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.
Radiat Oncol. 2023 Sep 12;18(1):150. doi: 10.1186/s13014-023-02339-9.
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.
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.
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.
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.
The trial was registered at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT02969473, October 2010).
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。
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。
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。
5 年随访证实，与 PF 方案相比，DP 方案的根治性 CCRT 并未改善 ESCC 患者的治疗反应、OS 或 PFS。PF 方案仍是局部晚期 ESCC 患者根治性 CCRT 的标准方案。长期随访还表明，适当和积极的挽救性治疗对部分患者有生存获益，随访期间应注意心肺迟发性毒性。
该试验在 https://clinicaltrials.gov 注册（ClinicalTrials.gov 标识符：NCT02969473，2010 年 10 月）。
