Background <p>Adjuvant nivolumab improves survival after esophageal cancer resection following neoadjuvant therapy; however, postoperative recurrence remains a major clinical challenge. This study investigated postoperative recurrence and identified the prognostic factors in patients receiving adjuvant nivolumab after esophagectomy.</p> Patients and Methods <p>This single-center retrospective study included 82 consecutive patients with locally advanced esophageal cancer who received adjuvant nivolumab after esophagectomy following preoperative therapy. Cox proportional hazards regression models were used to identify independent risk factors for postoperative recurrence.</p> Results <p>The cohort predominantly consisted of patients with esophageal squamous cell carcinoma treated with preoperative chemotherapy and minimally invasive esophagectomy, most of whom had pathological lymph node metastases. During a median follow-up of 30.6 months, 44 patients (54%) developed recurrence, and 30 (37%) developed recurrence during adjuvant nivolumab therapy. The median recurrence-free survival (RFS) was 30.8 months, with a 2-year RFS rate of 50.7% and an overall survival rate of 81.7%. Multivariable analysis identified poor response to preoperative therapy, ypN3 disease, pretreatment prognostic nutritional index (PNI) &lt; 44, and absence of immune-related adverse events (irAEs) as independent risk factors for postoperative recurrence. Subgroup analyses demonstrated markedly lower 2-year RFS rates in patients with stable disease compared with those with complete response or partial response (27.3% vs. 61.8%), ypN3 compared with ypN1–2 (19.4% vs. 58.5%), PNI &lt; 44 compared with ≥ 44 (24.2% vs. 57.8%), and non-irAEs compared with any irAEs (47.5% vs. 55.9%).</p> Conclusions <p>Tumor-related characteristics and host-related immune and nutritional factors were independently associated with the risk of recurrence after adjuvant nivolumab therapy.</p>

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Risk Stratification of Postoperative Recurrence After Adjuvant Nivolumab for Resected Locally Advanced Esophageal Cancer: A Real-World Study

  • Takahito Sugase,
  • Takashi Kanemura,
  • Norihiro Matsuura,
  • Kei Yamamoto,
  • Yuki Ushimaru,
  • Yasunori Masuike,
  • Yoshitomo Yanagimoto,
  • Kazuyoshi Yamamoto,
  • Yoshihiro Sakano,
  • Ryota Mori,
  • Masatoshi Kitakaze,
  • Masahiko Kubo,
  • Yasunari Fukuda,
  • Hisateru Komatsu,
  • Masaaki Miyo,
  • Toshinori Sueda,
  • Yoshinori Kagawa,
  • Kunihito Gotoh,
  • Shogo Kobayashi,
  • Hiroshi Miyata

摘要

Background

Adjuvant nivolumab improves survival after esophageal cancer resection following neoadjuvant therapy; however, postoperative recurrence remains a major clinical challenge. This study investigated postoperative recurrence and identified the prognostic factors in patients receiving adjuvant nivolumab after esophagectomy.

Patients and Methods

This single-center retrospective study included 82 consecutive patients with locally advanced esophageal cancer who received adjuvant nivolumab after esophagectomy following preoperative therapy. Cox proportional hazards regression models were used to identify independent risk factors for postoperative recurrence.

Results

The cohort predominantly consisted of patients with esophageal squamous cell carcinoma treated with preoperative chemotherapy and minimally invasive esophagectomy, most of whom had pathological lymph node metastases. During a median follow-up of 30.6 months, 44 patients (54%) developed recurrence, and 30 (37%) developed recurrence during adjuvant nivolumab therapy. The median recurrence-free survival (RFS) was 30.8 months, with a 2-year RFS rate of 50.7% and an overall survival rate of 81.7%. Multivariable analysis identified poor response to preoperative therapy, ypN3 disease, pretreatment prognostic nutritional index (PNI) < 44, and absence of immune-related adverse events (irAEs) as independent risk factors for postoperative recurrence. Subgroup analyses demonstrated markedly lower 2-year RFS rates in patients with stable disease compared with those with complete response or partial response (27.3% vs. 61.8%), ypN3 compared with ypN1–2 (19.4% vs. 58.5%), PNI < 44 compared with ≥ 44 (24.2% vs. 57.8%), and non-irAEs compared with any irAEs (47.5% vs. 55.9%).

Conclusions

Tumor-related characteristics and host-related immune and nutritional factors were independently associated with the risk of recurrence after adjuvant nivolumab therapy.