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Retrospective Study of Nivolumab Monotherapy Treatment Lines

2021 Year in Review - Gastrointestinal Cancer

Second-line or later nivolumab monotherapy yields no clear evidence of efficacy advantage for patients with advanced esophageal cancer.

Esophageal cancer is the seventh most common cancer type and the sixth most common cause of cancer mortality worldwide.1 In Western countries its incidence is low, but in certain regions in Africa and Asia it is a major health concern.1 There are 2 histological subtypes of esophageal cancer: adenocarcinoma and squamous-cell carcinoma (SCC), with SCC comprising 80% of all esophageal cancer cases.1 Treatment options for esophageal cancer are limited, and the prognosis is poor, with a 5-year survival rate for advanced SCC of 5%.1 Recent clinical trials have demonstrated that immunotherapy has proved to be efficacious in the treatment of SCC and has improved patient survival rates.1 Nivolumab is a PD-1 immune checkpoint inhibitor antibody that was evaluated in the ATTRACTION-1 and ATTRACTION-3 clinical trials as a treatment for patients with metastatic or recurrent esophageal cancer who became refractory or intolerant to fluoropyrimidine, taxane, and platinum-based chemotherapy.2,3 Since early 2020, nivolumab monotherapy has been used in Japan for the treatment of recurrent or metastatic esophageal cancer. Mikuni and colleagues performed a retrospective study on the use of nivolumab monotherapy for patients with advanced esophageal SCC to determine if treatment-line use affected the efficacy of nivolumab in clinical practice. The results of this study were presented at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

A retrospective review of medical records of 62 patients who had metastatic or recurrent esophageal SCC who received nivolumab monotherapy as second-, third-, or later-line treatment was performed. Overall survival, progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) were evaluated. There were 30 patients who received nivolumab monotherapy as second-line treatment, with a median age of 67 years (range, 33-80 years). Nivolumab monotherapy was the third- or later-line treatment for 32 patients. These patients had a median age of 61 years (range, 52-84 years). ORR evaluation for those patients receiving second-line treatment with nivolumab was 22.7% and 24.1% for those who received nivolumab as a third- or later-line treatment. DCR was 45.5% in the second-line treatment group and 44.8% in the third- or later-line treatment group. Both study groups had a median PFS of 2.3 months, with a range of 1.4 to 6.2 months for the second-line treatment group and a range of 1.2 to 3.6 months for the third- or later-line treatment group. Analysis of AEs determined the second-line treatment group had a 6.7% rate of grade ≥3 AEs and the third- or later-line treatment group had a 6.3% rate of grade ≥3 AEs.

There was no clear efficacy advantage between second-line or later-line treatment in this study.

Source: Mikuni H, Yamamoto S, Oshima K, et al. Retrospective study of nivolumab monotherapy for advanced esophageal squamous cell carcinoma. J Clin Oncol. 2021;39(suppl_3):179-179.


  1. Puhr HC, Preusser M, Ilhan-Mutlu A. Immunotherapy for esophageal cancers: what is practice changing in 2021? Cancers (Basel). 2021;13:4632.
  2. Guo L, Zhang H, Chen B. Nivolumab as programmed death-1 (PD-1) inhibitor for targeted immunotherapy in tumor. J Cancer. 2017;8:410-416.
  3. Kato K, Doki Y, Ura T, et al. Nivolumab in advanced esophageal squamous cell carcinoma (ATTRACTION-1/ONO-4538-07): minimum of five-year follow-up. J Clin Oncol. 2021;39(suppl_3):207-207.
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