Rathod Praveen S, Kundargi Rajshekar, Pallavi V R, Vijay C R, Devi Uma K, Bafna Uttam D
Departments of *Gynaecologic Oncology and †Biostatistics, Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India.
Int J Gynecol Cancer. 2015 Nov;25(9):1737-41. doi: 10.1097/IGC.0000000000000552.
The aim of this study was to evaluate the results with novel drug combination consisting of paclitaxel and carboplatin (PC) for salvage of refractory high-risk gestational trophoblastic neoplasia (GTN) previously treated with EMA-CO (etoposide, methotrexate, actinomycin, cyclophosphamide, and vincristine) and EMA-EP (etoposide, methotrexate, actinomycin, and cisplatin) regimens.
This was a prospective study conducted at a regional cancer institute from 2008 to 2012. The study group received the combination of paclitaxel (175 mg/m) and carboplatin (area under the curve, 6) intravenously every 3 weeks. After undetectable β-subunit of human chorionic gonadotropin values are achieved, 2 courses of additional chemotherapy were administered to reduce the risk of relapse. They were followed up and assessed by clinical examination, monthly β-subunit of human chorionic gonadotropin for a minimum of 24 months. The event-free survival and overall survival were calculated for all patients using Kaplan-Meier curve (SPSS version 19; SPSS Inc).
A total of 65 persistent GTN patients were treated during the study period. Eight (12.3%) of 65 patients having refractory GTN were treated with PC regimen. The initial International Federation of Gynecology and Obstetrics staging in the study group was stage I disease in 1 (12.5%), stage III in 4 (50%), and stage IV in 3 (37.5%) patients. According to the World Health Organization prognostic risk scores, 1 patient was in the low-risk group (12.5%), and 7 patients were in the high-risk group (87.5%). The study group received a total 35 courses of the combination PC. The median number of courses for each patient was 4.4. The complications include mucositis in 3 patients and thrombocytopenia, febrile neutropenia, and transient hepatic dysfunction in other patients. Six (75%) of 8 patients had good response, whereas 2 patients had progression. Five patients (62.5%) are in remission at median 30 months' follow-up, and 3 (37.5%) of 8 patients have died.
The combination of paclitaxel and carboplatin (PC) regimen produces durable complete remission and manageable side effect profile in patients with refractory GTN previously treated extensively with frontline chemotherapies.
本研究旨在评估由紫杉醇和顺铂(PC)组成的新型药物组合对先前接受EMA-CO(依托泊苷、甲氨蝶呤、放线菌素、环磷酰胺和长春新碱)和EMA-EP(依托泊苷、甲氨蝶呤、放线菌素和顺铂)方案治疗的难治性高危妊娠滋养细胞肿瘤(GTN)的挽救治疗效果。
这是一项于2008年至2012年在一家地区癌症研究所进行的前瞻性研究。研究组每3周静脉注射紫杉醇(175mg/m²)和顺铂(曲线下面积为6)的组合。在人绒毛膜促性腺激素β亚单位值检测不到后,再进行2个疗程的化疗以降低复发风险。通过临床检查、每月检测人绒毛膜促性腺激素β亚单位对患者进行随访和评估,至少持续24个月。使用Kaplan-Meier曲线(SPSS 19版;SPSS公司)计算所有患者的无事件生存期和总生存期。
研究期间共治疗了65例持续性GTN患者。65例难治性GTN患者中有8例(12.3%)接受了PC方案治疗。研究组最初的国际妇产科联合会分期为:1例(12.5%)为I期疾病,4例(50%)为III期,3例(37.5%)为IV期。根据世界卫生组织预后风险评分,1例患者属于低风险组(12.5%),7例患者属于高风险组(87.5%)。研究组共接受了35个疗程的PC组合治疗。每位患者的疗程中位数为4.4个。并发症包括3例患者出现粘膜炎,其他患者出现血小板减少、发热性中性粒细胞减少和短暂性肝功能障碍。8例患者中有6例(75%)反应良好,而2例患者病情进展。5例患者(62.5%)在中位随访30个月时处于缓解状态,8例患者中有3例(37.5%)死亡。
对于先前接受过广泛一线化疗的难治性GTN患者,紫杉醇和顺铂(PC)方案组合可产生持久的完全缓解,且副作用易于控制。