Morbidity after secondary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy for ovarian cancer: An analysis of a randomized phase II trial

Gynecol Oncol. 2023 Apr:171:23-30. doi: 10.1016/j.ygyno.2023.02.003. Epub 2023 Feb 16.

Abstract

Objective: 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.

Methods: 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.

Results: 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).

Conclusion: Postoperative complications following SCS with or without HIPEC were associated with slight delays in chemotherapy initiation but did not significantly impact oncologic outcomes.

Keywords: Hyperthermic intraperitoneal chemotherapy; Morbidity; Postoperative complications; Recurrent ovarian cancer; Secondary cytoreductive surgery; Survival.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carcinoma, Ovarian Epithelial / drug therapy
  • Carcinoma, Ovarian Epithelial / surgery
  • Combined Modality Therapy
  • Cytoreduction Surgical Procedures / adverse effects
  • Female
  • Humans
  • Hyperthermia, Induced* / adverse effects
  • Hyperthermic Intraperitoneal Chemotherapy / adverse effects
  • Morbidity
  • Ovarian Neoplasms* / drug therapy
  • Ovarian Neoplasms* / surgery
  • Postoperative Complications / epidemiology
  • Postoperative Complications / etiology