Sato Yasuyoshi, Mori Kazuhiko, Atsumi Shinichiro, Sakamoto Kei, Oya Shuichiro, Okamoto Asami, Urabe Masayuki, Miwa Yoshiyuki, Yajima Shoh, Yagi Koichi, Nomura Sachiyo, Yamashita Hiroharu, Seto Yasuyuki
Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Clinical Oncology, The University of Tokyo Hospital, 7-3-1 Hongou, Bunkyo-ku, Tokyo, 113-8655, Japan.
Esophagus. 2024 Oct;21(4):514-522. doi: 10.1007/s10388-024-01062-y. Epub 2024 Jul 10.
Preoperative chemotherapy with 5-fluorouracil and cisplatin (FP) followed by surgery has been considered a standard treatment for patients with stage II/III esophageal squamous cell carcinoma (ESCC) based on the results of a phase III trial (JCOG9907) in Japan. Subsequently, the phase III NExT trial (JCOG1109) revealed the survival benefit of the neoadjuvant DCF regimen, which adds docetaxel to FP, and it became a standard treatment. However, the long-term results and prognostic factors of neoadjuvant DCF therapy in the real world are unknown.
We retrospectively investigated 50 patients with ESCC treated with neoadjuvant DCF therapy from July 2012 to December 2017 at The University of Tokyo Hospital.
Median overall survival (OS) and progression-free survival (PFS) were 32.3 [95% confidence interval (CI) 21.0-NA] and 10.0 months (95% CI 6.3-15.6), respectively. Median OS [not reached (95% CI 31.5-NA) vs. 21.4 months (95% CI 13.5-33.0); p = 0.028] and PFS [83.3 months (95% CI 6.4-NA) vs. 7.4 months (95% CI 6.0-12.8] were significantly longer in patients with an objective response than in non-responders. Of 44 surgical cases, median PFS tended to be longer in pathological lymph node metastasis-negative patients. Conversely, survival did not differ according to cStage (II/III vs. IV) or the average relative dose intensity (ARDI, ≥ 85% vs. < 85%).
The response to neoadjuvant DCF therapy could predict patient prognosis. Additionally, pN+ tended to increase the recurrence risk, whereas cStage and ARDI did not influence survival.
基于日本一项III期试验(JCOG9907)的结果,术前使用5-氟尿嘧啶和顺铂(FP)进行化疗然后手术,一直被视为II/III期食管鳞状细胞癌(ESCC)患者的标准治疗方法。随后,III期NExT试验(JCOG1109)揭示了新辅助DCF方案(在FP基础上加用多西他赛)的生存获益,该方案成为了标准治疗方法。然而,新辅助DCF治疗在现实世界中的长期结果和预后因素尚不清楚。
我们回顾性研究了2012年7月至2017年12月在东京大学医院接受新辅助DCF治疗的50例ESCC患者。
中位总生存期(OS)和无进展生存期(PFS)分别为32.3个月[95%置信区间(CI)21.0 - 无上限(NA)]和10.0个月(95% CI 6.3 - 15.6)。客观缓解的患者中位OS[未达到(95% CI 31.5 - NA)vs. 21.4个月(95% CI 13.5 - 33.0);p = 0.028]和PFS[83.3个月(95% CI 6.4 - NA)vs. 7.4个月(95% CI 6.0 - 12.8)]显著长于未缓解的患者。在44例手术病例中,病理淋巴结转移阴性的患者中位PFS往往更长。相反,生存情况根据临床分期(II/III期vs. IV期)或平均相对剂量强度(ARDI,≥85% vs. <85%)并无差异。
对新辅助DCF治疗的反应可以预测患者预后。此外,病理淋巴结阳性(pN+)往往会增加复发风险,而临床分期和ARDI并不影响生存。