Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.
Comprehensive Gynecologic Cancer Center, CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do, Korea.
JAMA Surg. 2023 Nov 1;158(11):1133-1140. doi: 10.1001/jamasurg.2023.3944.
Hyperthermic intraperitoneal chemotherapy (HIPEC) followed by interval cytoreductive surgery (ICS) has shown survival benefits for patients with advanced-stage ovarian cancer. However, there is still a lack of consensus regarding the integration of HIPEC into clinical practice.
To evaluate the safety and effectiveness of ICS with HIPEC compared with ICS alone in clinical practice for patients with advanced-stage ovarian cancer.
DESIGN, SETTING, AND PARTICIPANTS: This prospective, multicenter, comparative effectiveness cohort study enrolled 205 patients with stage III or IV ovarian cancer who had received at least 3 cycles of neoadjuvant chemotherapy followed by ICS with HIPEC or ICS without HIPEC at 7 Korean Gynecologic Oncology Group institutions between September 1, 2017, and April 22, 2022. Nine patients were excluded because they did not meet the inclusion criteria.
Neoadjuvant chemotherapy followed by ICS with HIPEC or ICS without HIPEC.
The primary end point was progression-free survival (PFS). Overall survival (OS) and the safety profile were the key secondary end points.
This study included 196 patients (median age, 58.0 years [range, 38-82 years]), of whom 109 underwent ICS with HIPEC and 87 underwent ICS without HIPEC. The median duration of follow-up was 28.2 months (range, 3.5-58.6 months). Disease recurrence occurred in 128 patients (65.3%), and 30 patients (15.3%) died. Interval cytoreductive surgery with HIPEC was associated with a significant improvement in median PFS compared with ICS without HIPEC (22.9 months [95% CI, 3.5-58.6 months] vs 14.2 months [95% CI, 4.0-56.2 months]; P = .005) and median OS (not reached [95% CI, 3.5 months to not reached] vs 53.0 [95% CI, 4.6-56.2 months]; P = .002). The frequency of grade 3 or 4 postoperative complications was similar in both groups (ICS with HIPEC, 3 of 109 [2.8%] vs ICS without HIPEC, 3 of 87 [3.4%]; P > .99). Among patients with recurrence, the frequency of peritoneal recurrence was lower in the ICS with HIPEC group than in the ICS without HIPEC group (21 of 64 [32.8%] vs 41 of 64 [64.1%]; P = .001).
This study suggests that ICS in conjunction with HIPEC was associated with longer PFS and OS than ICS without HIPEC for patients with advanced-stage ovarian cancer and was not associated with higher rates of postoperative complications. The lower rate of peritoneal recurrence after HIPEC may be associated with improved OS.
腹腔内热灌注化疗（HIPEC）联合间隔细胞减灭术（ICS）已显示出对晚期卵巢癌患者的生存益处。然而，HIPEC 整合到临床实践中仍然缺乏共识。
评估与单独 ICS 相比，晚期卵巢癌患者接受 HIPEC 联合 ICS 的安全性和有效性。
设计、地点和参与者：这是一项前瞻性、多中心、比较有效性队列研究，纳入了 205 名在韩国妇科肿瘤学组 7 家机构接受至少 3 个周期新辅助化疗后接受 ICS 联合 HIPEC 或 ICS 联合 HIPEC 的 III 期或 IV 期卵巢癌患者，时间为 2017 年 9 月 1 日至 2022 年 4 月 22 日。由于不符合纳入标准，有 9 名患者被排除在外。
新辅助化疗后 ICS 联合 HIPEC 或 ICS 联合 HIPEC。
主要终点是无进展生存期（PFS）。总生存期（OS）和安全性是关键次要终点。
这项研究包括 196 名患者（中位年龄 58.0 岁[范围，38-82 岁]），其中 109 名接受了 ICS 联合 HIPEC，87 名接受了 ICS 联合 HIPEC。中位随访时间为 28.2 个月（范围，3.5-58.6 个月）。128 名患者（65.3%）出现疾病复发，30 名患者（15.3%）死亡。与单独 ICS 相比，HIPEC 联合 ICS 显著改善了中位 PFS（22.9 个月[95%CI，3.5-58.6 个月]与 14.2 个月[95%CI，4.0-56.2 个月]；P=0.005）和中位 OS（未达到[95%CI，3.5 个月至未达到]与 53.0[95%CI，4.6-56.2 个月]；P=0.002）。两组术后 3 级或 4 级并发症的发生率相似（ICS 联合 HIPEC，3/109[2.8%]与 ICS 联合 HIPEC，3/87[3.4%]；P>0.99）。在复发患者中，ICS 联合 HIPEC 组腹膜复发的频率低于 ICS 联合 HIPEC 组（21/64[32.8%]与 41/64[64.1%]；P=0.001）。
这项研究表明，与单独 ICS 相比，晚期卵巢癌患者接受 HIPEC 联合 ICS 可延长 PFS 和 OS，且术后并发症发生率无增加。HIPEC 后腹膜复发率较低可能与 OS 改善有关。
