Phase II study of adjuvant chemotherapy with paclitaxel and nedaplatin for uterine cervical cancer with lymph node metastasis |
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| Authors: | Munetaka Takekuma Mototsugu Shimokawa Shin Nishio Hideo Omi Tsutomu Tabata Yuji Takei Kaei Nasu Yoshiyuki Takahashi Shinji Toyota Yoshikazu Ichikawa Atsushi Arakawa Fuminori Ito Hiroshi Tsubamoto Taisuke Mori Yasuyuki Hirashima Kimihiko Ito |
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| Affiliation: | 1. Department of Gynecologic Oncology, Shizuoka Cancer Center, Shizuoka, Japan;2. Cancer Biostatistics Laboratory, Clinical Research Institute, National Kyusyu Cancer Center, Fukuoka, Japan;3. Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan;4. Department of Obstetrics and Gynecology, Iwate Medical University Hospital, Iwate, Japan;5. Department of Obstetrics and Gynecology, Mie University Hospital, Mie, Japan;6. Department of Obstetrics and Gynecology, Jichi Medical University, Tochigi, Japan;7. Department of Obstetrics and Gynecology, Oita University Faculty of Medicine, Oita, Japan;8. Department of Obstetrics and Gynecology, Okinawa Chubu Hospital, Okinawa, Japan;9. Department of Obstetrics and Gynecology, Nara Prefecture General Medical Center, Nara, Japan;10. Department of Obstetrics and Gynecology, Japanese Red Cross Shizuoka Hospital, Shizuoka, Japan;11. Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan;12. Department of Obstetrics and Gynecology, Nara Medical University, Nara, Japan;13. Department of Obstetrics and Gynecology, Hyogo College of Medicine, Hyogo, Japan;14. Department of Obstetrics and Gynecology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan;15. Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Hyogo, Japan |
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| Abstract: | 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 IB1‐IIA2 squamous cell carcinoma of the uterine cervix were enrolled. Histological confirmation of LNM was mandatory. Intravenous paclitaxel at 175 mg/m2 and nedaplatin at 80 mg/m2 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. |
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| Keywords: | cervical cancer paclitaxel and nedaplatin phase II study postoperative adjuvant therapy systemic chemotherapy |
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