Sook Hee Hong1, Soohyeon Lee2, Hoon-Gu Kim3, Hyo Jin Lee4, Kyung Hae Jung5, Sang-Cheol Lee6, Na-Ri Lee7, Jina Yun8, In Sook Woo9, Kyong Hwa Park10, Kyoung-Ha Kim6, Ho Young Kim11, Sun Young Rha12, Jae Ho Byun13. 1. Division of Oncology, Department of Internal Medicine, Cancer Research Institute, The Catholic University of Korea Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea. 2. Division of Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Republic of Korea. 3. Division of Hematology and Oncology, Department of Internal Medicine, Gyeongnam Regional Cancer Center, Institute of Health Sciences, Gyeongsang National University School of Medicine, Republic of Korea. 4. Division of Hematology Oncology, Department of Internal Medicine, Chungnam National University Hospital, School of Medicine, Chungnam National University, Republic of Korea. 5. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Republic of Korea. 6. Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Republic of Korea. 7. Division of Hematology and Oncology, Department of Internal Medicine, Chonbuk National University Medical School, Republic of Korea. 8. Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Republic of Korea. 9. Division of Oncology, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea. 10. Division of Oncology and Hematology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Republic of Korea. 11. Division of Oncology and Hematology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Republic of Korea. 12. Medical Oncology, Deparment of Internal Medicine, Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Republic of Korea. 13. Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea. Electronic address: jhbyun37@catholic.ac.kr.
Abstract
OBJECTIVE: The main aim of this study was to evaluate the antitumor activity and safety of vinorelbine and gemcitabine combination chemotherapy in patients with primary refractory or recurrent platinum-resistant epithelial ovarian and primary peritoneal cancers. METHODS: Patients with platinum-resistant or primary refractory disease were eligible. Patients were allowed one prior chemotherapy for the treatment of platinum-resistant or refractory disease. Vinorelbine 25mg/m(2), followed by gemcitabine 1000mg/m(2), was administered intravenously on days 1 and 8 every 3weeks. Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 and cancer antigen 125 test (CA-125 criteria) were adopted to classify responses. RESULTS: 44 patients received the median of 4 (range, 1-24) treatments with fifteen (34.1%) receiving six or more cycles. The overall objective response rate was 22.7%. One patient (2.3%) had complete while 9 patients (20.4%) had partial responses with median duration of response of 5.9months. 17 patients (38.6%) had stable disease for a median of 3.3months. Median progression-free survival (PFS) was 3.4months and overall survival (OS) was 14.5months. Four (9.1%) patients were not assessable. Neutropenia was the most frequently encountered toxicity, with grade 3 or 4 observed in 22 patients (50.0%). Fifteen patients (34.1%) needed immediate dose reduction. No treatment related death was reported. CONCLUSIONS: The combination chemotherapy with gemcitabine and vinorelbine achieved the primary end point of our clinical trial in management of platinum resistant recurrent ovarian cancer. However, further sophisticated dosing and scheduling of combination chemotherapy are needed because of a significant proportion of dose reduction.
OBJECTIVE: The main aim of this study was to evaluate the antitumor activity and safety of vinorelbine and gemcitabine combination chemotherapy in patients with primary refractory or recurrent platinum-resistant epithelial ovarian and primary peritoneal cancers. METHODS:Patients with platinum-resistant or primary refractory disease were eligible. Patients were allowed one prior chemotherapy for the treatment of platinum-resistant or refractory disease. Vinorelbine 25mg/m(2), followed by gemcitabine 1000mg/m(2), was administered intravenously on days 1 and 8 every 3weeks. Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 and cancer antigen 125 test (CA-125 criteria) were adopted to classify responses. RESULTS: 44 patients received the median of 4 (range, 1-24) treatments with fifteen (34.1%) receiving six or more cycles. The overall objective response rate was 22.7%. One patient (2.3%) had complete while 9 patients (20.4%) had partial responses with median duration of response of 5.9months. 17 patients (38.6%) had stable disease for a median of 3.3months. Median progression-free survival (PFS) was 3.4months and overall survival (OS) was 14.5months. Four (9.1%) patients were not assessable. Neutropenia was the most frequently encountered toxicity, with grade 3 or 4 observed in 22 patients (50.0%). Fifteen patients (34.1%) needed immediate dose reduction. No treatment related death was reported. CONCLUSIONS: The combination chemotherapy with gemcitabine and vinorelbine achieved the primary end point of our clinical trial in management of platinum resistant recurrent ovarian cancer. However, further sophisticated dosing and scheduling of combination chemotherapy are needed because of a significant proportion of dose reduction.
Authors: Silvia R Graziani; Carolina G Vital; Aleksandra T Morikawa; Brigitte M Van Eyll; Hezio J Fernandes Junior; Roberto Kalil Filho; Raul C Maranhão Journal: Med Oncol Date: 2017-07-29 Impact factor: 3.064
Authors: Andrea Milani; Rebecca Kristeleit; Mary McCormack; Fharat Raja; Daniela Luvero; Martin Widschwendter; Nicola MacDonald; Tim Mould; Adeola Olatain; Allan Hackshaw; Jonathan A Ledermann Journal: ESMO Open Date: 2017-01-31