Pressurized intraperitoneal aerosol chemotherapy (PIPAC) versus intravenous chemotherapy in unresectable peritoneal metastases secondary to platinum-resistant ovarian cancer: Interim analysis of Indian randomized control trial.

Authors

S.P. Somashekhar

S.P. Somashekhar

Manipal Comprehensive Cancer Center, Bangalore, India

S.P. Somashekhar , Rohit Kumar , Amit Rauthan , Poonam Patil , Priya Kapoor , Susmita Rakshit , Ashwin K. Rajgopal

Organizations

Manipal Comprehensive Cancer Center, Bangalore, India, Manipal Hospital, Bangalore, India, Manipal Comphrensive Cancer Center, Bengaluru, India, Manipal Comphrensive Cancer Center, Bangalore, India

Research Funding

No funding received

Background: PIPAC has emerged as a novel way to deliver intraperitoneal chemotherapy. PIPAC has shown improved response rate and quality of life in patients with inoperable peritoneal carcinomatosis. Methods: The trial is registered with Clinical Trials Registry – India (CTRI) REF/2018/08/021223. Interim analysis is presented here. Primary endpoint was to assess the objective response rate (With RECIST 1.1) between PIPAC and IV chemotherapy arm. Secondary endpoints were to assess quality of life (QLQ C-30) and morbidity (CTCAE 4.0 and Clavien dindo) between the two groups. PIPAC was done with dose of cisplatin 15mg /m2 and doxorubicin at 3mg/m2. The choice of chemotherapy was left at the discretion of treating physician. The response rate (With MRI & Ca-125) & quality of life assessment (QLQ C-30) of both the group was done periodically and recorded. Results: 40 patients underwent 105 PIPAC applications with nearly 25 (62.5%) had 3 cycles completed. 40 patients underwent IV chemotherapy same time with nearly 23 (57.5%) having received atleast 5 cycles. Mean age 57.3±8.05, PCI 24.45±6.39, with nearly 45.5% of patients had previous surgery and 72.5% of patients having received atleast 2 lines of prior chemotherapy and nearly 60 % having ascites. The objective response rate is 66.6% versus 22.5%, grade 3-4 events were 10.0% vs. 35.7 % in PIPAC and IV arm respectively. Histological regression was seen in 67.5% of patients with 3 cycles PIPAC. Functional, symptom and global health score at day 120 was significantly better with PIPAC arm when compared to IV arm. Conclusions: PIPAC is safe and feasible for patients with unresectable platinum resistant ovarian cancer. PIPAC showed better objective response rates and improved quality of life when compared to chemotherapy arm with acceptable morbidity. Clinical trial information: REF/2018/08/021223.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Biologic Correlates

Clinical Trial Registration Number

REF/2018/08/021223

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 5524)

DOI

10.1200/JCO.2022.40.16_suppl.5524

Abstract #

5524

Poster Bd #

403

Abstract Disclosures