Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study

BMC Cancer

Rafli van de Laar¹⁰  Petra LM Zusterzeel¹⁰  Toon Van Gorp⁸  Marrije R Buist¹²  Willemien J van Driel³  Katja N Gaarenstroom¹¹  Henriette JG Arts¹³  Johannes CM van Huisseling⁷  Ralph HM Hermans⁵  Johanna MA Pijnenborg²  Eltjo MJ Schutter⁶  Harold MP Pelikan⁹  Jos HA Vollebergh¹⁴  Mirjam JA Engelen⁴  Joanna IntHout¹  Roy FPM Kruitwagen⁸  Leon FAG Massuger¹⁰ 

[1] Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands

[2] Department of Obstetrics and Gynaecology, TweeSteden Hospital, Tilburg, The Netherlands

[3] Department of Obstetrics and Gynaecology, Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

[4] Department of Obstetrics and Gynaecology, Atrium Medical Center, Heerlen, The Netherlands

[5] Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands

[6] Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, The Netherlands

[7] Department of Obstetrics and Gynaecology, Groene Hart Hospital, Gouda, The Netherlands

[8] Department of Obstetrics and Gynaecology, Maastricht University Medical Center, GROW -School for Oncology and Developmental Biology, Maastricht, The Netherlands

[9] Department of Obstetrics and Gynaecology, Bronovo Hospital, Den Haag, The Netherlands

[10] Department of Obstetrics and Gynecology, Radboud University Medical Centre, PO Box 9101, 6500, HB, Nijmegen, The Netherlands

[11] Department of Obstetrics and Gynaecology, Leiden University Medical Center, Leiden, The Netherlands

[12] Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, The Netherlands

[13] Department of Gynaecology, University Medical Center Groningen, Groningen, The Netherlands

[14] Department of Obstetrics and Gynaecology, Bernhoven Hospital, Uden, The Netherlands

关键词: Ovarian cancer;    Platinum-sensitive;    Recurrent;    Secondary cytoreductive surgery;   

Others  :  859144
DOI  :  10.1186/1471-2407-14-22

 received in 2013-06-28, accepted in 2014-01-08,  发布年份 2014

【 摘 要 】

Background

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.

Discussion

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 4^th 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.

Trial registration

Netherlands Trial Register number: NTR3337.

【 授权许可】

   
2014 van de Laar et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Ledermann JA, Raja FA: Clinical trials and decision-making strategies for optimal treatment of relapsed ovarian cancer. Eur J Cancer 2011, 47:S104-S115.
• [2]Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, et al.: Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 2003, 361(9375):2099-2106.
• [3]Pfisterer J, Vergote I, Du Bois A, Eisenhauer E: Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer. Int J Gynecol Cancer 2005, 15(Suppl 1):36-41.
• [4]Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, Sovak MA, Yi J, Nycum LR: OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012, 30(17):2039-2045.
• [5]Bristow RE, Puri I, Chi DS: Cytoreductive surgery for recurrent ovarian cancer: a meta-analysis. Gynecol Oncol 2009, 112(1):265-274.
• [6]Harter P, du Bois A, Hahmann M, Hasenburg A, Burges A, Loibl S, Gropp M, Huober J, Fink D, Schroder W, et al.: Surgery in recurrent ovarian cancer: the Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) DESKTOP OVAR trial. Ann Surg Oncol 2006, 13(12):1702-1710.
• [7]Harter P, Sehouli J, Reuss A, Hasenburg A, Scambia G, Cibula D, Mahner S, Vergote I, Reinthaller A, Burges A, et al.: Prospective validation study of a predictive score for operability of recurrent ovarian cancer: the Multicenter Intergroup Study DESKTOP II. A project of the AGO Kommission OVAR, AGO Study Group, NOGGO, AGO-Austria, and MITO. Int J Gynecol Cancer 2011, 21(2):289-295.
• [8]Tian WJ, Chi DS, Sehouli J, Trope CG, Jiang R, Ayhan A, Cormio G, Xing Y, Breitbach GP, Braicu EI, et al.: A risk model for secondary cytoreductive surgery in recurrent ovarian cancer: an evidence-based proposal for patient selection. Ann Surg Oncol 2012, 19(2):597-604.
• [9]Woelber L, Jung S, Eulenburg C, Mueller V, Schwarz J, Jaenicke F, Mahner S: Perioperative morbidity and outcome of secondary cytoreduction for recurrent epithelial ovarian cancer. Eur J Surg Oncol 2010, 36(6):583-588.
• [10]Galaal K, Naik R, Bristow RE, Patel A, Bryant A, Dickinson HO: Cytoreductive surgery plus chemotherapy versus chemotherapy alone for recurrent epithelial ovarian cancer. Cochrane Database Syst Rev 2010., 6CD007822
• [11]Friedlander M, Trimble E, Tinker A, Alberts D, Avall-Lundqvist E, Brady M, Harter P, Pignata S, Pujade- Lauraine E, Sehouli J, et al.: Clinical trials in recurrent ovarian cancer. Int J Gynecol Cancer 2011, 21(4):771-775.
• [12]Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, et al.: New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45(2):228-247.
• [13]Rustin GJ, Vergote I, Eisenhauer E, Pujade-Lauraine E, Quinn M, Thigpen T, du Bois A, Kristensen G, Jakobsen A, Sagae S, et al.: Definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup (GCIG). Int J Gynecol Cancer 2011, 21(2):419-423.