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Aim <p>Nivolumab, approved for adjuvant therapy in resected esophageal cancer, is typically administered at 240&#xa0;mg every 2&#xa0;weeks (Q2W) or 480&#xa0;mg every 4&#xa0;weeks (Q4W). However, data on the 480&#xa0;mg Q4W regimen as an initial therapy are limited. In this study, we evaluated its safety and efficacy.</p> Methods <p>This prospective cohort study included 50 patients with pathologically confirmed lymph node metastases who underwent radical esophagectomy following preoperative therapy. All patients received at least one dose of nivolumab (480&#xa0;mg Q4W). The primary endpoint was the incidence of Grade 3 or higher nivolumab-related adverse events (AEs).</p> Results <p>Of the cohort, 88% (44/50) received preoperative chemotherapy. The pathological lymph node status was distributed as follows: ypN1 (42%), ypN2 (40%), and ypN3 (18%). A total of 26 patients (52%) completed one year of therapy. Therapy discontinuation occurred because of relapse (30%), nivolumab-related AEs (10%), or patient preference (8%). Nivolumab-related AEs occurred in 70% of the patients, with Grade 3 or higher AEs occurring in 8%. The most common AEs were skin-related reactions (30%), elevated aspartate aminotransferase levels (24%), fatigue (12%), hypothyroidism (12%), and hyperthyroidism (10%). The majority of AEs occurred during the first four cycles, whereas thyroid dysfunction, arthritis, and pulmonary AEs appeared even later. One- and two-year disease-free survival (DFS) rates were 78.0% and 52.2%, respectively. Patients aged &lt; 65&#xa0;years and those with ypN2 disease demonstrated better DFS.</p> Conclusion <p>Adjuvant nivolumab 480&#xa0;mg Q4W may represent a potential treatment option with a manageable safety profile and favorable short-term DFS.</p>

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Safety and short-term outcomes of adjuvant nivolumab therapy at 480 mg dose every four weeks in resected esophageal cancer: a prospective cohort study

  • 期刊论文

  • 发表日期：

    2025年6月8日

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  • Takahito Sugase,
  • Takashi Kanemura,
  • Norihiro Matsuura,
  • Tomohira Takeoka,
  • Yuki Ushimaru,
  • Yasunori Masuike,
  • Yoshitomo Yanagimoto,
  • Kazuyoshi Yamamoto,
  • Takeshi Omori,
  • Ryota Mori,
  • Masatoshi Kitakaze,
  • Masahiko Kubo,
  • Yosuke Mukai,
  • Hisateru Komatsu,
  • Toshinori Sueda,
  • Yoshinori Kagawa,
  • Hiroshi Wada,
  • Kunihito Goto,
  • Masayoshi Yasui,
  • Hiroshi Miyata

摘要

Aim

Nivolumab, approved for adjuvant therapy in resected esophageal cancer, is typically administered at 240 mg every 2 weeks (Q2W) or 480 mg every 4 weeks (Q4W). However, data on the 480 mg Q4W regimen as an initial therapy are limited. In this study, we evaluated its safety and efficacy.

Methods

This prospective cohort study included 50 patients with pathologically confirmed lymph node metastases who underwent radical esophagectomy following preoperative therapy. All patients received at least one dose of nivolumab (480 mg Q4W). The primary endpoint was the incidence of Grade 3 or higher nivolumab-related adverse events (AEs).

Results

Of the cohort, 88% (44/50) received preoperative chemotherapy. The pathological lymph node status was distributed as follows: ypN1 (42%), ypN2 (40%), and ypN3 (18%). A total of 26 patients (52%) completed one year of therapy. Therapy discontinuation occurred because of relapse (30%), nivolumab-related AEs (10%), or patient preference (8%). Nivolumab-related AEs occurred in 70% of the patients, with Grade 3 or higher AEs occurring in 8%. The most common AEs were skin-related reactions (30%), elevated aspartate aminotransferase levels (24%), fatigue (12%), hypothyroidism (12%), and hyperthyroidism (10%). The majority of AEs occurred during the first four cycles, whereas thyroid dysfunction, arthritis, and pulmonary AEs appeared even later. One- and two-year disease-free survival (DFS) rates were 78.0% and 52.2%, respectively. Patients aged < 65 years and those with ypN2 disease demonstrated better DFS.

Conclusion

Adjuvant nivolumab 480 mg Q4W may represent a potential treatment option with a manageable safety profile and favorable short-term DFS.