Academic Journal

Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) experience in patients with recurrent low grade serous ovarian carcinoma (LGSOC): sub-cohort report of phase 1 clinical trial

التفاصيل البيبلوغرافية
العنوان: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) experience in patients with recurrent low grade serous ovarian carcinoma (LGSOC): sub-cohort report of phase 1 clinical trial
المؤلفون: Nakamura, Brad, Senguttuvan, Rosemary, Ruel, Nora H., Frankel, Paul H., Yost, Susan E., Cole, Sarah, Chang, Sue, Jung, Alexander, Eng, Melissa, Tinsley, Raechelle, Stewart, Daphne, Wang, Edward, Cohen, Joshua, Villella, Jeannine, Whelan, Richard L., Merchea, Amit, DePeralta, Danielle K., Cristea, Mihaela, Wakabayashi, Mark T., Raoof, Mustafa, Dellinger, Thanh Hue
المصدر: Frontiers in Oncology ; volume 14 ; ISSN 2234-943X
بيانات النشر: Frontiers Media SA
سنة النشر: 2024
المجموعة: Frontiers (Publisher - via CrossRef)
الوصف: Introduction Low grade serous ovarian carcinoma (LGSOC) is a rare subtype of ovarian cancer (OC) that is challenging to treat due to its relative chemoresistance. Given that LGSOC patients often recur in the peritoneal cavity, novel intraperitoneal (IP) chemotherapy should be explored. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a method that has demonstrated peritoneal disease control in cancers with peritoneal metastases. Methods NCT04329494 is a US multicenter phase 1 trial evaluating the safety of PIPAC in recurrent ovarian, uterine, and GI cancers with peritoneal metastases. This analysis describes the outcomes of a sub-cohort of four LGSOC patients treated with IP cisplatin 10.5 mg/m 2 , doxorubicin 2.1 mg/m 2 PIPAC q4-6 weeks. Primary endpoints included dose-limiting toxicities (DLT) and incidence of adverse events (AE). Secondary endpoints were progression free survival (PFS) and treatment response based on radiographic, intraoperative, and pathological findings. Results Four patients with LGSOC were enrolled of which three were heavily pretreated. Median prior lines of therapy was 5 (range 2-10). Three patients had extraperitoneal metastases, and two patients had baseline partial small bowel obstructive (SBO) symptoms. Median age of patients was 58 (38-68). PIPAC completion rate (≥2 PIPACs) was 75%. No DLTs or Clavien-Dindo surgical complications occurred. No G4/G5 AEs were observed, and one G3 abdominal pain was reported. One patient had a partial response after 3 cycles of PIPAC and completed an additional 3 cycles with compassionate use amendment. Two patients came off study after 2 cycles due to extraperitoneal progressive disease. One patient came off study after 1 cycle due to toxicity. Median decrease in peritoneal carcinomatosis index between cycles 1 and 2 was 5.0%. Ascites decreased in 2 out of 3 patients who had ≥2 PIPACs. Median PFS was 4.3 months (1.7-21.6), median overall survival was 11.6 months (5.4-30.1), and objective response rate was 25%. Conclusion PIPAC with ...
نوع الوثيقة: article in journal/newspaper
اللغة: unknown
DOI: 10.3389/fonc.2024.1404936
DOI: 10.3389/fonc.2024.1404936/full
الاتاحة: http://dx.doi.org/10.3389/fonc.2024.1404936
https://www.frontiersin.org/articles/10.3389/fonc.2024.1404936/full
Rights: https://creativecommons.org/licenses/by/4.0/
رقم الانضمام: edsbas.B6037CFF
قاعدة البيانات: BASE
الوصف
DOI:10.3389/fonc.2024.1404936