Phase I dose-escalation study of weekly paclitaxel and cisplatin followed by radical hysterectomy in Stages IB2 and IIA2 cervical cancer

Hung Hsueh Chou, Huei Jean Huang, Hao Lin, Lan Yan Yang, Swei Hsueh, Feng Yuan Liu, Yen Lyin Liou, Jui Der Liou, Min Yu Chen, Angel Chao, Gigin Lin, Ting Chang Chang, Chyong Huey Lai*

*此作品的通信作者

研究成果: 期刊稿件文章同行評審

4 引文 斯高帕斯(Scopus)

摘要

Purpose: To define the optimal dose of paclitaxel combining cisplatin, as weekly neoadjuvant chemotherapy (NAC) for early-stage bulky squamous cell carcinoma of the uterine cervix. Methods: A prospective trial was conducted for International Federation of Gynecology and Obstetrics stages IB2 and IIA2 cervical squamous cell carcinoma patients with magnetic resonance imaging or positron emission tomography-defined lymph node negative. Weekly fixed-dose cisplatin (40 mg/m 2) and 4-level dose escalation of paclitaxel (50, 60, 70, 80 mg/m 2) for 3 courses was given and followed by radical hysterectomy and pelvic lymph node dissection (RH-PLND) 14 to 28 days later. Postoperative adjuvant therapy was tailored according to pathologic response. Results: No dose-limiting toxicity occurred. Twelve subjects were enrolled without reaching maximum tolerated dose, nor was any RH-PLND procedure delayed for >2 weeks. Pathologic response rate was 50% (complete in 2 and partial in 4). Paclitaxel dose level seemed unrelated to pathologic response. No subjects had grade ≥3 acute adverse events. Seven patients (58.3%) received postoperative radiotherapy or chemoradiation. Patients with human papillomavirus 16-negative tumor and aged 55 years and older had marginally higher risk (100%) of adjuvant radiotherapy or chemoradiation after NAC than those with human papillomavirus 16-positive or age less than 55 (P=0.081). With a median follow-up of 45.5 months, all 12 patients remained alive without disease. Conclusions: Weekly paclitaxel and cisplatin NAC for 3 courses can be tolerated with excellent short-term outcome. With the caveat of small number of patients, this study supports future phase II trials of weekly paclitaxel and cisplatin NAC for 4 to 5 cycles.

原文英語
頁(從 - 到)241-249
頁數9
期刊American Journal of Clinical Oncology: Cancer Clinical Trials
40
發行號3
DOIs
出版狀態已出版 - 01 05 2017

文獻附註

Publisher Copyright:
© 2014 Wolters Kluwer Health, Inc.

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