Phase II study of adjuvant chemotherapy with paclitaxel and nedaplatin for FIGO stage IB-IIA uterine cervical cancer with lymph node metastasis following radical hysterectomy: A Kansai Clinical Oncology Group study (KCOG-G1101).

Abstract

e17024 Background: A multicenter phase II trial was conducted to assess the efficacy and toxicity of paclitaxel and nedaplatin as the initial postoperative adjuvant chemotherapy for high-risk uterine cervical cancer. Methods: The patients with FIGO stages IB1-IIA2 squamous cell carcinoma of the uterine cervix were enrolled. Histologic confirmation of lymph node metastasis was mandatory. Intravenous paclitaxel 175 mg/m(2) over 3hours and nedaplatin 80 mg/m(2) over 1 hour were administered on day 1 of a every 28 day cycle, of which there were 5 cycles after radical hysterectomy. Results: 62 patients were enrolled into the study protocol from November 2011 to July 2015. The median age of patients was 48.5 years (range; 28-64). Median tumor diameter was 37 mm (0-34). 10 patients (16.1%) had parametrial invasion, 44 (71.0%) had deep stromal invasion, and 53 (85.5%) had lymph-vascular invasion. 30 patients (48.4%) had one metastatic lymph node, 11 (17.7%) had two, 3 (4.8%) had three, 5 (8.1%) had four and 13 (21.0%) had five or more. With a median follow-up of 36.9 months (range: 17.2-61.5), the 2-year progression-free survival rate and pelvic disease progression-free rate were 78.9% (95% CI, 68.5% to 89.3%) and 85.0% (95% CI, 75.8% to 94.3%), respectively. The 2-year overall survival rate was 93.3% (95% CI, 86.8% to 99.8%). Adverse events were almost acceptable. Grade 3-4 adverse events (NCI-CTC ver4.0) that occurred in 5% or more patients were neutropenia (60.7%) and infection (6.6%). The proportion of patients who completed 5 cycles of treatment was 90.3%. Conclusions: Adjuvant chemotherapy with paclitaxel and nedaplatin for patients with high-risk cervical cancer after radical hysterectomy was demonstrated to be an effective and feasible treatment. Phase III trial should compare this with concurrent chemoradiotherapy. Clinical trial information: 000005605.