DOI: 10.1093/dote/doad052.134 ISSN:


Hiromichi Miyagaki, Kentaro Nishida, Yukihiro Yoshikawa, Souichiro Mori, Masatoshi Nomura, Toshinori Sueda, Chikato Koga, Mitsuyoshi Tei, Masanori Tsujie, Yusuke Akamaru
  • Gastroenterology
  • General Medicine



The results of the Checkmate 648 trial have made nivolumab plus ipilimumab available in general practice as first-line treatment for advanced recurrent esophageal squamous cell carcinoma.

Unlike regimens that include chemotherapy, this regimen can be used in patients with renal dysfunction, and the Department’s policy is to use this regimen in elderly or renally impaired patients.

We report four patients with advanced or recurrent esophageal cancer treated with nivolumab plus ipilimumab by March 2023.


Reasons for selecting this regimen; renal dysfunction (4 cases), Disease stage II/IV/recurrent: 1/1/2 patients. Course of treatment: ≤2/≥3 courses: 2/2 pts, 2nd line treatment; FOLFOX for 2 patients, FOLFOX + RT for 1 patient, none for 1 patient.

Nivolumab(administered intravenously at a dose of 360 mg per body every3weeks) plus Ipilimumab(administered intravenously at a dose of 1 mg per kilogram every 6 week) were administrated to four patients.

Adverse events: liver dysfunction in 2 patients, interstitial pneumonia in 2 patients, adrenal insufficiency in 1 patient, rheumatoid arthritis in 1 patient, thyroid dysfunction in 1 patient. Best response: PR for 2, PD for 1, NE for 1 patient.

Patient 1: 86-year-old male, mid-thoracic esophageal cancer T3N0M0 Stage II. After 2 weeks administrated IPI + NIVO, elevations of serum liver enzymes were observed and irAE hepatitis was diagnosed by liver biopsy.

Patient 4: 60-year-old woman, lower thoracic esophageal cancer, T3N2M1 (LYM) Stage IVb. After 2 courses of IPI + NIVO, she developed general malaise and headache, she was diagnosed as irAE adrenal insufficiency and started corticosteroid administration. After the fourth course, a CT scan of the chest showed a frosted glass shadow in the left upper lobe of the lung, irAE interstitial pneumonia was developed, additionally. Steroid pulse therapy was started, and the treatment was switched to FOLFOX therapy.


The response rate was 50%, so the treatment was seemed promising, but irAEs were observed in many patients especially with hepatitis and interstitial pneumonia, and these adverse effect forced patient difficult to continue the treatment. We should be managed to accumulate more patients to evaluate occurrence of irAE.

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