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The purpose of this phase  II  trial was to assess the efficacy and toxicity of paclitaxel and nedaplatin ( TN ) as the initial postoperative adjuvant chemotherapy for uterine cervical cancer with lymph node metastases ( LNM ). Patients with  FIGO  stage  IB 1‐ IIA 2 squamous cell carcinoma of the uterine cervix were enrolled. Histological confirmation of  LNM  was mandatory. Intravenous paclitaxel at 175 mg/m 2  and nedaplatin at 80 mg/m 2  were administered every 28‐day cycle, of which there were 5 cycles after radical hysterectomy. Sixty‐two patients were enrolled in the study from November 2011 to July 2015. Their median age was 48.5 years (range 28‐64). The median tumor diameter was 37 mm (5‐64). Overall, 30 patients (48.4%) had 1 metastatic lymph node, 11 (17.7%) had 2, 3 (4.8%) had 3, 5 (8.1%) had 4, and 13 (21.0%) had 5 or more. With a median follow‐up of 45.7 months (range 23.4‐69.5), the 2‐year relapse‐free survival and 2‐year overall survival rates were 79.0% (90%  CI , 69.0%‐86.2%) and 93.5% (95%  CI , 83.7%‐97.5%), respectively. Almost all adverse events were relatively mild. Grade 3‐4 adverse events ( NCI ‐ CTC  ver. 4.0) that occurred in 5% or more of patients were neutropenia (60.7%) and infection (6.6%). The proportion of patients who completed 5 cycles of treatment was 90.3%. Postoperative adjuvant chemotherapy with  TN  for cervical cancer with  LNM  was demonstrated to be an effective and feasible treatment. A phase  III  trial is warranted to compare this with concurrent chemoradiotherapy.

Phase II study of adjuvant chemotherapy with paclitaxel and nedaplatin for uterine cervical cancer with lymph node metastasis