A phase II study of postoperative concurrent carboplatin and paclitaxel combined with intensity-modulated pelvic radiotherapy followed by consolidation chemotherapy in surgically treated cervical cancer patients with positive pelvic lymph nodes

作者：Mabuchi Seiji^*; Isohashi Fumiaki; Yokoi Takeshi; Takemura Masahiko; Yoshino Kiyoshi; Shiki Yasuhiko; Ito Kimihiko; Enomoto Takayuki; Ogawa Kazuhiko; Kimura Tadashi

来源：Gynecologic Oncology, 2016, 141(2): 240-246.

DOI：10.1016/j.ygyno.2016.02.011

• Cervical cancer
• IMRT
• Carboplatin
• Paclitaxel
• Phase II study
• Consolidation chemotherapy

Objectives. A phase II study was conducted to evaluate the efficacy and toxicity of carboplatin plus paclitaxel (TC)-based postoperative concurrent chemoradiotherapy (CCRT) followed by TC-based consolidation chemotherapy in surgically-treated early-stage cervical cancer patients.
Methods. Women with surgically-treated early-stage cervical cancer with positive pelvic lymph nodes were eligible for this study. The patients were postoperatively treated with pelvic intensity modulated radiotherapy (50.4 Gy) and concurrent weekly carboplatin (AUC: 2) and paclitaxel (35 mg/m(2)) (TC-based CCRT). Three cycles of consolidation chemotherapy involving carboplatin (AUC: 5) and paclitaxel (175 mg/m2) were administered after TC-based CCRT.
Results. Thirty-one patients were enrolled and treated. Overall, the treatment was well tolerated, and 26 patients (83.9%) completed the planned TC-based CCRT. The most frequently observed acute grade 3/4 hematological toxicities were leukopenia and neutropenia, and diarrhea was the most common acute grade 3/4 non hematological toxicity. After a median follow-up period of 36.5 months,. 2 patients (6.5%) had developed recurrent disease. The patients' estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 88.5% and 93.8%, respectively. In comparisons with historical control groups, TC-based CCRT followed by TC-based consolidation chemotherapy was found to be significantly superior to CCRT involving a single platinum agent in terms of PFS (p = 0.026) and significantly superior to extended-field radiotherapy in terms of both PFS (p = 0.0004) and OS (p = 0.034).
Conclusions. In women with surgically treated early-stage cervical cancer, pelvic TC-based CCRT followed by TC-based consolidation chemotherapy is feasible and highly effective. Future randomized trials are needed to verify the efficacy of this regimen.

• 出版日期2016-5