来自一项艾日布林联合吉西他滨对比紫杉醇联合吉西他滨作为HER2阴性转移性乳腺癌的一线化疗的Ⅱ期、多中心、随机试验的包含神经病变相关量表的生活质量结果：韩国癌症研究组试验(KCSG BR13-11)

背景与目的一项比较艾日布林联合吉西他滨(eribulin plus gemcitabine,EG)或紫杉醇联合吉西他滨(paclitaxel plus gemcitabine,PG)作为转移性乳腺癌(metastatic breast cancer,MBC)患者一线化疗方案的II期临床试验发现,EG方案的神经毒性较低,但疗效与PG方案相似。在本研究中,我们分析了该临床实验中的癌症患者生命质量测评量表–紫杉烷(functional assessment of cancer therapy-taxane,FACT-Taxane)问卷评分以确定他们的生活质量(quality of life,QoL)。方法使用韩国版的FACT-Taxane问卷评估QoL。在评估基线之后,前12个疗程中每2个疗程评估1次QoL,之后每3个疗程评估1次QoL。使用线性混合模型评估EG组和PG组QoL的差异。结果在118例入组患者中,117例在基线时回复了FACT-Taxane问卷,PG组中有1例患者没有回复。EG组和PG组之间的基线QoL评分没有差异。在治疗期间,除了第11个疗程外,在第2–13个化疗疗程后,PG组紫杉烷亚量表评分显著高于EG组(均P<0.05)。神经病变特异性分析显示PG组患者的神经病症状比EG组患者更早出现且更严重(P<0.001)。结论在我们的QoL分析中,与PG方案相比,EG方案延迟并减少神经病变的发生。因此,艾日布林是MBC一线化疗药物紫杉醇的合理替代品。

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)

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.