From the University of Texas M.D. Anderson Cancer Center, Houston (R.L.C., K.B.-E.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); NRG Oncology Statistical and Data Management Center, Roswell Park Cancer Institute, Buffalo (D.E., H.Q.H., M.F.B.), and Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (P.S.) - both in New York; the University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati (T.J.H.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (D.K.A.); Seoul National University College of Medicine (J.-W.K.), Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.), and Asan Medical Center, University of Ulsan College of Medicine (J.-H.N.), Seoul, and the Research Institute and Hospital, National Cancer Center, Goyang (S.-Y.P.) - all in South Korea; Saitama Medical University International Medical Center, Hidaka, Japan (K.F.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.L.W., R.S.M.); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology, U.S. Oncology Research, and Metro-Minnesota Community Oncology Research Consortium, Minneapolis (A.C.C.); Duke Cancer Institute, Duke University Medical Center, Durham, NC (A.A.S.); Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.R.); Gynecologic Cancer Program, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco (J.K.C.); Women and Infants Hospital, Providence, RI (P.D.); the University of Colorado School of Medicine, Aurora, and Denver Health Medical Center, Denver (S.A.D.); Ohio State University, Columbus (D.E.C.); and the University of California, Irvine, Orange (K.S.T.).
N Engl J Med. 2019 Nov 14;381(20):1929-1939. doi: 10.1056/NEJMoa1902626.
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.
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.
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.
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.).
在铂类敏感、复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌（“卵巢”）的女性中进行二次手术细胞减灭术被广泛应用，但尚未在 3 期研究中进行评估。
我们随机分配了接受过一次治疗、铂类无治疗间隔（platinum-free interval）为 6 个月或更长时间且研究者确定可切除疾病（无肉眼残留疾病）的铂类敏感、复发性卵巢癌患者，这些患者将接受二次手术细胞减灭术，然后接受铂类化疗或单独接受铂类化疗。辅助化疗（紫杉醇-卡铂或吉西他滨-卡铂）和贝伐单抗的使用由研究者决定。主要终点是总生存期。
共有 485 名患者进行了随机分组，240 名患者接受二次细胞减灭术联合化疗，245 名患者接受单独化疗。中位随访时间为 48.1 个月。接受手术的患者中有 67%实现了完全肉眼切除。84%的患者接受了含贝伐单抗的铂类化疗，随后接受了贝伐单抗维持治疗，两组之间的分配比例相同。手术组死亡风险（手术与非手术）为 1.29（95%置信区间[CI]，0.97 至 1.72；P=0.08），分别对应于中位总生存期分别为 50.6 个月和 64.7 个月。对铂类无治疗间隔和化疗选择进行调整并未改变该结果。疾病进展或死亡的风险（手术与非手术）为 0.82（95%CI，0.66 至 1.01；无进展生存期中位数分别为 18.9 个月和 16.2 个月）。术后 30 天的手术发病率为 9%；1 例（0.4%）患者术后并发症死亡。手术后患者报告的生活质量显著下降，但在恢复后两组之间没有显著差异。
在这项涉及铂类敏感、复发性卵巢癌患者的试验中，二次手术细胞减灭术联合化疗并未导致总生存期长于单独化疗。（由美国国立癌症研究所等资助；GOG-0213 临床试验.gov 编号，NCT00565851。）
