亚洲结直肠癌患者辅助口服卡培他滨联合静脉注射奥沙利铂(XELOX方案)的疗效及耐受性:4年分析
Efficacy and tolerability of adjuvant oral capecitabine plus intravenous oxaliplatin (XELOX) in Asian patients with colorectal cancer: 4-year analysis.
作者信息
Chiu Joanne, Tang Vikki, Leung Roland, Wong Hilda, Chu Kin Wah, Poon Jensen, Epstein Richard J, Yau Thomas
机构信息
University Department of Medicine, Queen Mary Hospital, Hong Kong, China E-mail :
出版信息
Asian Pac J Cancer Prev. 2014 Jan;14(11):6585-90. doi: 10.7314/apjcp.2013.14.11.6585.
BACKGROUND
Although FOLFOX (infusional fluorouracil/leucovorin plus oxaliplatin) is established as a standard chemotherapeutic regimen, the long term efficacy of adjuvant XELOX (oral capecitabine plus intravenous oxaliplatin) in Asian colorectal cancer (CRC) patients remains anecdotal. Moreover, uncertainties persist as to whether pharmacogenetic differences in Asian populations preclude equally tolerable and effective administration of these drugs.
METHOD
One hundred consecutive patients with resected colorectal cancer received adjuvant XELOX (oxaliplatin 130 mg/m2 on day 1 plus capecitabine 900 mg/m2 twice daily on day 1 to 14 every 3 weeks for 8 cycles) at Queen Mary Hospital, Hong Kong. Endpoints monitored during follow-up were disease-free survival (DFS) and disease recurrence, overall survival (OS) and adverse events (AEs).
RESULTS
The median patient age was 56 years, 56% were diagnosed with rectal cancer and 44% with colonic cancer. After a median follow-up of 4.3 years (95% confidence interval, 3.2-4.7), 24 recurrences were confirmed including 13 patients who died due to progressive disease. Four-year DFS was 81% in colon cancer patients and 67% in rectal cancer patients (p=0.06 by log-rank test). For the cohort as a whole, OS was 90% at 3 years and 84% at 5 years. Treatment-related AEs led to early withdrawal in four patients. The commonest non-hematological AEs were neuropathy (91%), hand-foot syndrome (49%) and diarrhea (46%), while the commonest grade 3/4 AEs were neutropenia (11%) and diarrhea (10%).
CONCLUSION
These results confirm the favourable long term survival benefit with good tolerability in using adjuvant XELOX in treating East Asian colorectal cancer patients.
背景
尽管FOLFOX(持续输注氟尿嘧啶/亚叶酸钙加奥沙利铂)已被确立为标准化疗方案,但辅助性XELOX(口服卡培他滨加静脉注射奥沙利铂)对亚洲结直肠癌(CRC)患者的长期疗效仍缺乏充分证据。此外,亚洲人群的药物遗传学差异是否会妨碍这些药物同样耐受性良好且有效的应用,仍存在不确定性。
方法
在香港玛丽医院,100例连续的接受过结直肠癌切除术的患者接受了辅助性XELOX治疗(第1天给予奥沙利铂130mg/m²,第1至14天给予卡培他滨900mg/m²,每日两次,每3周重复,共8个周期)。随访期间监测的终点指标为无病生存期(DFS)、疾病复发、总生存期(OS)和不良事件(AE)。
结果
患者中位年龄为56岁,56%被诊断为直肠癌,44%为结肠癌。中位随访4.3年(95%置信区间,3.2 - 4.7)后,确认24例复发,其中13例患者因疾病进展死亡。结肠癌患者的4年DFS为81%,直肠癌患者为67%(对数秩检验p = 0.06)。对于整个队列,3年OS为90%,5年为84%。与治疗相关的AE导致4例患者提前停药。最常见的非血液学AE为神经病变(91%)、手足综合征(49%)和腹泻(46%),而最常见的3/4级AE为中性粒细胞减少(11%)和腹泻(10%)。
结论
这些结果证实了辅助性XELOX治疗东亚结直肠癌患者具有良好的长期生存获益和耐受性。