新辅助化疗和手术前联合放化疗治疗局部晚期食管癌的长期结果：单中心经验。

Long-term results of neoadjuvant chemotherapy and combined chemoradiotherapy before surgery in the management of locally advanced oesophageal cancer: a single-centre experience.

机构信息

Medical Oncology Unit, University Hospital La Fe, Valencia, Spain.

出版信息

Clin Transl Oncol. 2009 Dec;11(12):835-41. doi: 10.1007/s12094-009-0452-5.

DOI:10.1007/s12094-009-0452-5

PMID:20045790

Abstract

INTRODUCTION

Neoadjuvant chemoradiotherapy before surgery is an option in the treatment of locally advanced resectable oesophageal cancer (EC). However toxicity is substantial and the improvement in overall survival (OS) with this approach is controversial.

METHODS

This was a prospective, single-centre study of neoadjuvant chemotherapy and concomitant chemoradiotherapy with CDDP and 5-FU and 50.4 Gy of external radiotherapy before possible radical surgery in patients with locally advanced resectable EC. If surgery was not possible, a second-phase radiotherapy boost of 10 Gy and one cycle of modified dose chemotherapy were used.

RESULTS

Seventy-three patients included between 1998 and 2007: 96% males, median age 61, 83% squamous cell carcinomas, 23% lower third tumours, 36% stage II and 54% stage III and 47% local lymph node involvement. Eighty-six percent completed the combined protocol. Main grade 3-4 toxicities: mucositis (19%) and infections (8%); 4 toxic deaths. Clinical response rates: complete response 54%, partial response 27%, stable disease 8%. Twenty-five patients proceeded to surgery, with radical resection in 24. Pathological response rate: complete response 32%, partial response 52%, progression 16%. There were 7 postoperative deaths and 16 of 34 patients that did not have surgery received the second-phase RT boost. Survival analysis: Median follow-up of 64 months (range 6-134 months). Median OS of 10.33 months. 2-year and 5-year OS of 22 and 16%. The only significant prognostic factor in OS is the clinical complete response rate: 13.9 vs. 7.7 months (p=0.0049).

CONCLUSIONS

Our protocol offers a high rate of clinical activity although it is relatively toxic and seems to increase the postoperative mortality, which would blunt any small improvement in survival. The achievement of a complete response is a powerful prognostic factor.

摘要

简介

手术前的新辅助放化疗是局部可切除食管鳞癌（EC）的一种治疗选择。然而，这种方法的毒性较大，其在总生存（OS）方面的改善仍存在争议。

方法

这是一项前瞻性的单中心研究，在局部可切除的 EC 患者中，采用 CDDP 和 5-FU 联合放化疗，联合外照射 50.4Gy 新辅助化疗和同期放化疗，然后行可能的根治性手术。如果不能手术，则使用第二阶段 10Gy 的放疗增敏和一个周期的改良剂量化疗。

结果

1998 年至 2007 年期间共纳入 73 例患者：96%为男性，中位年龄 61 岁，83%为鳞状细胞癌，23%为下段肿瘤，36%为 II 期，54%为 III 期，47%有局部淋巴结受累。86%的患者完成了联合方案。主要的 3-4 级毒性为：黏膜炎（19%）和感染（8%）；4 例毒性死亡。临床反应率：完全缓解 54%，部分缓解 27%，稳定疾病 8%。25 例患者接受了手术，24 例为根治性切除。病理反应率：完全缓解 32%，部分缓解 52%，进展 16%。术后死亡 7 例，34 例未手术患者中有 16 例接受了第二阶段 RT 增敏。生存分析：中位随访 64 个月（范围 6-134 个月）。中位 OS 为 10.33 个月。2 年和 5 年 OS 分别为 22%和 16%。OS 的唯一显著预后因素是临床完全缓解率：13.9 个月与 7.7 个月（p=0.0049）。