

  • cervix cancer
  • radiotherapy
  • chemotherapy
  • phase 2 study

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Footnotes

  • This study was supported in part by grants from the Ministry of Health, Labor and Welfare (Grants-in-Aid for Cancer Research nos. 16-12 and 20S-5), and a Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (Nos. 18591387 and 21591614).

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