Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer

被引:256
作者
Coleman, Robert L. [1 ]
Spirtos, Nick M. [2 ]
Enserro, Danielle [3 ]
Herzog, Thomas J. [6 ]
Sabbatini, Paul [4 ,5 ]
Armstrong, Deborah K. [7 ]
Kim, Jae-Weon [8 ]
Park, Sang-Yoon [11 ]
Kim, Byoung-Gie [9 ]
Nam, Joo-Hyun [10 ]
Fujiwara, Keiichi [12 ]
Walker, Joan L. [13 ]
Casey, Ann C. [14 ,15 ]
Alvarez Secord, Angeles [16 ]
Rubin, Steve [17 ]
Chan, John K. [18 ]
DiSilvestro, Paul [19 ]
Davidson, Susan A. [20 ,21 ]
Cohn, David E. [22 ]
Tewari, Krishnansu S. [23 ]
Basen-Engquist, Karen [1 ]
Huang, Helen Q. [3 ]
Brady, Mark F. [3 ]
Mannel, Robert S. [13 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[2] Womens Canc Ctr Nevada, Las Vegas, NV USA
[3] Roswell Park Canc Inst, NRG Oncol Stat & Data Management Ctr, Buffalo, NY 14263 USA
[4] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
[5] Weill Cornell Med Coll, New York, NY USA
[6] Univ Cincinnati, Inst Canc, Cincinnati, OH USA
[7] Johns Hopkins Univ, Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA
[8] Seoul Natl Univ, Coll Med, Seoul, South Korea
[9] Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Seoul, South Korea
[10] Univ Ulsan, Coll Med, Asan Med Ctr, Seoul, South Korea
[11] Natl Canc Ctr, Res Inst & Hosp, Goyang, South Korea
[12] Saitama Med Univ, Int Med Ctr, Hidaka, Japan
[13] Univ Oklahoma, Hlth Sci Ctr, Oklahoma City, OK USA
[14] US Oncol Res, Natl Surg Adjuvant Breast & Bowel ProjectNRG Onco, Minneapolis, MN USA
[15] Metro Minnesota Community Oncol Res Consortium, Minneapolis, MN USA
[16] Duke Univ, Med Ctr, Duke Canc Inst, Durham, NC USA
[17] Univ Penn, Abramson Canc Ctr, Philadelphia, PA 19104 USA
[18] Calif Pacific Palo Alto Med Fdn, Sutter Res Inst, Gynecol Canc Program, San Francisco, CA USA
[19] Women & Infants Hosp Rhode Isl, Providence, RI USA
[20] Univ Colorado, Sch Med, Aurora, CO USA
[21] Denver Hlth Med Ctr, Aurora, CO USA
[22] Ohio State Univ, Columbus, OH 43210 USA
[23] Univ Calif Irvine, Orange, CA 92668 USA
基金
美国国家卫生研究院;
关键词
EPITHELIAL OVARIAN; DOUBLE-BLIND; MAINTENANCE THERAPY; SURGERY; BEVACIZUMAB; CHEMOTHERAPY; SENSITIVITY; MULTICENTER; SELECTION; SURVIVAL;
D O I
10.1056/NEJMoa1902626
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
An NCI-sponsored, randomized clinical trial tested whether patients with relapsed ovarian cancer might benefit from surgical debulking of tumors followed by chemotherapy, as compared with chemotherapy alone. No significant outcome differences were noted between the patients who underwent surgery and those treated with chemotherapy alone. Background Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube ("ovarian") cancer is widely practiced but has not been evaluated in phase 3 investigation. Methods We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. Results A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P=0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. Conclusions In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).)
引用
收藏
页码:1929 / 1939
页数:11
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