PHASE I STUDY OF PREOPERATIVE SHORT-COURSE CHEMORADIATION WITH PROTON BEAM THERAPY AND CAPECITABINE FOR RESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA OF THE HEAD
PHASE I STUDY OF PREOPERATIVE SHORT-COURSE CHEMORADIATION WITH PROTON BEAM THERAPY AND CAPECITABINE FOR RESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA OF THE HEAD
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DOI：
10.1016/j.ijrobp.2009.10.061
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发表时间：
2011-01-01
影响因子：
7
通讯作者：
Fernandez-Del Castillo, Carlos
中科院分区：
文献类型：
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作者：
Hong, Theodore S.;Ryan, David P.;Fernandez-Del Castillo, Carlos
目的：为了评估的安全性，1周的放化疗与质子束治疗和卡培他滨，然后早期surgery.Methods和材料：15例局部可切除，胰腺癌的头部，从2006年5月至2008年9月入组。患者接受质子束放射治疗。在剂量水平I中，患者接受3 GyE x 10（第1周，周一至周五;第2周，周一至周五）。剂量水平2至4的患者接受5 GyE x Sin逐渐缩短的时间表：水平2（第1周，周一、周三和周五;第2周，周二和周四），水平3（第1周，周一、周二、周四和周五;第2周，周一），水平4（第1周，周一至周五）。卡培他滨剂量为825 mg/m2，每日两次。第1周和第2周，周一至周五，所有剂量水平共10天。剂量水平1 ~ 3组化疗结束后4 ~ 6周行手术，剂量水平4组化疗结束后1 ~ 3周行手术。结果：剂量水平1 ~ 3组3例，剂量水平4组6例，均为MTD。未观察到剂量限制性毒性。在4名患者中观察到3级毒性（1名患者疼痛; 3名患者支架阻塞或感染）。11例患者接受了切除术。未切除的原因是转移性疾病（3例患者）和不可切除的肿瘤（1例患者）。平均术后住院时间为6天（范围：5-10天）。术后30天内未发现意外并发症，包括泄漏或梗阻，被发现。结论：术前放化疗与1周的质子束治疗和卡培他滨随后早期手术是可行的。第二阶段研究正在进行中。(C)2011 Elsevier Inc.
Purpose: To evaluate the safety of 1 week of chemoradiation with proton beam therapy and capecitabine followed by early surgery.Methods and Materials: Fifteen patients with localized resectable, pancreatic adenocarcinoma of the head were enrolled from May 2006 to September 2008. Patients received radiation with proton beam. In dose level I, patients received 3 GyE x 10 (Week 1, Monday-Friday; Week 2, Monday-Friday). Patients in Dose Levels 2 to 4 received 5 GyE x Sin progressively shortened schedules: level 2 (Week 1, Monday, Wednesday, and Friday; Week 2, Tuesday and Thursday), Level 3 (Week I, Monday, Tuesday, Thursday, and Friday; Week 2, Monday), Level 4 (Week 1, Monday through Friday). Capecitabine was given as 825 mg/m(2) b.i.d. Weeks 1 and 2 Monday through Friday for a total of 10 days in all dose levels. Surgery was performed 4 to 6 weeks after completion of chemotherapy for Dose Levels 1 to 3 and then after 1 to 3 weeks for Dose Level 4.Results: Three patients were treated at Dose Levels 1 to 3 and 6 patients at Dose Level 4, which was selected as the MTD. No dose limiting toxicities were observed. Grade 3 toxicity was noted in 4 patients (pain in 1; stent obstruction or infection in 3). Eleven patients underwent resection. Reasons for no resection were metastatic disease (3 patients) and unresectable tumor (1 patient). Mean postsurgical length of stay was 6 days (range, 5-10 days). No unexpected 30-day postoperative complications, including leak or obstruction, were found.Conclusions: Preoperative chemoradiation with 1 week of proton beam therapy and capecitabine followed by early surgery is feasible. A Phase II study is underway. (C) 2011 Elsevier Inc.