Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial.
Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial.
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3 种以紫杉醇为基础的放化疗方案对局部晚期食管鳞状细胞癌患者的比较：一项随机临床试验
DOI：
10.1001/jamanetworkopen.2022.0120
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发表时间：
2022-02-01
影响因子：
13.8
通讯作者：
Zhao K
中科院分区：
文献类型：
--
作者：
Ai D;Ye J;Wei S;Li Y;Luo H;Cao J;Zhu Z;Zhao W;Lin Q;Yang H;Zheng X;Zhou J;Huang G;Li L;Li J;Zhang Z;Zhou G;Gu D;Du M;Mo M;Jia H;Zhang Z;Zhao K
在氟尿嘧啶、顺铂和卡铂中，哪一种基于紫杉醇的方案能为局部晚期食管鳞状细胞癌患者提供最佳预后和最少不良事件？在中国11个癌症中心接受治疗的321例食管鳞状细胞癌患者的随机临床试验中，氟尿嘧啶组、顺铂组和卡铂组的3年总生存率分别为57.2%、60.1%和56.5%。在接受放化疗的局部晚期食管鳞状细胞癌患者中，紫杉醇联合氟尿嘧啶方案与紫杉醇联合顺铂或卡铂方案相比，总体生存率无优势。由于不同的方案可能会导致不同的不良反应，同时放化疗治疗局部晚期食管癌的患者，这些结果表明，专家在临床实践中有更多的选择，并为未来的研究，可以考虑患者的需求，而不牺牲生存的几率。这项随机临床试验比较了食管鳞状细胞癌患者使用紫杉醇联合氟尿嘧啶、顺铂或卡铂进行放化疗的3年总生存率和不良事件。多种基于紫杉醇的方案被广泛用于食管癌的放化疗治疗，包括紫杉醇与氟尿嘧啶、顺铂和卡铂的联合方案。然而，这3种方案中哪种方案提供最佳预后且不良事件最少仍是未知数。比较氟尿嘧啶、顺铂和卡铂在食管鳞状细胞癌（ESCC）患者确定性放化疗中的疗效和不良事件。这项随机临床试验在中国的11个治疗中心进行。符合条件的患者年龄为18至75岁，组织学证实为ESCC IIa至IVa期，既往未接受过治疗，东部肿瘤协作组体能状态为2或更低，器官功能良好。该研究于2015年7月至2018年2月期间进行，数据分析的截止日期为2020年8月31日。局部晚期ESCC患者被随机分配（1：1：1）至紫杉醇联合氟尿嘧啶、顺铂或卡铂治疗组。顺铂组患者接受2个周期的同步放化疗，随后接受2个周期的紫杉醇联合顺铂巩固化疗。氟尿嘧啶组患者在同步放化疗中接受紫杉醇+氟尿嘧啶每周一次治疗6个周期，随后接受紫杉醇+氟尿嘧啶每月一次巩固化疗2个周期。卡铂组采用紫杉醇联合卡铂每周1次同步放化疗6个周期，紫杉醇联合卡铂每月1次巩固化疗2个周期。所有患者均接受了61.2戈伊的放射治疗，分34次进行。主要终点是总生存期（OS）。次要终点是无进展生存期和不良事件。总体而言，2015年7月至2018年2月期间，来自11个中心的321例ESCC患者（中位[IQR]年龄，64岁[59-69岁]; 248例[77.3%]男性）被随机分配至氟尿嘧啶、顺铂或卡铂组。存活患者的中位（IQR）随访时间为46.0个月氟尿嘧啶组、顺铂组和卡铂组的3年OS率分别为57.2%、60.1%和56.5（氟尿嘧啶vs顺铂：HR，1.06; 95% CI，0.71-1.60; P = .77;氟尿嘧啶vs卡铂：HR，0.94; 95% CI，0.63-1.40; P = .77）。顺铂组急性3级或4级中性粒细胞减少症的发生率显著较高（69例事件[60.8%] vs氟尿嘧啶组19例[17.8%]和卡铂组37例[34.6%]; P < .001），血小板减少症（14起事件[13.1%] vs氟尿嘧啶组4起[3.7%]和卡铂组5起[4.7%]; P = .01），贫血（50例2级以上事件[46.7%] vs氟尿嘧啶组25例[23.4%]和卡铂组37例[34.6%]; P = 0.35），疲乏（11起事件[10.3%] vs氟尿嘧啶组2起[1.9%]和卡铂组1起[0.9%]; P = 0.007）和呕吐（2级以上事件17起[15.9%]，氟尿嘧啶组3起[2.8%]，卡铂组5起[4.7%]; P < .001）高于其他2组。在这项随机临床试验中，紫杉醇联合氟尿嘧啶在局部晚期ESCC患者的确定性放化疗中未显示出优于紫杉醇联合顺铂或紫杉醇联合卡铂方案的OS。顺铂组的血液学和胃肠道毒性反应发生率高于氟尿嘧啶或卡铂组。ClinicalTrials.gov标识符：NCT 02459457
Which paclitaxel-based regimen, among fluorouracil, cisplatin, and carboplatin, provides the best prognosis with minimum adverse events for patients with locally advanced esophageal squamous cell carcinoma? In this randomized clinical trial of 321 patients with esophageal squamous cell carcinoma treated in 11 cancer centers in China, the 3-year overall survival rates were 57.2% in the fluorouracil group, 60.1% in the cisplatin group, and 56.5% in the carboplatin group, respectively. The paclitaxel plus fluorouracil regimen did not show overall survival superiority over paclitaxel regimens with cisplatin or carboplatin in patients with locally advanced esophageal squamous cell carcinoma who are in chemoradiation therapy. Because different regimens may lead to different adverse effects in patients treated with concurrent chemoradiotherapy for locally advanced esophageal cancer, these results suggest that specialists have more choices in clinical practice and for future research that can account for the needs of patients, without sacrificing odds of survival. This randomized clinical trial compares 3-year overall survival rates and adverse events for chemoradiotherapy using paclitaxel in combination with fluorouracil, cisplatin, or carboplatin among patients with esophageal squamous cell carcinoma. Multiple paclitaxel-based regimens are widely used in chemoradiation therapy against esophageal cancer, including regimens combining paclitaxel with fluorouracil, cisplatin, and carboplatin. However, which among these 3 regimens provides the best prognosis with minimum adverse events is still unknown. To compare the efficacy and adverse events of