Benedetti Panici Pierluigi, Palaia Innocenza, Marchetti Claudia, Ruscito Ilary, Fischetti Margherita, Musella Angela, Di Donato Violante, Perniola Giorgia, Vertechy Laura, Muzii Ludovico
Department of Gynecology, Obstetrics and Urology, Sapienza University of Rome, Rome, Italy.
Oncology. 2015;89(2):103-10. doi: 10.1159/000381461. Epub 2015 Apr 29.
To assess the efficacy and toxicity profile of dose-dense cisplatin-based neoadjuvant chemotherapy (NACT) followed by radical surgery in patients affected by locally advanced cervical cancer.
Patients affected by carcinoma of the uterine cervix FIGO (International Federation of Obstetrics and Gynecology) stage IB2-IIIB were enrolled into the study. The treatment schedule consisted of 5 cycles of intravenous paclitaxel 60 mg/m(2) plus cisplatin 60 mg/m(2) every 10 days; patients were then submitted to radical hysterectomy and pelvic lymphadenectomy.
From January 2011 to March 2013, 22 patients were enrolled. Median age was 47 (26-83) years. FIGO stages included 1 IIA, 15 IIB, 1 IIIA, and 5 IIIB. Ninety-one percent of patients completed all the 5 planned cycles of NACT. Three patients experienced allergic reactions to paclitaxel. Grade 3-4 hematological toxicity was observed in 18% of cases. In 3 cases, grade 3-4 extra-hematological adverse and life-threatening events were reported (1 ototoxicity, 1 transient ischemic attack, and 1 myocardial infarction). No treatment-related death occurred. The operability rate was 86.4%. The overall response rate was 52.6%: 5 patients (26.3%) experienced clinical complete response, and 5 (26.3%) showed a clinical partial response. Stable disease was observed in 47.4% of patients, with no progressive disease recorded. Pathological response was observed in 57.9% of cases. Six out of 19 (31.6%) patients were submitted to adjuvant treatment.
Dose-dense cisplatin-based NACT showed a response rate in approximately half of patients. However, in consideration of the reported extra-hematological toxicity, further studies on and new strategies with dose-dense platinum-based NACT are required to improve outcome in cervical cancer patients.
评估剂量密集型顺铂新辅助化疗（NACT）联合根治性手术治疗局部晚期宫颈癌患者的疗效及毒性特征。
纳入国际妇产科联盟（FIGO）分期为IB2-IIIB期的子宫颈癌患者。治疗方案为每10天静脉注射紫杉醇60mg/m²和顺铂60mg/m²，共5个周期；之后患者接受根治性子宫切除术和盆腔淋巴结清扫术。
2011年1月至2013年3月，共纳入22例患者。中位年龄为47（26-83）岁。FIGO分期包括1例IIA期、15例IIB期、1例IIIA期和5例IIIB期。91%的患者完成了所有5个计划周期的NACT。3例患者出现对紫杉醇的过敏反应。18%的病例观察到3-4级血液学毒性。3例报告了3-4级血液外不良事件及危及生命的事件（1例耳毒性、1例短暂性脑缺血发作和1例心肌梗死）。未发生与治疗相关的死亡。手术切除率为86.4%。总缓解率为52.6%：5例患者（26.3%）达到临床完全缓解，5例（26.3%）显示临床部分缓解。47.4%的患者病情稳定，无疾病进展记录。57.9%的病例观察到病理缓解。19例患者中有6例（31.6%）接受了辅助治疗。
剂量密集型顺铂新辅助化疗在约一半的患者中显示出缓解率。然而，考虑到所报告的血液外毒性，需要对剂量密集型铂类新辅助化疗进行进一步研究并制定新策略，以改善宫颈癌患者的治疗结局。
