细胞减灭术联合化疗治疗复发性卵巢癌可显著延长生存期
2021-12-11   阅读:606   来源:新英格兰医学杂志

德国埃森米特诊所Philipp Harter团队研究了细胞减灭术治疗复发性卵巢癌的疗效。2021年12月1日出版的《新英格兰医学杂志》发表了这项成果。

复发性卵巢癌的治疗主要以系统治疗为主。二次细胞减灭术的作用尚不清楚。

研究组招募复发性卵巢癌患者,他们在6个月或更长时间的无铂间隔(不使用铂基化疗的间隔)后首次复发,将其随机分组,分别接受二次细胞减灭术+铂基化疗或单独接受铂基化疗。

患者的AGO评分均为阳性,定义为东方合作肿瘤表现-状态评分为0分(5分制,得分更高表示残疾程度更大),腹水少于500毫升,在初次手术时完成卵巢切除。阳性评分用来确定哪些患者可进行完全切除。主要终点为总体生存率。研究组还评估了生活质量和生存的预后因素。

共有407名患者接受了随机分组:206名患者接受细胞减灭术和化疗,201名患者单独接受化疗。手术组75.5%的患者全部切除。手术组的平均总生存期为53.7个月,显著长于非手术组的46.0个月,死亡危险比为0.75。

完全切除的患者疗效最好,平均总生存期为61.9个月。根据预后因素,所有亚组分析均显示手术获益。两组术后1年随访的生活质量指标无差异,术后30天内无围手术期死亡。

研究结果表明,对于卵巢癌复发的女性,细胞减灭术后化疗比单纯化疗的总生存期更长。

附:英文原文

Title: Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author: Philipp Harter, M.D., Ph.D.,, Jalid Sehouli, M.D., Ph.D.,, Ignace Vergote, M.D., Ph.D.,, Gwenael Ferron, M.D., Ph.D.,, Alexander Reuss, M.Sc.,, Werner Meier, M.D., Ph.D.,, Stefano Greggi, M.D., Ph.D.,, Berit J. Mosgard, M.D., Ph.D.,, Frederic Selle, M.D., Ph.D.,, Frédéric Guyon, M.D., Ph.D.,, Christophe Pomel, M.D., Ph.D.,, Fabrice Lécuru, M.D., Ph.D.,, Rongyu Zang, M.D., Ph.D.,, Elisabeth Avall-Lundqvist, M.D., Ph.D.,, Jae-Weon Kim, M.D., Ph.D.,, Jordi Ponce, M.D., Ph.D.,, Francesco Raspagliesi, M.D., Ph.D.,, Gunnar Kristensen, M.D., Ph.D.,, Jean-Marc Classe, M.D., Ph.D.,, Peter Hillemanns, M.D., Ph.D.,, Pernille Jensen, M.D., Ph.D.,, Annette Hasenburg, M.D., Ph.D.,, Sadaf Ghaem-Maghami, M.D., Ph.D.,, Mansoor R. Mirza, M.D., Ph.D.,, Bente Lund, M.D., Ph.D.,, Alexander Reinthaller, M.D., Ph.D.,, Ana Santaballa, M.D., Ph.D.,, Adeola Olaitan, M.D., Ph.D.,, Felix Hilpert, M.D., Ph.D.,, and Andreas du Bois, M.D., Ph.D.

Issue&Volume: 2021-12-01

Abstract:

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 Gynkologische 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.

DOI: 10.1056/NEJMoa2103294

 

编辑:小柯机器人

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