多西他赛联合顺铂与氟尿嘧啶联合顺铂同步放化疗治疗食管鳞癌的前瞻性随机对照Ⅱ期临床试验长期随访结果

Definitive concurrent chemoradiotherapy with docetaxel plus cisplatin versus 5-fluorouracil plus cisplatin in patients with esophageal squamous cell carcinoma: long-term follow-up results of a phase II randomized controlled trial.

机构信息

Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, Guangdong, P.R. China.

出版信息

Radiat Oncol. 2023 Sep 12;18(1):150. doi: 10.1186/s13014-023-02339-9.

BACKGROUND

Definitive radiotherapy plus concurrent chemotherapy has been a standard treatment for esophagus patients who are unfit to undergo surgery. However, there are a variety of concurrent chemotherapy regimens with varying efficacy. In this phase II prospective study, we compared the efficacy and toxicity of DP (docetaxel and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens with concurrent chemoradiotherapy (CCRT) in patients with esophageal squamous cell carcinoma (ESCC) and analyzed the 5-year overall survival (OS) and progression free survival (PFS). We also summarized the salvage treatments and late toxicities.

METHODS

We enrolled 86 patients with clinical stage II-IVA from the Sun Yat-sen University Cancer Center. The patients were divided into two groups: PF group (41) and DP group (45). Statistics were analyzed using SPSS version 19.0.

RESULTS

The 5-year OS rates were 62.9% ± 7.6% in PF group, and 52.7% ± 7.5% in DP group (P = 0.131), respectively. The 5-year PFS rates were 43.9% ± 7.8% for PF group, and 40.0% ± 7.3% for DP group (P = 0.398), respectively. Sixteen patients in the DP group and thirteen in the PF group received salvage treatment. For those patients with local residual or local recurrent disease, the median survival time after salvage treatment was 13.5 months and the 1, 2, and 3-year survival rates were 79.0%, 50.3%, and 43.1%, respectively. For all patients, thirteen (15.1%) had Grade 2 late cardiac toxicities. One patient had Grade 2 pleural effusion and required diuretic. Most patients with pneumonia are mild, and only one patient in PF group had Grade 2 pneumonia. One patient in the DP group developed tracheoesophageal fistula.

CONCLUSIONS

The 5-year follow-up confirmed that definitive CCRT with the DP regimen did not improve the treatment response, OS, or PFS in patients with ESCC compared to the PF regimen. The PF regimen remains the standard regimen for definitive CCRT for patients with locally advanced ESCC. Long-term follow-up also suggested that appropriate and active salvage treatment has a survival benefit for some patients, and late cardiopulmonary toxicities should be noticed during follow-up.

TRIAL REGISTRATION

The trial was registered at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT02969473, October 2010).

背景

对于不适合手术的食管患者，根治性放疗加同期化疗一直是标准治疗方法。然而，有多种疗效不同的同期化疗方案。在这项 II 期前瞻性研究中，我们比较了 DP（多西他赛和顺铂）和 PF（顺铂和 5-氟尿嘧啶）方案联合放化疗（CCRT）在食管鳞状细胞癌（ESCC）患者中的疗效和毒性，并分析了 5 年总生存率（OS）和无进展生存率（PFS）。我们还总结了挽救性治疗和晚期毒性。

方法

我们从中山大学肿瘤防治中心招募了 86 名临床 II-IVA 期的患者。患者分为两组：PF 组（41 例）和 DP 组（45 例）。使用 SPSS 版本 19.0 进行统计分析。

结果

PF 组 5 年 OS 率为 62.9%±7.6%，DP 组为 52.7%±7.5%（P=0.131）。PF 组 5 年 PFS 率为 43.9%±7.8%，DP 组为 40.0%±7.3%（P=0.398）。DP 组 16 例和 PF 组 13 例患者接受了挽救性治疗。对于局部残留或局部复发的患者，挽救性治疗后中位生存时间为 13.5 个月，1、2、3 年生存率分别为 79.0%、50.3%和 43.1%。所有患者中有 13 例（15.1%）发生 2 级迟发性心脏毒性。1 例患者发生 2 级胸腔积液，需要利尿剂治疗。大多数肺炎患者症状较轻，仅 PF 组 1 例患者发生 2 级肺炎。DP 组 1 例患者发生气管食管瘘。