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06/14/2021 - 08:52 | Wissenschaft

Modulierte Elektrohyperthermie mit wöchentlichem Paclitaxel oder Cisplatin bei Patienten mit rezidivierendem oder persistierendem epithelialem Ovarial-, Eileiter- oder primärem Peritonealkarzinom: die KGOG 3030-Studie

Modulated electro‑hyperthermia
Modulated electro‑hyperthermia

Kidong Kim, JaeeHoon Kim, Seung Cheol Kim, Yong Beom Kim, ByungHo Nam, Jae Hong No, Hanyboul Cho, Woong Ju, Dong Hoon Suh and Yun Hwanr Kim

The study (KGOG 3030) aimed to evaluate the safety of modulated electrohyperthermia (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/m2) or cisplatin (40 mg/m2) 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 4week cycle. The primary endpoint was the occurrence of doselimiting toxicity (DLT). The secondary endpoints were treatmentemergent adverse events (TEAEs), objective response rate, carbohydrate antigen 125 (CA125) response rate, progressionfree 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, 1.74.6 months) and 6.8 months (range, 3.911.8 months), respectively, while the median OS time was 11.5 months (range, 8.428.8+ months) and not reached (range, 3.938.5+ months), respectively. In conclusion, mEHT therapy with weekly paclitaxel or cisplatin appeared safe and warrants further investigation. The present trial was registered with www.clinicaltrials.gov on January 22, 2015 (trial registration no. NCT02344095).