TY - JOUR
T1 - Safety and Efficacy of Cisplatin and Doxorubicin Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients with Ovarian Cancer with Peritoneal Metastases
T2 - A Multicenter US Phase I Trial
AU - Nakamura, Brad
AU - Senguttuvan, Rosemary
AU - Ruel, Nora H.
AU - Frankel, Paul H.
AU - Yost, Susan E.
AU - Cole, Sarah
AU - Chang, Sue
AU - Jung, Alexander
AU - Eng, Melissa
AU - Tinsley, Raechelle
AU - Synold, Timothy
AU - Stewart, Daphne
AU - Wang, Edward
AU - Cohen, Joshua
AU - Villella, Jeannine
AU - Whelan, Richard L.
AU - Merchea, Amit
AU - DePeralta, Danielle K.
AU - Woo, Yanghee
AU - Raoof, Mustafa
AU - Dellinger, Thanh Hue
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2026/1
Y1 - 2026/1
N2 - Background: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel, minimally invasive method of delivering intraperitoneal chemotherapy with promising peritoneal disease control in ovarian cancer. Methods: This US multicenter prospective phase I trial (NCT04329494) evaluated the safety and efficacy of PIPAC cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 (PIPAC-CD) every 6 weeks in ovarian cancer at three US centers. Primary endpoints were dose-limiting toxicities and adverse events. Secondary endpoints included response according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, laparoscopic peritoneal carcinomatosis index, histologic peritoneal regression grading score, progression-free survival (PFS), and overall survival (OS). Results: In total, 15 patients were enrolled. The median prior lines of therapy was 3 (range 1–10). The PIPAC completion rate (≥2 PIPACs) was 86.7%. A total of 76.9% of patients had extraperitoneal disease at baseline. One patient discontinued treatment for toxicity because of deterioration of her baseline Eastern Cooperative Oncology Group 2 performance status. There was one grade 3 abdominal pain, one grade 3 anorexia, and no grade 4 or 5 adverse events. Laparoscopic best response (peritoneal carcinomatosis index) and histologic response (peritoneal regression grading score) occurred in 30.8% and 46.2%, respectively. Radiologic best response (RECIST) was 6.7%, with one partial response and a stable disease rate of 26.7%. Median PFS and OS were 2.3 months (95% confidence interval 1.7–3.2) and 17.1 months (95% confidence interval 5.6–not reached), respectively (n=15). Conclusions: PIPAC-CD is feasible, safe, and well tolerated at academic US centers. OS and PFS were limited in patients with heavily pretreated ovarian carcinoma who underwent PIPAC-CD. Future trials should focus on optimizing PIPAC drug combinations and determining optimal patient selection criteria for ovarian cancer.
AB - Background: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel, minimally invasive method of delivering intraperitoneal chemotherapy with promising peritoneal disease control in ovarian cancer. Methods: This US multicenter prospective phase I trial (NCT04329494) evaluated the safety and efficacy of PIPAC cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 (PIPAC-CD) every 6 weeks in ovarian cancer at three US centers. Primary endpoints were dose-limiting toxicities and adverse events. Secondary endpoints included response according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, laparoscopic peritoneal carcinomatosis index, histologic peritoneal regression grading score, progression-free survival (PFS), and overall survival (OS). Results: In total, 15 patients were enrolled. The median prior lines of therapy was 3 (range 1–10). The PIPAC completion rate (≥2 PIPACs) was 86.7%. A total of 76.9% of patients had extraperitoneal disease at baseline. One patient discontinued treatment for toxicity because of deterioration of her baseline Eastern Cooperative Oncology Group 2 performance status. There was one grade 3 abdominal pain, one grade 3 anorexia, and no grade 4 or 5 adverse events. Laparoscopic best response (peritoneal carcinomatosis index) and histologic response (peritoneal regression grading score) occurred in 30.8% and 46.2%, respectively. Radiologic best response (RECIST) was 6.7%, with one partial response and a stable disease rate of 26.7%. Median PFS and OS were 2.3 months (95% confidence interval 1.7–3.2) and 17.1 months (95% confidence interval 5.6–not reached), respectively (n=15). Conclusions: PIPAC-CD is feasible, safe, and well tolerated at academic US centers. OS and PFS were limited in patients with heavily pretreated ovarian carcinoma who underwent PIPAC-CD. Future trials should focus on optimizing PIPAC drug combinations and determining optimal patient selection criteria for ovarian cancer.
KW - Cisplatin
KW - Doxorubicin
KW - Ovarian cancer
KW - PIPAC
KW - Peritoneal metastases
KW - Pressurized intraperitoneal aerosolized chemotherapy
UR - https://www.scopus.com/pages/publications/105018227915
U2 - 10.1245/s10434-025-18432-0
DO - 10.1245/s10434-025-18432-0
M3 - Article
C2 - 41028642
AN - SCOPUS:105018227915
SN - 1068-9265
VL - 33
SP - 415
EP - 425
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
IS - 1
ER -