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

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

Authors:	Praiss, A. M.; Zhou, Q.; Iasonos, A.; Moukarzel, L.; Dessources, K.; Soldan, K.; Su, K.; Sonoda, Y.; Roche, K. L.; Gardner, G. J.; Troso-Sandoval, T.; Tew, W. P.; Grisham, R. N.; Chi, D. S.; O'Cearbhaill, R. E.; Zivanovic, O.
Article Title:	Morbidity after secondary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy for ovarian cancer: An analysis of a randomized phase II trial
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. © 2023
Keywords:	survival; controlled study; aged; human cell; major clinical study; overall survival; clinical trial; bevacizumab; multimodality cancer therapy; paclitaxel; combined modality therapy; cancer staging; follow up; antineoplastic agent; cytoreductive surgery; ovarian neoplasms; carboplatin; progression free survival; ovary cancer; phase 2 clinical trial; thrombocyte; randomized controlled trial; antineoplastic combined chemotherapy protocols; morbidity; hemoglobin; postoperative complication; postoperative complications; adjuvant chemotherapy; ovary tumor; medical record; interventional radiology; disease free interval; nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor; hospital readmission; hyperthermia, induced; secondary cytoreductive surgery; adverse event; recurrent ovarian cancer; thermotherapy; transfusion; response evaluation criteria in solid tumors; Common Terminology Criteria for Adverse Events; ostomy; hyperthermic intraperitoneal chemotherapy; disease burden; humans; human; female; article; cytoreduction surgical procedures; carcinoma, ovarian epithelial
Journal Title:	Gynecologic Oncology
Volume:	171
ISSN:	0090-8258
Publisher:	Elsevier Inc.
Date Published:	2023-04-01
Start Page:	23
End Page:	30
Language:	English
DOI:	10.1016/j.ygyno.2023.02.003
PUBMED:	36804618
PROVIDER:	scopus
PMCID:	PMC10206782
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-85148704286&doi=10.1016%2fj.ygyno.2023.02.003&partnerID=40&md5=3981ed962efd37d4f23ee20f498d8366
Notes:	The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Corresponding author is MSK author: Oliver Zivanovic -- Source: Scopus