van de Laar Rafli, Zusterzeel Petra L M, Van Gorp Toon, Buist Marrije R, van Driel Willemien J, Gaarenstroom Katja N, Arts Henriette J G, van Huisseling Johannes C M, Hermans Ralph H M, Pijnenborg Johanna M A, Schutter Eltjo M J, Pelikan Harold M P, Vollebergh Jos H A, Engelen Mirjam J A, Inthout Joanna, Kruitwagen Roy F P M, Massuger Leon F A G
Department of Obstetrics and Gynecology, Radboud University Medical Centre, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.
BMC Cancer. 2014 Jan 14;14:22. doi: 10.1186/1471-2407-14-22.
Improvement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence.
METHODS/DESIGN: Multicentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.
Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.
复发性卵巢癌患者的治疗需要改进。铂敏感复发性卵巢癌患者的标准治疗包括铂类化疗。据报道，总生存期的中位数在18至35个月之间。目前，手术在复发性卵巢癌中的作用尚不清楚。在部分选择性患者中，接受完全性二次细胞减灭术的患者的生存获益可达62个月。由于缺乏I-II级证据，复发性铂敏感卵巢癌的细胞减灭术是否有益仍存在疑问。
方法/设计：多中心随机对照试验，包括荷兰所有9个妇科肿瘤中心及其附属医院。符合条件的患者为患有国际妇产科联盟（FIGO）Ic-IV期铂敏感上皮性卵巢癌、原发性腹膜癌或输卵管癌首次复发且符合纳入标准的女性。参与者被随机分配至由至少六个周期静脉铂类化疗组成的标准治疗组和由二次细胞减灭术加至少六个周期静脉铂类化疗组成的试验治疗组。主要结局指标是无进展生存期。总共230名患者将被随机分组。数据将根据意向性分析进行分析。
虽然细胞减灭术在卵巢癌初始治疗中的作用已被广泛接受，但到目前为止，其在复发性铂敏感上皮性卵巢癌中的价值尚未确立。必须更好地了解二次细胞减灭术的获益和患者选择标准。因此，2010年第四届卵巢癌共识会议指出，迫切需要进行随机对照3期试验来评估手术在铂敏感复发性上皮性卵巢癌中的作用。我们开展了一项最近启动的多中心随机对照试验，该试验将研究二次细胞减灭术联合化疗是否能改善部分铂敏感上皮性卵巢癌首次复发患者的无进展生存期。