fluorouracil, cisplatin, and carboplatin in definitive chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC). This randomized clinical trial of patients with ESCC was conducted in 11 treatment centers in China. Eligible patients were aged 18 to 75 years and had histologically confirmed ESCC stages IIa to IVa with no prior treatment, Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ functions. The study was conducted between July 2015 and February 2018, and the cutoff date for data analysis was August 31, 2020. Patients with locally advanced ESCC were randomly assigned (1:1:1) to groups combining paclitaxel treatment with fluorouracil, cisplatin, or carboplatin. Patients in the cisplatin group were treated with 2 cycles of concurrent chemoradiotherapy followed by 2 cycles of consolidation chemotherapy with monthly paclitaxel plus cisplatin. For the fluorouracil group, patients were administered 6 cycles of weekly paclitaxel plus fluorouracil in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus fluorouracil in consolidation chemotherapy. Patients in the carboplatin group were treated with 6 cycles of weekly paclitaxel plus carboplatin in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus carboplatin in consolidation chemotherapy. All patients received radiotherapy of 61.2 Gy delivered in 34 fractions. The primary end point was overall survival (OS). The secondary end points were progression-free survival and adverse events. Overall, 321 patients (median [IQR] age, 64 years [59-69 years]; 248 [77.3%] men) with ESCC from 11 centers were randomized into fluorouracil, cisplatin, or carboplatin groups between July 2015 and February 2018. Over a median (IQR) follow-up time of surviving patients of 46.0 months (36.6-53.0 months), the 3-year OS rates were 57.2% in the fluorouracil group, 60.1% in the cisplatin group, and 56.5% in the carboplatin group, respectively (fluorouracil vs cisplatin: HR, 1.06; 95% CI, 0.71-1.60; P = .77; fluorouracil vs carboplatin: HR, 0.94; 95% CI, 0.63-1.40; P = .77). The cisplatin group had significantly higher incidences of acute grade 3 or 4 neutropenia (69 events [60.8%] vs 19 [17.8%] for fluorouracil and 37 [34.6%] carboplatin; P < .001), thrombocytopenia (14 events [13.1%] vs 4 [3.7%] for fluorouracil and 5 [4.7%] for carboplatin; P = .01), anemia (50 events above grade 2 [46.7%] vs 25 [23.4%] for fluorouracil and 37 [34.6%] for carboplatin; P = .35), fatigue (11 events [10.3%] vs 2 [1.9%] for fluorouracil and 1 [0.9%] carboplatin; P = .007), and vomiting (17 events above grade 2 [15.9%] vs 3 [2.8%] for fluorouracil and 5 [4.7%] for carboplatin; P < .001) than the other 2 groups. In this randomized clinical trial, paclitaxel plus fluorouracil did not show OS superiority over paclitaxel plus cisplatin or paclitaxel plus carboplatin regimens in definitive chemoradiation in patients with locally advanced ESCC. Higher rates of hematologic and gastrointestinal toxic effects were reported in the cisplatin group compared with those in the fluorouracil or carboplatin groups. ClinicalTrials.gov Identifier: NCT02459457
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影响因子：
3.8
作者：
Mohammad, Nadia Haj;Hulshof, Maarten C. C. M.;van Laarhoven, Hanneke W. M.
通讯作者：
van Laarhoven, Hanneke W. M.
影响因子：
45.3
作者：
Adelstein, DJ;Rice, TW;Zuccaro, G
通讯作者：
Zuccaro, G
影响因子：
2.9
作者：
Ai D;Chen Y;Liu Q;Zhang J;Deng J;Zhu H;Ren W;Zheng X;Li Y;Wei S;Ye J;Zhou J;Lin Q;Luo H;Cao J;Li J;Huang G;Wu K;Fan M;Yang H;Zhu Z;Zhao W;Li L;Fan J;Badakhshi H;Zhao K
通讯作者：
Zhao K
影响因子：
45.3
作者：
Chen, Yun;Ye, Jinjun;Zhao, Kuaile
通讯作者：
Zhao, Kuaile
影响因子：
45.3
作者：
Ajani, Jaffer A.;Winter, Kathryn;Willett, Christopher G.
通讯作者：
Willett, Christopher G.