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首页> 外文期刊>BMC Cancer >Safety and efficacy of lobaplatin combined with 5-fluorouracil as first-line induction chemotherapy followed by lobaplatin-radiotherapy in locally advanced nasopharyngeal carcinoma: preliminary results of a prospective phase II trial
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Safety and efficacy of lobaplatin combined with 5-fluorouracil as first-line induction chemotherapy followed by lobaplatin-radiotherapy in locally advanced nasopharyngeal carcinoma: preliminary results of a prospective phase II trial

机译：洛巴铂联合5-氟尿嘧啶作为一线诱导化疗再加洛巴铂放疗在局部晚期鼻咽癌中的安全性和有效性：一项前瞻性II期试验的初步结果

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Background Due to improvements in imaging and radiological techniques as well as the use of chemotherapy, distant metastasis has become the predominant mode of treatment failure in patients with locally advanced nasopharyngeal carcinoma (LA-NPC). Platinum-based systemic chemotherapy has shown survival benefits and is now the standard strategy for systemic therapy in patients with LA-NPC. Notably, the third-generation platinum reagent lobaplatin has shown anti-tumor effects in several solid tumors with lower incidences of gastrointestinal, hepatic and renal toxicity relative to other platinum drugs. However, the safety and efficacy of lobaplatin as a first-line regimen in patients with LA-NPC are undetermined. Methods Patients with stage III–IVa-b NPC received lobaplatin at a dose of 30?mg/m2 on days 1 and 22 combined with a continuous 120-h intravenous injection of 5-fluorouracil at a dose of 4?g/m2 followed by lobaplatin at a dose of 50?mg/m2 on days 43 and 64 concomitant with intensity-modulated radiation therapy. Objective response rates and acute toxicity were assessed based on RECIST (1.1) and CTCAE v.3.0, respectively. Kaplan-Meier analysis was used to calculate survival rates. Results Fifty-nine patients were enrolled, and 44 patients (74.6%) received allocated cycles of chemotherapy. The objective response rates were 88.1% (95% confidence interval [CI], 0.77 to 0.95) and 100% after induction chemotherapy (ICT) and concurrent chemoradiotherapy (CRT), respectively. With a median follow-up period of 44?months, the 3-year estimated progression-free survival and overall survival were 86.4% (95% CI, 69.8 to 98.8) and 94.9% (95% CI, 89.5 to 100), respectively. The most common grade 3–4 toxicities were neutropenia (8.5%) and thrombocytopenia (40.7%) after ICT and CRT, respectively. Conclusion Lobaplatin combined with 5-fluorouracil followed by lobaplatin-RT treatment showed encouraging anti-tumor effects with tolerable toxicities in patients with LA-NPC. Randomized controlled trials of lobaplatin in patients with LA-NPC are warranted. Trial registration This trial was registered with the Chinese Clinical Trials Registry and approved on March 31st, 2012, number ChiCTR-ONC-12002060 .
机译：背景技术由于影像学和放射学技术的改进以及化学疗法的使用，远处转移已成为局部晚期鼻咽癌（LA-NPC）患者治疗失败的主要方式。基于铂的全身化疗已显示出生存益处，现在已成为LA-NPC患者全身治疗的标准策略。值得注意的是，第三代铂试剂洛巴铂已在几种实体瘤中显示出抗肿瘤作用，相对于其他铂类药物，其胃肠道，肝和肾毒性的发生率更低。但是，洛巴铂作为一线治疗LA-NPC患者的安全性和疗效尚未确定。方法III–IVa-b期NPC患者在第1天和第22天接受洛巴铂的剂量为30？mg / m2，并以120？h的剂量连续静脉注射5-氟尿嘧啶，剂量为4？g / m2，然后洛巴铂在第43和64天的剂量为50？mg / m2，同时进行强度调节的放射治疗。分别基于RECIST（1.1）和CTCAE v.3.0评估了客观缓解率和急性毒性。 Kaplan-Meier分析用于计算存活率。结果共有59例患者入选，其中44例（74.6％）接受了指定的化疗周期。诱导化疗（ICT）和同步放化疗（CRT）后的客观缓解率分别为88.1％（95％置信区间[CI]，0.77至0.95）和100％。中位随访期为44个月，估计的3年无进展生存期和总生存期分别为86.4％（95％CI，69.8至98.8）和94.9％（95％CI，89.5至100）。 。 ICT和CRT后最常见的3-4级毒性分别为中性粒细胞减少症（8.5％）和血小板减少症（40.7％）。结论洛巴铂联合5-氟尿嘧啶再加洛巴铂-RT治疗对LA-NPC患者具有令人鼓舞的抗肿瘤作用和可耐受的毒性。洛巴铂治疗LA-NPC患者的随机对照试验是必要的。试验注册该试验已在中国临床试验注册中心进行注册，并于2012年3月31日批准，注册号为ChiCTR-ONC-12002060。

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