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复发性卵巢癌的二次肿瘤细胞减灭术
Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer


Robert L. Coleman ... 肿瘤 妇产科和儿科 • 2019.11.14
相关阅读
• 关于晚期卵巢肿瘤患者淋巴结清扫术的随机试验 • 卵巢癌的腹腔热灌注化疗

摘要


背景

二次肿瘤细胞减灭术已被广泛应用于对铂类药物敏感的复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌(统称为“卵巢”癌)患者,但尚未在3期研究中进行评估。

 

方法

我们将接受过一种治疗,未使用铂类化疗的间期(无铂间期)≥6个月并且研究者确定肿瘤可切除(切除至无肉眼可见的残留病灶)的复发性卵巢癌患者随机分组,分别接受二次肿瘤细胞减灭术+后续铂类化疗或接受单独铂类化疗。辅助化疗(紫杉醇-卡铂或吉西他滨-卡铂)和贝伐珠单抗的应用由研究者决定。主要终点是总生存期。

 

结果

共计485例患者被随机分组,其中240例被分配接受二次肿瘤细胞减灭术+后续化疗,245例被分配接受单独化疗。中位随访时间为48.1个月。在被分配接受手术并实际接收了手术的患者中,67%完成了肉眼完全切除。所有患者中有84%接受了铂类化疗+贝伐珠单抗治疗,以及后续贝伐珠单抗维持治疗,并且此类患者在两组之间均衡分布。死亡的风险比(手术vs.非手术)为1.29(95% CI,0.97~1.72;P=0.08),相当于中位总生存期分别为50.6个月和64.7个月。针对无铂间期和化疗方案选择所做的校正未改变效应。疾病进展或死亡的风险比(手术vs.非手术)为0.82(95% CI,0.66~1.01;中位无进展生存期,分别为18.9个月和16.2个月)。30日时的手术发病率为9%;1例患者(0.4%)死于术后并发症。患者报告术后生活质量显著降低,但康复后两组的生活质量无显著差异。

 

结论

在纳入对铂类药物敏感的复发性卵巢癌患者的这项试验中,二次肿瘤细胞减灭术+后续化疗组的总生存期未超过单独化疗组(由美国国立癌症研究所[National Cancer Institute]等资助;GOG-0213在ClinicalTrials.gov注册号为NCT00565851)。





作者信息

Robert L. Coleman, M.D., Nick M. Spirtos, M.D., Danielle Enserro, Ph.D., Thomas J. Herzog, M.D., Paul Sabbatini, M.D., Deborah K. Armstrong, M.D., Jae-Weon Kim, M.D., Sang-Yoon Park, M.D., Byoung-Gie Kim, M.D., Joo-Hyun Nam, M.D., Keiichi Fujiwara, M.D., Joan L. Walker, M.D., Ann C. Casey, M.D., Angeles Alvarez Secord, M.D., Steve Rubin, M.D., John K. Chan, M.D., Paul DiSilvestro, M.D., Susan A. Davidson, M.D., David E. Cohn, M.D., Krishnansu S. Tewari, M.D., Karen Basen-Engquist, Ph.D., Helen Q. Huang, M.S., Mark F. Brady, Ph.D., and Robert S. Mannel, M.D.
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.). Address reprint requests to Dr. Coleman at the University of Texas M.D. Anderson Cancer Center, Department of Gynecologic Oncology and Reproductive Medicine, 1155 Herman Pressler Dr., CPB 6.3590, Houston, TX 77030, or at rcoleman@mdanderson.org.

 

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