Introduction/Background In the AURELIA trial, adding of bevacizumab to chemotherapy significantly improved response and survival without problematic toxicity in women with platinum-resistant ovarian cancer. However, information about bevacizumab in combination with gemcitabine is insufficient. We conducted a feasibility study to assess clinical activity and toxicity.
Methodology Women with platinum-resistant recurrent ovarian cancer who received one to three regimens of platinum-based chemotherapy were registered in this study. They received 15 mg/kg of bevacizumab intravenously on day 1 and gemcitabine 1000 mg/m2of gemcitabine intravenously on day 1 and 8 every 21 days to disease progression or unacceptable toxicity. The primary endpoint was completion rate of 3 cycles of chemotherapy. The secondary endpoints were clinical response rate, progression free survival,overall survival, and dose-limiting toxicity including bowel perforation, febrile neutropenia, and grade 4 thrombocytopenia. This study is registered with UMIN-CTR, number UMIN000016619.
Results Between April 1, 2015 and December 31, 2018, 19 patients were enrolled into this study. There were 12 high grade serous, 1 endometrial, 4 clear cell, and 2 other types of carcinoma. Eighteen of 19 (95%) received 3 or more, and 9 (47%) received 6 or more cycles of study treatment. Objective responses were observed in 8 of 19 patients (42% overall; complete response 16%, partial response 26%), with an additional 8 (42%) having stable disease. Hematologic toxicity was neutropenia grade 3/4 in 9 (47%), anemia grade 3/4 in 2 (11%), thrombocytopenia grade 3/4 in 1 (5%). Non-hematologic toxicity included grade 3 hypertension in 1 (5%), grade 3 protein urea in one (5%) and possibly-related grade 3 interstitial pneumonia in 1 (5%). No patient encountered dose-limiting toxicity. Median progression free survival was 5.1 months, and median overall survival was 21.3 months.
Conclusion Combination chemotherapy with gemcitabine and bevacizumab is feasible in women with platinum-resistant recurrent ovarian cancer.
Disclosure Nothing to disclose.
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