卵巢癌次级细胞减灭手术合并或不合并腹腔热化学治疗后的发病率：一项随机II期试验的分析。
Morbidity after secondary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy for ovarian cancer: An analysis of a randomized phase II trial.
发表日期：2023 Feb 16
作者：
Aaron M Praiss, Qin Zhou, Alexia Iasonos, Lea Moukarzel, Kimberly Dessources, Krysten Soldan, Katy Su, Yukio Sonoda, Kara Long Roche, Ginger J Gardner, Tiffany Troso-Sandoval, William P Tew, Rachel N Grisham, Dennis S Chi, Roisin E O'Cearbhaill, Oliver Zivanovic
来源：
GYNECOLOGIC ONCOLOGY
摘要：
为了评估在铂敏感复发性卵巢癌患者中进行二次减容手术（SCS）并行或不行腹腔热灌注化疗（HIPEC）后的术后并发症，我们进行了一项探索性分析。该分析所使用的对象皆在随机分组的第二期实验证明中。术后30天内的并发症使用了CTCAE版本5.0进行了分级；只有红细胞计数和血小板水平进行了评估。患者分组使用CTCAE级别进行分组，且包括CTCAE级别≥ 3 和< 3 的并发症。在83名符合条件的患者中，33人（40％）为CTCAE级别≥ 3，50人（60％）为CTCAE级别< 3; 贫血和腹部感染是最常见的症状。在术中没有死亡病例。出现≥ 3级和< 3级事件的患者术后开始化疗的时间分别为34天（范围为18-60天）和31天（范围为21-43天）（P = .017）。无论是≥3级还是<3级的并发症，中位无进展生存期（PFS）并没有明显差异（分别为11.2个月[95％CI：9.3-14.4]和14.9个月[95％CI：11.3- 16.5]; P = .186），中位总生存期（OS）也没有明显差异（分别为46.9个月[95％CI：34-不确定]和68.2个月[95％CI：52.1-不确定]; P = .053）。SCS术后并发症与化疗开始稍有延迟，但无明显影响肿瘤治疗结果。 Copyright © 2023。Elsevier Inc.出版。
To assess postoperative complications after secondary cytoreductive surgery (SCS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC), we conducted an exploratory analysis of patients with platinum-sensitive recurrent ovarian cancer enrolled in a randomized phase II trial.Complications occurring within 30 days of surgery were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0; only hemoglobin and platelet levels were assessed. Patients were grouped by CTCAE grade ≥ 3 and < 3 complications.Among 83 eligible patients, 33 (40%) had grade ≥ 3 complications and 50 (60%) had grade < 3 complications; anemia and abdominal infections were the most common. There were no perioperative mortalities. Time to initiation of postoperative chemotherapy for patients with grade ≥ 3 and grade < 3 events was 34 days (range, 18-60) and 31 days (range, 21-43), respectively (P = .017). Median progression-free survival (PFS) did not significantly differ between patients with grade ≥ 3 and grade < 3 complications (11.2 months [95% CI: 9.3-14.4] vs 14.9 months [95% CI: 11.3-16.5], respectively; P = .186), nor did median overall survival (OS) (46.9 months [95% CI: 34-NE] vs 68.2 months [95% CI: 52.1-NE], respectively; P = .053).Postoperative complications following SCS with or without HIPEC were associated with slight delays in chemotherapy initiation but did not significantly impact oncologic outcomes.Copyright © 2023. Published by Elsevier Inc.