Quality of life outcomes including neuropathy-associated scale from a phase II,multicenter,randomized trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy for HER2-negative metastatic breast cancer:Korean Cancer Study Group Trial(KCSG BR13-11)  

作　　者：Ji-Yeon Kim Seri Park Seock-Ah Im Sung-Bae Kim Joohyuk Sohn Keun Seok Lee Yee Soo Chae Ki Hyeong Lee Jee Hyun Kim Young-Hyuck Im Tae-Yong Kim Kyung-Hun Lee Jin-Hee Ahn Gun Min Kim In Hae Park Soo Jung Lee Hye Sook Han Se Hyun Kim Kyung Hae Jung Yeon Hee Park Korean Cancer Study Group 

机构地区：[1]Division of Hematology-Oncology,Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine,81 Irwon-ro,Gangnam-gu,Seoul 06351,South Korea [2]Department of Health Sciences and Technology,Samsung Advanced Institute for Health Sciences and Technology,Sungkyunkwan University,Seoul 06351,South Korea [3]Department of Internal Medicine,Seoul National University Hospital,Cancer Research Institute,College of Medicine,Seoul National University,Seoul 03080,South Korea [4]Department of Oncology,Asan Medical Center,University of Ulsan College of Medicine,Seoul 05505,South Korea [5]Division of Medical Oncology,Department of Internal Medicine,Yonsei University College of Medicine,Seoul 03722,South Korea [6]Center for Breast Cancer,National Cancer Center,Goyang 10408,South Korea [7]Department of Internal Medicine,Kyungpook National University Hospital,Daegu 41944,South Korea [8]Deparment of Internal Medicine,Chungbuk National University Hospital,Cheongju 28644,South Korea [9]Department of Internal Medicine,Seoul National University Bundang Hospital,Seoul National University College of Medicine,Seongnam 13620,South Korea

出　　处：《Cancer Communications》2019年第1期271-278,共8页癌症通讯（英文）

基　　金：This study was supported by Eisai Korea Inc.(supplied eribulin),Dong-A ST Co.,Ltd.(supplied gemcitabine),and Samyang Biopharmaceuticals(supplied paclitaxel);This work was supported by a grant from the Ministry of Health and Welfare,Republic of Korea(HA17C0055);by the National R&D Program for Cancer Control,Ministry of Health and Welfare,Republic of Korea(1720150)

摘　　要：Background: A phase II clinical trial of the comparison between eribulin plus gemcitabine (EG) and paclitaxel plus gemcitabine (PG) as first-line chemotherapy for patients with metastatic breast cancer (MBC) found that the EG regimen was less neurotoxic, but was similar in efficacy to the PG regimen. In the present study, we analyzed functional assessment of cancer therapy-taxane (FACT-Taxane) questionnaires from patients in this clinical trial to determine their quality of life (QoL). Methods: QoL was assessed using the Korean version of the FACT-Taxane questionnaires. After baseline assessment, QoL was assessed every 2 cycles for 12 cycles and every 3 cycles thereafter. The linear mixed model was used to evaluate the difference in QoL between the EG and PG arms. Results: Of the 118 enrolled patients, 117 responded to the FACT-Taxane questionnaires at baseline, 1 in the PG arm did not. Baseline QoL scores were not different between the EG and PG arms. During treatment, taxane subscale scores were significantly higher in the PG arm than in the EG arm after 2-13 cycles of chemotherapy (all P < 0.05), except for the 11th cycle. Neuropathy-specific analysis showed that patients in the PG arm had earlier and more severe neuropathic symptoms than those in the EG arm (P < 0.001). Conclusions: In our QoL analysis, the EG regimen delayed and decreased neuropathy as compared with the PG regimen. Therefore, eribulin would be a reasonable substitute for paclitaxel as first-line chemotherapy for MBC.

关 键 词：Metastatic breast cancer ERIBULIN PACLITAXEL NEUROPATHY Quality of life Functional assessment of cancer therapy-taxane questionnaires 

分 类 号：R73[医药卫生—肿瘤]