随机化试验：细胞减灭术治疗复发性卵巢癌。
Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer.
机构信息
From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).
出版信息
N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294.
BACKGROUND
Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear.
METHODS
We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival.
RESULTS
A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery.
CONCLUSIONS
In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overall survival than chemotherapy alone. (Funded by the AGO Study Group and others; DESKTOP III ClinicalTrials.gov number, NCT01166737.).
背景
复发性卵巢癌患者的治疗主要基于系统治疗。二次细胞减灭术的作用尚不清楚。
方法
我们将首次铂类药物治疗后无铂间隔（无铂类化疗间隔）6 个月或以上的复发性卵巢癌患者随机分为接受二次细胞减灭术和随后接受铂类化疗或单独接受铂类化疗。如果患者具有阳性 Arbeitsgemeinschaft Gynäkologische Onkologie（AGO）评分（定义为东部肿瘤协作组表现状态评分 0 分[在 5 分制中，得分越高表示残疾程度越大]，腹水少于 500ml，且初始手术时完全切除），则符合入组条件。阳性 AGO 评分用于识别可能完全切除的患者。主要终点为总生存期。我们还评估了生活质量和生存预后因素。
结果
共 407 例患者进行了随机分组：206 例患者接受细胞减灭术和化疗，201 例患者接受单纯化疗。手术组中接受手术的患者中有 75.5%达到完全切除。手术组的中位总生存期为 53.7 个月，无手术组为 46.0 个月（死亡风险比，0.75；95%置信区间，0.59 至 0.96；P=0.02）。完全切除的患者预后最佳，中位总生存期为 61.9 个月。根据预后因素进行的所有亚组分析均显示手术有益。两组在 1 年随访期间的生活质量测量值无差异，且手术后 30 天内未观察到围手术期死亡。
结论
在复发性卵巢癌患者中，细胞减灭术加化疗的总生存期长于单纯化疗。（由 AGO 研究组等资助；DESKTOP III ClinicalTrials.gov 编号，NCT01166737）。
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