Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer

被引:1899
作者
Vergote, Ignace [1 ]
Trope, Claes G. [2 ,3 ,4 ]
Amant, Frederic
Kristensen, Gunnar B. [3 ,4 ]
Ehlen, Tom [5 ]
Johnson, Nick [6 ]
Verheijen, Rene H. M. [9 ]
van der Burg, Maria E. L. [10 ]
Lacave, Angel J. [12 ]
Panici, Pierluigi Benedetti [13 ]
Kenter, Gemma G. [11 ]
Casado, Antonio
Mendiola, Cesar [15 ,16 ]
Coens, Corneel
Verleye, Leen [2 ]
Stuart, Gavin C. E. [5 ]
Pecorelli, Sergio [14 ]
Reed, Nick S. [7 ,8 ]
机构
[1] Katholieke Univ Leuven, Univ Hosp, Div Gynecol Oncol, Dept Obstet & Gynecol, B-3000 Louvain, Belgium
[2] European Org Res & Treatment Canc Headquarters, Brussels, Belgium
[3] Norwegian Radium Hosp, Oslo, Norway
[4] Inst Med Informat, Oslo, Norway
[5] Univ British Columbia, Vancouver, BC V5Z 1M9, Canada
[6] Royal United Hosp, Bath BA1 3NG, Avon, England
[7] Gartnavel Royal Hosp, Glasgow, Lanark, Scotland
[8] Western Infirm & Associated Hosp, Beatson Oncol Ctr, Glasgow G11 6NT, Lanark, Scotland
[9] Vrije Univ Amsterdam, Med Ctr, Amsterdam, Netherlands
[10] Erasmus MC Univ Med Ctr Rotterdam, Rotterdam, Netherlands
[11] Leiden Univ, Med Ctr, Leiden, Netherlands
[12] Hosp Univ Cent Asturias, Oviedo, Spain
[13] Univ Roma La Sapienza, Rome, Italy
[14] Univ Brescia, Brescia, Italy
[15] Hosp Univ San Carlos, Madrid, Spain
[16] Hosp Univ 12 Octubre, Madrid, Spain
关键词
EPITHELIAL OVARIAN; CYTOREDUCTIVE SURGERY; DEBULKING SURGERY; SURGICAL CYTOREDUCTION; OPEN LAPAROSCOPY; CARCINOMA; SURVIVAL; MANAGEMENT; METAANALYSIS; EVALUATE;
D O I
10.1056/NEJMoa0908806
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Primary debulking surgery before initiation of chemotherapy has been the standard of care for patients with advanced ovarian cancer. METHODS We randomly assigned patients with stage IIIC or IV epithelial ovarian carcinoma, fallopian-tube carcinoma, or primary peritoneal carcinoma to primary debulking surgery followed by platinum-based chemotherapy or to neoadjuvant platinum-based chemotherapy followed by debulking surgery (so-called interval debulking surgery). RESULTS Of the 670 patients randomly assigned to a study treatment, 632 (94.3%) were eligible and started the treatment. The majority of these patients had extensive stage IIIC or IV disease at primary debulking surgery (metastatic lesions that were larger than 5 cm in diameter in 74.5% of patients and larger than 10 cm in 61.6%). The largest residual tumor was 1 cm or less in diameter in 41.6% of patients after primary debulking and in 80.6% of patients after interval debulking. Postoperative rates of adverse effects and mortality tended to be higher after primary debulking than after interval debulking. The hazard ratio for death (intention-to-treat analysis) in the group assigned to neoadjuvant chemotherapy followed by interval debulking, as compared with the group assigned to primary debulking surgery followed by chemotherapy, was 0.98 (90% confidence interval [CI], 0.84 to 1.13; P = 0.01 for non-inferiority), and the hazard ratio for progressive disease was 1.01 (90% CI, 0.89 to 1.15). Complete resection of all macroscopic disease (at primary or interval surgery) was the strongest independent variable in predicting overall survival. CONCLUSIONS Neoadjuvant chemotherapy followed by interval debulking surgery was not inferior to primary debulking surgery followed by chemotherapy as a treatment option for patients with bulky stage IIIC or IV ovarian carcinoma in this study. Complete resection of all macroscopic disease, whether performed as primary treatment or after neoadjuvant chemotherapy, remains the objective whenever cytoreductive surgery is performed.
引用
收藏
页码:943 / 953
页数:11
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