Simoni Nicola, Pavarana Michele, Micera Renato, Weindelmayer Jacopo, Mengardo Valentina, Rossi Gabriella, Cenzi Daniela, Tomezzoli Anna, Del Bianco Paola, Giacopuzzi Simone, De Manzoni Giovanni, Mazzarotto Renzo
Department of Radiotherapy, Ospedale Civile Maggiore, Azienda Ospedaliera Universitaria Integrata Verona, 37126 Verona, Italy.
Department of Oncology, Ospedale G.B. Rossi, Azienda Ospedaliera Universitaria Integrata Verona, 37126 Verona, Italy.
Cancers (Basel). 2020 Dec 3;12(12):3614. doi: 10.3390/cancers12123614.
A phase II intensive neoadjuvant chemo-radiotherapy (nCRT) protocol for esophageal cancer (EC) was previously tested at our Center with promising results. We here present an observational study to evaluate the efficacy of the protocol also in "real life" patients.
We retrospectively reviewed 122 ECs (45.1% squamous cell (SCC) and 54.9% adenocarcinoma (ADC)) treated with induction docetaxel, cisplatin, and 5-fluorouracil (TCF), followed by concomitant TCF and radiotherapy (50-50.4 Gy/25-28 fractions), between 2008 and 2017. Primary endpoints were overall survival (OS), event-free survival (EFS) and pathological complete response (pCR).
With a median follow-up of 62.1 months (95% CI 50-67.6 months), 5-year OS and EFS rates were 54.8% (95% CI 44.7-63.9) and 42.7% (95% CI 33.1-51.9), respectively. A pCR was observed in 71.1% of SCC and 37.1% of ADC patients ( = 0.001). At multivariate analysis, ypN+ was a significant prognostic factor for OS (Hazard Ratios (HR) 4.39 [95% CI 2.36-8.18]; < 0.0001), while pCR was a strong predictor of EFS (HR 0.38 [95% CI 0.22-0.67]; < 0.0001).
The nCRT protocol achieved considerable long-term survival and pCR rates also in "real life" patients. Further research is necessary to evaluate this protocol in a watch-and-wait approach.
我们中心之前曾对一项针对食管癌（EC）的II期强化新辅助放化疗（nCRT）方案进行过测试，结果令人鼓舞。我们在此开展一项观察性研究，以评估该方案在“现实生活”患者中的疗效。
我们回顾性分析了2008年至2017年间接受诱导多西他赛、顺铂和5-氟尿嘧啶（TCF）治疗，随后同步进行TCF和放疗（50 - 50.4 Gy/25 - 28次分割）的122例食管癌患者（45.1%为鳞状细胞癌（SCC），54.9%为腺癌（ADC））。主要终点为总生存期（OS）、无事件生存期（EFS）和病理完全缓解（pCR）。
中位随访时间为62.1个月（95%置信区间50 - 67.6个月），5年总生存率和无事件生存率分别为54.8%（95%置信区间44.7 - 63.9）和42.7%（95%置信区间33.1 - 51.9）。SCC患者和ADC患者的病理完全缓解率分别为71.1%和37.1%（P = 0.001）。多因素分析显示，ypN+是总生存期的显著预后因素（风险比（HR）4.39 [95%置信区间2.36 - 8.18]；P < 0.0001），而病理完全缓解是无事件生存期的有力预测因素（HR 0.38 [95%置信区间0.22 - 0.67]；P < 0.0001）。
该新辅助放化疗方案在“现实生活”患者中也取得了可观的长期生存率和病理完全缓解率。有必要进一步研究以评估该方案采用观察等待方法的效果。
