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Postoperative chemotherapy for node-positive cervical cancer: Results of a multicenter phase II trial (JGOG1067)

Gynecologic Oncology Apr 23, 2018

Matoda M, et al. - In this multicenter phase II Japanese Gynecologic Oncology Group study (JGOG1067), researchers assessed the efficacy and safety of postoperative chemotherapy in patients with node-positive cervical cancer. High efficacy of postoperative chemotherapy without radiotherapy was demonstrated in high-risk patients with node-positive cervical cancer.

Methods

  • Eligible patients were those with stage IB–IIA squamous cervical cancer who underwent radical hysterectomy and were confirmed to have pelvic lymph node metastasis.
  • Postoperatively, irinotecan (CPT-11; 60 mg/m2intravenously on days 1 and 8) and nedaplatin (NDP; 80 mg/m2 intravenously on day 1) were administered to patients.
  • Within 6 weeks post operation, chemotherapy administration commenced and was repeated every 28 days for up to 5 cycles.
  • The 2-year recurrence-free survival (RFS) rate was the primary endpoint and 5-year overall survival (OS) rate, 5-year RFS rate, and adverse events such as complications of chemotherapy and lower-limb edema were secondary endpoints.

Results

  • Among 62 patients who were analyzed according to the protocol, 55 (88.7%) completed 5 cycles of scheduled treatment.
  • Median follow-up of 66.1 months was carried out (range, 16.8–96.6 months).
  • As per findings, 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.
  • During follow-up, recurrence was noted in 14 patients (22.5%), 8 of whom died of the disease.
  • Five-year OS rate was 86.5% (95% CI: 74.8–93.0).
  • Lymphedema in legs was detected in only 9.7% of the patients.

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