美国德克萨斯大学Robert L. Coleman研究小组在研究中取得进展。他们对二次细胞减灭术治疗复发性卵巢癌的疗效进行了研究。相关论文2019年11月14日发表在《新英格兰医学杂志》上。

二次细胞减灭术目前已广泛应用于铂敏感、复方性上皮性卵巢癌、原发性腹膜癌或输卵管癌（卵巢癌）患者，但尚未在临床3期的研究中进行评估。

研究组招募了485例既往接受过一次治疗的复发性卵巢癌患者，至少6个月未使用铂类化疗。经由研究者评估，240例患者实施二次细胞减灭术 + 铂类化疗，245例患者仅接受铂类化疗。由研究者决定是否使用辅助化疗和贝伐单抗治疗。

中位随访48.1个月后，接受二次细胞减灭术的患者中有67%获得完全切除。两组间贝伐单抗的用药率无显著差异。手术组的中位总生存期为50.6个月，非手术组为64.7个月，死亡风险比为1.29。调整无铂间隔或化疗方案未影响疗效。手术组的中位无进展生存期为18.9个月，非手术组为16.2个月，疾病进展或死亡的风险比为0.82。手术组术后30天并发症的发生率为9%，1例患者因并发症死亡。术后患者的生活质量显著下降，但两组患者康复后的生活质量无显著差异。

总之，在这项涉及铂敏感的复发性卵巢癌患者的试验中，二次细胞减灭术后联合化疗与单纯化疗相比并未延长患者的总生存期。

附：英文原文

Title: Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer

Author: 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.

Issue&Volume: 2019-11-13

Abstract:

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.

ConclusionsIn 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.)

DOI: NJ201911143812008

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1902626