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术前紫杉醇/顺铂联合放疗用于局部晚期食管癌的II期研究。

Phase II study of preoperative paclitaxel/cisplatin with radiotherapy in locally advanced esophageal cancer.

作者信息

Kim Dong W, Blanke Charles D, Wu Huiyun, Shyr Yu, Berlin Jordan, Beauchamp R Daniel, Chakravarthy Bapsi

机构信息

Department of Radiation Oncology, Vanderbilt University School of Medicine, Nashville, TN, USA.

出版信息

Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):397-404. doi: 10.1016/j.ijrobp.2006.08.062. Epub 2006 Nov 9.

DOI:10.1016/j.ijrobp.2006.08.062
PMID:17097833
Abstract

PURPOSE

Preoperative paclitaxel-based chemoradiotherapy may improve the response rates and survival in patients with localized esophageal cancer. We evaluated paclitaxel-based induction chemoradiotherapy in patients with localized esophageal cancer to determine its feasibility, clinical response, pathologic response, and overall survival.

METHODS AND MATERIALS

Between 1995 and 1998, 50 patients were enrolled in this study. At study entry, patients were categorized as either resectable or unresectable according to evaluation by an experienced thoracic surgeon. All patients were treated with paclitaxel 175 mg/m2 and cisplatin 75 mg/m2 on Day 1, 29 with radiotherapy to 3,000 cGy in 15 fractions. Resectable patients underwent esophagectomy 4 weeks later. Postoperatively, patients received two cycles of paclitaxel 175 mg/m2 on Day 1 and 5-fluorouracil 350 mg/m2 and leucovorin 300 mg on Days 1-3, given every 28 days. Patients who were deemed unsuitable for resection from the outset continued radiotherapy to a total dose of 6,000 cGy.

RESULTS

Of the 50 patients, all began neoadjuvant chemoradiotherapy, 40 patients underwent surgery, and 25 patients completed postoperative chemotherapy. A pathologic complete response was seen in 7 patients (17.5%). Patients with a pathologic response had a median survival of 32.4 months vs. 14.4 months for nonresponders (p < 0.001). Patients with a clinical response had a median survival of 25.2 months compared with 15.6 months for nonresponders (p = 0.002). At a median follow up of 19.8 months (range 2.4-100.8), the median survival was 20.4 months and the 3-year overall survival rate was 23.2%.

CONCLUSION

Although preoperative cisplatin/paclitaxel with 3,000 cGy was tolerable, this multimodality regimen did not appear to be superior to standard cisplatin/5-fluorouracil-containing regimens and its use is not recommended.

摘要

目的

术前基于紫杉醇的放化疗可能提高局部食管癌患者的缓解率和生存率。我们评估了局部食管癌患者接受基于紫杉醇的诱导放化疗的可行性、临床反应、病理反应和总生存期。

方法与材料

1995年至1998年期间,50例患者纳入本研究。在研究开始时,根据经验丰富的胸外科医生的评估,将患者分为可切除或不可切除两类。所有患者在第1天接受紫杉醇175mg/m²和顺铂75mg/m²治疗,第29天开始放疗,分15次给予3000cGy。可切除患者4周后接受食管切除术。术后,患者在第1天接受两个周期的紫杉醇175mg/m²治疗,第1 - 3天接受5-氟尿嘧啶350mg/m²和亚叶酸钙300mg治疗,每28天重复一次。从一开始就被认为不适合切除的患者继续放疗至总剂量6000cGy。

结果

50例患者均开始新辅助放化疗,40例患者接受了手术,25例患者完成了术后化疗。7例患者(17.5%)出现病理完全缓解。有病理反应的患者中位生存期为32.4个月,无反应者为14.4个月(p < 0.001)。有临床反应的患者中位生存期为25.2个月,无反应者为15.6个月(p = 0.002)。中位随访19.8个月(范围2.4 - 100.8个月),中位生存期为20.4个月,3年总生存率为23.2%。

结论

尽管术前顺铂/紫杉醇联合3000cGy放疗是可耐受的,但这种多模式方案似乎并不优于含标准顺铂/5-氟尿嘧啶的方案,不建议使用。

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