Department of Obstetrics-Gynecology and Urology, Sapienza University of Rome, 155, Viale del Policlinico, Rome, Italy.
Gynecol Oncol. 2011 Aug;122(2):285-90. doi: 10.1016/j.ygyno.2011.04.013. Epub 2011 May 8.
To evaluate the feasibility, toxicity and activity of neoadjuvant chemotherapy (NACT) using cisplatin and topotecan in patients affected by locally advanced cervical cancer (IB2-IIIB).
Patients with histologically confirmed FIGO stage IB2-IIIB uterine cervical cancer were treated with topotecan 0.75 mg/m(2)/day (days 1-3) followed by cisplatin 75 mg/m(2) (day 1), every 21 days for three consecutive cycles. After the last cycle of chemotherapy, within 3 or 4 weeks, patients underwent radical surgery with lymph node dissection.
In the years 2007-2010, 46 women were enrolled into the study. Hematologic toxicity was the most relevant side effect. Thirty-eight patients (82.6%) underwent radical surgery after neoadjuvant chemotherapy (NACT) and were assessable for pathologic responses; surgery was not performed in 8 (17.4%) non-responder patients or with progression disease. Objective pathological response was recorded in 34 patients (89.5%); 6 patients (15.8%) achieved a complete response (CR), 28 (73.7%) patients achieved a partial response (PR); stable disease (SD) occurred in 2 patients (5.3%) with IIA initial disease and progression disease (PD) was registered in 2 patients (5.3%) with IIIB initial disease. The cumulative 2-year progression free survival (PFS) and overall survival (OS) of the 46 enrolled patients in the study were 70% and 81%, respectively; the 2-year PFS and OS of the 38 operated patients were respectively 79% and 95%.
The cisplatin-topotecan combination seems to be feasible and with an acceptable toxicity profile and a promising response rate for the treatment of locally advanced cervical cancer (LACC). Phase II and III studies are needed to compare this combination with other platinum-based chemotherapeutic associations.
评估顺铂和拓扑替康新辅助化疗（NACT）在局部晚期宫颈癌（IB2-IIIB）患者中的可行性、毒性和疗效。
组织学确诊为 FIGO 分期 IB2-IIIB 子宫颈癌的患者接受拓扑替康 0.75mg/m²/天（第 1-3 天），随后顺铂 75mg/m²（第 1 天），每 21 天为一个周期，共三个周期。化疗最后一个周期后 3 或 4 周内，患者接受根治性手术加淋巴结清扫。
2007 年至 2010 年期间，共有 46 名女性入组该研究。血液学毒性是最相关的副作用。38 名（82.6%）患者在新辅助化疗（NACT）后接受根治性手术，并可评估病理反应；8 名（17.4%）无反应或疾病进展的患者未行手术。34 名患者（89.5%）观察到客观病理反应；6 名患者（15.8%）完全缓解（CR），28 名患者（73.7%）部分缓解（PR）；2 名初始疾病为 IIA 的患者病情稳定（SD），2 名初始疾病为 IIIB 的患者疾病进展（PD）。46 名入组患者的 2 年无进展生存（PFS）和总生存（OS）累积率分别为 70%和 81%；38 名接受手术的患者的 2 年 PFS 和 OS 分别为 79%和 95%。
顺铂-拓扑替康联合方案似乎可行，毒性可耐受，对局部晚期宫颈癌（LACC）的治疗具有良好的反应率。需要进行 II 期和 III 期研究，以比较该联合方案与其他铂类化疗联合方案的疗效。
