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Modulated electro-hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial

Title
Modulated electro-hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial
Authors
Kim, KidongKim, Jae-HoonKim, Seung CheolKim, Yong BeomNam, Byung-HoNo, Jae HongCho, HanbyoulJu, WoongSuh, Dong HoonKim, Yun Hwan
Ewha Authors
김승철주웅김윤환
SCOPUS Author ID
김승철scopus; 주웅scopus; 김윤환scopus
Issue Date
2021
Journal Title
EXPERIMENTAL AND THERAPEUTIC MEDICINE
ISSN
1792-0981JCR Link

1792-1015JCR Link
Citation
EXPERIMENTAL AND THERAPEUTIC MEDICINE vol. 22, no. 1
Keywords
cisplatininduced hyperthermiaovarian epithelial carcinomapaclitaxeltoxicity
Publisher
SPANDIDOS PUBL LTD
Indexed
SCIE; SCOPUS WOS
Document Type
Article
Abstract
The present study (KGOG 3030) aimed to evaluate the safety of modulated electro-hyperthermia (mEHT) therapy with weekly administration of paclitaxel or cisplatin in female patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. A total of 12 patients were randomized into the paclitaxel or cisplatin arm at a 1:1 ratio. Patients received weekly administration of paclitaxel (70 mg/m(2)) or cisplatin (40 mg/m(2)) intravenously on days 1, 8 and 15, and underwent mEHT therapy for 1 h on days 1, 4, 8, 11, 15, 18, 21 and 24 for each 4-week cycle. The primary endpoint was the occurrence of dose-limiting toxicity (DLT). The secondary endpoints were treatment-emergent adverse events (TEAEs), objective response rate, carbohydrate antigen 125 (CA125) response rate, progression-free survival (PFS) and overall survival (OS). In total, 16 patients were recruited, but four patients dropped out. None of the 12 remaining patients (6 each in the two arms) experienced DLT. Overall, 0 and 4 grade 3 TEAEs (anemia, nausea, neutrophil count decreased and platelet count decreased) occurred in the paclitaxel and cisplatin arm, respectively. Furthermore, one confirmed partial response and two CA125 responses were observed in the cisplatin arm. The median PFS time in the paclitaxel and cisplatin arms was 3.0 months (range, 1.7-4.6 months) and 6.8 months (range, 3.9-11.8 months), respectively, while the median OS time was 11.5 months (range, 8.4-28.8+ months) and not reached (range, 3.9-38.5+ months), respectively. In conclusion, mEHT therapy with weekly paclitaxel or cisplatin appeared safe and warrants further investigation. The present trial was registered with on January 22, 2015 (trial registration no. NCT02344095).
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DOI
10.3892/etm.2021.10219
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의과대학 > 의학과 > Journal papers
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