顺铂加卡培他滨与顺铂加氟尿嘧啶诱导化疗对局部晚期鼻咽癌的疗效比较
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摘要
目的对比PX方案(顺铂+卡培他滨)或PF方案(顺铂+氟尿嘧啶)作为诱导化疗方案治疗局部晚期鼻咽癌的效果,评价PX方案的优劣和可行性。方法Ⅲ～Ⅳa期鼻咽癌患者246例随机分配到PX组和PF组,各123例。分别采用PX方案和PF方案进行2周期诱导化疗。两组均进行顺铂3周方案同期放化疗,共2～3周期。评价两组的疗效和不良反应。结果两组的3年无进展生存率(PFS)分别为83.2%(95%CI:74.8～91.6),80.3%(95%CI:72.1～88.5),差异无统计学意义(P>0.05);总生存率(OS)分别为92.4%(95%CI:85.9～98.9),91.1%(95%CI:85.0～97.2),差异无统计学意义(P>0.05)。最常见的3～4级不良反应为粒细胞减少。PX方案皮肤反应增多,经处理可以缓解。结论 PX方案诱导化疗+同期放化疗的疗效不劣于PF诱导化疗+同期放化疗,不良反应可以耐受。
Objective To evaluate the clinical outcomes and adverse effects of induction chemotherapy with cisplatin plus capecitabine(PX regimen) through compare to induction chemotherapy with cisplatin plus fluorouracil(PF regimen) followed by concurrent chemoradiotherapy with cisplatin in locally advanced nasopharyngeal carcinoma(NPC). Methods Stage III-IVa NPC patients were randomized allocated to PX or PF group. The induction chemotherapy regimen in PX group was cisplatin(80 mg/m~2 d1) plus capecitabine(1 000 mg/m~2, twice a day, d1-14), while in PF group was cisplatin(80 mg/m~2 d1) plus fluorouracil(800 mg/m~2/day, continuous intravenous 120 h). After two cycles of induction chemotherapy(every 3 weeks), patients in both groups received concurrent chemoradiotherapy with cisplatin(100 mg/m~2 d1, every 3 weeks). Clinical outcomes and adverse effects were compared between the two groups. Results Between January 1, 2015 and March 1, 2017, 246 patients were enrolled in trial, 123 in each group. The progress-free survivals(PFSs) were 83.2%(95% CI: 74.8-91.6) and 80.3%(95% CI: 72.1-88.5) in PX group and PF group, respectively. The overall survivals(OSs) were 92.4%(95% CI: 85.9-98.9) and 91.1%(95% CI: 85.0-97.2) in PX group and PF group, respectively. There was no statistically significant difference between the 2 groups. Neutropenia was the most common Grade 3-4 adverse event. Conclusion PX regimen as induction chemotherapy for locally advanced NPC patients is not inferiority than PF regimen with tolerable adverse events.
Objective To evaluate the clinical outcomes and adverse effects of induction chemotherapy with cisplatin plus capecitabine(PX regimen) through compare to induction chemotherapy with cisplatin plus fluorouracil(PF regimen) followed by concurrent chemoradiotherapy with cisplatin in locally advanced nasopharyngeal carcinoma(NPC). Methods Stage III-IVa NPC patients were randomized allocated to PX or PF group. The induction chemotherapy regimen in PX group was cisplatin(80 mg/m~2 d1) plus capecitabine(1 000 mg/m~2, twice a day, d1-14), while in PF group was cisplatin(80 mg/m~2 d1) plus fluorouracil(800 mg/m~2/day, continuous intravenous 120 h). After two cycles of induction chemotherapy(every 3 weeks), patients in both groups received concurrent chemoradiotherapy with cisplatin(100 mg/m~2 d1, every 3 weeks). Clinical outcomes and adverse effects were compared between the two groups. Results Between January 1, 2015 and March 1, 2017, 246 patients were enrolled in trial, 123 in each group. The progress-free survivals(PFSs) were 83.2%(95% CI: 74.8-91.6) and 80.3%(95% CI: 72.1-88.5) in PX group and PF group, respectively. The overall survivals(OSs) were 92.4%(95% CI: 85.9-98.9) and 91.1%(95% CI: 85.0-97.2) in PX group and PF group, respectively. There was no statistically significant difference between the 2 groups. Neutropenia was the most common Grade 3-4 adverse event. Conclusion PX regimen as induction chemotherapy for locally advanced NPC patients is not inferiority than PF regimen with tolerable adverse events.
