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比较新辅助放化疗联合卡铂/紫杉醇或顺铂/ 5-氟尿嘧啶治疗食管鳞癌的疗效。

Comparison of neoadjuvant chemoradiation with carboplatin/ paclitaxel or cisplatin/ 5-fluoruracil in patients with squamous cell carcinoma of the esophagus.

机构信息

Department of Radiation Oncology, Klinikum rechts der Isar, Technical University Munich, Ismaninger Str. 22, D-81675, Munich, Germany.

German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany.

出版信息

Radiat Oncol. 2017 Nov 21;12(1):182. doi: 10.1186/s13014-017-0904-y.

Abstract

PURPOSE

Neoadjuvant chemoradiation (nCRT) is the treatment of choice for patients with locally advanced squamous cell carcinoma of the esophagus (SCC). Today radiation oncologists can choose between two different therapy regimes including chemoradiation with cisplatin and 5-fluoruracil (CDDP/5FU) and chemoradiation analogue to the CROSS-regime with carboplatin and paclitaxel (Carb/TAX). However, there is a lack of studies comparing these regimes, especially for the subgroup of patients with SCC. In this study, we want to compare nCRT with CDDP/5FU and nCRT with Carb/TAX for patients with locally advanced SCC.

PATIENTS AND METHODS

We retrospectively compared 20 patients who were scheduled for nCRT with a total radiation dose of 41.4 Gy (daily dose of 1.8 Gy) and weekly chemotherapy with carboplatin (Area under the curve 2) and Paclitaxel (50 mg per square meter of body-surface area) according to the CROSS-regime to 31 patients who were scheduled for nCRT with a total radiation dose of 45 Gy (daily dose of 1.8 Gy) and simultaneous chemotherapy with cisplatin (20 mg/m/d) and 5-fluoruracil (500 mg/m/d) on day 1-5 and day 29-33. For the per-protocol (PP) analysis, per protocol treatment was defined as either complete radiation with 41.4 Gy, at least three complete cycles of Carb/TAX and subsequent surgery or complete radiation with 45 Gy, at least one complete cycle of CDDP/5FU and subsequent surgery.

RESULTS

Fifty-one patients (31 patients treated with CDDP/5FU and 20 patients treated with Carb/TAX) were evaluated for the intention-to-treat (ITT) analysis and 44 patients (26 patients treated with CDDP/5FU and 18 patients treated with Carb/TAX) were evaluated for the PP analysis. No significant differences were seen for baseline and tumor characteristics like age, sex, TNM-stage, grading and tumor extension between patients treated with Carb/TAX and patients treated with CDDP/5FU. The most common tumor regression grade after nCRT was grade I as classified by Becker et al., which was observed in 84 and 79% of patients. No significant differences in tumor regression grades were seen between both regimes. Postoperative insufficiency of the anastomosis was seen in 6 patients (33%) who were treated with Carb/TAX and 4 patients (15%) who were treated with CDDP/5FU (p = 0.273). Patients treated with CDDP/5FU developed significantly more cumulative hematologic III° (CTCAE) toxicities (58% vs 20%; p = 0.010) than patients treated with Carb/TAX. In contrast to that, there was no significant difference for overall survival (OS) and freedom from relapse (FFR) between treatment groups.

CONCLUSION

In this retrospective analysis, no significant difference was seen for OS and FFR between nCRT with CDDP/5FU and nCRT with Carb/TAX. However, the application of CDDP/5FU was associated with significantly more hematologic III°- toxicities compared to Carb/TAX. Future prospective trials should investigate if these results are reproducible in randomized patient cohorts.

摘要

目的

新辅助放化疗(nCRT)是局部晚期食管鳞状细胞癌(SCC)患者的首选治疗方法。今天,放射肿瘤学家可以在包括顺铂和 5-氟尿嘧啶(CDDP/5FU)的放化疗和与 CROSS 方案类似的卡铂和紫杉醇(Carb/TAX)放化疗方案之间进行选择。然而,缺乏比较这些方案的研究,特别是对于 SCC 亚组患者。在这项研究中,我们希望比较局部晚期 SCC 患者的 nCRT 与 CDDP/5FU 和 nCRT 与 Carb/TAX。

方法

我们回顾性比较了 20 名计划接受 nCRT 的患者,总放疗剂量为 41.4 Gy(每日剂量 1.8 Gy),每周化疗采用卡铂(AUC 2)和紫杉醇(每平方米体表面积 50mg)根据 CROSS 方案进行,与 31 名计划接受 nCRT 的患者进行比较,总放疗剂量为 45 Gy(每日剂量 1.8 Gy),同时化疗采用顺铂(20mg/m/d)和 5-氟尿嘧啶(500mg/m/d)在第 1-5 天和第 29-33 天。对于协议(PP)分析,协议治疗定义为接受 41.4 Gy 的完整放疗、至少三个完整周期的 Carb/TAX 治疗和随后的手术,或接受 45 Gy 的完整放疗、至少一个完整周期的 CDDP/5FU 治疗和随后的手术。

结果

对 51 名患者(31 名接受 CDDP/5FU 治疗,20 名接受 Carb/TAX 治疗)进行意向治疗(ITT)分析,对 44 名患者(26 名接受 CDDP/5FU 治疗,18 名接受 Carb/TAX 治疗)进行方案(PP)分析。接受 Carb/TAX 和 CDDP/5FU 治疗的患者在年龄、性别、TNM 分期、分级和肿瘤扩展等基线和肿瘤特征方面无显著差异。nCRT 后最常见的肿瘤消退分级为 Becker 等人分类的 I 级,在 84%和 79%的患者中观察到。两种方案之间未见肿瘤消退分级的显著差异。接受 Carb/TAX 治疗的 6 名(33%)患者和接受 CDDP/5FU 治疗的 4 名(15%)患者出现吻合口术后不足(p=0.273)。接受 CDDP/5FU 治疗的患者发生累积血液学 III°(CTCAE)毒性的比例明显高于接受 Carb/TAX 治疗的患者(58% vs 20%;p=0.010)。相比之下,两组之间的总生存(OS)和无复发生存(FFR)无显著差异。

结论

在这项回顾性分析中,接受 CDDP/5FU 和 Carb/TAX 的 nCRT 患者的 OS 和 FFR 无显著差异。然而,与 Carb/TAX 相比,CDDP/5FU 的应用与显著更多的血液学 III°毒性相关。未来的前瞻性试验应研究这些结果在随机患者队列中是否具有可重复性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1045/5696681/21442dfe8f7f/13014_2017_904_Fig1_HTML.jpg

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