1. A prospective cohort study on the safety and efficacy of bevacizumab combined with chemotherapy in Japanese patients with relapsed ovarian, fallopian tube or primary peritoneal cancer
- Author
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Fumio Kataoka, Keiko Saotome, Naomi Iwasa, Yoshiko Nanki, Takuro Hirano, Tatsuyuki Chiyoda, Daisuke Aoki, Wataru Yamagami, Hiroyuki Nomura, Ai Dozen, Tomoko Yoshihama, and Shiho Hashimoto
- Subjects
Adult ,Cancer Research ,medicine.medical_specialty ,Bevacizumab ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Mucositis ,Fallopian Tube Neoplasms ,Humans ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Prospective Studies ,Adverse effect ,Prospective cohort study ,Peritoneal Neoplasms ,Aged ,Ovarian Neoplasms ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Chemotherapy regimen ,medicine.anatomical_structure ,Oncology ,030220 oncology & carcinogenesis ,Fallopian tube cancer ,Female ,Neoplasm Recurrence, Local ,Ovarian cancer ,business ,medicine.drug ,Fallopian tube - Abstract
Objective this prospective cohort study aimed to assess the safety and efficacy of bevacizumab combined with chemotherapy in Japanese patients with relapsed ovarian, fallopian tube or primary peritoneal cancer. Methods in this study, 40 Japanese patients with relapsed ovarian, fallopian tube or primary peritoneal cancer selected to receive bevacizumab with chemotherapy were enrolled. Patients in poor general condition were excluded. Each patient was monitored prospectively for adverse events, administration status, disease status and survival. Treatment was continued until intolerable adverse events or disease progression. The primary endpoint was safety. Results bevacizumab plus platinum-based chemotherapy was performed for 30 patients (median cycle; 16.5), while bevacizumab plus non-platinum chemotherapy was performed for 10 patients (median cycle; 5.5). Among bevacizumab-related adverse events, hypertension occurred in 80% of patients, proteinuria in 83%, mucositis in 25%, bleeding in 20%, thromboembolic events in 5.0% and fistula in 2.5%. Gastrointestinal perforation or other life-threatening lethal adverse events were not observed. Response rate and median progression-free survival were 73% and 19.3 months for patients with bevacizumab plus platinum-based chemotherapy, and 30% and 3.9 months for patients with bevacizumab plus non-platinum chemotherapy, respectively. There was no correlation between response rate and occurrence of adverse events such as hypertension or proteinuria. Conclusion bevacizumab combined with chemotherapy was tolerable and effective for Japanese patients with relapsed ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Hypertension and proteinuria are frequently occurred and managed properly for continuing treatment.
- Published
- 2020