引文
[1] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Head and Neck Cancers. (Version 2.2018)[DB/OL]. http://www.nccn.org. 2018-07-20.
[2] Lang J, Gao L, Guo Y, et al. Comprehensive treatment of squamous cell cancer of head and neck: Chinese expert consensus 2013[J]. Future Oncol, 2014, 10(9): 1635-1648.
[3] Cao SM, Yang Q, Guo L, et al. Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial[J]. Eur J Cancer, 2017, 75: 14-23.
[4] Lee AW, Ngan RK, Tung SY, et al. Preliminary results of trial NPC-0501 evaluating the therapeutic gain by changing from concurrent-adjuvant to induction-concurrent chemoradiotherapy, changing from fluorouracil to capecitabine, and changing from conventional to accelerated radiotherapy fractionation in patients with locoregionally advanced nasopharyngeal carcinoma[J]. Cancer, 2015, 121(8): 1328-1838.
[5] Tang LQ, Chen DP, Guo L, et al. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial[J]. Lancet Oncol, 2018, 19(4): 461-473.
[6] 陈冬平, 齐斌, 余意, 等. 鼻咽癌远期生存率及预后因素分析[J]. 实用医学杂志, 2012, 28(12): 1999-2001.
[7] Cassidy J, Saltz L, Twelves C, et al. Efficacy of capecitabine versus 5-fluorouracil in colorectal and gastric cancers: a meta-analysis of individual data from 6171 patients[J]. Ann Oncol, 2011, 22(12): 2604-2609.
[8] Wang Y, Yang H, Wei JF, et al. Efficacy and toxicity of capecitabine-based chemotherapy in patients with metastatic or advanced breast cancer: results from ten randomized trials[J]. Curr Med Res Opin, 2012, 28(12): 1911-1919.
[9] 杨利, 徐志渊, 李济时, 等. 顺铂加卡培他滨诱导化疗治疗局部晚期鼻咽癌的疗效及毒副反应[J]. 现代肿瘤医学, 2018,26(4): 516-519.
[10] Sun Y, Li WF, Chen NY, et al. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial[J]. Lancet Oncol, 2016, 17(11): 1509-1520.
[2] Lang J, Gao L, Guo Y, et al. Comprehensive treatment of squamous cell cancer of head and neck: Chinese expert consensus 2013[J]. Future Oncol, 2014, 10(9): 1635-1648.
[3] Cao SM, Yang Q, Guo L, et al. Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial[J]. Eur J Cancer, 2017, 75: 14-23.
[4] Lee AW, Ngan RK, Tung SY, et al. Preliminary results of trial NPC-0501 evaluating the therapeutic gain by changing from concurrent-adjuvant to induction-concurrent chemoradiotherapy, changing from fluorouracil to capecitabine, and changing from conventional to accelerated radiotherapy fractionation in patients with locoregionally advanced nasopharyngeal carcinoma[J]. Cancer, 2015, 121(8): 1328-1838.
[5] Tang LQ, Chen DP, Guo L, et al. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial[J]. Lancet Oncol, 2018, 19(4): 461-473.
[6] 陈冬平, 齐斌, 余意, 等. 鼻咽癌远期生存率及预后因素分析[J]. 实用医学杂志, 2012, 28(12): 1999-2001.
[7] Cassidy J, Saltz L, Twelves C, et al. Efficacy of capecitabine versus 5-fluorouracil in colorectal and gastric cancers: a meta-analysis of individual data from 6171 patients[J]. Ann Oncol, 2011, 22(12): 2604-2609.
[8] Wang Y, Yang H, Wei JF, et al. Efficacy and toxicity of capecitabine-based chemotherapy in patients with metastatic or advanced breast cancer: results from ten randomized trials[J]. Curr Med Res Opin, 2012, 28(12): 1911-1919.
[9] 杨利, 徐志渊, 李济时, 等. 顺铂加卡培他滨诱导化疗治疗局部晚期鼻咽癌的疗效及毒副反应[J]. 现代肿瘤医学, 2018,26(4): 516-519.
[10] Sun Y, Li WF, Chen NY, et al. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial[J]. Lancet Oncol, 2016, 17(11): 1509-1520.