Neoadjuvant Paclitaxel Poliglumex, Cisplatin, and Radiation for Esophageal Cancer A Phase 2 Trial

Neoadjuvant Paclitaxel Poliglumex, Cisplatin, and Radiation for Esophageal Cancer A Phase 2 Trial
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DOI:
10.1097/coc.0b013e318201a126
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发表时间:
2012-02-01
影响因子:
2.6
通讯作者:
Safran, Howard
Safran, Howard
中科院分区:
医学4区
文献类型:
--
作者:
Dipetrillo, Thomas;Suntharalingam, Mohan;Safran, Howard

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目的:评价紫杉醇聚葡胺(PPX)、顺铂和同步放射治疗食管癌患者的病理完全缓解(CR)率和安全性。患者和方法:无远处转移证据的食管或胃食管连接部腺癌或鳞状细胞癌患者接受PPX治疗顺铂(25 mg/m2/wk)和顺铂(50 mg/m2/wk)联合放疗6周,放疗剂量50.4戈伊。结果:共纳入40例患者,其中腺癌37例,鳞癌3例。治疗相关的3级非血液学毒性包括食管炎(7%)、恶心(7%)和疲乏(5%)。3例临床内镜CR患者(2例鳞状细胞癌)拒绝手术。其余37例患者中有12例(32%)达到病理学CR。12例病理学完全缓解患者均为腺癌。结论:PPX、顺铂联合放疗是一种耐受性好、易于实施的食管癌治疗方案,显著食管炎发生率低,病理学完全缓解率高,与PPX联合放疗的临床前数据一致。
Purpose: To evaluate the pathologic complete response (CR) rate and safety of paclitaxel poliglumex (PPX), cisplatin, and concurrent radiation for patients with esophageal cancer.Patients and Methods: Patients with adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction with no evidence of distant metastasis received PPX (50 mg/m(2)/wk) and cisplatin (25 mg/m(2)/wk) for 6 weeks with 50.4 Gy concurrent radiation. Six to eight weeks after completion of chemoradiotherapy, patients underwent surgical resection.Results: Forty patients were enrolled, 37 patients with adenocarcinoma and 3 patients with squamous cell cancer. The treatment-related grade 3 nonhematologic toxicities included esophagitis (7%), nausea (7%), and fatigue (5%). Three patients with clinical endoscopic CR (2 with squamous cell cancer) refused surgery. Twelve of the remaining 37 patients (32%) had a pathologic CR. The 12 patients with pathologic CR all had adenocarcinoma.Conclusion: PPX, cisplatin, and concurrent radiation are well tolerated, easily administered regimen for esophageal cancer with a low incidence of significant esophagitis and a high pathologic CR rate consistent with the preclinical data of PPX and radiation.