Maki Matoda1, Nobuhiro Takeshima2, Hirofumi Michimae3, Takashi Iwata4, Harushige Yokota5, Yutaka Torii6, Yorito Yamamoto7, Kazuhiro Takehara8, Shin Nishio9, Hirokuni Takano10, Mika Mizuno11, Yoshiyuki Takahashi12, Yuji Takei13, Tetsuya Hasegawa14, Mikio Mikami15, Takayuki Enomoto16, Daisuke Aoki4, Toru Sugiyama17. 1. Department of Gynecology, Cancer Institute Hospital, Tokyo, Japan. Electronic address: maki.matsumura@jfcr.or.jp. 2. Department of Gynecology, Cancer Institute Hospital, Tokyo, Japan. 3. Kitasato University School of Pharmacy, Tokyo, Japan. 4. Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan. 5. Department of Gynecology, Saitama Cancer Center, Saitama, Japan. 6. Department of Obstetrics and Gynecology, Fujita Health University School of Medicine, Aichi, Japan. 7. Department of Gynecology, National Hospital Organization Kochi National Hospital, Kochi, Japan. 8. Department of Gynecology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan. 9. Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan. 10. Department of Obstetrics and Gynecology, The Jikei University Kashiwa Hospital, Chiba, Japan. 11. Department of Obstetrics and Gynecology, Department of Gynecology, Aichi Cancer Center Hospital, Aichi, Japan. 12. Department of Obstetrics and Gynecology, Okinawa Chubu Hospital, Okinawa, Japan. 13. Department of Obstetrics and Gynecology, Jichi Medical University of Medicine, Gunma, Japan. 14. Department of Obstetrics and Gynecology, Yokohama City University School of Medicine, Kanagawa, Japan. 15. Department of Obstetrics and Gynecology, Tokai University School of Medicine, Kanagawa, Japan. 16. Department of Obstetrics and Gynecology, Niigata University School of Medicine, Niigata City, Japan. 17. Department of Obstetrics and Gynecology, Iwate Medical University, Iwate, Japan.
Abstract
OBJECTIVE: This multicenter phase II Japanese Gynecologic Oncology Group study (JGOG1067) was designed to evaluate the efficacy and safety of postoperative chemotherapy in patients with node-positive cervical cancer. METHODS: Patients with stage IB-IIA squamous cervical cancer who underwent radical hysterectomy and were confirmed to have pelvic lymph node metastasis were eligible for this study. The patients postoperatively received irinotecan (CPT-11; 60mg/m2 intravenously on days 1 and 8) and nedaplatin (NDP; 80mg/m2 intravenously on day 1). Chemotherapy administration commenced within 6weeks after surgery and was repeated every 28days for up to 5cycles. The primary endpoint of this study was the 2-year recurrence-free survival (RFS) rate. The secondary endpoints were the 5-year overall survival (OS) rate, 5-year RFS rate, and adverse events such as complications of chemotherapy and lower-limb edema. RESULTS: Sixty-two patients were analyzed according to our protocol, among whom 55 (88.7%) completed 5cycles of scheduled treatment. The median follow-up period was 66.1months (range, 16.8-96.6months). The 2-year and 5-year RFS rates were 87.1% (95% confidence interval [CI]: 75.9-99.3) and 77.2% (95% CI: 64.5-85.8), respectively. Fourteen patients (22.5%) experienced recurrence during the follow-up period, 8 of whom died of the disease. The 5-year OS rate in this study was 86.5% (95% CI: 74.8-93.0). Only 9.7% of the patients experienced lymphedema in their legs. CONCLUSION: Postoperative chemotherapy without radiotherapy was found to be very effective in high-risk patients with node-positive cervical cancer.
OBJECTIVE: This multicenter phase II Japanese Gynecologic Oncology Group study (JGOG1067) was designed to evaluate the efficacy and safety of postoperative chemotherapy in patients with node-positive cervical cancer. METHODS:Patients with stage IB-IIA squamous cervical cancer who underwent radical hysterectomy and were confirmed to have pelvic lymph node metastasis were eligible for this study. The patients postoperatively received irinotecan (CPT-11; 60mg/m2 intravenously on days 1 and 8) and nedaplatin (NDP; 80mg/m2 intravenously on day 1). Chemotherapy administration commenced within 6weeks after surgery and was repeated every 28days for up to 5cycles. The primary endpoint of this study was the 2-year recurrence-free survival (RFS) rate. The secondary endpoints were the 5-year overall survival (OS) rate, 5-year RFS rate, and adverse events such as complications of chemotherapy and lower-limb edema. RESULTS: Sixty-two patients were analyzed according to our protocol, among whom 55 (88.7%) completed 5cycles of scheduled treatment. The median follow-up period was 66.1months (range, 16.8-96.6months). The 2-year and 5-year RFS rates were 87.1% (95% confidence interval [CI]: 75.9-99.3) and 77.2% (95% CI: 64.5-85.8), respectively. Fourteen patients (22.5%) experienced recurrence during the follow-up period, 8 of whom died of the disease. The 5-year OS rate in this study was 86.5% (95% CI: 74.8-93.0). Only 9.7% of the patients experienced lymphedema in their legs. CONCLUSION: Postoperative chemotherapy without radiotherapy was found to be very effective in high-risk patients with node-positive cervical cancer.
Authors: Yanzhu Lin; Fanqing Meng; Zhiyuan Lu; Kai Chen; Yalan Tao; Yi Ouyang; Xinping Cao Journal: Cancer Manag Res Date: 2018-10-04 Impact factor: 3.989