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一种用于II期和III期食管癌患者的、由紫杉醇、卡铂、5-氟尿嘧啶和放射治疗组成的高效且耐受性良好的新辅助治疗方案。

A highly active and tolerable neoadjuvant regimen combining paclitaxel, carboplatin, 5-FU, and radiation therapy in patients with stage II and III esophageal cancer.

作者信息

van de Schoot L, Romme E A P M, van der Sangen M J, Creemers G J, van Lijnschoten G, van Driel O J Repelaer, Rutten H J T, Nieuwenhuijzen G A P

机构信息

Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.

出版信息

Ann Surg Oncol. 2008 Jan;15(1):88-95. doi: 10.1245/s10434-007-9582-6. Epub 2007 Sep 26.

Abstract

BACKGROUND

The present phase II study aimed to assess the feasibility and efficacy of a new paclitaxel-based neoadjuvant chemoradiation regimen followed by surgery in patients with stage II-III esophageal cancer.

METHODS

From January 2002 to November 2004, 50 patients with a potentially resectable stage II-III esophageal cancer received chemotherapy with paclitaxel, carboplatin, and 5-FU in combination with radiotherapy 45 Gy in 25 fractions. Surgery followed 6-8 weeks after completion of neoadjuvant treatment.

PATIENT CHARACTERISTICS

male/female: 44/6, median age 60 years (34-75), median WHO 1 (0-2), adenocarcinoma (n = 42), squamous cell carcinoma (n = 8). Toxicity was mild, and 84 % of the patients completed the whole regimen. Forty-seven patients underwent surgery with a curative intention (transhiatal n = 44, transthoracic n = 3). Pathologic complete tumor regression was achieved in 18 of 47 operated patients (38%). R0 resection was achieved in 45 of 47 operated patients (96%). There were four postoperative deaths (8.5). Postoperative complications were comparable with other studies. After a median follow-up of 41.5 months (21-59) estimated 3- and 5-year survival on an intention-to-treat basis was 56 and 48%. Estimated 3-year survival in responders was 61%, in nonresponders 33%.

CONCLUSION

This novel neoadjuvant chemoradiation regimen for treatment of patients with stage II-III esophageal cancer is feasible. Results are encouraging with a high pathologic complete tumor regression and R0 resection rate and an acceptable morbidity and mortality. Preliminary survival data are very promising.

摘要

背景

本II期研究旨在评估一种以紫杉醇为基础的新辅助放化疗方案联合手术治疗II - III期食管癌患者的可行性和疗效。

方法

2002年1月至2004年11月,50例具有潜在可切除性的II - III期食管癌患者接受了紫杉醇、卡铂和5 - 氟尿嘧啶联合化疗,并同时接受45 Gy分25次的放射治疗。新辅助治疗完成后6 - 8周进行手术。

患者特征

男/女为44/6,中位年龄60岁(34 - 75岁),世界卫生组织体能状态中位数为1(0 - 2),腺癌(n = 42),鳞状细胞癌(n = 8)。毒性反应轻微,84%的患者完成了整个治疗方案。47例患者接受了根治性手术(经裂孔手术n = 44,经胸手术n = 3)。47例接受手术的患者中有18例实现了病理完全肿瘤消退(38%)。47例接受手术的患者中有45例实现了R0切除(96%)。有4例术后死亡(8.5%)。术后并发症与其他研究相当。中位随访41.5个月(21 - 59个月)后,意向性治疗分析的3年和5年生存率估计分别为56%和48%。反应者的估计3年生存率为61%,无反应者为33%。

结论

这种用于治疗II - III期食管癌患者的新型新辅助放化疗方案是可行的。结果令人鼓舞,病理完全肿瘤消退率和R0切除率高,发病率和死亡率可接受。初步生存数据非常有前景。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2be8/2190342/e8ef2fabe422/10434_2007_9582_Fig1_HTML.jpg

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