Division of Gynecologic Oncology, Leuven Cancer Institute, University Hospitals Leuven, Katholieke Universiteit Leuven, Belgium.
Int J Gynecol Cancer. 2012 Jun;22(5):865-8. doi: 10.1097/IGC.0b013e31824b4058.
To evaluate efficacy of weekly paclitaxel/carboplatin chemotherapy in patients with locally advanced, metastatic, or recurrent vulvar squamous cell carcinoma.
A prospective, single-arm, single-center pilot study was initiated to study response rate of 9 weekly courses of paclitaxel (60 mg/m) and carboplatin (area under the curve, 2.7). We used this regimen in the neoadjuvant or metastatic setting when surgery would cause serious morbidity or was not an option owing to distant metastases. Primary outcome was response rate, measured according to Response Criteria in Solid Tumors criteria. Treatment toxicity, surgical morbidity, and type of surgery were also evaluated.
We treated 6 patients in the period between May 2009 and May 2011, of which 4 patients had a diagnosis of locally advanced disease and 2 patients had a diagnosis of recurrent disease. A median number of 7.5 cycles of paclitaxel/carboplatin weekly was administered (range, 3-9). No objective response was observed. Paclitaxel/carboplatin weekly was discontinued after a mean of 4.3 weekly cycles in 3 patients owing to local disease progression. After a median follow-up of 4.2 months (range, 1-29 months), 3 patients died owing to progressive disease and 1 patient died owing to intercurrent disease. The 2 remaining patients underwent radical vulvectomy + bilateral inguinofemoral lymphadenectomy after neoadjuvant chemotherapy. The main chemotherapy-related toxicity was anemia and could be managed conservatively with erythropoietin and intravenous iron therapy.
Weekly administration of paclitaxel-carboplatin has limited clinical benefit in the treatment of vulvar squamous cell carcinoma.
评估每周紫杉醇/卡铂化疗治疗局部晚期、转移性或复发性外阴鳞状细胞癌患者的疗效。
启动了一项前瞻性、单臂、单中心的试验性研究,以研究 9 个疗程每周紫杉醇(60mg/m)和卡铂(曲线下面积 2.7)的反应率。我们在新辅助或转移性环境中使用该方案,当手术会导致严重发病率或由于远处转移而不是选择手术时。主要结局是根据实体瘤反应标准评估的反应率。还评估了治疗毒性、手术发病率和手术类型。
我们在 2009 年 5 月至 2011 年 5 月期间治疗了 6 例患者,其中 4 例患者诊断为局部晚期疾病,2 例患者诊断为复发性疾病。中位数为每周 7.5 个周期的紫杉醇/卡铂(范围 3-9)。未观察到客观反应。由于局部疾病进展,3 例患者在平均 4.3 个周期的每周紫杉醇/卡铂后停止治疗。中位随访 4.2 个月(范围 1-29 个月)后,3 例患者因进展性疾病死亡,1 例患者因并发疾病死亡。2 例其余患者在新辅助化疗后接受了根治性外阴切除术+双侧腹股沟股淋巴结切除术。主要化疗相关毒性是贫血,可以通过促红细胞生成素和静脉铁治疗保守治疗。
每周给予紫杉醇-卡铂治疗外阴鳞状细胞癌的临床获益有限。