Abstract 834P
Background
Patients with advanced ovarian clear-cell carcinoma (OCC) have poor prognosis in the absence of an effective standard treatment. The response rate of chemotherapy for relapsed OCC is <10%. Gemcitabine and cisplatin are reported to have a synergic effect on ovarian cancer. Evidence indicates that addition of bevacizumab to a chemotherapy regimen improves progression-free survival. We conducted a multi institutional phase II trial in Japan to examine the efficacy and safety of a gemcitabine, cisplatin, and bevacizumab combination (GPB) therapy for OCC.
Methods
Eighteen first recurrence or refractory patients with pathologically confirmed OCC and having evaluable region judged by RECIST were recruited between January 2017 and May 2019. Gemcitabine (1,000 mg/m2), cisplatin (40 mg/m2), and bevacizumab (10 mg/kg) were administered intravenously on day 1 and 15 every 28 days for 6–10 cycles until the progression of disease or appearance of intolerable toxicity. The primary endpoint was the overall response rate. The secondary endpoints included disease control rate and adverse events, among others. The trial was approved by institutional ethics boards of the participating institutions, and registered in UMIN (ID 000023097).
Results
Fifteen patients (83.3%) completed 6–10 treatment cycles, except for three patients (two with adverse events and one with PD). Overall response rate was 61.1% (CR 3, PR 8) and disease control rate was 88.9% (CR 3, PR 8, SD 5). Median duration of response was 10.5+ months (range: 4.7–34.1+). Hematological adverse events (AEs) of any grade were observed in 88.9% patients; those of grade 3 and 4 were observed in 16.7% and 5.6% (one patient with neutropenia) patients. Non-hematological AEs of any grade were observed in all patients; those of grade 3 and 4 were observed in 27.8% and 5.6% (one patient with serous retinal detachment) patients.
Conclusions
GPB therapy showed a very high response rate and acceptable toxicity and is promising for OCC.
Clinical trial identification
UMIN000023097; 2016/07/11.
Editorial acknowledgement
Legal entity responsible for the study
Non-profit Organization Kansai Clinical Oncology Group.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.