术期热疗腹腔内化疗治疗术后,对于晚期卵巢癌患者,特别是已接受新辅助化疗的患者。
Hyperthermic Intraperitoneal Chemotherapy After Interval Cytoreductive Surgery for Patients With Advanced-Stage Ovarian Cancer Who Had Received Neoadjuvant Chemotherapy.
发表日期:2023 Sep 06
作者:
Jung-Yun Lee, Yong Jae Lee, Joo-Hyuk Son, Sunghoon Kim, Min Chul Choi, Dong Hoon Suh, Jae-Yun Song, Dae Gy Hong, Mi Kyung Kim, Jae-Hoon Kim, Suk-Joon Chang
来源:
JAMA Surgery
摘要:
高温腹腔化疗(HIPEC)后进行间歇细胞减少手术(ICS)已经显示对晚期卵巢癌患者具有生存益处。然而,关于HIPEC在临床实践中的整合仍存在缺乏共识。为了评估ICS联合HIPEC与ICS单独在临床实践中对晚期卵巢癌患者的安全性和有效性。该前瞻性、多中心、比较有效性队列研究纳入了2017年9月1日至2022年4月22日间在韩国7家妇产科肿瘤研究组机构招募的205名接受至少3个周期新辅助化疗并随后进行ICS联合HIPEC或ICS单独手术的III期或IV期卵巢癌患者。因不符合纳入标准而排除了9名患者。新辅助化疗后进行ICS联合HIPEC或ICS单独手术。主要终点为无进展生存期(PFS)。总生存期(OS)和安全性为关键次要终点。本研究纳入了196名患者(中位年龄58.0岁[范围38-82岁]),其中109名接受ICS联合HIPEC,87名接受ICS单独手术。随访的中位持续时间为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ICS单独手术相比,间歇细胞减少手术联合HIPEC显著改善了中位PFS(22.9个月[95% CI, 3.5-58.6个月] vs 14.2个月[95% CI, 4.0-56.2个月];P = .005)和中位OS(未达到[95% CI, 3.5个月至未达到] vs 53.0个月[95% CI, 4.6-56.2个月];P = .002)。两组术后3级或4级并发症的发生率相似(ICS联合HIPEC,109例中的3例[2.8%] vs ICS单独手术,87例中的3例[3.4%];P > .99)。在复发患者中,ICS联合HIPEC组中腹膜复发的发生率低于ICS单独手术组(64例中的21例[32.8%] vs 64例中的41例[64.1%];P = .001)。本研究表明,ICS联合HIPEC与ICS单独手术相比,对于晚期卵巢癌患者,能够延长PFS和OS,并且不会增加术后并发症的发生率。HIPEC后腹膜复发率的降低可能与OS的改善有关。
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.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.